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NCT04166435 · ClinicalTrials.gov registry record · Phase 2
TMZ + Olaparib for MGMT Hypermethylated Colorectal Cancer
A Phase 2 study of Colorectal Cancer, sponsored by Yale University.
- Completed
- Registry status
- Phase 2
- Development phase
- 11
- Enrollment target
- 1
- Study location
NCT04166435: Completed Phase 2 study of Colorectal Cancer, sponsored by Yale University.
NCT04166435 is a Phase 2 study of Colorectal Cancer that has completed, run by Yale University. The registered enrollment target is 11 participants, below the 1,545-participant average among 381 other Colorectal Cancer trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04166435, a Phase 2 study of Colorectal Cancer, has completed, sponsored by Yale University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 11 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a Phase II, non-randomized, open-label study to evaluate temozolomide in combination with olaparib in patients with MGMT promoter hypermethylated advanced colorectal cancer.
Primary Outcome
To determine the efficacy of TMZ in combination with olaparib in subjects with MGMT promoter hypermethylated advanced colorectal cancer. The overall response rate (ORR) was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) before and after treatment. Complete Response (CR): disappearance of all target lesions, Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor su
Conditions Studied
Interventions
- DRUG Temozolomide + Olaparib
Study Locations (1)
Connecticut
- Yale New Haven Hospital - New Haven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2020-06-17 |
| Est. Completion | 2023-06-12 |
| Phase | Phase 2 |
What the finished NCT04166435 record still lists
NCT04166435 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 1,545-participant average among 381 other Colorectal Cancer trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Colorectal Cancer appearing as the primary indexed condition, and to 1 intervention - of which Temozolomide + Olaparib is the first listed.
NCT04166435 reports a single indexed study location in Connecticut.
Frequently Asked Questions
What is clinical trial NCT04166435 about?
NCT04166435 is a clinical study titled "TMZ + Olaparib for MGMT Hypermethylated Colorectal Cancer". This is a Phase II, non-randomized, open-label study to evaluate temozolomide in combination with olaparib in patients with MGMT promoter hypermethylated advanced colorectal cancer.
What is the current status of trial NCT04166435?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 11 participants. The study started on 2020-06-17. Estimated completion is 2023-06-12.
What conditions does trial NCT04166435 study?
This clinical trial studies the following conditions: Colorectal Cancer.
What interventions are being tested in trial NCT04166435?
The interventions under investigation include: Temozolomide + Olaparib (DRUG).
Who is sponsoring clinical trial NCT04166435?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04166435 being conducted?
This trial has 1 study location across Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04166435's enrollment target sits among peer trials
11 371st of 381 higher than 11 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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