Talazoparib and Radiation Therapy in Treating Patients With Locally Recurrent Gynecologic Cancers (NCT03968406) | Clinical Trial Compass
RecruitingPhase 1
Talazoparib and Radiation Therapy in Treating Patients With Locally Recurrent Gynecologic Cancers
United States24 participantsStarted 2019-09-26
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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 myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) on peripheral blood smear (within 28 days prior to administration of study treatment)
* White blood cells (WBC) \> 3 x 10\^9/L (within 28 days prior to administration of study treatment)
* Platelet count \>= 100 x 10\^9/L (within 28 days prior to administration of study treatment)
* Total bilirubin =\< 1.5 x institutional upper limit of normal (ULN) (within 28 days prior to administration of study treatment)
* Aspartate aminotransfera…