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NCT01237067 · ClinicalTrials.gov registry record · Phase 1
Olaparib in Combination With Carboplatin for Refractory or Recurrent Women s Cancers
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 77
- Enrollment target
NCT01237067: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT01237067 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 77 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (28% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01237067, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 77 participants
- Enrollment target
Study Summary
Background: \- Olaparib is an experimental anti-cancer drug that is part of a class of drugs called PARP inhibitors. PARP is a protein that is involved in repairing DNA damage, but it may also encourage precancerous cells to develop into cancer cells. Olaparib has been given safely in combination with carboplatin, a drug used to treat breast, ovarian, uterine, and cervical cancer, but more research is needed to determine whether the drugs are more effective when given together or which drug should be given first. Objectives: \- To determine the safety and effectiveness of combined carboplatin and olaparib as a treatment for gynecologic (female organ) or breast cancer. Eligibility: * Women at least 18 years of age who have breast, ovarian, uterine, or cervical cancer that has not responded to standard treatments. * Men at least 18 years of age who have metastatic breast cancer and have a BRCA-1/2 mutation. Design: * Participants will be screened with a physical examination and medical history, as well as blood and tumor samples and imaging studies as required by the researchers. Study participants will then be divided into two groups. * Group 1: Participants will receive olaparib tablets twice a day for 7 days (14 doses) and will receive carboplatin by vein on day 1 or 2, for a 21-day treatment cycle. Group 1 study is designed to determine the safety of new tablet formulation of olaparib. * Group 2: Participants will be divided into two smaller groups, with reversed treatment schedules. Group 2 study is designed to evaluate which drug should be given first through endpoint studies in blood samples. * Group 2A: Participants will receive olaparib tablets twice a day for 7 days (14 doses) and then carboplatin on day 8 of the first cycle. Cycle 2 will start with carboplatin on day 1 and olaparib starting on day 2 for 7 days (14 doses). * Group 2B: Participants will receive carboplatin on the first day of the first cycle, and then olaparib on day 2, twice a day for
Primary Outcome
Pharmacodynamic study results and toxicity during Cycle 1 at 24 and 48 hours
Interventions
- DRUG Carboplatin
- DRUG Olaparib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 77 participants |
| Start Date | 2011-02-07 |
| Est. Completion | 2019-12-12 |
| Phase | Phase 1 |
What the finished NCT01237067 record still lists
NCT01237067 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 77 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (28% higher).
The record links to 0 conditions, and to 2 interventions - of which Carboplatin is the first listed.
NCT01237067 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01237067 about?
NCT01237067 is a clinical study titled "Olaparib in Combination With Carboplatin for Refractory or Recurrent Women s Cancers". Background: \- Olaparib is an experimental anti-cancer drug that is part of a class of drugs called PARP inhibitors. PARP is a protein that is involved in repairing DNA damage, but it may also encourage precancerous cells to develop into cancer cells. Olaparib has been given safely in combination w...
What is the current status of trial NCT01237067?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 77 participants. The study started on 2011-02-07. Estimated completion is 2019-12-12.
What interventions are being tested in trial NCT01237067?
The interventions under investigation include: Carboplatin (DRUG), Olaparib (DRUG).
Who is sponsoring clinical trial NCT01237067?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01237067's enrollment target sits among peer trials
77 703rd of 2000 higher than 1,296 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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