Circulating Tumor DNA Guiding (Olaparib) Lynparza® Treatment in Ovarian Cancer
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
- Study ID
- NCT02822157
- Phase
- PHASE2
- Status
- Unknown
Conditions
- Ovarian Epithelial Cancer
Eligibility Criteria
- Sex
- FEMALE
- Age
- 18 Years - 100 Years
- Healthy Volunteers
- Not accepted
Interventions
- Olaparib — DRUG
- carboplatin + gemcitabine or carboplatin + paclitaxel or carboplatin + liposomal doxorubicin or liposomal doxorubicin 4-weekly or topotecan or paclitaxel weekly — DRUGphysician's choice chemotherapy
Study Details
This is a randomized, open-label, two-arm study in patients with relapsed epithelial ovarian tumors. Patients will be randomized in a 1:1 ratio to receive olaparib or standard chemotherapy with the possibility of crossover at the time of progression.
Key Dates
- Start date
- Aug 31, 2016
- Status verified
- Jan 2021
- Primary completion
- Jul 31, 2021
- Completion
- Jul 31, 2023
Study Design
- Enrollment
- 160 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- CROSSOVER
- Primary purpose
- TREATMENT
Arms
- Experimental: Olaparibolaparib 300mg oral tablets twice daily for 28 days in 28-day cycles
- Active Comparator: Chemotherapyphysician's choice chemotherapy
Primary Outcome Measure
Overall Objective Response [ Time Frame: 1 year after end inclusion ]