Talazoparib and Radiation Therapy in Treating Patients With Locally Recurrent Gynecologic Cancers
NCT03968406 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24
Last updated 2026-03-11
Summary
This phase I trial studies the side effects and best dose of talazoparib in combination with radiation therapy and to see how well they work in treating patients with gynecologic cancers that have come back after previous treatment (recurrent). Talazoparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving talazoparib in combination with radiation therapy may work better in treating patients with gynecologic cancers.
Conditions
- Malignant Female Reproductive System Neoplasm
- Recurrent Cervical Carcinoma
- Recurrent Endometrial Carcinoma
- Recurrent Fallopian Tube Carcinoma
- Recurrent Ovarian Carcinoma
- Recurrent Primary Peritoneal Carcinoma
- Recurrent Vaginal Carcinoma
- Stage IV Cervical Cancer AJCC v8
- Stage IV Fallopian Tube Cancer AJCC v8
- Stage IV Ovarian Cancer AJCC v8
- Stage IV Primary Peritoneal Cancer AJCC v8
- Stage IV Uterine Corpus Cancer AJCC v8
- Stage IV Vaginal Cancer AJCC v8
- Stage IVA Cervical Cancer AJCC v8
- Stage IVA Fallopian Tube Cancer AJCC v8
- Stage IVA Ovarian Cancer AJCC v8
- Stage IVA Primary Peritoneal Cancer AJCC v8
- Stage IVA Uterine Corpus Cancer AJCC v8
- Stage IVA Vaginal Cancer AJCC v8
- Stage IVB Cervical Cancer AJCC v8
- Stage IVB Fallopian Tube Cancer AJCC v8
- Stage IVB Ovarian Cancer AJCC v8
- Stage IVB Primary Peritoneal Cancer AJCC v8
- Stage IVB Uterine Corpus Cancer AJCC v8
- Stage IVB Vaginal Cancer AJCC v8
Interventions
- OTHER
-
Quality-of-Life Assessment
Ancillary studies
- RADIATION
-
Radiation Therapy
Undergo radiation therapy
- DRUG
-
Talazoparib
Given PO
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
M.D. Anderson Cancer Center
lead OTHER
Principal Investigators
-
Lilie L Lin · M.D. Anderson Cancer Center
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-09-26
- Primary Completion
- 2027-10-01
- Completion
- 2027-10-01
- FDA Drug
- Yes
Countries
- United States
Study Locations
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