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Recruiting Phase 1 NCT03968406

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

Trial Parameters

Condition Malignant Female Reproductive System Neoplasm
Sponsor M.D. Anderson Cancer Center
Study Type INTERVENTIONAL
Phase Phase 1
Enrollment 24
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2019-09-26
Completion 2027-10-01
All 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
Quality-of-Life AssessmentRadiation TherapyTalazoparib

Brief 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.

Eligibility Criteria

Inclusion Criteria: * Provision of informed consent prior to any study specific procedures * Histologically-confirmed recurrent ovarian, fallopian tube, primary peritoneal cancer, endometrial, vaginal, or cervical cancer in the abdomen and pelvis * Subjects with stage IV disease are eligible as long as disease elsewhere (other than the site(s) to receive radiation therapy \[RT\]) is undetectable or stable (\>= 3 months) and immediate chemotherapy is not required. Willingness to discontinue any cytotoxic chemotherapeutic agents, immunotherapy, biologic therapy, and targeted therapies at least three weeks prior to start of investigational therapy * Hemoglobin \>= 10.0 g/dL and no blood transfusions in the 28 days prior to entry/randomization (choose whichever is most applicable to the study) (within 28 days prior to administration of study treatment) * Absolute neutrophil count (ANC) \>= 1.5 x 10\^9/L (within 28 days prior to administration of study treatment) * No features suggestive of

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