NCT04598321

BrUOG 390: Neoadjuvant Treatment With Talazoparib

BrUOG 390: Neoadjuvant Treatment With Talazoparib for Women With Newly Diagnosed, Advanced Ovarian Cancer Associated With a Mutation in BRCA1 or BRCA2 (mBRCA)

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Brown University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Ovarian cancer is the most fatal gynecologic cancer; in the US alone an estimated 22,000 women will be diagnosed in 2019, with over 13,000 dying of the disease. Approximately half of epithelial ovarian cancers (EOC) exhibit defective DNA repair through alterations in the homologous recombination (HR) pathway, with 14% accounted for by germline mutations in BRCA genes (mBRCA); this goes up to about one in five (20%) women when one includes tumor-associated (somatic) mBRCA.The approach to women with mBRCA-associated ovarian cancer has heralded precision treatment in our field with the availability of PARP inhibitors. Now indicated as treatment for women with documented mBRCA (genomic or somatic), it also has shown significant benefits for women with recurrent EOC who respond to platinum-based therapy when administered as maintenance treatment.

Conditions

• BRCA1 Mutation
• BRCA2 Mutation
• Ovarian Cancer
• Fallopian Tube Cancer
• High Grade Serous Carcinoma

Interventions

Type	Name	Description
DRUG	Talazoparib Oral Capsule	An orally available PARP inhibitor for the treatment of advanced breast cancer with germline BRCA mutations.

Timeline

• Start date: 2021-03-29
• Primary completion: 2022-11-30
• Completion: 2022-12-06
• First posted: 2020-10-22
• Last updated: 2023-10-12
• Results posted: 2023-10-12

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study