Circulating Tumor DNA Guiding (Olaparib) Lynparza® Treatment in Ovarian Cancer

• Status: Active, not recruiting
• Trial end date: 2023-07-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Universitaire Ziekenhuizen Leuven
• Collaborator: AstraZeneca
• Treatments: Carboplatin; Doxorubicin; Gemcitabine; Liposomal doxorubicin; Olaparib; Paclitaxel; Topotecan

Criteria

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