NCT07265739

Losartan and Paclitaxel in Platinum Resistant Ovarian Cancer

A Phase 2 Study of Losartan in Combination With Weekly Paclitaxel in Platinum Resistant Ovarian Cancer

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 27 (estimated)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this Phase II study is to measure the effects of a combination of study drugs, losartan and paclitaxel, on platinum resistant ovarian cancer.

Detailed description

This is a prospective, single-arm, open label study of daily oral losartan in combination with intravenous weekly paclitaxel in patients with platinum resistant ovarian cancer. The primary endpoint of this study is overall response rate (ORR) and the secondary endpoint is progression free survival. The U.S. Food and Drug Administration (FDA) has not approved losartan for this specific disease but it has been approved for other uses. The U.S. Food and Drug Administration (FDA) has approved paclitaxel as a treatment option for this disease. This research study involves screening for eligibility, study treatment with the study drugs, and study visits. Participants will receive study treatment until disease progression, withdrawal, or unacceptable side effects are experienced. Participants that stop study treatment due to disease progression will be followed for 30 days. Participants that stop study treatment due to an unacceptable side effect will have visits and imaging scans every 9 weeks until a different treatment is started. It is expected that about 27 people will take part in this research study.

Conditions

• Platinum Resistant Ovarian Cancer

Interventions

Type	Name	Description
DRUG	losartan	Treatment with losartan will be administered orally once daily starting on day 1 of every 21-day cycle and will be taken continuously throughout the cycle. Losartan is administered at 25 mg a day for the first 7 days of cycle 1. Losartan may be increased to 50 mg daily on day 8 if systolic blood pressure ≥ 120 mm Hg.
DRUG	Paclitaxel	Paclitaxel 80 mg/m2 will be administered as a 60-min intravenous infusion after any premedication as per institutional guidelines. A ramp-up infusion rate is also acceptable as per institutional guidelines. Paclitaxel will be administered on days 1, 8 and 15 of a 21-day cycle and treatment will continue until unacceptable toxicity or disease progression.

Timeline

• Start date: 2026-04-01
• Primary completion: 2027-12-30
• Completion: 2028-12-30
• First posted: 2025-12-05
• Last updated: 2025-12-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study