Phase Ib Study of Olaparib Plus Weekly Carboplatin and Paclitaxel in Relapsed Ovarian Cancer

PHASE1/PHASE2UnknownINTERVENTIONAL
Enrollment

52

Participants

Timeline

Start Date

August 31, 2012

Primary Completion Date

December 31, 2018

Study Completion Date

December 31, 2019

Conditions
Stage III Ovarian CancerStage IV Ovarian CancerUterine Cancer
Interventions
DRUG

Olaparib

Olaparib will be administered orally on Days 1, 2, and 3 of each week until DLT or disease progression. A minimum of 3 patients will be enrolled into each cohort. The anticipated dose escalation sequence of olaparib is 50, 100, 150 and 200 mg, taken twice a day will be used.

DRUG

Carboplatin

AUC 2 weekly for 3 weeks of a 4 week cycle. For patients who experience a complete response, the carboplatin and paclitaxel will be discontinued and olaparib monotherapy (400 mg, taken twice a day) will continue until disease progression and as long as the investigator feels they are benefiting from the treatment.

DRUG

Paclitaxel

60mg/m2 weekly for 3 weeks of a 4 week cycle. For patients who experience a complete response, the carboplatin and paclitaxel will be discontinued and olaparib monotherapy (400 mg, taken twice a day) will continue until disease progression and as long as the investigator feels they are benefiting from the treatment.

Trial Locations (5)

98026

Swedish Cancer Institute Edmonds Campus, Edmonds

98029

Swedish Cancer Institute Issaquah Campus, Issaquah

98104

Pacific Gynecology Specialists, Seattle

Swedish Medical Center Cancer Institute, Seattle

98107

Swedish Cancer Institute Ballard Campus, Seattle

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

AstraZeneca

INDUSTRY

lead

Swedish Medical Center

OTHER