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NCT03215264 · ClinicalTrials.gov registry record · Phase 1
To Determine the Safety of Regorafenib, Hydroxychloroquine, and Entinostat Metastatic Colorectal Cancer
A Phase 1 study, sponsored by Abramson Cancer Center at Penn Medicine.
- Completed
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
NCT03215264: Completed Phase 1 study, sponsored by Abramson Cancer Center at Penn Medicine.
NCT03215264 is a Phase 1 study that has completed, run by Abramson Cancer Center at Penn Medicine. The registered enrollment target is 20 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03215264, a Phase 1 study, has completed, sponsored by Abramson Cancer Center at Penn Medicine.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
Study Summary
The main purpose of this study is to find the best dose of hydroxychloroquine (HCQ) when given in combination with regorafenib and entinostat.
Primary Outcome
Participants were evaluable for toxicity if they have taken one dose of HCQ and one dose of entinostat. To be considered for evaluability in a Phase I cohort in the absence of dose-limiting toxicity, patients should have completed \> 85% of HCQ doses, and at least 3 of 4 entinostat doses. The MTD will be defined as a) the dose producing DLT in 1 out of 6 patients, or b) the dose level below the dose which produced DLT in ≥ 2 out of 3 patients, or in ≥ 2 out of 6 patients. DLTs will be defined by
Interventions
- DRUG regorafenib
- DRUG entinostat
- DRUG hydroxychloroquine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2017-10-02 |
| Est. Completion | 2020-06-01 |
| Phase | Phase 1 |
What the finished NCT03215264 record still lists
NCT03215264 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower).
The record links to 0 conditions, and to 3 interventions - of which regorafenib is the first listed.
NCT03215264 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03215264 about?
NCT03215264 is a clinical study titled "To Determine the Safety of Regorafenib, Hydroxychloroquine, and Entinostat Metastatic Colorectal Cancer". The main purpose of this study is to find the best dose of hydroxychloroquine (HCQ) when given in combination with regorafenib and entinostat.
What is the current status of trial NCT03215264?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2017-10-02. Estimated completion is 2020-06-01.
What interventions are being tested in trial NCT03215264?
The interventions under investigation include: regorafenib (DRUG), entinostat (DRUG), hydroxychloroquine (DRUG).
Who is sponsoring clinical trial NCT03215264?
This trial is sponsored by Abramson Cancer Center at Penn Medicine, which has 402 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03215264's enrollment target sits among peer trials
20 1629th of 2000 higher than 285 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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