CancerPhase 1NCT04729205
Assessment of Safety and Therapeutic Efficacy of Promitil in Combination With Folfox in Patients With GI Malignancies
A Phase 1 study testing Promitil in people with Cancer and Gastro-Intestinal Intraepithelial Neoplasia, run by Lipomedix Pharmaceuticals Inc. at 1 site in Israel.
Trial summary
This single center, Phase 1b, prospective, dose limiting toxicity (DLT)-clearing study, will assess the safety and efficacy of intravenously administered PROMITIL in combination with FOLFOX in cancer patients with inoperable, locally advanced or metastatic GI solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Gastro-Intestinal Intraepithelial Neoplasia
- What is being tested?
- Promitil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteIsrael
- Study dates
- 13 Jan 2021to 12 Sep 2023
- Phase
- Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with histologically or cytologically confirmed diagnoses of GI malignancies, deemed incurable (inoperable and locally advanced or metastatic), and X-ray computed tomography (CT)-evaluable (measurable or non-measurable) disease, with or without contrast enhancement
- Patients must have one the following carcinomas (including adenocarcinomas, signet ring cell, and mucinous carcinomas) to be eligible to be included in the study:
- Esophagus (non-squamous) and GE junction
- Stomach
- Hepatocellular carcinoma
- Pancreas (exocrine) and ampulla
Show all 25Show fewer
- Cholangiocarcinoma (intra-hepatic)
- Bile ducts and gall bladder
- Small bowel
- Large bowel
- Rectum
- Age 18-year or older
- ECOG Performance Status ≤ 2
- Estimated life expectancy of at least 3 months
- Adequate bone marrow function (absolute neutrophil count ≥1500/mm3, hemoglobin ≥9.5 g/dl, and a platelet count ≥100,000/mm3
- Adequate liver function (serum bilirubin ≤2.0 mg/100 ml; alanine aminotransferase ≤3× upper limit of normal [ULN], albumin ≥30 g/L, normal INR of prothrombin time (unless on coumadin treatment)
- Adequate renal function (serum creatinine ≤1.5 mg/100 ml or creatinine clearance ≥45 ml/min/1.73m2).
- A ≥21-day treatment-free interval from chemotherapeutic treatment, with the exception of 5-FU, capecitabine and biological therapies, where ≥14-day treatment-free intervals suffice.
- No other myelosuppressive treatment within 4 weeks of initiation of the study drug.
- No prior intravenous treatment with mitomycin-C, either alone or in combination
- No prior oxaliplatin treatment for inoperable locally advanced or metastatic disease
- A ≥6-month treatment-free interval from oxaliplatin, if given as adjuvant therapy or as neoadjuvant therapy for potentially operable disease
- No prior extensive radiotherapy (e.g., whole pelvis, total neuroaxis or greater than 50% of neuroaxis, whole abdomen, whole body or half body) or bone marrow transplantation with high-dose chemotherapy and/or total body irradiation.
- Women of child-bearing potential must be practicing an acceptable method of birth control.
- Understanding of study procedures and willingness to comply throughout the entire course of the study and to provide written informed consent
Who cannot join
- Patients with squamous cell cancer, stromal tumor, sarcoma, neuroendocrine tumor
- Known hypersensitivity to the study drugs or to any of their components
- Cirrhosis (Child-Pugh Class C score)
- Serum albumin level < 3.0 g/dl
- Any other severe concurrent disease, which in the judgment of the investigator, would make the subject inappropriate for entry into this study
- History of human immunodeficiency virus (HIV) infection
Show all 14Show fewer
- History of chronic active hepatitis, including subjects who are carriers of hepatitis B virus (HBV) or hepatitis C virus (HCV).
- Uncontrolled diabetes: HgbA1C≥7.5%,
- Presence of uncontrolled infection
- Evidence of active bleeding or bleeding diathesis
- Untreated (no surgery, no radiation) brain metastases, whether patient is symptomatic or asymptomatic. Patients with brain metastases treated by surgery or radiation who are stable and symptom-free requiring ≤4 mg dexamethasone/day, are eligible.
- Pregnant or lactating women
- Treatment with other investigational non-myelosuppressive drugs within 14 days of start of the study drug, and/or with myelosuppressive agents within 28 days of start of the study drug.
- Uncontrolled ascites (defined as 2 or more palliative taps within 30 days of screening
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Phase 1B Study for Assessment of Safety and Therapeutic Efficacy of Promitil in Combination With Oxaliplatin-based Chemotherapy in Patients With Gastro-intestinal Malignancies
This single center, Phase 1b, prospective, dose limiting toxicity (DLT)-clearing study, will assess the safety and efficacy of intravenously administered PROMITIL in combination with FOLFOX in cancer patients with inoperable, locally advanced or metastatic GI solid tumors.
Based on previous clinical results, we hypothesized that the addition of PROMITIL to FOLFOX, a treatment protocol consisting of oxaliplatin and fluoropyrimidine and commonly used to treat gastrointestinal (GI) malignancies, may enhance the overall efficacy of this combination regimen while maintain a reasonable safety profile.
Read the detailed description
Each patient will undergo screening, conducted up to 21 days before start of treatment, and receive 3 cycles of PROMITIL treatment, administered at four-week intervals, in combination with FOLFOX, administered at two-week intervals. Thereafter, patients may continue treatment with FOLFOX only, or with another regime at the investigator's discretion and will be followed up until death. Patients will be successively assigned, in order of accrual, to be concomitantly treated with PROMITIL and FOLFOX, at doses of PROMITIL meant to clear a dose of this combination treatment from DLT. Six patients will be treated with an initial DLT-clearing dose (Cohort 1). PROMITIL dose escalation from Cohort 1 to Cohort 2 will be authorized after 5 or 6 Cohort 1 patients complete their first two cycles of combination treatment with up to 1 DLT event reported for all 6 treated patients. If 2 or more Cohort 1 patients suffer from a DLT event in the first two cycles of treatment, 6 patients will be enrolled to Cohort -1 and treated with one dose level lower of PROMITIL. If 2 or more DLT events occur in Cohorts 2 or -1, the study will be discontinued for these patients and only patients in Cohort 1 will complete the study as planned. In any case, the total number of evaluable patients in the DLT-clearing phase will be no more than 12.
- Being tested
- Promitil
- Keywords
- Solid tumors, metastatic, locally advanced, inoperable
- Medical subject headings
- Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PromitilDrug
Also called Pegylated Liposomal Mitomycin-C Lipid-based Prodrug, Folfox
The first 6 patients recruited to the study will receive 1.6 mg/kg Promitil. Dose escalation to cohort 2 (PROMITIL dose of 2mg/kg) will be authorized after 5 or 6 patients of cohort 1 have completed the second cycle with DLT detected in fewer than two patients. If ≥2 patients of Cohort 1 develop DLT, dose escalation will be halted and Cohort -1 (PROMITIL dose of 1.2 mg/kg) will be opened. Should ≥2 patients in Cohort -1 or Cohort 2 experience DLT events, the study will be discontinued. In parallel, on days 1 and 15 of each cycle, patients will be treated with the mFOLFOX6 regime, which involves concurrent treatment with oxaliplatin 85 mg/m2 IV and leucovorin 200 mg/m2 IV, immediately followed by 5-FU 400 mg/m2 IV bolus, and then continuous infusion of 5-FU 1200 mg/m2/day, for 2 days (46-48 h).
| Study group | Role | What they receive |
|---|---|---|
| Promitil 1.6 mg/kg | Experimental | PROMITIL (1.6 mg/kg body weight) will be intravenously (IV) administered on the first day of three 28-day cycles. On days 1 and 15 of each PROMITIL cycle, patients will be treated with the mFOLFOX6 regimen, which includes concurrent treatment with oxaliplatin 85 mg/m2 IV and leucovorin 200 mg/m2 IV, immediately followed by 5-FU 400 mg/m2 IV bolus, and then continuous infusion of 5-FU 1200 mg/m2/day, for 2 days (46-48 h Receives: Drug: Promitil |
| Promitil 2.0 mg/kg | Experimental | PROMITIL (2.0 mg/kg body weight) will be intravenously (IV) administered on the first day of three 28-day cycles. On days 1 and 15 of each PROMITIL cycle, patients will be treated with the mFOLFOX6 regimen, which includes concurrent treatment with oxaliplatin 85 mg/m2 IV and leucovorin 200 mg/m2 IV, immediately followed by 5-FU 400 mg/m2 IV bolus, and then continuous infusion of 5-FU 1200 mg/m2/day, for 2 days (46-48 h Receives: Drug: Promitil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events
The incidence FOLFOX and characteristics of adverse events associated with the PROMITIL-combination treatment
Measured: 12 weeks
Report Dose limiting toxicity (DLT)
Dose clearance of PROMITIL in combination therapy with FOLFOX at week 8
Measured: 8 weeks
Evaluate Disease Control Rate
Disease control rate (complete response [CR] + partial response [PR]+ stable disease [SD]), according to RECIST 1.1 criteria, at 11-12 weeks
Measured: 12 weeks
Secondary outcomes (3)
Measurement of Progression free survival (PFS)
Progression free survival (PFS), measured in weeks from time of first dose of PROMITIL until PD
Measured: 24 weeks
Measure Overall survival
Overall survival, measured in weeks from start of study treatment until death due to any cause
Measured: 52 weeks
Plasma MLP level after Promitil infusion
Pharmacokinetic of PROMITIL when administered along with FOLFOX, as measured in cycles 1 and 3
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2021
- Study start13 Jan 2021
- Primary completion10 Sep 2023
- Study completion12 Sep 2023
Why it stopped: Investigational drug not available
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for CancerStudies 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- There will be up to two cohorts, with six subjects per cohort. Eligible subjects will be consecutively assigned, in order of accrual, to receive three cycles of PROMITIL-FOLFOX treatment. Dosing regimens will begin with cohort 1 (PROMITIL dose of 1.6 mg/kg).Dose limiting toxicity (DLT) for the combination treatment will be considered cleared if fewer than two patients per cohort experience DLT events during the first two cycles of treatment. Dose escalation to cohort 2 (PROMITIL dose of 2mg/kg) will be authorized after 5 or 6 patients of cohort 1 have completed the second cycle with DLT detected in fewer than two patients. If ≥2 patients of Cohort 1 develop DLT, dose escalation will be halted and Cohort -1 (PROMITIL dose of 1.2 mg/kg) will be opened. Should ≥2 patients in Cohort -1 or Cohort 2 experience DLT events, the study will be discontinued.
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lipomedix Pharmaceuticals Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Esther Tahover, MD, Principal investigator, Shaare Zedek Medica Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04729205
- Sponsor's protocol ID
- PROMIFOX
- Status last verified
- Sep 2023
- First submitted
- 24 Jan 2021
- Last updated
- 14 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gabizon A, Shmeeda H, Tahover E, Kornev G, Patil Y, Amitay Y, Ohana P, Sapir E, Zalipsky S. Development of Promitil(R), a lipidic prodrug of mitomycin c in PEGylated liposomes: From bench to bedside. Adv Drug Deliv Rev. 2020;154-155:13-26. doi: 10.1016/j.addr.2020.07.027. Epub 2020 Aug 7.
PubMed 32777239Amitay Y, Shmeeda H, Patil Y, Gorin J, Tzemach D, Mak L, Ohana P, Gabizon A. Pharmacologic Studies of a Prodrug of Mitomycin C in Pegylated Liposomes (Promitil((R))): High Stability in Plasma and Rapid Thiolytic Prodrug Activation in Tissues. Pharm Res. 2016 Mar;33(3):686-700. doi: 10.1007/s11095-015-1819-7. Epub 2015 Nov 16.
PubMed 26572644Gabizon AA, Tahover E, Golan T, Geva R, Perets R, Amitay Y, Shmeeda H, Ohana P. Pharmacokinetics of mitomycin-c lipidic prodrug entrapped in liposomes and clinical correlations in metastatic colorectal cancer patients. Invest New Drugs. 2020 Oct;38(5):1411-1420. doi: 10.1007/s10637-020-00897-3. Epub 2020 Jan 18.
PubMed 31955309Golan T, Grenader T, Ohana P, Amitay Y, Shmeeda H, La-Beck NM, Tahover E, Berger R, Gabizon AA. Pegylated liposomal mitomycin C prodrug enhances tolerance of mitomycin C: a phase 1 study in advanced solid tumor patients. Cancer Med. 2015 Oct;4(10):1472-83. doi: 10.1002/cam4.491. Epub 2015 Jul 14.
PubMed 26172205
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Phase 1B Study for Assessment of Safety and Therapeutic Efficacy of Promitil in Combination With Oxaliplatin-based Chemotherapy in Patients With Gastro-intestinal Malignancies
- ClinicalTrials.gov ID
- NCT04729205
- Acronym / sponsor ID
- PROMIFOX
- Keywords
- Solid tumors, metastatic, locally advanced, inoperable
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Investigational drug not available
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Lipomedix Pharmaceuticals Inc.Industry (pharma, biotech, devices)
- Study start
- 13 Jan 2021 (actual)
- Primary completion
- 10 Sep 2023 (actual)
- Study completion
- 12 Sep 2023 (actual)
- First posted
- 28 Jan 2021 (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 single center, Phase 1b, prospective, dose limiting toxicity (DLT)-clearing study, will assess the safety and efficacy of intravenously administered PROMITIL in combination with FOLFOX in cancer patients with inoperable, locally advanced or metastatic GI solid tumors.
Based on previous clinical results, we hypothesized that the addition of PROMITIL to FOLFOX, a treatment protocol consisting of oxaliplatin and fluoropyrimidine and commonly used to treat gastrointestinal (GI) malignancies, may enhance the overall efficacy of this combination regimen while maintain a reasonable safety profile.
Detailed description
Each patient will undergo screening, conducted up to 21 days before start of treatment, and receive 3 cycles of PROMITIL treatment, administered at four-week intervals, in combination with FOLFOX, administered at two-week intervals. Thereafter, patients may continue treatment with FOLFOX only, or with another regime at the investigator's discretion and will be followed up until death. Patients will be successively assigned, in order of accrual, to be concomitantly treated with PROMITIL and FOLFOX, at doses of PROMITIL meant to clear a dose of this combination treatment from DLT. Six patients will be treated with an initial DLT-clearing dose (Cohort 1). PROMITIL dose escalation from Cohort 1 to Cohort 2 will be authorized after 5 or 6 Cohort 1 patients complete their first two cycles of combination treatment with up to 1 DLT event reported for all 6 treated patients. If 2 or more Cohort 1 patients suffer from a DLT event in the first two cycles of treatment, 6 patients will be enrolled to Cohort -1 and treated with one dose level lower of PROMITIL. If 2 or more DLT events occur in Cohorts 2 or -1, the study will be discontinued for these patients and only patients in Cohort 1 will complete the study as planned. In any case, the total number of evaluable patients in the DLT-clearing phase will be no more than 12.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- There will be up to two cohorts, with six subjects per cohort. Eligible subjects will be consecutively assigned, in order of accrual, to receive three cycles of PROMITIL-FOLFOX treatment. Dosing regimens will begin with cohort 1 (PROMITIL dose of 1.6 mg/kg).Dose limiting toxicity (DLT) for the combination treatment will be considered cleared if fewer than two patients per cohort experience DLT events during the first two cycles of treatment. Dose escalation to cohort 2 (PROMITIL dose of 2mg/kg) will be authorized after 5 or 6 patients of cohort 1 have completed the second cycle with DLT detected in fewer than two patients. If ≥2 patients of Cohort 1 develop DLT, dose escalation will be halted and Cohort -1 (PROMITIL dose of 1.2 mg/kg) will be opened. Should ≥2 patients in Cohort -1 or Cohort 2 experience DLT events, the study will be discontinued.
| Arm | Type | Receives |
|---|---|---|
| Promitil 1.6 mg/kg | Experimental | Drug: PromitilPROMITIL (1.6 mg/kg body weight) will be intravenously (IV) administered on the first day of three 28-day cycles. On days 1 and 15 of each PROMITIL cycle, patients will be treated with the mFOLFOX6 regimen, which includes concurrent treatment with oxaliplatin 85 mg/m2 IV and leucovorin 200 mg/m2 IV, immediately followed by 5-FU 400 mg/m2 IV bolus, and then continuous infusion of 5-FU 1200 mg/m2/day, for 2 days (46-48 h |
| Promitil 2.0 mg/kg | Experimental | Drug: PromitilPROMITIL (2.0 mg/kg body weight) will be intravenously (IV) administered on the first day of three 28-day cycles. On days 1 and 15 of each PROMITIL cycle, patients will be treated with the mFOLFOX6 regimen, which includes concurrent treatment with oxaliplatin 85 mg/m2 IV and leucovorin 200 mg/m2 IV, immediately followed by 5-FU 400 mg/m2 IV bolus, and then continuous infusion of 5-FU 1200 mg/m2/day, for 2 days (46-48 h |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- Patients with histologically or cytologically confirmed diagnoses of GI malignancies, deemed incurable (inoperable and locally advanced or metastatic), and X-ray computed tomography (CT)-evaluable (measurable or non-measurable) disease, with or without contrast enhancement
- Patients must have one the following carcinomas (including adenocarcinomas, signet ring cell, and mucinous carcinomas) to be eligible to be included in the study:
- Age 18-year or older
- ECOG Performance Status ≤ 2
- Estimated life expectancy of at least 3 months
Key exclusion criteria (14 listed)
- Patients with squamous cell cancer, stromal tumor, sarcoma, neuroendocrine tumor
- Known hypersensitivity to the study drugs or to any of their components
- Cirrhosis (Child-Pugh Class C score)
- Serum albumin level < 3.0 g/dl
- Any other severe concurrent disease, which in the judgment of the investigator, would make the subject inappropriate for entry into this study
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 |
|---|---|---|
| PromitilAlso: Pegylated Liposomal Mitomycin-C Lipid-based Prodrug, FolfoxThe first 6 patients recruited to the study will receive 1.6 mg/kg Promitil. Dose escalation to cohort 2 (PROMITIL dose of 2mg/kg) will be authorized after 5 or 6 patients of cohort 1 have completed the second cycle with DLT detected in fewer than two patients. If ≥2 patients of Cohort 1 develop DLT, dose escalation will be halted and Cohort -1 (PROMITIL dose of 1.2 mg/kg) will be opened. Should ≥2 patients in Cohort -1 or Cohort 2 experience DLT events, the study will be discontinued. In parallel, on days 1 and 15 of each cycle, patients will be treated with the mFOLFOX6 regime, which involves concurrent treatment with oxaliplatin 85 mg/m2 IV and leucovorin 200 mg/m2 IV, immediately followed by 5-FU 400 mg/m2 IV bolus, and then continuous infusion of 5-FU 1200 mg/m2/day, for 2 days (46-48 h). | Drug | Promitil 1.6 mg/kg, Promitil 2.0 mg/kg |
Primary outcome
Incidence of Treatment-Emergent Adverse Events
Time frame: 12 weeks
The incidence FOLFOX and characteristics of adverse events associated with the PROMITIL-combination treatment
Report Dose limiting toxicity (DLT)
Time frame: 8 weeks
Dose clearance of PROMITIL in combination therapy with FOLFOX at week 8
Evaluate Disease Control Rate
Time frame: 12 weeks
Disease control rate (complete response [CR] + partial response [PR]+ stable disease [SD]), according to RECIST 1.1 criteria, at 11-12 weeks
3 secondary outcomes
Measurement of Progression free survival (PFS)
Time frame: 24 weeks
Measure Overall survival
Time frame: 52 weeks
Plasma MLP level after Promitil infusion
Time frame: 10 weeks
Results and safety
The study was stopped early (reason given: Investigational drug not available). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2023.
- Background: PubMed 32777239Gabizon A, Shmeeda H, Tahover E, Kornev G, Patil Y, Amitay Y, Ohana P, Sapir E, Zalipsky S. Development of Promitil(R), a lipidic prodrug of mitomycin c in PEGylated liposomes: From bench to bedside. Adv Drug Deliv Rev. 2020;154-155:13-26. doi: 10.1016/j.addr.2020.07.027. Epub 2020 Aug 7.
- Background: PubMed 26572644Amitay Y, Shmeeda H, Patil Y, Gorin J, Tzemach D, Mak L, Ohana P, Gabizon A. Pharmacologic Studies of a Prodrug of Mitomycin C in Pegylated Liposomes (Promitil((R))): High Stability in Plasma and Rapid Thiolytic Prodrug Activation in Tissues. Pharm Res. 2016 Mar;33(3):686-700. doi: 10.1007/s11095-015-1819-7. Epub 2015 Nov 16.
- Results publication: PubMed 31955309Gabizon AA, Tahover E, Golan T, Geva R, Perets R, Amitay Y, Shmeeda H, Ohana P. Pharmacokinetics of mitomycin-c lipidic prodrug entrapped in liposomes and clinical correlations in metastatic colorectal cancer patients. Invest New Drugs. 2020 Oct;38(5):1411-1420. doi: 10.1007/s10637-020-00897-3. Epub 2020 Jan 18.
- Results publication: PubMed 26172205Golan T, Grenader T, Ohana P, Amitay Y, Shmeeda H, La-Beck NM, Tahover E, Berger R, Gabizon AA. Pegylated liposomal mitomycin C prodrug enhances tolerance of mitomycin C: a phase 1 study in advanced solid tumor patients. Cancer Med. 2015 Oct;4(10):1472-83. doi: 10.1002/cam4.491. Epub 2015 Jul 14.
- 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.
Esther Tahover, MD principal investigator
Shaare Zedek Medica Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Promitil in people with Cancer and Gastro-Intestinal Intraepithelial Neoplasia, run by Lipomedix Pharmaceuticals Inc. at 1 site in Israel.
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 25 inclusion and 14 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: stopped early, as of the sponsor's last update on 14 Sep 2023. 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 Israel. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Investigational drug not available). 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?
Incidence of Treatment-Emergent Adverse Events (time frame: 12 weeks). The study lists 3 primary outcomes in all. 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 NCT04729205, which also lists 4 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 14 Sep 2023.