NCT03462342

Combination ATR and PARP Inhibitor (CAPRI) Trial With AZD6738 and Olaparib in Recurrent Ovarian Cancer

Combination ATR and PARP Inhibitor (CAPRI) Trial With AZD 6738 and Olaparib in Recurrent Ovarian Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 123 (actual)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Investigational agent, AZD6738 will be given in combination with Olaparib to women with recurrent ovarian cancer (platinum-sensitive or platinum-resistant). This study will determine if using Olaparib in combination with AZD6738 is safe and tolerable and also determine the objective response rate and progression free survival of combination of AZD6738 and Olaparib in women with recurrent ovarian cancer in distinct platinum-sensitive and platinum-resistant cohorts.

Conditions

• High Grade Serous Carcinoma

Interventions

Type	Name	Description
DRUG	Olaparib Pill	For Cohorts A, B, and C: 300 mg twice daily by mouth which is taken continuously for 28 days, which is one cycle. Cohort D 1-2: prescribed lower dose of olaparib (100-200mg daily for a 28-day cycle). Three to five dosing schedules will be evaluated. Dose Levels 1-3: olaparib 100 mg twice daily, Days 1-28. For Dose Levels 4-5: 100-200 mg twice daily, Days 1-28. Other dose levels may be considered and will not exceed AZD6738 160mg twice daily by mouth and olaparib 150mg twice daily by mouth.
DRUG	AZD6738	For Cohorts A, B, and C: 160 mg orally once daily for first 7 days of every cycle (Days 1-7 of each 28-day cycle). Cohort D 1-2: Prescribed higher dose of AZD6738 (120-320 mg daily for about 14 days). Three to five dosing schedules will be evaluated. Dose Levels 1-3: 120-160 mg twice daily, Days 1-14, in combination with olaparib twice daily, Days 1-28. Alternatively, AZD6738 at 160 mg once daily Days 1-14 with olaparib at 100-150 mg Days 1-28 may be evaluated. Dose Levels 4-5: Alternative dosing schedule of AZD6738 at 80-160 mg once or twice daily, weekly intermittent schedule (Days 1-5, 8-12, 15-19) in combination with olaparib 100-200 mg twice daily, Days 1-28 may be evaluated. AZD6738 at 160 mg twice daily, Days 1-7 or 240 mg once daily Days 1-14 with olaparib 100-200 mg twice daily Days 1-28 may be evaluated. Other dose levels may be considered and will not exceed AZD6738 160mg twice daily by mouth and olaparib 150mg twice daily by mouth.

Timeline

• Start date: 2018-03-09
• Primary completion: 2025-07-21
• Completion: 2025-07-21
• First posted: 2018-03-12
• Last updated: 2026-04-13

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study