Ovarian Epithelial Cancer
Conditions
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.
Interventions
DRUGOlaparib
DRUGcarboplatin + gemcitabine or carboplatin + paclitaxel or carboplatin + liposomal doxorubicin or liposomal doxorubicin 4-weekly or topotecan or paclitaxel weekly
physician's choice chemotherapy
Sponsors
AstraZeneca
Universitaire Ziekenhuizen KU Leuven
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Objective Response | 1 year after end inclusion |
Countries
Belgium
Outcome results
None listed