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NCT03878095 · ClinicalTrials.gov registry record · Phase 2
Testing Olaparib and AZD6738 in IDH1 and IDH2 Mutant Tumors
A Phase 2 study of Malignant Solid Neoplasm and Refractory Malignant Solid Neoplasm, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 2
- Development phase
- 24
- Enrollment target
- 13
- Study locations
NCT03878095: Active Phase 2 study of Malignant Solid Neoplasm and Refractory Malignant Solid Neoplasm, sponsored by National Cancer Institute (NCI).
NCT03878095 is a Phase 2 study of Malignant Solid Neoplasm and Refractory Malignant Solid Neoplasm that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 24 participants, below the 1,141-participant average among 176 other Malignant Solid Neoplasm trials with a reported enrollment target (98% lower). The trial reports 13 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03878095, a Phase 2 study of Malignant Solid Neoplasm and Refractory Malignant Solid Neoplasm, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 24 participants
- Enrollment target
- 13
- Study locations
Study Summary
This phase II trial studies how well olaparib and ceralasertib (AZD6738) work in treating patients with IDH mutant cholangiocarcinoma or solid tumors. Cancer is caused by changes (mutations) to genes that control the way cells function. Laboratory studies have shown that olaparib and AZD6738 can shrink IDH mutant tumors or stop them from growing. Olaparib and ceralasertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Primary Outcome
The exact two-sided 95% confidence intervals (CIs) for the ORR will be reported. No responses were recorded to be able to calculate the statistics as outlined at registration.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Bone Marrow Aspiration
- PROCEDURE Bone Marrow Biopsy
- PROCEDURE Biopsy Procedure
- DRUG Ceralasertib
Study Locations (13)
Connecticut
- Smilow Cancer Center/Yale-New Haven Hospital - New Haven
- Yale University - New Haven
- Smilow Cancer Hospital Care Center-Trumbull - Trumbull
Michigan
- Wayne State University/Karmanos Cancer Institute - Detroit
- Weisberg Cancer Treatment Center - Farmington Hills
Alabama
- University of Alabama at Birmingham Cancer Center - Birmingham
Florida
- UF Health Cancer Institute - Gainesville - Gainesville
Illinois
- Northwestern University - Chicago
Maryland
- Johns Hopkins University/Sidney Kimmel Cancer Center - Baltimore
Ohio
- Ohio State University Comprehensive Cancer Center - Columbus
Texas
- M D Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2020-01-30 |
| Est. Completion | 2026-07-10 |
| Phase | Phase 2 |
What the registry record for NCT03878095 still lists
NCT03878095 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 1,141-participant average among 176 other Malignant Solid Neoplasm trials with a reported enrollment target (98% lower).
The record links to 3 conditions, with Malignant Solid Neoplasm appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT03878095 lists 13 locations in 10 states (Connecticut, Michigan, Alabama).
Frequently Asked Questions
What is clinical trial NCT03878095 about?
NCT03878095 is a clinical study titled "Testing Olaparib and AZD6738 in IDH1 and IDH2 Mutant Tumors". This phase II trial studies how well olaparib and ceralasertib (AZD6738) work in treating patients with IDH mutant cholangiocarcinoma or solid tumors. Cancer is caused by changes (mutations) to genes that control the way cells function. Laboratory studies have shown that olaparib and AZD6738 can shr...
What is the current status of trial NCT03878095?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 24 participants. The study started on 2020-01-30. Estimated completion is 2026-07-10.
What conditions does trial NCT03878095 study?
This clinical trial studies the following conditions: Malignant Solid Neoplasm, Refractory Malignant Solid Neoplasm, Refractory Cholangiocarcinoma.
What interventions are being tested in trial NCT03878095?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Bone Marrow Aspiration (PROCEDURE), Bone Marrow Biopsy (PROCEDURE), Biopsy Procedure (PROCEDURE), Ceralasertib (DRUG).
Who is sponsoring clinical trial NCT03878095?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03878095 being conducted?
This trial has 13 study locations across Alabama, Connecticut, Florida, Illinois, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Malignant Solid Neoplasm
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 NCT03878095's enrollment target sits among peer trials
24 156th of 176 higher than 18 of 176 other Malignant Solid Neoplasm trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Malignant Solid Neoplasm 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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