Phase I Study of Talazoparib with Radiation Therapy for Treating Recurrent Gynecologic Cancers

What this Trial Is About

Researchers are evaluating the combination of talazoparib and radiation therapy in treating patients with gynecologic cancers that have returned after previous treatments. This phase I trial focuses on determining the best dose and side effects of talazoparib given with radiation therapy in patients with ovarian, fallopian tube, primary peritoneal, cervical, vaginal, or endometrial cancer. Talazoparib may work by blocking enzymes needed for tumor cell growth, while radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Participants receive talazoparib orally once daily starting about 7 to 10 days before radiation therapy and continuing for up to 8 weeks, unless the disease worsens or side effects become unacceptable. Radiation therapy is given five days a week Monday to Friday for up to 7 weeks. After treatment, patients are followed for 1 year with visits at 1, 3, 6, 9, and 12 months, then every 6 months for another year. During the study, patients undergo regular assessments to monitor safety, side effects, and the dose patients can tolerate. Researchers also evaluate tumor response and control, time to disease progression, survival, and quality of life, including gastrointestinal side effects. Blood tests, imaging scans, and tumor biopsies may be collected to explore biomarkers and treatment effects. Participation can last up to 2 years for outcome assessments and follow-up.

Talazoparib and Radiation Therapy in Treating Patients With Locally Recurrent Gynecologic Cancers