Circulating Tumor DNA Guiding (Olaparib) Lynparza® Treatment in Ovarian Cancer
Phase 2
- Conditions
- Ovarian Epithelial Cancer
- Interventions
- Registration Number
- NCT02822157
- Lead Sponsor
- Universitaire Ziekenhuizen KU Leuven
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 160
Inclusion Criteria
- with recurrent epithelial carcinoma of the ovary, fallopian tube or primary peritoneum
- At least 1 previous line of chemotherapy
- Measurable disease
- Patients have a normal organ and bone marrow function measured within 28 days of randomization
- WHO 0-2
Exclusion Criteria
- Primary platinum-refractory disease
- Known hypersensitivity to olaparib
- Resting ECG with QTc > 470 msec
- Concomitant use of known potent CYP3A4 inhibitors
- Symptomatic uncontrolled brain metastases
- Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Chemotherapy carboplatin + gemcitabine or carboplatin + paclitaxel or carboplatin + liposomal doxorubicin or liposomal doxorubicin 4-weekly or topotecan or paclitaxel weekly physician's choice chemotherapy Olaparib Olaparib olaparib 300mg oral tablets twice daily for 28 days in 28-day cycles
- Primary Outcome Measures
Name Time Method Overall Objective Response 1 year after end inclusion
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
UZLeuven
🇧🇪Leuven, Belgium