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

Sponsor

Universitaire Ziekenhuizen Leuven (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT02822157

Collaborator

AstraZeneca (Industry)

160

Enrollment

Location

Arms

Duration (Months)

1.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ovarian Epithelial Cancer	Drug: Olaparib Drug: carboplatin + gemcitabine or carboplatin + paclitaxel or carboplatin + liposomal doxorubicin or liposomal doxorubicin 4-weekly or topotecan or paclitaxel weekly	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

160 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Aug 1, 2016

Anticipated Primary Completion Date :

Jul 1, 2021

Anticipated Study Completion Date :

Jul 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Olaparib olaparib 300mg oral tablets twice daily for 28 days in 28-day cycles	Drug: Olaparib Other Names: Lynparza
Active Comparator: Chemotherapy physician's choice chemotherapy	Drug: carboplatin + gemcitabine or carboplatin + paclitaxel or carboplatin + liposomal doxorubicin or liposomal doxorubicin 4-weekly or topotecan or paclitaxel weekly physician's choice chemotherapy

Arm

Intervention/Treatment

Experimental: Olaparib

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

Drug: Olaparib

Other Names:

Lynparza

Active Comparator: Chemotherapy

physician's choice chemotherapy

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

physician's choice chemotherapy

Outcome Measures

Primary Outcome Measures

Overall Objective Response [1 year after end inclusion]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

Female

Accepts 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