NCT04041128

PARP Inhibition During Pre-surgical Window in Breast/Ovary Cancer

Pre-Surgical Window Pilot Investigation of the Effect of PARP Inhibition on the Cellular and Molecular Changes in Primary Ovarian and Breast Cancer

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: University of Texas Southwestern Medical Center · Academic / Other
• Sex: Female
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

Study involves surgery for cytoreduction or laparoscopy to determine if you are a candidate for tumor debulking or a tissue biopsy. Following this surgery you will receive chemotherapy. This study will administer 7 days of treatment with a targeted therapy called Lynparza. Lynparza and/or other PARP inhibitors have been FDA approved for the treatment of ovarian and breast cancer. Tissue biopsy will be done before a 7 day course of Lynparza in order to correlate molecular changes to response to treatment. Participation in this trial will require an additional tumor biopsy which will occur either before or after treatment of Lynparza.

Conditions

• Ovarian Cancer
• Breast Cancer

Interventions

Type	Name	Description
DRUG	Lynparza	Lynparza taken orally at a dose of 300mg twice daily for 7 days

Timeline

• Start date: 2019-07-23
• Primary completion: 2021-06-15
• Completion: 2021-06-15
• First posted: 2019-08-01
• Last updated: 2023-03-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study