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NCT01844986 · ClinicalTrials.gov registry record · Phase 3
Olaparib Maintenance Monotherapy in Patients With BRCA Mutated Ovarian Cancer Following First Line Platinum Based Chemotherapy.
A Phase 3 study of BRCA Mutation and Advanced Ovarian Cancer, sponsored by AstraZeneca.
- Active
- Registry status
- Phase 3
- Development phase
- 450
- Enrollment target
- 20
- Study locations
NCT01844986: Active Phase 3 study of BRCA Mutation and Advanced Ovarian Cancer, sponsored by AstraZeneca.
NCT01844986 is a Phase 3 study of BRCA Mutation and Advanced Ovarian Cancer that is active but no longer recruiting, run by AstraZeneca. The registered enrollment target is 450 participants, above the 120-participant average among 4 other BRCA Mutation trials with a reported enrollment target (275% higher). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01844986, a Phase 3 study of BRCA Mutation and Advanced Ovarian Cancer, is active but no longer recruiting, sponsored by AstraZeneca.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 450 participants
- Enrollment target
- 20
- Study locations
Study Summary
Olaparib Monotherapy in Patients with BRCA Mutated Ovarian Cancer following First Line Platinum Based Chemotherapy.
Primary Outcome
To determine the efficacy by progression free survival (PFS) using investigator assessment according to modified Response Evaluation Criteria in Solid Tumours (RECIST 1.1) of olaparib maintenance monotherapy compared to placebo in BRCA mutated high risk advanced ovarian cancer patients who are in clinical complete response or partial response following first line platinum based chemotherapy.
Conditions Studied
Interventions
- DRUG Olaparib 300mg tablets
Study Locations (20)
California
- Cedars-Sinai Medical Center - Los Angeles
- University of California, Los Angeles - Los Angeles
- Kaiser Permanente - Oakland
- Kaiser Permanente - Roseville
- Stanford Women's Cancer Center - Stanford
- Babak Edraki - Walnut Creek
Florida
- Florida Hospital Cancer Institute - Orlando
- Gynecologic Cancer Center - Orlando
- H Lee Moffitt Cancer Center and Research Institute - Tampa
Georgia
- Northside Hospital - Atlanta
- Northeast Georgia Medical Center - Gainesville
- Nancy N. & J.C. Lewis Cancer and Research Pavillion - Savannah
Connecticut
- Univ of Connecticut Health Center - Farmington
- Smilow Cancer Hospital at Yale New Haven - New Haven
Hawaii
- The Queen's Medical Center - Honolulu
- University of Hawaii - Honolulu
Alabama
- Clearview Cancer Institute - Huntsville
Alaska
- Providence Cancer Center - Anchorage
Arizona
- St. Joseph's Hospital & Medical Center - Phoenix
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 450 participants |
| Start Date | 2013-08-26 |
| Est. Completion | 2028-08-29 |
| Phase | Phase 3 |
What the registry record for NCT01844986 still lists
NCT01844986 is an interventional study that assigns participants to a tested intervention. The registered 450 participants enrollment target is mid-sized for trials with a published cap, above the 120-participant average among 4 other BRCA Mutation trials with a reported enrollment target (275% higher).
The record links to 7 conditions, with BRCA Mutation appearing as the primary indexed condition, and to 1 intervention - of which Olaparib 300mg tablets is the first listed.
NCT01844986 names 20 study sites across 9 states, led by California, Florida, Georgia.
Frequently Asked Questions
What is clinical trial NCT01844986 about?
NCT01844986 is a clinical study titled "Olaparib Maintenance Monotherapy in Patients With BRCA Mutated Ovarian Cancer Following First Line Platinum Based Chemotherapy.". Olaparib Monotherapy in Patients with BRCA Mutated Ovarian Cancer following First Line Platinum Based Chemotherapy.
What is the current status of trial NCT01844986?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 450 participants. The study started on 2013-08-26. Estimated completion is 2028-08-29.
What conditions does trial NCT01844986 study?
This clinical trial studies the following conditions: BRCA Mutation, Advanced Ovarian Cancer, Newly Diagnosed, FIGO Stage III-IV, Complete Response.
What interventions are being tested in trial NCT01844986?
The interventions under investigation include: Olaparib 300mg tablets (DRUG).
Who is sponsoring clinical trial NCT01844986?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01844986 being conducted?
This trial has 20 study locations across Alabama, Alaska, Arizona, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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