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NCT02861300 · ClinicalTrials.gov registry record · Phase 1
CB-839 + Capecitabine in Solid Tumors and Fluoropyrimidine Resistant PIK3CA Mutant Colorectal Cancer
A Phase 1 study of Colorectal Cancer and Solid Tumor, sponsored by David Bajor, MD.
- Completed
- Registry status
- Phase 1
- Development phase
- 50
- Enrollment target
- 2
- Study locations
NCT02861300: Completed Phase 1 study of Colorectal Cancer and Solid Tumor, sponsored by David Bajor, MD.
NCT02861300 is a Phase 1 study of Colorectal Cancer and Solid Tumor that has completed, run by David Bajor, MD. The registered enrollment target is 50 participants, below the 1,545-participant average among 381 other Colorectal Cancer trials with a reported enrollment target (97% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02861300, a Phase 1 study of Colorectal Cancer and Solid Tumor, has completed, sponsored by David Bajor, MD.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 50 participants
- Enrollment target
- 2
- Study locations
Study Summary
This study has two portions. The main goal of the Phase I portion of this research study is to see what doses of CB-839 and capecitabine can safely be given to patients without having too many side effects. Other purposes of this research study will be to determine what side effects are seen with this combination of medicines. The Phase II portion of the study will test how many patients show shrinkage in their tumor with this combination of medicines and what changes occur inside the cancer cells and blood cells after treatment.
Primary Outcome
The Phase I study has been designed to define the recommended phase II dose of CB-839 and capecitabine. A traditional 3+3 dose escalation design will be adopted. Nine to twenty-four patients are expected to be enrolled, depending on the number of dose escalations and assuming that a total of 6 patients will be treated at the final recommended phase II dose level. Patients who complete the first 21 day treatment cycle of CB-839 and capecitabine chemotherapy will be included in the analysis.
Conditions Studied
Interventions
- DRUG Capecitabine
- DRUG CB-839
Study Locations (2)
Ohio
- University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center - Cleveland
- Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2016-09-12 |
| Est. Completion | 2023-01-10 |
| Phase | Phase 1 |
What the finished NCT02861300 record still lists
NCT02861300 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 1,545-participant average among 381 other Colorectal Cancer trials with a reported enrollment target (97% lower).
The record links to 4 conditions, with Colorectal Cancer appearing as the primary indexed condition, and to 2 interventions - of which Capecitabine is the first listed.
NCT02861300 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT02861300 about?
NCT02861300 is a clinical study titled "CB-839 + Capecitabine in Solid Tumors and Fluoropyrimidine Resistant PIK3CA Mutant Colorectal Cancer". This study has two portions. The main goal of the Phase I portion of this research study is to see what doses of CB-839 and capecitabine can safely be given to patients without having too many side effects. Other purposes of this research study will be to determine what side effects are seen with th...
What is the current status of trial NCT02861300?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 50 participants. The study started on 2016-09-12. Estimated completion is 2023-01-10.
What conditions does trial NCT02861300 study?
This clinical trial studies the following conditions: Colorectal Cancer, Solid Tumor, Colon Cancer, Rectal Cancer.
What interventions are being tested in trial NCT02861300?
The interventions under investigation include: Capecitabine (DRUG), CB-839 (DRUG).
Who is sponsoring clinical trial NCT02861300?
This trial is sponsored by David Bajor, MD, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02861300 being conducted?
This trial has 2 study locations across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02861300's enrollment target sits among peer trials
50 272nd of 381 higher than 108 of 381 other Colorectal Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Colorectal Cancer 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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