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: Recruiting
Location: See all (23) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ Master Protocol:

• Participants who have histologically or cytologically documented advanced or recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer, considered to be suitable for treatment with study intervention, as applicable to each substudy.

• Participants must provide sufficient archival or fresh tumour sample for biomarker testing.

• Life expectancy at the time of screening ≥ 12 weeks in the opinion of the Investigator.

• Measurable disease as per RECIST 1.1 criteria: at least one lesion that can be accurately measured at baseline as ≥ 10 mm in the longest diameter.

• ECOG PS of 0 to 1, with no deterioration over the previous 2 weeks prior to baseline at screening, and prior to study intervention administration.

• Adequate organ and marrow function.

⁃ Substudy 1:

• Participants must have histologically or cytologically confirmed newly diagnosed FIGO 2014 Stage III/IV epithelial ovarian\*, fallopian tube, or primary peritoneal cancer who are eligible for neoadjuvant treatment with planned IDS.

• Participants who are treatment-naïve.

• Participants with evidence of predicted loss of function tBRCA1/2m (by local testing) as assessed by a commercially available diagnostic test.

Locations
United States
California
Research Site
RECRUITING
Fullerton
New Mexico
Research Site
RECRUITING
Albuquerque
New York
Research Site
WITHDRAWN
New York
Research Site
WITHDRAWN
New York
Oklahoma
Research Site
NOT_YET_RECRUITING
Oklahoma City
South Dakota
Research Site
RECRUITING
Sioux Falls
Washington
Research Site
NOT_YET_RECRUITING
Seattle
Wisconsin
Research Site
WITHDRAWN
Milwaukee
Other Locations
Italy
Research Site
NOT_YET_RECRUITING
Milan
Research Site
RECRUITING
Milan
Research Site
NOT_YET_RECRUITING
Milan
Research Site
RECRUITING
Milan
Research Site
NOT_YET_RECRUITING
Monza
Research Site
RECRUITING
Ravenna
Research Site
RECRUITING
Rome
Republic of Korea
Research Site
RECRUITING
Goyang
Research Site
RECRUITING
Seoul
Research Site
NOT_YET_RECRUITING
Seoul
Research Site
RECRUITING
Seoul
Spain
Research Site
RECRUITING
Barcelona
Research Site
NOT_YET_RECRUITING
Barcelona
Research Site
NOT_YET_RECRUITING
Valencia
Research Site
NOT_YET_RECRUITING
Valencia
Contact Information
Primary
AstraZeneca Clinical Study Information Center
information.center@astrazeneca.com
1-877-240-9479
Time Frame
Start Date: 2025-09-02
Estimated Completion Date: 2029-05-29
Participants
Target number of participants: 30
Treatments
Experimental: Saruparib
Participants will receive saruparib via oral administration.
Related Therapeutic Areas
Sponsors
Leads: AstraZeneca
Collaborators: Parexel

This content was sourced from clinicaltrials.gov

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