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NCT02393755 · ClinicalTrials.gov registry record · Phase 1
Nintedanib and Capecitabine in Treating Patients With Refractory Metastatic Colorectal Cancer
A Phase 1 study of Rectal Adenocarcinoma and Colon Adenocarcinoma, sponsored by Roswell Park Cancer Institute.
- Completed
- Registry status
- Phase 1
- Development phase
- 42
- Enrollment target
- 2
- Study locations
NCT02393755: Completed Phase 1 study of Rectal Adenocarcinoma and Colon Adenocarcinoma, sponsored by Roswell Park Cancer Institute.
NCT02393755 is a Phase 1 study of Rectal Adenocarcinoma and Colon Adenocarcinoma that has completed, run by Roswell Park Cancer Institute. The registered enrollment target is 42 participants, below the 122-participant average among 17 other Rectal Adenocarcinoma trials with a reported enrollment target (66% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02393755, a Phase 1 study of Rectal Adenocarcinoma and Colon Adenocarcinoma, has completed, sponsored by Roswell Park Cancer Institute.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 42 participants
- Enrollment target
- 2
- Study locations
Study Summary
This phase I/II trial studies the side effects and best dose of nintedanib when given together with capecitabine and to see how well they work in treating patients with colorectal cancer that has not responded to previous treatment (refractory) and has spread to other places in the body (metastatic). Nintedanib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It may also block the growth of new blood vessels necessary for tumor growth. Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving nintedanib with capecitabine may be a better treatment for colorectal cancer.
Primary Outcome
The recommended Phase II dose is of the Nintedanib and Capecitabine combination is defined as the dose level that causes dose limiting toxicities (DLTs) in ≤ 1 out of 6 patients at highest dose level below the maximally administered dose. Capecitabine is fixed dose at 2000 mg/m2; while Nintedanib is evaluated at 150mg (dose level 1) and 200 mg (dose level 2).
Conditions Studied
Interventions
- DRUG Capecitabine
- OTHER Laboratory Biomarker Analysis
- DRUG Nintedanib
- OTHER Pharmacological Study
Study Locations (2)
California
- City of Hope Comprehensive Cancer Center - Duarte
New York
- Roswell Park Cancer Institute - Buffalo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2015-05-08 |
| Est. Completion | 2021-05-18 |
| Phase | Phase 1 |
What the finished NCT02393755 record still lists
NCT02393755 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 122-participant average among 17 other Rectal Adenocarcinoma trials with a reported enrollment target (66% lower).
The record links to 8 conditions, with Rectal Adenocarcinoma appearing as the primary indexed condition, and to 4 interventions - of which Capecitabine is the first listed.
NCT02393755 reports a single indexed study location in California, New York.
Frequently Asked Questions
What is clinical trial NCT02393755 about?
NCT02393755 is a clinical study titled "Nintedanib and Capecitabine in Treating Patients With Refractory Metastatic Colorectal Cancer". This phase I/II trial studies the side effects and best dose of nintedanib when given together with capecitabine and to see how well they work in treating patients with colorectal cancer that has not responded to previous treatment (refractory) and has spread to other places in the body (metastatic)...
What is the current status of trial NCT02393755?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 42 participants. The study started on 2015-05-08. Estimated completion is 2021-05-18.
What conditions does trial NCT02393755 study?
This clinical trial studies the following conditions: Rectal Adenocarcinoma, Colon Adenocarcinoma, Recurrent Colon Carcinoma, Recurrent Rectal Carcinoma, Stage IVA Rectal Cancer.
What interventions are being tested in trial NCT02393755?
The interventions under investigation include: Capecitabine (DRUG), Laboratory Biomarker Analysis (OTHER), Nintedanib (DRUG), Pharmacological Study (OTHER).
Who is sponsoring clinical trial NCT02393755?
This trial is sponsored by Roswell Park Cancer Institute, which has 365 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02393755 being conducted?
This trial has 2 study locations across California, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02393755's enrollment target sits among peer trials
42 10th of 17 higher than 8 of 17 other Rectal Adenocarcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Rectal Adenocarcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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