OncoMatch/Clinical Trials/NCT03968406
Talazoparib and Radiation Therapy in Treating Patients With Locally Recurrent Gynecologic Cancers
Is NCT03968406 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies Talazoparib for malignant female reproductive system neoplasm.
Treatment: Talazoparib — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Cervical Cancer
Endometrial Cancer
Ovarian Cancer
Disease stage
Required: Stage IV, IVA, IVB
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: radiotherapy
Exception: prior radiotherapy in the region of planned radiotherapy
Prior radiotherapy in the region of planned radiotherapy
Cannot have received: chemotherapy
Exception: within the 3 weeks prior to start of therapy
Chemotherapy, radiotherapy, endocrine therapy, immunotherapy or use of other investigational agents within the 3 weeks prior to start of therapy
Cannot have received: radiotherapy
Exception: within the 3 weeks prior to start of therapy
Chemotherapy, radiotherapy, endocrine therapy, immunotherapy or use of other investigational agents within the 3 weeks prior to start of therapy
Cannot have received: endocrine therapy
Exception: within the 3 weeks prior to start of therapy
Chemotherapy, radiotherapy, endocrine therapy, immunotherapy or use of other investigational agents within the 3 weeks prior to start of therapy
Cannot have received: immunotherapy
Exception: within the 3 weeks prior to start of therapy
Chemotherapy, radiotherapy, endocrine therapy, immunotherapy or use of other investigational agents within the 3 weeks prior to start of therapy
Cannot have received: investigational agent
Exception: within the 3 weeks prior to start of therapy
Chemotherapy, radiotherapy, endocrine therapy, immunotherapy or use of other investigational agents within the 3 weeks prior to start of therapy
Lab requirements
Blood counts
Hemoglobin >= 10.0 g/dL and no blood transfusions in the 28 days prior to entry/randomization; ANC >= 1.5 x 10^9/L; WBC > 3 x 10^9/L; Platelet count >= 100 x 10^9/L; No features suggestive of myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) on peripheral blood smear
Kidney function
Serum creatinine <= 1.5 x institutional upper limit of normal (ULN)
Liver function
Total bilirubin <= 1.5 x institutional upper limit of normal (ULN); AST/ALT <= 2.5 x ULN unless liver metastases are present in which case <= 5 x ULN
Hemoglobin >= 10.0 g/dL and no blood transfusions in the 28 days prior to entry/randomization... ANC >= 1.5 x 10^9/L... WBC > 3 x 10^9/L... Platelet count >= 100 x 10^9/L... Total bilirubin <= 1.5 x institutional upper limit of normal (ULN)... AST/ALT <= 2.5 x ULN unless liver metastases are present in which case <= 5 x ULN... Serum creatinine <= 1.5 x institutional upper limit of normal (ULN)... Resting ECG with corrected QT (QTc) > 470 msec on 2 or more time points within a 24 hour period or family history of long QT syndrome [excluded]
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Johns Hopkins University/Sidney Kimmel Cancer Center · Baltimore, Maryland
- M D Anderson Cancer Center · Houston, Texas
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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