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NCT02822157 Clinical Trial

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

Ovarian Epithelial Cancer Clinical Trial

— CLIO  

Official title:
Circulating Tumor DNA Guiding (Olaparib) Lynparza® Treatment in Ovarian

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT02822157
Other study ID # CLIO
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date August 2016
Est. completion date July 2023

Study information
Verified date January 2021
Source Universitaire Ziekenhuizen Leuven
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 160
Est. completion date July 2023
Est. primary completion date July 2021
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 100 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Olaparib

• carboplatin + gemcitabine or carboplatin + paclitaxel or carboplatin + liposomal doxorubicin or liposomal doxorubicin 4-weekly or topotecan or paclitaxel weekly
physician's choice chemotherapy

Locations
Country Name City State
Belgium UZLeuven Leuven

Sponsors (2)
Lead Sponsor Collaborator
Universitaire Ziekenhuizen Leuven AstraZeneca

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary Overall Objective Response 1 year after end inclusion
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