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NCT01105377 · ClinicalTrials.gov registry record · Phase 2
Azacitidine and Entinostat in Treating Patients With Metastatic Colorectal Cancer
A Phase 2 study of Recurrent Colon Cancer and Recurrent Rectal Cancer, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 47
- Enrollment target
- 14
- Study locations
NCT01105377: Completed Phase 2 study of Recurrent Colon Cancer and Recurrent Rectal Cancer, sponsored by National Cancer Institute (NCI).
NCT01105377 is a Phase 2 study of Recurrent Colon Cancer and Recurrent Rectal Cancer that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 47 participants, above the 26-participant average among 10 other Recurrent Colon Cancer trials with a reported enrollment target (81% higher). The trial reports 14 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01105377, a Phase 2 study of Recurrent Colon Cancer and Recurrent Rectal Cancer, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 47 participants
- Enrollment target
- 14
- Study locations
Study Summary
This phase II trial is studying how well giving azacitidine together with entinostat works in treating patients with metastatic colorectal cancer. Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Entinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving azacitidine together with entinostat may kill more tumor cells.
Primary Outcome
Each evaluable patient is classified as having a confirmed tumor response if they have either a complete response (CR) or partial response (PR) lasts at least 4 weeks. Tumor response is measured by using RECIST v1.1 (Response Evaluation Criteria in Solid Tumors). A CR is defined as a disappearance of all target lesions, and each target lymph node must have reduction in short axis to \<1.0 cm. A PR is defined as a 30% decrease in the sum of the longest diameter for all target lesions plus the sum
Conditions Studied
Interventions
- OTHER laboratory biomarker analysis
- DRUG azacitidine
- DRUG entinostat
Study Locations (14)
Minnesota
- Minnesota Oncology Hematology PA-Maplewood - Maplewood
- Mayo Clinic - Rochester
- Metro-Minnesota CCOP - Saint Louis Park
- United Hospital - Saint Paul
- Lakeview Hospital - Stillwater
Pennsylvania
- University of Pittsburgh Cancer Institute - Pittsburgh
- University of Pittsburgh - Pittsburgh
Arizona
- Mayo Clinic in Arizona - Scottsdale
California
- University of Southern California/Norris Cancer Center - Los Angeles
Florida
- Mayo Clinic in Florida - Jacksonville
Maryland
- Johns Hopkins University/Sidney Kimmel Comprehensive Cancer Center - Baltimore
Michigan
- Wayne State University/Karmanos Cancer Institute - Detroit
Missouri
- Washington University School of Medicine - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 47 participants |
| Start Date | 2010-04 |
| Est. Completion | 2014-05 |
| Phase | Phase 2 |
What the finished NCT01105377 record still lists
NCT01105377 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 47 participants, a relatively small participant target, above the 26-participant average among 10 other Recurrent Colon Cancer trials with a reported enrollment target (81% higher).
The record links to 4 conditions, with Recurrent Colon Cancer appearing as the primary indexed condition, and to 3 interventions - of which laboratory biomarker analysis is the first listed.
NCT01105377 lists 14 locations in 9 states (Minnesota, Pennsylvania, Arizona).
Frequently Asked Questions
What is clinical trial NCT01105377 about?
NCT01105377 is a clinical study titled "Azacitidine and Entinostat in Treating Patients With Metastatic Colorectal Cancer". This phase II trial is studying how well giving azacitidine together with entinostat works in treating patients with metastatic colorectal cancer. Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping the...
What is the current status of trial NCT01105377?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 47 participants. The study started on 2010-04. Estimated completion is 2014-05.
What conditions does trial NCT01105377 study?
This clinical trial studies the following conditions: Recurrent Colon Cancer, Recurrent Rectal Cancer, Stage IV Colon Cancer, Stage IV Rectal Cancer.
What interventions are being tested in trial NCT01105377?
The interventions under investigation include: laboratory biomarker analysis (OTHER), azacitidine (DRUG), entinostat (DRUG).
Who is sponsoring clinical trial NCT01105377?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01105377 being conducted?
This trial has 14 study locations across Arizona, California, Florida, Maryland, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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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 NCT01105377's enrollment target sits among peer trials
47 3rd of 10 higher than 8 of 10 other Recurrent Colon Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Recurrent Colon 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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