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NCT01445418 · ClinicalTrials.gov registry record · Phase 1
AZD2281 Plus Carboplatin to Treat Breast and Ovarian Cancer
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 103
- Enrollment target
NCT01445418: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT01445418 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 103 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (72% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01445418, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 103 participants
- Enrollment target
Study Summary
Background: * Carboplatin is approved by the Food and Drug Administration to treat cancer. * AZD2281 is an experimental drug in a class of agents called PARP inhibitors. PARP is a protein that is -involved in repairing DNA damage; PARP inhibitors interfere with that process. Objectives: * To determine the optimum doses of AZD2281 and carboplatin that can safely be used in patients with breast and ovarian cancer. * To evaluate the response of the tumor to the drug combination and determine the side effects of the treatment. Eligibility: -Patients 18 years of age or older with breast or ovarian cancer who have a family history of cancer or who have a BRCA1 or BRCA2 mutation. Design: * In this dose escalation study, the first small group of patients receives the smallest study doses of AZD2281 and carboplatin. Subsequent groups receive incrementally higher doses of first AZD2281 and then carboplatin as long as the preceding group has not experienced unacceptable side effects. When the highest safe dose is determined, additional patients receive that dose. * Patients receive treatment in 21-day cycles as follows: AZD2281 by mouth twice a day every day; carboplatin thorough a vein on day 8 of each cycle. Treatment may continue until it is no longer beneficial. * Evaluations during treatment include the following: * Physical examination 1 week after starting treatment and then every 3 weeks. * Blood tests weekly for the first 4 weeks of treatment and then every 3 weeks. * CT scans or other imaging tests such as ultrasound or MRI every 6 weeks to evaluate the tumor.
Primary Outcome
Determine the safety and toxicity of the combination of AZD2281 (KU- 0059436) and carboplatin in recurrent BRCA1/2-associated or familial breast and ovarian cancer patients, in recurrent low genetic risk serous ovarian cancer patients, and in recurrent low genetic risk triple negative breast cancer patients.
Interventions
- DRUG AZ2281 + Carboplatin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 103 participants |
| Start Date | 2008-05-12 |
| Est. Completion | 2019-10-18 |
| Phase | Phase 1 |
What the finished NCT01445418 record still lists
NCT01445418 is an interventional study that assigns participants to a tested intervention. The registered 103 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (72% higher).
The record links to 0 conditions, and to 1 intervention - of which AZ2281 + Carboplatin is the first listed.
NCT01445418 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01445418 about?
NCT01445418 is a clinical study titled "AZD2281 Plus Carboplatin to Treat Breast and Ovarian Cancer". Background: * Carboplatin is approved by the Food and Drug Administration to treat cancer. * AZD2281 is an experimental drug in a class of agents called PARP inhibitors. PARP is a protein that is -involved in repairing DNA damage; PARP inhibitors interfere with that process. Objectives: * To dete...
What is the current status of trial NCT01445418?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 103 participants. The study started on 2008-05-12. Estimated completion is 2019-10-18.
What interventions are being tested in trial NCT01445418?
The interventions under investigation include: AZ2281 + Carboplatin (DRUG).
Who is sponsoring clinical trial NCT01445418?
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 NCT01445418's enrollment target sits among peer trials
103 541st of 2000 higher than 1,458 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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