NCT06617923

Study of Senaparib in Combination With Temozolomide in ARID1A Mutation Associated Ovarian Cancer

A Phase 2 Study of Senaparib in Combination With Temozolomide in ARID1A Mutation Associated Ovarian Cancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase 2 study to test the effectiveness (anti-tumor activity) of the combination of the study drugs, Senaparib and Temozolomide, in patients with clear cell or endometrioid ovarian cancers that have ARID1A pathologic variants.

Detailed description

This is a single-arm phase 2, two-stage, non-randomized multicenter Phase 2 study designed to evaluate the clinical activity (response frequency) of senaparib and temozolomide (TMZ) in patients with recurrent or persistent clear cell or endometrioid ovarian cancer. Up to 18 adult female subjects will be enrolled and receive senaparib 80mg orally daily Days 1-28 and TMZ 20mg daily Days 1-21 of a 28 day cycle. Tumor assessments will be performed every 8 weeks for first 3 cycles then every 12 weeks thereafter until progressive disease is confirmed. Treatment will continue until either unacceptable toxicity, progression of disease, or withdrawal of consent.

Conditions

• Ovary Cancer
• Fallopian Tube Cancer
• Primary Peritoneal Cavity Cancer

Interventions

Type	Name	Description
DRUG	Senaparib	Participants will receive orally 80mg daily Days 1-28 of a 28 day cycle.
DRUG	Temozolomide	Participants will receive orally 20mg daily Days 1-21 of a 28 day cycle.

Timeline

• Start date: 2025-02-06
• Primary completion: 2027-10-01
• Completion: 2029-12-01
• First posted: 2024-10-01
• Last updated: 2025-10-27

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study