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NCT01306032 · ClinicalTrials.gov registry record · Phase 2
Phase II ABT-888 With Cyclophosphamide
A Phase 2 study of Ovarian Cancer and Triple Negative Breast Cancer, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 124
- Enrollment target
- 10
- Study locations
NCT01306032: Completed Phase 2 study of Ovarian Cancer and Triple Negative Breast Cancer, sponsored by National Cancer Institute (NCI).
NCT01306032 is a Phase 2 study of Ovarian Cancer and Triple Negative Breast Cancer that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 124 participants, below the 728-participant average among 322 other Ovarian Cancer trials with a reported enrollment target (83% lower). The trial reports 10 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01306032, a Phase 2 study of Ovarian Cancer and Triple Negative Breast Cancer, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 124 participants
- Enrollment target
- 10
- Study locations
Study Summary
Background: \- The experimental cancer treatment drug ABT-888 (Veliparib) works by preventing deoxyribonucleic acid (DNA) repair in tumor cells. Cyclophosphamide is a cancer treatment drug that works by causing DNA damage in cells, including cancer cells, resulting in cell death. However, because cyclophosphamide has strong and unpleasant side effects, researchers are interested in finding drugs that can be given in combination with cyclophosphamide that will allow a lower dose of cyclophosphamide to be given with similar effects. The combination of ABT-88 and cyclophosphamide may be an effective treatment for some types of cancer, such as certain kinds of breast or ovarian cancer and non-Hodgkin's lymphoma that often do not respond to standard therapies. Objectives: \- To evaluate the safety and effectiveness of ABT-888 and cyclophosphamide in ovarian and breast cancer and in non-Hodgkin's lymphoma that have not responded to standard treatments. Eligibility: \- Individuals at least 18 years of age who have been diagnosed with (1) (Breast cancer 1/2) BRCA1/2 ovarian cancer, primary peritoneal or ovarian high-grade carcinoma, or fallopian tube cancer; (2) triple-negative breast cancer (not responsive to hormone-related therapy); or (3) low grade non-Hodgkin's lymphoma. Design: * Participants will be screened with a full medical history and physical examination, blood and urine tests, and tumor imaging studies. Participants will be divided into two groups with different treatment subgroups. * Group 1: Participants who have BRCA-positive ovarian cancer, primary peritoneal or ovarian high-grade serous carcinoma, or fallopian tube cancer * Participants will receive either the combination of ABT-888 and cyclophosphamide, or cyclophosphamide alone. * Participants will take the study drug by mouth once a day for 21-day cycles of treatment, and will keep a diary to record drug doses and any side effects. * Participants will have clinic visits with blood and urine test
Primary Outcome
Complete response (CR) + partial response (PR)) of the combination of ABT-888 with metronomic oral cyclophosphamide to the response rate (CR+PR) of metronomic oral cyclophosphamide in patients with deleterious BRCA mutations and refractory ovarian cancer or patients with primary peritoneal or ovarian high-grade serous carcinoma or fallopian tube cancer. CR + PR was determined by the Response Evaluation Criteria in Solid Tumors (RECIST). CR is disappearance of all target lesions. Any pathological
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG ABT-888
Study Locations (10)
New York
- Memorial Sloan Kettering Cancer Center - New York
- Montefiore Medical Center - The Bronx
California
- University of California, Davis - Davis
Florida
- H. Lee Moffitt Cancer Center & Research Institute - Tampa
Illinois
- University of Chicago - Chicago
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
Minnesota
- Mayo Clinic, Rochester - Rochester
Ohio
- Ohio State University - Columbus
Texas
- MD Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 124 participants |
| Start Date | 2011-01-12 |
| Est. Completion | 2016-12-15 |
| Phase | Phase 2 |
What the finished NCT01306032 record still lists
NCT01306032 is an interventional study that assigns participants to a tested intervention. The registered 124 participants enrollment target is mid-sized for trials with a published cap, below the 728-participant average among 322 other Ovarian Cancer trials with a reported enrollment target (83% lower).
The record links to 5 conditions, with Ovarian Cancer appearing as the primary indexed condition, and to 2 interventions - of which Cyclophosphamide is the first listed.
NCT01306032 lists 10 locations in 9 states (New York, California, Florida).
Frequently Asked Questions
What is clinical trial NCT01306032 about?
NCT01306032 is a clinical study titled "Phase II ABT-888 With Cyclophosphamide". Background: \- The experimental cancer treatment drug ABT-888 (Veliparib) works by preventing deoxyribonucleic acid (DNA) repair in tumor cells. Cyclophosphamide is a cancer treatment drug that works by causing DNA damage in cells, including cancer cells, resulting in cell death. However, because c...
What is the current status of trial NCT01306032?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 124 participants. The study started on 2011-01-12. Estimated completion is 2016-12-15.
What conditions does trial NCT01306032 study?
This clinical trial studies the following conditions: Ovarian Cancer, Triple Negative Breast Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer, Serous Carcinoma Cancer.
What interventions are being tested in trial NCT01306032?
The interventions under investigation include: Cyclophosphamide (DRUG), ABT-888 (DRUG).
Who is sponsoring clinical trial NCT01306032?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01306032 being conducted?
This trial has 10 study locations across California, Florida, Illinois, Maryland, Minnesota. 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 NCT01306032's enrollment target sits among peer trials
124 132nd of 322 higher than 190 of 322 other Ovarian Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Ovarian 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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