NCT07060365

A Master Protocol Study to Investigate Biomarker-guided Novel Anticancer Agent(s) as Monotherapy or Combination Therapy in Participants With Advanced/Recurrent Ovarian Cancer

A Master Protocol Phase I/II Study to Investigate Biomarker-Guided Novel Anticancer Agent(s) as Monotherapy or Combination Therapy for the Treatment of Participants With Advanced/Recurrent Ovarian Cancer (Ovarian Platform)

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main purpose of this study is to investigate the safety, tolerability, preliminary efficacy, pharmacokinetics (PK) and pharmacodynamics (PD) of biomarker-guided novel anticancer agent(s) as monotherapy or combination therapy for the treatment of participants with advanced/recurrent ovarian cancer. Substudy 1 will investigate the safety, tolerability, preliminary efficacy, PK and PD of saruparib monotherapy in participants with BReast CAncer gene (BRCA) mutated epithelial ovarian, fallopian tube, or primary peritoneal cancer.

Detailed description

This Phase I/II, open-label, multicentre study will employ a platform design utilising a Master Protocol with multiple parallel, open-label substudies. Substudy 1 is a single-arm, open label, Phase II multicentre study investigating the safety, tolerability, preliminary efficacy, PK, and PD of saruparib monotherapy, as neoadjuvant treatment in participants with newly diagnosed, tBRCA1/2m International Federation of Gynecology and Obstetrics (FIGO) 2014 Stage III/IV epithelial ovarian, fallopian tube, or primary peritoneal cancer, and who are eligible for neoadjuvant treatment with planned interval debulking surgery (IDS).

Conditions

• Advanced/Recurrent Ovarian Cancer

Interventions

Type	Name	Description
DRUG	Saruparib	Participants will receive saruparib via oral administration.

Timeline

• Start date: 2025-09-02
• Primary completion: 2025-12-19
• Completion: 2025-12-19
• First posted: 2025-07-11
• Last updated: 2026-04-03

Locations

1 site across 1 country: Spain

Regulatory

• FDA-regulated drug study