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NCT01051596 · ClinicalTrials.gov registry record · Phase 2
A Study of ABT-888 in Combination With Temozolomide for Colorectal Cancer
A Phase 2 study, sponsored by Georgetown University.
- Completed
- Registry status
- Phase 2
- Development phase
- 75
- Enrollment target
NCT01051596: Completed Phase 2 study, sponsored by Georgetown University.
NCT01051596 is a Phase 2 study that has completed, run by Georgetown University. The registered enrollment target is 75 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (44% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01051596, a Phase 2 study, has completed, sponsored by Georgetown University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 75 participants
- Enrollment target
Study Summary
People with colorectal cancer that cannot be cured by surgery are being asked to participate in this study. The purpose of this study is to test the efficacy (effectiveness) of a new combination of drugs, ABT-888 and temozolomide for patients with colorectal cancer. Temozolomide acts by damaging deoxyribonucleic acid (DNA) in rapidly dividing cells, in other words, cancer cells. ABT-888 inhibits an enzyme called "PARP" which helps to fix damaged DNA. By inhibiting this enzyme, ABT-888 prevents cancer cells from repairing the damage caused by the temozolomide, and will hopefully increase the killing of cancer cells, and decrease the tumors in the body. ABT-888 is an investigational or experimental anti-cancer agent that has not yet been approved by the Food and Drug Administration (FDA) for use in colorectal cancer. This study will help find out what effects (good and bad) the combination of drugs, temozolomide and ABT-888 has on colorectal cancer. This research is being done because it is not known if ABT-888 will increase the effectiveness of temozolomide for colorectal cancer.
Primary Outcome
Disease control rate defined as stable disease, partial response, or complete response according to the Response Evaluation Criteria in Solid Tumors (RECIST).
Interventions
- DRUG Temozolomide
- DRUG ABT-888
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2009-09 |
| Est. Completion | 2013-12 |
| Phase | Phase 2 |
What the finished NCT01051596 record still lists
NCT01051596 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 75 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (44% lower).
The record links to 0 conditions, and to 2 interventions - of which Temozolomide is the first listed.
NCT01051596 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01051596 about?
NCT01051596 is a clinical study titled "A Study of ABT-888 in Combination With Temozolomide for Colorectal Cancer". People with colorectal cancer that cannot be cured by surgery are being asked to participate in this study. The purpose of this study is to test the efficacy (effectiveness) of a new combination of drugs, ABT-888 and temozolomide for patients with colorectal cancer. Temozolomide acts by damaging de...
What is the current status of trial NCT01051596?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 75 participants. The study started on 2009-09. Estimated completion is 2013-12.
What interventions are being tested in trial NCT01051596?
The interventions under investigation include: Temozolomide (DRUG), ABT-888 (DRUG).
Who is sponsoring clinical trial NCT01051596?
This trial is sponsored by Georgetown University, which has 227 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01051596's enrollment target sits among peer trials
75 900th of 2000 higher than 1,081 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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