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

Universitaire Ziekenhuizen KU Leuven160 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

160

Conditions

Ovarian Epithelial Cancer

Interventions

OlaparibDRUG

carboplatin + gemcitabine or carboplatin + paclitaxel or carboplatin + liposomal doxorubicin or liposomal doxorubicin 4-weekly or topotecan or paclitaxel weeklyDRUG

physician's choice chemotherapy

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

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

Locations (1)

UZLeuven

Leuven, Belgium

Outcomes

Primary Outcomes

Overall Objective Response

Time frame: 1 year after end inclusion

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.