Neoplasm, StomachPhase 1/2PA001NCT05587088
Evaluation of the Safety and Efficacy of Esperanza Extract (PA001)
A Phase 1/2 study testing Petiveria Alliacea Preparation in people with Neoplasm, Stomach and Gastric Neoplasms Malignant, run by Hospital Universitario San Ignacio at 1 site in Colombia.
Trial summary
This is a phase Ib/II clinical study that has two phases. In phase Ib, the safety evaluation of the extract of Petiveria alliacea (Esperanza) will be carried out in patients with metastatic gastrointestinal tumors (colon, pancreas, stomach, and biliary tract) and patients with newly diagnosed and relapsed acute… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Neoplasm, Stomach, Gastric Neoplasms Malignant, Pancreatic Neoplasms
- What is being tested?
- Petiveria Alliacea Preparation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 82 participants
- Where
- 1 siteColombia
- Study dates
- 15 Dec 2022to 15 Jun 2023
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must be over 18 years of age, with no upper age limit
- Histological diagnosis of gastrointestinal cancer may include stomach, colon, bile ducts, and pancreas.
- Measurable disease through diagnostic tests and who will receive chemotherapy as primary treatment for their disease.
- At least one discrete metastatic site identified
- ECOG scale status from 0 to 2 with survival more significant than two months.
- Subject can swallow and retain oral medication and does not have uncontrolled emesis or persistent diarrhea.
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- Adequate renal, hematological, hepatic, and cardiac function at the investigator's discretion.
- Without uncontrolled or significant comorbidities determined by clinical history, physical examination, and screening laboratories at the investigator's discretion.
- Patients of childbearing age and without safe non-hormonal planning methods must have a negative pregnancy test before the screening.
- Fertile female subjects (those who have not been postmenopausal for at least 12 months or are surgically sterile by bilateral tubal ligation, bilateral oophorectomy, or hysterectomy) and their male partners must use at least one of the contraceptive methods listed below during study entry, throughout the study, and for at least six months after use of the P2Et extract (the effects of the P2Et extract on the developing human fetus are unknown):
- Complete abstinence from sexual intercourse, beginning at least one complete menstrual cycle before administration of study drug; (It should be noted: sexual abstinence as a contraceptive method should be limited to those cases where it is already established as the patient's pre-existing lifestyle choice).
- Vasectomy in the partner of a female subject c. Intrauterine device (IUD) d. Double-barrier method (condom, contraceptive sponge, diaphragm, or vaginal ring with spermicidal jelly or cream).
- Desire to complete the study and follow-up interventions.
- Patients must be over 18 years of age, with no upper age limit
- Patients who have had a new diagnosis of acute myeloid leukemia (AML) or acute lymphoblastic leukemia (ALL) will be eligible for the study and are eligible for chemotherapy treatment.
- Patients must be newly diagnosed
- Patients must have failed initial therapy, which may manifest in any of the following ways:
- Demonstration of primary refractory disease (primary induction failure) as evidenced by mid-cycle bone marrow analysis showing lack of complete tumor clearance (CTC).
- Relapse of the initial disease after a period of achieving complete remission.
- Subject can swallow and retain oral medication and does not have uncontrolled emesis or persistent diarrhea.
- Adequate renal, hematological, and hepatic function at the investigator's discretion.
- Without uncontrolled or significant comorbidities determined by clinical history, physical examination, and screening laboratories at the investigator's discretion.
- Patients of childbearing age and without safe non-hormonal planning, methods must have a negative pregnancy test before the screening.
- Fertile female subjects (those who have not been postmenopausal for at least 12 months or are surgically sterile by bilateral tubal ligation, bilateral oophorectomy, or hysterectomy) and their male partners must use at least one of the contraceptive methods listed below. Listed below during study entry, throughout the study, and for at least six months after use of the P2Et extract (the effects of the P2Et extract on the developing human fetus are unknown):
- Complete abstinence from sexual intercourse, beginning at least one complete menstrual cycle before administration of study drug; (It should be noted: sexual abstinence as a contraceptive method should be limited to those cases where it is already established as the patient's pre-existing lifestyle choice).
- Vasectomy in the partner of a female subject c. Intrauterine device (IUD) d. Double-barrier method (condom, contraceptive sponge, diaphragm, or vaginal ring with spermicidal jelly or cream).
- Desire to complete the study and follow-up interventions.
Who cannot join
- The exclusion criteria apply to solid tumors as well as hematological tumors.
- Subjects with one or more conditions are not eligible for this study.
- Subjects treated in any other therapeutic clinical protocol 30 days prior to study entry or during study participation.
- Patients receiving other investigational agents.
- The female subject is pregnant or nursing. A negative serum or urine pregnancy test obtained at screening should confirm that the woman is not pregnant. Pregnancy tests are not required for postmenopausal or surgically sterilized women.
- Serious concomitant morbidity, active at the discretion of the investigator
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- Subjects with a confirmed diagnosis of HIV before enrollment or a positive diagnosis of HIV at the time of screening.
- Recipients of solid organ transplants.
- Any condition that, in the opinion of the principal investigator, makes the subject ineligible to participate in this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Safety and Efficacy of Esperanza Extract (Petiveria Alliacea) in Patients With Metastatic Gastrointestinal Tumors and Acute Leukemia
This is a phase Ib/II clinical study that has two phases. In phase Ib, the safety evaluation of the extract of Petiveria alliacea (Esperanza) will be carried out in patients with metastatic gastrointestinal tumors (colon, pancreas, stomach, and biliary tract) and patients with newly diagnosed and relapsed acute leukemia. In phase IIb, the safety will continue to be evaluated, and the efficacy of the Esperanza extract will be explored in combination with chemotherapy in patients with metastatic gastrointestinal tumors (colon, pancreas, stomach, and biliary tract) with newly diagnosed acute leukemias and relapses.
Read the detailed description
Anamú, Petiveria alliacea, has been used by traditional medicine to treat leukemia and breast cancer. However, its activity on tumor metabolism makes it a therapeutic candidate for many tumors with alterations in glycolytic metabolism, but also uses the mitochondria to produce energy.
Given the glycolytic nature of some tumor cells, the modulating activity of cell metabolism exerted by anamú extract may be partly responsible for the anti-tumor activity.
Previous reports show that some patients with ALL or AML whose response to treatment was evaluated in vitro are sensitive to a standardized extract of Petiveria alliacea. Even more interesting is the fact that when we treat the cells with allopathic therapy, explicitly established for each of these pathologies, the sensitivity of the blasts increases when they are treated concomitantly with the extract, which suggests that the intrinsic resistance of each one of tumor cells in the different tissues evaluated can be reduced by the action of the phytomedicine. The same thing was observed when spheres obtained from human breast cancer were co-treated with the anamú extract and anthracyclines. These observations allow to validate the traditional use of anamú in the treatment of some tumors, such as leukemia and breast cancer, among others. However, to observe the safety and effects on patients, it is necessary to develop a clinical study that would allow the anamú phytomedicine produced in the appropriate pharmaceutical conditions, to be included as a complementary therapy based on a standardized extract of the plant and that can overcome the resistance of tumor cells to conventional treatments, improving response and increasing overall survival of patients in Colombia.
Although the explosion of new therapies in solid tumors and hematological alterations is not so high, countries such as Germany, France, and Italy have used traditional medicine from which herbal pharmaceutical preparations are derived in the treatment of different types of diseases, including cancer. , estimating the use of these products between 30 and 75% of patients worldwide. These herbal products are mainly used to reduce allopathic therapies' side effects and organic toxicity, protect and stimulate the immune system, or prevent future neoplasms or their recurrence. Currently, various extracts from natural products are in clinical trials in the United States, and there is significant evidence about some plants' role in leukemia's evolution.
This is a phase Ib/II clinical study that has two phases. In phase Ib, the safety evaluation of the extract of Petiveria alliacea (Esperanza) will be carried out in patients with metastatic gastrointestinal tumors (colon, pancreas, stomach, and biliary tract) and patients with newly diagnosed and relapsed acute leukemia. In phase IIb, the safety will continue to be evaluated, and the efficacy of the Esperanza extract will be explored in combination with chemotherapy in patients with metastatic gastrointestinal tumors (colon, pancreas, stomach, and biliary tract) with newly diagnosed acute leukemias and relapses.
- Conditions
- Neoplasm, Stomach, Gastric Neoplasms Malignant, Pancreatic Neoplasms, Colorectal Neoplasms, Acute Leukemia, Acute Leukemia in Relapse
- Being tested
- Petiveria Alliacea Preparation, Placebo
- Medical subject headings
- Stomach Neoplasms, Pancreatic Neoplasms, Colorectal Neoplasms, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Petiveria Alliacea PreparationDrug
Petiveria Alliacea Preparation in pill
PlaceboDrug
Placebo in pill
| Study group | Role | What they receive |
|---|---|---|
| Metastatic gastrointestinal tumors and acute leukemia patients | Experimental | Patients with metastatic gastrointestinal tumors (colon, pancreas, stomach, and bile ducts) and newly diagnosed/relapse acute leukemias who meet the inclusion criteria will take the anamu extract with chemotherapy to evaluate the adverse drug-related side effects. Receives: Drug: Petiveria Alliacea Preparation |
| Stage II Metastatic gastrointestinal tumors including pancreas | Experimental | For solid metastatic tumors, 30 patients will be recruited, which can be from the colon, pancreas, stomach, and bile ducts, divided into two groups of 15 patients, an intervention group and a placebo group. The intervention group will receive the Esperanza extract at DMT for three continuous treatment cycles (approximately 12 weeks), and the other group will receive the placebo. Receives: Drug: Petiveria Alliacea Preparation |
| Stage II Placebo Metastatic gastrointestinal tumors including pancreas | Placebo comparator | For solid metastatic tumors, 30 patients will be recruited, which can be from the colon, pancreas, stomach, and bile ducts, divided into two groups of 15 patients, an intervention group and a placebo group. The intervention group will receive the Esperanza extract at DMT for three continuous treatment cycles (approximately 12 weeks), and the other group will receive the placebo. Both groups will receive standard chemotherapy treatment for their underlying disease. The safety evaluation will be carried out in each treatment cycle, and the efficacy evaluation will be carried out at the end of the three cycles. Receives: Drug: Placebo |
| Acute leukemia (Newly/Relapse) | Experimental | For newly diagnosed hematological tumors, 28 patients will be recruited and will receive the Esperanza extract at DMT. The intervention group will continuously receive the Esperanza extract at DMT for four weeks with the standard chemotherapy regimen for their underlying disease. The safety and efficacy evaluation will be carried out at the end of the treatment cycle.
Patients with relapsed or refractory acute leukemias will be admitted to receive the calculated DMT in phase Ib; A total of 6 patients will be recruited, and safety and efficacy evaluations will be performed during three treatment cycles or progression and death of the patient.
For the analysis of the response in patients with acute leukemia, a comparison will be made with a group followed historically. A propensity score matching will be performed for statistical analysis in case of differences in their baseline characteristics. Receives: Drug: Petiveria Alliacea Preparation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and efficacy
Evaluate the adverse drug reactions of cancer patients treated with anamú extract and chemotherapy through the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
Measured: 12 months
Secondary outcomes (3)
Quality of life in patients
Changes of at least 5 points above the difference between the groups of the functional scales of the patients evaluated using the EORTC QLQ-C-30 scale
Measured: 12 months
Tumor response
To determine the impact of treatment with Esperanza extract in combination with chemotherapy on the number and size of metastases.
Measured: 12 months
Survival
To determine event/progression-free survival in patients with metastatic gastrointestinal tumors (colon, pancreas, stomach, and bile ducts) and patients with newly diagnosed and relapsed acute leukemias.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2022
- Study start15 Dec 2022 (estimated)
- Primary completion15 Mar 2023 (estimated)
- Study completion15 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for Neoplasm, StomachStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- This is a phase Ib/II clinical study that has two phases. In phase Ib, the safety evaluation of the extract of Petiveria alliacea (Esperanza) will be carried out in patients with metastatic gastrointestinal tumors (colon, pancreas, stomach and biliary tract) and patients with newly diagnosed and relapsed acute leukemia. In phase IIb, the safety will continue to be evaluated and the efficacy of the Esperanza extract will be explored in combination with chemotherapy in patients with metastatic gastrointestinal tumors (colon, pancreas, stomach and biliary tract) and patients with newly diagnosed acute leukemias and relapses
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario San Ignacio
- Sponsor type
- University, hospital or other
- Collaborators
- Pontificia Universidad Javeriana
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05587088
- Sponsor's protocol ID
- PA001
- Acronym
- PA001
- Status last verified
- Oct 2022
- First submitted
- 13 Oct 2022
- Last updated
- 19 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Di Martino MT, Zazzeroni F, Donadelli M, Chiodoni C, Caraglia M, Scotlandi K, Meschini S, Leonetti C. Reprogramming Tumor-Immune Cell Interface in Solid and Hematological Malignancies to Enhance Response to Therapy. J Exp Clin Cancer Res. 2018 Mar 5;37(1):48. doi: 10.1186/s13046-018-0710-x. No abstract available.
PubMed 29506548Uruena C, Sandoval TA, Lasso P, Tawil M, Barreto A, Torregrosa L, Fiorentino S. Evaluation of chemotherapy and P2Et extract combination in ex-vivo derived tumor mammospheres from breast cancer patients. Sci Rep. 2020 Nov 12;10(1):19639. doi: 10.1038/s41598-020-76619-9.
PubMed 33184339Sharma SV, Lee DY, Li B, Quinlan MP, Takahashi F, Maheswaran S, McDermott U, Azizian N, Zou L, Fischbach MA, Wong KK, Brandstetter K, Wittner B, Ramaswamy S, Classon M, Settleman J. A chromatin-mediated reversible drug-tolerant state in cancer cell subpopulations. Cell. 2010 Apr 2;141(1):69-80. doi: 10.1016/j.cell.2010.02.027.
PubMed 20371346Bergers G, Fendt SM. The metabolism of cancer cells during metastasis. Nat Rev Cancer. 2021 Mar;21(3):162-180. doi: 10.1038/s41568-020-00320-2. Epub 2021 Jan 18.
PubMed 33462499Fong MY, Zhou W, Liu L, Alontaga AY, Chandra M, Ashby J, Chow A, O'Connor ST, Li S, Chin AR, Somlo G, Palomares M, Li Z, Tremblay JR, Tsuyada A, Sun G, Reid MA, Wu X, Swiderski P, Ren X, Shi Y, Kong M, Zhong W, Chen Y, Wang SE. Breast-cancer-secreted miR-122 reprograms glucose metabolism in premetastatic niche to promote metastasis. Nat Cell Biol. 2015 Feb;17(2):183-94. doi: 10.1038/ncb3094. Epub 2015 Jan 26.
PubMed 25621950Eddy RJ, Weidmann MD, Sharma VP, Condeelis JS. Tumor Cell Invadopodia: Invasive Protrusions that Orchestrate Metastasis. Trends Cell Biol. 2017 Aug;27(8):595-607. doi: 10.1016/j.tcb.2017.03.003. Epub 2017 Apr 12.
PubMed 28412099Kang X, Wang J, Li C. Exposing the Underlying Relationship of Cancer Metastasis to Metabolism and Epithelial-Mesenchymal Transitions. iScience. 2019 Nov 22;21:754-772. doi: 10.1016/j.isci.2019.10.060. Epub 2019 Oct 31.
PubMed 31739095Xian ZY, Liu JM, Chen QK, Chen HZ, Ye CJ, Xue J, Yang HQ, Li JL, Liu XF, Kuang SJ. Inhibition of LDHA suppresses tumor progression in prostate cancer. Tumour Biol. 2015 Sep;36(10):8093-100. doi: 10.1007/s13277-015-3540-x. Epub 2015 May 16.
PubMed 25983002Zhu J, Ma J, Wang X, Ma T, Zhang S, Wang W, Zhou X, Shi J. High Expression of PHGDH Predicts Poor Prognosis in Non-Small Cell Lung Cancer. Transl Oncol. 2016 Dec;9(6):592-599. doi: 10.1016/j.tranon.2016.08.003.
PubMed 27916294Butler LM, Perone Y, Dehairs J, Lupien LE, de Laat V, Talebi A, Loda M, Kinlaw WB, Swinnen JV. Lipids and cancer: Emerging roles in pathogenesis, diagnosis and therapeutic intervention. Adv Drug Deliv Rev. 2020;159:245-293. doi: 10.1016/j.addr.2020.07.013. Epub 2020 Jul 23.
PubMed 32711004Shah US, Dhir R, Gollin SM, Chandran UR, Lewis D, Acquafondata M, Pflug BR. Fatty acid synthase gene overexpression and copy number gain in prostate adenocarcinoma. Hum Pathol. 2006 Apr;37(4):401-9. doi: 10.1016/j.humpath.2005.11.022. Epub 2006 Feb 7.
PubMed 16564913Koundouros N, Poulogiannis G. Reprogramming of fatty acid metabolism in cancer. Br J Cancer. 2020 Jan;122(1):4-22. doi: 10.1038/s41416-019-0650-z. Epub 2019 Dec 10.
PubMed 31819192Itkonen HM, Brown M, Urbanucci A, Tredwell G, Ho Lau C, Barfeld S, Hart C, Guldvik IJ, Takhar M, Heemers HV, Erho N, Bloch K, Davicioni E, Derua R, Waelkens E, Mohler JL, Clarke N, Swinnen JV, Keun HC, Rekvig OP, Mills IG. Lipid degradation promotes prostate cancer cell survival. Oncotarget. 2017 Jun 13;8(24):38264-38275. doi: 10.18632/oncotarget.16123.
PubMed 28415728Zadra G, Photopoulos C, Tyekucheva S, Heidari P, Weng QP, Fedele G, Liu H, Scaglia N, Priolo C, Sicinska E, Mahmood U, Signoretti S, Birnberg N, Loda M. A novel direct activator of AMPK inhibits prostate cancer growth by blocking lipogenesis. EMBO Mol Med. 2014 Apr;6(4):519-38. doi: 10.1002/emmm.201302734. Epub 2014 Feb 4.
PubMed 24497570Song K, Li M, Xu X, Xuan LI, Huang G, Liu Q. Resistance to chemotherapy is associated with altered glucose metabolism in acute myeloid leukemia. Oncol Lett. 2016 Jul;12(1):334-342. doi: 10.3892/ol.2016.4600. Epub 2016 May 17.
PubMed 27347147
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety and Efficacy of Esperanza Extract (Petiveria Alliacea) in Patients With Metastatic Gastrointestinal Tumors and Acute Leukemia
- ClinicalTrials.gov ID
- NCT05587088
- Acronym / sponsor ID
- PA001 / PA001
- Conditions
- Neoplasm, Stomach, Gastric Neoplasms Malignant, Pancreatic Neoplasms, Colorectal Neoplasms, Acute Leukemia, Acute Leukemia in Relapse
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Hospital Universitario San IgnacioUniversity, hospital or other
- Collaborators
- Pontificia Universidad Javeriana
- Study start
- 15 Dec 2022 (estimated)
- Primary completion
- 15 Mar 2023 (estimated)
- Study completion
- 15 Jun 2023 (estimated)
- First posted
- 19 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase Ib/II clinical study that has two phases. In phase Ib, the safety evaluation of the extract of Petiveria alliacea (Esperanza) will be carried out in patients with metastatic gastrointestinal tumors (colon, pancreas, stomach, and biliary tract) and patients with newly diagnosed and relapsed acute leukemia. In phase IIb, the safety will continue to be evaluated, and the efficacy of the Esperanza extract will be explored in combination with chemotherapy in patients with metastatic gastrointestinal tumors (colon, pancreas, stomach, and biliary tract) with newly diagnosed acute leukemias and relapses.
Detailed description
Anamú, Petiveria alliacea, has been used by traditional medicine to treat leukemia and breast cancer. However, its activity on tumor metabolism makes it a therapeutic candidate for many tumors with alterations in glycolytic metabolism, but also uses the mitochondria to produce energy.
Given the glycolytic nature of some tumor cells, the modulating activity of cell metabolism exerted by anamú extract may be partly responsible for the anti-tumor activity.
Previous reports show that some patients with ALL or AML whose response to treatment was evaluated in vitro are sensitive to a standardized extract of Petiveria alliacea. Even more interesting is the fact that when we treat the cells with allopathic therapy, explicitly established for each of these pathologies, the sensitivity of the blasts increases when they are treated concomitantly with the extract, which suggests that the intrinsic resistance of each one of tumor cells in the different tissues evaluated can be reduced by the action of the phytomedicine. The same thing was observed when spheres obtained from human breast cancer were co-treated with the anamú extract and anthracyclines. These observations allow to validate the traditional use of anamú in the treatment of some tumors, such as leukemia and breast cancer, among others. However, to observe the safety and effects on patients, it is necessary to develop a clinical study that would allow the anamú phytomedicine produced in the appropriate pharmaceutical conditions, to be included as a complementary therapy based on a standardized extract of the plant and that can overcome the resistance of tumor cells to conventional treatments, improving response and increasing overall survival of patients in Colombia.
Although the explosion of new therapies in solid tumors and hematological alterations is not so high, countries such as Germany, France, and Italy have used traditional medicine from which herbal pharmaceutical preparations are derived in the treatment of different types of diseases, including cancer. , estimating the use of these products between 30 and 75% of patients worldwide. These herbal products are mainly used to reduce allopathic therapies' side effects and organic toxicity, protect and stimulate the immune system, or prevent future neoplasms or their recurrence. Currently, various extracts from natural products are in clinical trials in the United States, and there is significant evidence about some plants' role in leukemia's evolution.
This is a phase Ib/II clinical study that has two phases. In phase Ib, the safety evaluation of the extract of Petiveria alliacea (Esperanza) will be carried out in patients with metastatic gastrointestinal tumors (colon, pancreas, stomach, and biliary tract) and patients with newly diagnosed and relapsed acute leukemia. In phase IIb, the safety will continue to be evaluated, and the efficacy of the Esperanza extract will be explored in combination with chemotherapy in patients with metastatic gastrointestinal tumors (colon, pancreas, stomach, and biliary tract) with newly diagnosed acute leukemias and relapses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
- Model description
- This is a phase Ib/II clinical study that has two phases. In phase Ib, the safety evaluation of the extract of Petiveria alliacea (Esperanza) will be carried out in patients with metastatic gastrointestinal tumors (colon, pancreas, stomach and biliary tract) and patients with newly diagnosed and relapsed acute leukemia. In phase IIb, the safety will continue to be evaluated and the efficacy of the Esperanza extract will be explored in combination with chemotherapy in patients with metastatic gastrointestinal tumors (colon, pancreas, stomach and biliary tract) and patients with newly diagnosed acute leukemias and relapses
| Arm | Type | Receives |
|---|---|---|
| Metastatic gastrointestinal tumors and acute leukemia patients | Experimental | Drug: Petiveria Alliacea PreparationPatients with metastatic gastrointestinal tumors (colon, pancreas, stomach, and bile ducts) and newly diagnosed/relapse acute leukemias who meet the inclusion criteria will take the anamu extract with chemotherapy to evaluate the adverse drug-related side effects. |
| Stage II Metastatic gastrointestinal tumors including pancreas | Experimental | Drug: Petiveria Alliacea PreparationFor solid metastatic tumors, 30 patients will be recruited, which can be from the colon, pancreas, stomach, and bile ducts, divided into two groups of 15 patients, an intervention group and a placebo group. The intervention group will receive the Esperanza extract at DMT for three continuous treatment cycles (approximately 12 weeks), and the other group will receive the placebo. |
| Stage II Placebo Metastatic gastrointestinal tumors including pancreas | Placebo comparator | Drug: PlaceboFor solid metastatic tumors, 30 patients will be recruited, which can be from the colon, pancreas, stomach, and bile ducts, divided into two groups of 15 patients, an intervention group and a placebo group. The intervention group will receive the Esperanza extract at DMT for three continuous treatment cycles (approximately 12 weeks), and the other group will receive the placebo. Both groups will receive standard chemotherapy treatment for their underlying disease. The safety evaluation will be carried out in each treatment cycle, and the efficacy evaluation will be carried out at the end of the three cycles. |
| Acute leukemia (Newly/Relapse) | Experimental | Drug: Petiveria Alliacea PreparationFor newly diagnosed hematological tumors, 28 patients will be recruited and will receive the Esperanza extract at DMT. The intervention group will continuously receive the Esperanza extract at DMT for four weeks with the standard chemotherapy regimen for their underlying disease. The safety and efficacy evaluation will be carried out at the end of the treatment cycle. Patients with relapsed or refractory acute leukemias will be admitted to receive the calculated DMT in phase Ib; A total of 6 patients will be recruited, and safety and efficacy evaluations will be performed during three treatment cycles or progression and death of the patient. For the analysis of the response in patients with acute leukemia, a comparison will be made with a group followed historically. A propensity score matching will be performed for statistical analysis in case of differences in their baseline characteristics. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (27 listed)
- Patients must be over 18 years of age, with no upper age limit
- Histological diagnosis of gastrointestinal cancer may include stomach, colon, bile ducts, and pancreas.
- Measurable disease through diagnostic tests and who will receive chemotherapy as primary treatment for their disease.
- At least one discrete metastatic site identified
- ECOG scale status from 0 to 2 with survival more significant than two months.
Key exclusion criteria (9 listed)
- The exclusion criteria apply to solid tumors as well as hematological tumors.
- Subjects with one or more conditions are not eligible for this study.
- Subjects treated in any other therapeutic clinical protocol 30 days prior to study entry or during study participation.
- Patients receiving other investigational agents.
- The female subject is pregnant or nursing. A negative serum or urine pregnancy test obtained at screening should confirm that the woman is not pregnant. Pregnancy tests are not required for postmenopausal or surgically sterilized women.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Petiveria Alliacea PreparationPetiveria Alliacea Preparation in pill | Drug | Acute leukemia (Newly/Relapse), Metastatic gastrointestinal tumors and acute leukemia patients, Stage II Metastatic gastrointestinal tumors including pancreas |
| PlaceboPlacebo in pill | Drug | Stage II Placebo Metastatic gastrointestinal tumors including pancreas |
Primary outcome
Safety and efficacy
Time frame: 12 months
Evaluate the adverse drug reactions of cancer patients treated with anamú extract and chemotherapy through the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
3 secondary outcomes
Quality of life in patients
Time frame: 12 months
Tumor response
Time frame: 12 months
Survival
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2022.
- Results publication: PubMed 29506548Di Martino MT, Zazzeroni F, Donadelli M, Chiodoni C, Caraglia M, Scotlandi K, Meschini S, Leonetti C. Reprogramming Tumor-Immune Cell Interface in Solid and Hematological Malignancies to Enhance Response to Therapy. J Exp Clin Cancer Res. 2018 Mar 5;37(1):48. doi: 10.1186/s13046-018-0710-x. No abstract available.
- Results publication: PubMed 33184339Uruena C, Sandoval TA, Lasso P, Tawil M, Barreto A, Torregrosa L, Fiorentino S. Evaluation of chemotherapy and P2Et extract combination in ex-vivo derived tumor mammospheres from breast cancer patients. Sci Rep. 2020 Nov 12;10(1):19639. doi: 10.1038/s41598-020-76619-9.
- Results publication: PubMed 20371346Sharma SV, Lee DY, Li B, Quinlan MP, Takahashi F, Maheswaran S, McDermott U, Azizian N, Zou L, Fischbach MA, Wong KK, Brandstetter K, Wittner B, Ramaswamy S, Classon M, Settleman J. A chromatin-mediated reversible drug-tolerant state in cancer cell subpopulations. Cell. 2010 Apr 2;141(1):69-80. doi: 10.1016/j.cell.2010.02.027.
- Results publication: PubMed 33462499Bergers G, Fendt SM. The metabolism of cancer cells during metastasis. Nat Rev Cancer. 2021 Mar;21(3):162-180. doi: 10.1038/s41568-020-00320-2. Epub 2021 Jan 18.
- Results publication: PubMed 25621950Fong MY, Zhou W, Liu L, Alontaga AY, Chandra M, Ashby J, Chow A, O'Connor ST, Li S, Chin AR, Somlo G, Palomares M, Li Z, Tremblay JR, Tsuyada A, Sun G, Reid MA, Wu X, Swiderski P, Ren X, Shi Y, Kong M, Zhong W, Chen Y, Wang SE. Breast-cancer-secreted miR-122 reprograms glucose metabolism in premetastatic niche to promote metastasis. Nat Cell Biol. 2015 Feb;17(2):183-94. doi: 10.1038/ncb3094. Epub 2015 Jan 26.
- Results publication: PubMed 28412099Eddy RJ, Weidmann MD, Sharma VP, Condeelis JS. Tumor Cell Invadopodia: Invasive Protrusions that Orchestrate Metastasis. Trends Cell Biol. 2017 Aug;27(8):595-607. doi: 10.1016/j.tcb.2017.03.003. Epub 2017 Apr 12.
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- Results publication: PubMed 31819192Koundouros N, Poulogiannis G. Reprogramming of fatty acid metabolism in cancer. Br J Cancer. 2020 Jan;122(1):4-22. doi: 10.1038/s41416-019-0650-z. Epub 2019 Dec 10.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Petiveria Alliacea Preparation in people with Neoplasm, Stomach and Gastric Neoplasms Malignant, run by Hospital Universitario San Ignacio at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 27 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and efficacy (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05587088, which also lists 25 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2022.