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NCT02260440 · ClinicalTrials.gov registry record · Phase 2
A Phase 2 Study of Pembrolizumab (MK-3475) in Combination With Azacitidine in Subjects With Chemo-refractory Metastatic Colorectal Cancer
A Phase 2 study of Metastatic Colorectal Cancer, sponsored by Anuradha Krishnamurthy.
- Completed
- Registry status
- Phase 2
- Development phase
- 31
- Enrollment target
- 1
- Study location
NCT02260440: Completed Phase 2 study of Metastatic Colorectal Cancer, sponsored by Anuradha Krishnamurthy.
NCT02260440 is a Phase 2 study of Metastatic Colorectal Cancer that has completed, run by Anuradha Krishnamurthy. The registered enrollment target is 31 participants, below the 185-participant average among 45 other Metastatic Colorectal Cancer trials with a reported enrollment target (83% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02260440, a Phase 2 study of Metastatic Colorectal Cancer, has completed, sponsored by Anuradha Krishnamurthy.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 31 participants
- Enrollment target
- 1
- Study location
Study Summary
This is an open label, single-arm, Phase 2 trial to evaluate the anti-tumor activity, safety, and tolerability of Pembrolizumab in combination with azacitidine in subjects with chemo-refractory mCRC without any further standard treatment options Dosage and regimen for all study periods * Pembrolizumab will be given at 200 mg every 21 days. * Azacitidine will be given at 100 mg daily subcutaneous injection on days 1-5 every 21 days. The first assessment of tumor response will be performed after cycle 3 (9 weeks), and thereafter approximately every 9 weeks, every 3 cycles of therapy. The modified RECIST 1.1 will be used to establish disease response or progression. All patients will be evaluated and graded for adverse events according to the NCI Common Terminology for Adverse Events, version 4.0 (NCI-CTCAE).
Primary Outcome
The objective response rate is estimated by the proportion (percentage) of participants with the best response of complete response (CR), or partial response (PR) by RECIST 1.1 criteria, with corresponding exact 95% confidence limits being reported. Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of targ
Conditions Studied
Interventions
- DRUG Pembrolizumab
- DRUG Azacitidine
Study Locations (1)
Pennsylvania
- Hillman Cancer Center - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2015-01 |
| Est. Completion | 2017-09 |
| Phase | Phase 2 |
What the finished NCT02260440 record still lists
NCT02260440 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 185-participant average among 45 other Metastatic Colorectal Cancer trials with a reported enrollment target (83% lower).
The record links to 1 condition, with Metastatic Colorectal Cancer appearing as the primary indexed condition, and to 2 interventions - of which Pembrolizumab is the first listed.
NCT02260440 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT02260440 about?
NCT02260440 is a clinical study titled "A Phase 2 Study of Pembrolizumab (MK-3475) in Combination With Azacitidine in Subjects With Chemo-refractory Metastatic Colorectal Cancer". This is an open label, single-arm, Phase 2 trial to evaluate the anti-tumor activity, safety, and tolerability of Pembrolizumab in combination with azacitidine in subjects with chemo-refractory mCRC without any further standard treatment options Dosage and regimen for all study periods * Pembroliz...
What is the current status of trial NCT02260440?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 31 participants. The study started on 2015-01. Estimated completion is 2017-09.
What conditions does trial NCT02260440 study?
This clinical trial studies the following conditions: Metastatic Colorectal Cancer.
What interventions are being tested in trial NCT02260440?
The interventions under investigation include: Pembrolizumab (DRUG), Azacitidine (DRUG).
Who is sponsoring clinical trial NCT02260440?
This trial is sponsored by Anuradha Krishnamurthy, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02260440 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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