Colorectal CancerPhase 1/2NCT01193517
Azacitidine and CAPOX in Metastatic Colorectal Cancer
A Phase 1/2 study testing Azacitidine, Capecitabine and Oxaliplatin in people with Colorectal Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of the Phase I portion of this study is to find the highest tolerable dose of azacitidine combined with capecitabine and oxaliplatin (CAPOX) that can be given to patients with metastatic colorectal cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Azacitidine, Capecitabine and Oxaliplatin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2010to Nov 2016
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Phase I: Patient must have histologically or cytologically confirmed colorectal adenocarcinoma with metastatic disease documented on diagnostic imaging studies. Disease may be measurable or non-measurable as per RECIST version 1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- For patients on full-dose low-molecular weight anticoagulation, no active bleeding or pathological condition that carries a high risk of bleeding (e.g., tumor involving major vessels or know varices) is allowed.
- Serum bilirubin levels </= 1.5 times the upper limit of the normal range for the laboratory (ULN)
- Serum aspartate aminotransferase (AST) or serum alanine aminotransferase (ALT) levels </= 2.5 x ULN and </= 5 x ULN in patients with liver metastases
- Serum creatinine levels </= 1.5 x ULN
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- Absolute neutrophil count of >/=1,500/mm^3 (ie, >/=1.5 x 10^9/L by International Units [IU]).
- Platelet count >/=100,000/mm^3 (IU: ≥100 x 10^9/L).
- Hemoglobin value of >/=9.0 g/dL.
- No limit to number of prior therapies.
- Women of childbearing potential must have a negative serum pregnancy test and must be advised to avoid becoming pregnant. Men should be advised to not father a child while receiving treatment. Sexually active women of childbearing potential and men must use an effective method of birth control during the course of the study, in a manner such that risk of failure is minimized.
- Patient must be refractory to treatment with 5-FU (either intravenous 5-FU or as the oral prodrug, capecitabine) and oxaliplatin, defined as previous clinical or radiographic progression on or within 3 months of treatment with 5-FU and oxaliplatin. There is no limit to the number of prior lines of therapy.
- Phase II: Patient must have histologically or cytologically confirmed colorectal adenocarcinoma with measurable metastatic disease documented on diagnostic imaging studies by RECIST version 1.1 criteria
- Phase II: Patient must be known to have CpG island methylator phenotype.
Who cannot join
- Patients with known brain metastases or carcinomatous meningitis
- Patients unable to swallow oral medications or with gastrointestinal disorders that might interfere with proper absorption of oral drugs.
- Known dihydropyrimidine (DPD) deficiency
- Grade 3 or more peripheral neuropathy
- Chemotherapy or any other investigational agents within 14 days of first receipt of study treatment, or major surgery within 28 days of first receipt of study treatment, or palliative radiation within 7 days of first receipt of study treatment.
- Concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study such as unstable angina, myocardial infarction within 6 months, unstable symptomatic arrhythmia, uncontrolled diabetes, serious active or uncontrolled infection.
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- Known or suspected hypersensitivity to azacitidine or mannitol
- Pregnant or breast feeding
- Because of the interaction between coumadin and capecitabine patients taking therapeutic doses of coumarin-derivative anticoagulants, are not eligible. Low-dose Coumadin (e.g. 1 mg PO per day) in patients with in-dwelling venous access devices is allowed but increased frequency of international normalized ratio (INR) monitoring is recommended.
- Interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the lung.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Phase I/II Study of Azacitidine and CAPOX (Capecitabine + Oxaliplatin) in Metastatic Colorectal Cancer Patients Enriched for Hypermethylation of CpG Promoter Islands
The goal of the Phase I portion of this study is to find the highest tolerable dose of azacitidine combined with capecitabine and oxaliplatin (CAPOX) that can be given to patients with metastatic colorectal cancer.
The goal of the Phase II portion of this study is to learn if azacitidine, given in combination with CAPOX, can help to control metastatic colorectal cancer. The safety of this drug combination will also be studied.
Read the detailed description
The Study Drugs:
Azacitidine is designed to block certain proteins in cancer cells whose job is to stop the function of the tumor-fighting proteins. By blocking the "bad" proteins, the tumor-fighting genes may be able to work better.
Capecitabine is designed to interfere with the growth of cancer cells.
Oxaliplatin is designed to keep new cancer cells from growing.
Study Groups:
If you are found to be eligible to take part in this study, you will be assigned to a study group based on when you joined this study. Up to 4 groups of up to 3-6 participants will be enrolled in the Phase I portion of the study, and up to 30 participants will be enrolled in Phase II.
If you are enrolled in the Phase I portion, the dose of azacitidine and oxaliplatin you receive will depend on when you joined this study. All participants will receive the same dose of capecitabine. The first group of participants will receive a low dose level of the combination. Each new group will receive a higher dose of the combination than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of the combination of azacitidine, oxaliplatin, and capecitabine is found.
If you are enrolled in the Phase II portion, you will receive the combination of azacitidine, oxaliplatin, and capecitabine at the highest dose that was tolerated in the Phase I portion.
Central Venous Catheter (CVC):
Before you can begin to receive oxaliplatin on this study, you will have a CVC placed if you do not have one already. A CVC is a sterile, flexible tube that will be placed into a large vein while you are under local anesthesia. Your doctor will explain this procedure to you in more detail, and you will be required to sign a separate consent form for this procedure.
Study Drug Administration:
A cycle of treatment is defined as 21 days.
Azacitidine will be injected under your skin on Days 1-5 of each cycle.
You will receive oxaliplatin by vein over 2 hours on Day 2 of each cycle.
You will take capecitabine by mouth 2 times each day on Days 1-14 of each cycle. Capecitabine tablets should be taken 12 hours apart, within 30 minutes after eating a meal.
Study Visits:
Up to 3 days before or on Day 1 of each cycle, the following tests and procedures will be performed:
- You will have a physical exam, including measurement of your weight and vital signs.
- You will have a neurosensory assessment.
- Your performance status will be recorded.
- You will be asked about any symptoms and/or side effects you may be experiencing and any drugs you may be taking.
- Blood (about 2 tablespoons) will be drawn for routine tests.
On Day 5 of Cycle 1 and Days 1 and 5 of Cycle 2, before you receive any of the study drugs, blood (about 2 teaspoons each time) will be drawn to test for CIMP, a chemical "marker" in the blood that may be related to how the drug may affect the cancer.
After every 3 cycles (Cycles 4, 7, 10 and so on), you will have a CT or MRI scan of the chest, abdomen, and/or pelvis to check the status of the disease.
Length of Study:
You may continue to take the study drugs for as long as you are benefitting. You will be taken off the study drugs if the disease gets worse, you experience any intolerable side effects, or if the study doctor thinks it is in your best interest to stop taking the study drugs.
If you chose to stop your participation in this study at any time, you should tell the study doctor or study staff right away. They will make sure that proper procedures are followed and a final visit is made for your safety.
End-of-Treatment Visit:
Within 10 days after your study treatment ends for any reason, you will return to the clinic and the following tests and procedures will be performed:
- You will have a physical exam, including measurement of your weight and vital signs.
- You will have a neurosensory assessment.
- Your performance status will be recorded.
- You will have a CT scan or MRI scan of the chest, abdomen, and/or pelvis to check the status of the disease.
- You will be asked about any symptoms and/or side effects you may be experiencing and any drugs you may be taking.
- Blood (about 2 tablespoons) will be drawn for routine tests.
Follow-Up:
The study doctor and study staff will follow your health status for the first 30 days after you stop taking the study drugs to check if you are experiencing any treatment-related side effects. The follow-up will be done during your regularly scheduled routine clinic visits and/or by phone call, which should last about 5 minutes.
If you continue to experience any treatment-related side effects after the 30 days of follow-up, the study staff will continue to follow up with you during your regularly scheduled clinic visits until the side effects have gotten better or become stable.
Long-Term Follow-Up:
Every 3 months after the end-of-treatment visit, the study staff will contact you by phone or email to check on how you are doing. If you are contacted by phone, the call should last about 5 minutes. Your medical records may also be reviewed.
This is an investigational study. Azacitidine is FDA approved and commercially available for myelodysplastic syndrome (MDS - a blood disease that often leads to cancer). Its use in colorectal cancer is investigational.
Oxaliplatin and capecitabine are both FDA approved and commercially available as treatment for colorectal cancer.
The use of azacitidine, oxaliplatin, and capecitabine in combination is investigational.
Up to 54 patients will take part in this study. All will be enrolled at MD Anderson.
- Conditions
- Colorectal Cancer
- Being tested
- Azacitidine, Capecitabine, Oxaliplatin, Azacitidine MTD
- Keywords
- Refractory metastatic colorectal cancer, CRC, colorectal adenocarcinoma with metastatic disease, Azacitidine, 5-Azacytidine, 5-aza, Vidaza, 5-AZC, AZA-CR, Ladakamycin, NSC-102816, Capecitabine, Oxaliplatin, CAPOX, Xeloda, Eloxatin, Hypermethylation, CpG island methylator phenotype
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AzacitidineDrug
Also called 5-Azacytidine, 5-aza, Vidaza, 5-AZC
Starting dose level 75 mg/m2/day subcutaneously on Days 1-5 of a 21 day cycle.
CapecitabineDrug
Also called Xeloda
1500 mg/m2/day by mouth twice daily in divided doses on Days 1-14 of a 21 day cycle.
OxaliplatinDrug
Also called Eloxatin
Starting dose level 90 mg/m2 by vein on Day 2 of a 21 day cycle.
Azacitidine MTDDrug
Also called 5-Azacytidine, 5-aza, Vidaza, 5-AZC
Highest tolerable dose of combination azacitidine with CAPOX found in Phase I.
| Study group | Role | What they receive |
|---|---|---|
| Phase I | Experimental | Dose Escalation of Azacitidine + CAPOX (Capecitabine, Oxaliplatin) Receives: Drug: Azacitidine; Drug: Capecitabine; Drug: Oxaliplatin |
| Phase II | Experimental | MTD of Azacitidine + CAPOX Receives: Drug: Capecitabine; Drug: Oxaliplatin; Drug: Azacitidine MTD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD) of Azacitidine, and Capecitabine and Oxaliplatin (CAPOX)
Dose just below the one at which ≥ 1/3 of subjects experience a dose limiting toxicity (DLT) considered the MTD.
Measured: Up to 3 weeks from the first dose
Secondary outcomes (1)
Response Rate of Azacitidine, and Capecitabine and Oxaliplatin (CAPOX)
Per Response Evaluation Criteria in solid Tumors Criteria (RECISTv1.0) for target lesions and assessed by CT or MRI: Partial Response (PR), >= 30%decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither PD nor PR, the sum of the longest diameters no change or increase by <20% from baseline or from nadir (smallest sum on treatment); Progressive Disease (PD), the sum of the longest diameters increases by>= 20% from nadir (smallest sum on treatment). For non-target lesions assessed by CT or MRI: Stable Disease (SD), Persistence of >=1 non-target lesion; Progressive Disease (PD), Enlargement of non-target lesions and/or appearance of new lesions.
Measured: After 9 weeks (three, 21 day cycles)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2010 (estimated)
- Study startAug 2010
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Celgene
- Responsible party
- Sponsor
- Investigators
- Michael Overman, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01193517
- Sponsor's protocol ID
- 2009-0625
- Other IDs
- NCI-2010-01973
- Status last verified
- Apr 2020
- First submitted
- 31 Aug 2010
- Last updated
- 15 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Study of Azacitidine and CAPOX (Capecitabine + Oxaliplatin) in Metastatic Colorectal Cancer Patients Enriched for Hypermethylation of CpG Promoter Islands
- ClinicalTrials.gov ID
- NCT01193517
- Acronym / sponsor ID
- 2009-0625
- Conditions
- Colorectal Cancer
- Keywords
- Refractory metastatic colorectal cancer, CRC, colorectal adenocarcinoma with metastatic disease, Azacitidine, 5-Azacytidine, 5-aza, Vidaza, 5-AZC
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Celgene
- Study start
- Aug 2010
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 2 Sep 2010 (estimated)
- Results
- Posted 15 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of the Phase I portion of this study is to find the highest tolerable dose of azacitidine combined with capecitabine and oxaliplatin (CAPOX) that can be given to patients with metastatic colorectal cancer.
The goal of the Phase II portion of this study is to learn if azacitidine, given in combination with CAPOX, can help to control metastatic colorectal cancer. The safety of this drug combination will also be studied.
Detailed description
The Study Drugs:
Azacitidine is designed to block certain proteins in cancer cells whose job is to stop the function of the tumor-fighting proteins. By blocking the "bad" proteins, the tumor-fighting genes may be able to work better.
Capecitabine is designed to interfere with the growth of cancer cells.
Oxaliplatin is designed to keep new cancer cells from growing.
Study Groups:
If you are found to be eligible to take part in this study, you will be assigned to a study group based on when you joined this study. Up to 4 groups of up to 3-6 participants will be enrolled in the Phase I portion of the study, and up to 30 participants will be enrolled in Phase II.
If you are enrolled in the Phase I portion, the dose of azacitidine and oxaliplatin you receive will depend on when you joined this study. All participants will receive the same dose of capecitabine. The first group of participants will receive a low dose level of the combination. Each new group will receive a higher dose of the combination than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of the combination of azacitidine, oxaliplatin, and capecitabine is found.
If you are enrolled in the Phase II portion, you will receive the combination of azacitidine, oxaliplatin, and capecitabine at the highest dose that was tolerated in the Phase I portion.
Central Venous Catheter (CVC):
Before you can begin to receive oxaliplatin on this study, you will have a CVC placed if you do not have one already. A CVC is a sterile, flexible tube that will be placed into a large vein while you are under local anesthesia. Your doctor will explain this procedure to you in more detail, and you will be required to sign a separate consent form for this procedure.
Study Drug Administration:
A cycle of treatment is defined as 21 days.
Azacitidine will be injected under your skin on Days 1-5 of each cycle.
You will receive oxaliplatin by vein over 2 hours on Day 2 of each cycle.
You will take capecitabine by mouth 2 times each day on Days 1-14 of each cycle. Capecitabine tablets should be taken 12 hours apart, within 30 minutes after eating a meal.
Study Visits:
Up to 3 days before or on Day 1 of each cycle, the following tests and procedures will be performed:
- You will have a physical exam, including measurement of your weight and vital signs.
- You will have a neurosensory assessment.
- Your performance status will be recorded.
- You will be asked about any symptoms and/or side effects you may be experiencing and any drugs you may be taking.
- Blood (about 2 tablespoons) will be drawn for routine tests.
On Day 5 of Cycle 1 and Days 1 and 5 of Cycle 2, before you receive any of the study drugs, blood (about 2 teaspoons each time) will be drawn to test for CIMP, a chemical "marker" in the blood that may be related to how the drug may affect the cancer.
After every 3 cycles (Cycles 4, 7, 10 and so on), you will have a CT or MRI scan of the chest, abdomen, and/or pelvis to check the status of the disease.
Length of Study:
You may continue to take the study drugs for as long as you are benefitting. You will be taken off the study drugs if the disease gets worse, you experience any intolerable side effects, or if the study doctor thinks it is in your best interest to stop taking the study drugs.
If you chose to stop your participation in this study at any time, you should tell the study doctor or study staff right away. They will make sure that proper procedures are followed and a final visit is made for your safety.
End-of-Treatment Visit:
Within 10 days after your study treatment ends for any reason, you will return to the clinic and the following tests and procedures will be performed:
- You will have a physical exam, including measurement of your weight and vital signs.
- You will have a neurosensory assessment.
- Your performance status will be recorded.
- You will have a CT scan or MRI scan of the chest, abdomen, and/or pelvis to check the status of the disease.
- You will be asked about any symptoms and/or side effects you may be experiencing and any drugs you may be taking.
- Blood (about 2 tablespoons) will be drawn for routine tests.
Follow-Up:
The study doctor and study staff will follow your health status for the first 30 days after you stop taking the study drugs to check if you are experiencing any treatment-related side effects. The follow-up will be done during your regularly scheduled routine clinic visits and/or by phone call, which should last about 5 minutes.
If you continue to experience any treatment-related side effects after the 30 days of follow-up, the study staff will continue to follow up with you during your regularly scheduled clinic visits until the side effects have gotten better or become stable.
Long-Term Follow-Up:
Every 3 months after the end-of-treatment visit, the study staff will contact you by phone or email to check on how you are doing. If you are contacted by phone, the call should last about 5 minutes. Your medical records may also be reviewed.
This is an investigational study. Azacitidine is FDA approved and commercially available for myelodysplastic syndrome (MDS - a blood disease that often leads to cancer). Its use in colorectal cancer is investigational.
Oxaliplatin and capecitabine are both FDA approved and commercially available as treatment for colorectal cancer.
The use of azacitidine, oxaliplatin, and capecitabine in combination is investigational.
Up to 54 patients will take part in this study. All will be enrolled at MD Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase I | Experimental | Drug: Azacitidine, Drug: Capecitabine, Drug: OxaliplatinDose Escalation of Azacitidine + CAPOX (Capecitabine, Oxaliplatin) |
| Phase II | Experimental | Drug: Capecitabine, Drug: Oxaliplatin, Drug: Azacitidine MTDMTD of Azacitidine + CAPOX |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Phase I: Patient must have histologically or cytologically confirmed colorectal adenocarcinoma with metastatic disease documented on diagnostic imaging studies. Disease may be measurable or non-measurable as per RECIST version 1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- For patients on full-dose low-molecular weight anticoagulation, no active bleeding or pathological condition that carries a high risk of bleeding (e.g., tumor involving major vessels or know varices) is allowed.
- Serum bilirubin levels </= 1.5 times the upper limit of the normal range for the laboratory (ULN)
- Serum aspartate aminotransferase (AST) or serum alanine aminotransferase (ALT) levels </= 2.5 x ULN and </= 5 x ULN in patients with liver metastases
Key exclusion criteria (10 listed)
- Patients with known brain metastases or carcinomatous meningitis
- Patients unable to swallow oral medications or with gastrointestinal disorders that might interfere with proper absorption of oral drugs.
- Known dihydropyrimidine (DPD) deficiency
- Grade 3 or more peripheral neuropathy
- Chemotherapy or any other investigational agents within 14 days of first receipt of study treatment, or major surgery within 28 days of first receipt of study treatment, or palliative radiation within 7 days of first receipt of study treatment.
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 |
|---|---|---|
| AzacitidineAlso: 5-Azacytidine, 5-aza, Vidaza, 5-AZCStarting dose level 75 mg/m2/day subcutaneously on Days 1-5 of a 21 day cycle. | Drug | Phase I |
| CapecitabineAlso: Xeloda1500 mg/m2/day by mouth twice daily in divided doses on Days 1-14 of a 21 day cycle. | Drug | Phase I, Phase II |
| OxaliplatinAlso: EloxatinStarting dose level 90 mg/m2 by vein on Day 2 of a 21 day cycle. | Drug | Phase I, Phase II |
| Azacitidine MTDAlso: 5-Azacytidine, 5-aza, Vidaza, 5-AZCHighest tolerable dose of combination azacitidine with CAPOX found in Phase I. | Drug | Phase II |
Primary outcome
Maximum Tolerated Dose (MTD) of Azacitidine, and Capecitabine and Oxaliplatin (CAPOX)
Time frame: Up to 3 weeks from the first dose
Dose just below the one at which ≥ 1/3 of subjects experience a dose limiting toxicity (DLT) considered the MTD.
1 secondary outcome
Response Rate of Azacitidine, and Capecitabine and Oxaliplatin (CAPOX)
Time frame: After 9 weeks (three, 21 day cycles)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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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.
Michael Overman, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Azacitidine, Capecitabine and Oxaliplatin in people with Colorectal Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
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 14 inclusion and 10 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: finished, as of the sponsor's last update on 15 Apr 2020. 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 United States. 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 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?
Yes. Results are posted in the registry (first posted 15 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Maximum Tolerated Dose (MTD) of Azacitidine, and Capecitabine and Oxaliplatin (CAPOX) (time frame: Up to 3 weeks from the first dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Apr 2020.