Olaparib Tablets Maintenance Monotherapy Ovarian Cancer Patients After Complete or Partial Response to Platinum Chemotherapy
- Sponsor
- AstraZeneca
- Study ID
- NCT03534453
- Phase
- PHASE3
- Status
- Completed
Conditions
- Following Complete or Partial Response to Platinum Based Chemotherapy
- Platinum Sensitive
- Relapsed Ovarian Cancer
Eligibility Criteria
- Sex
- FEMALE
- Age
- 18 Years - 130 Years
- Healthy Volunteers
- Not accepted
Interventions
- Olaparib 300mg tablets — DRUG300mg Olaparib tablets taken orally twice daily until objective radiological disease progression as per RECIST as assessed by the investigator (or as long as in the investigator's opinion they are benefiting from treatment and they do not meet any other discontinuation criteria). Dose reduction to 250mg and subsequently 200mg is permitted following confirmation of toxicity.
Study Details
This is a prospective, open-label, single arm, multi-centre interventional study to assess the clinical efficacy and safety of olaparib maintenance monotherapy and will be conducted in patients with platinum sensitive relapsed (PSR) high grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete response or partial response) to platinum-based chemotherapy
Key Dates
- Start date
- May 29, 2018
- Status verified
- Jul 2025
- Primary completion
- Jan 27, 2025
- Completion
- Jan 27, 2025
Study Design
- Enrollment
- 229 participants (actual)
- Allocation
- NON_RANDOMIZED
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Olaparib 300mg tabletsTaken orally twice daily
Primary Outcome Measure
Time from first dosing date of olaparib to date of disease progression or death from any cause (if this occurs before disease progression) [ Time Frame: from first dosing date until objective radiological disease progression by RECIST 1.1, or death from any cause, whichever come first, assessed 45 months. ]