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NCT05576896 · ClinicalTrials.gov registry record · Phase 2
Hydroxychloroquine in Combination With Encorafenib and Cetuximab or Panitumumab in the Treatment of Metastatic BRAF-mutated Colorectal Cancer Refractory
A Phase 2 study of Colorectal Cancer and Colorectal Cancer Stage IV, sponsored by Northwestern University.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 43
- Enrollment target
- 1
- Study location
NCT05576896: Recruiting Phase 2 study of Colorectal Cancer and Colorectal Cancer Stage IV, sponsored by Northwestern University.
NCT05576896 is a Phase 2 study of Colorectal Cancer and Colorectal Cancer Stage IV that is actively recruiting participants, run by Northwestern University. The registered enrollment target is 43 participants, below the 1,545-participant average among 381 other Colorectal Cancer trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05576896, a Phase 2 study of Colorectal Cancer and Colorectal Cancer Stage IV, is actively recruiting participants, sponsored by Northwestern University.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 43 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a Phase II, open label, single-arm trial study of adding hydroxychloroquine to encorafenib and cetuximab in patients with metastatic BRAF V600E colon cancer with progression on at least 1 prior line of therapy. We hypothesize that autophagy is a major mechanism of resistance to BRAF inhibition in stage IV BRAF V600E colorectal cancer, and that the addition of hydroxychloroquine to standard encorafenib and cetuximab therapy will help overcome this resistance.
Primary Outcome
To determine the ORR by Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1 criteria for the combination of encorafenib, cetuximab or panitumumab, and hydroxychloroquine. This will be assessed based on RECIST1.1 criteria by cross-sectional imaging done every 2 cycles.
Conditions Studied
Interventions
- DRUG Hydroxychloroquine in Combination With Encorafenib and Cetuximab or Panitumumab
Study Locations (1)
Illinois
- Northwestern University - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2022-10-10 |
| Est. Completion | 2028-07-01 |
| Phase | Phase 2 |
What NCT05576896 shows while recruiting
NCT05576896 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 43 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 3 conditions, with Colorectal Cancer appearing as the primary indexed condition, and to 1 intervention - of which Hydroxychloroquine in Combination With Encorafenib and Cetuximab or Panitumumab is the first listed.
NCT05576896 reports a single indexed study location in Illinois.
Frequently Asked Questions
What is clinical trial NCT05576896 about?
NCT05576896 is a clinical study titled "Hydroxychloroquine in Combination With Encorafenib and Cetuximab or Panitumumab in the Treatment of Metastatic BRAF-mutated Colorectal Cancer Refractory". This is a Phase II, open label, single-arm trial study of adding hydroxychloroquine to encorafenib and cetuximab in patients with metastatic BRAF V600E colon cancer with progression on at least 1 prior line of therapy. We hypothesize that autophagy is a major mechanism of resistance to BRAF inhibiti...
What is the current status of trial NCT05576896?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 43 participants. The study started on 2022-10-10. Estimated completion is 2028-07-01.
What conditions does trial NCT05576896 study?
This clinical trial studies the following conditions: Colorectal Cancer, Colorectal Cancer Stage IV, Stage IV Colorectal Cancer Positive for BRAF V600E Mutation.
What interventions are being tested in trial NCT05576896?
The interventions under investigation include: Hydroxychloroquine in Combination With Encorafenib and Cetuximab or Panitumumab (DRUG).
Who is sponsoring clinical trial NCT05576896?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05576896 being conducted?
This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05576896's enrollment target sits among peer trials
43 291st of 381 higher than 90 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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