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

Universitaire Ziekenhuizen KU Leuven

Status and phase: Unknown; Phase 2

Conditions: Ovarian Epithelial Cancer

Treatments: Drug: Olaparib; Drug: carboplatin + gemcitabine or carboplatin + paclitaxel or carboplatin + liposomal doxorubicin or liposomal doxorubicin 4-weekly or topotecan or paclitaxel weekly

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02822157

CLIO

Details and patient eligibility

About

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.

Enrollment: 160 patients

Sex: Female

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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160 participants in 2 patient groups

Olaparib

Experimental group

Description:

olaparib 300mg oral tablets twice daily for 28 days in 28-day cycles

Treatment:

Drug: Olaparib

Chemotherapy

Active Comparator group

Description:

physician's choice chemotherapy

Treatment:

Drug: carboplatin + gemcitabine or carboplatin + paclitaxel or carboplatin + liposomal doxorubicin or liposomal doxorubicin 4-weekly or topotecan or paclitaxel weekly