Actively Recruiting
Talazoparib and Radiation Therapy in Treating Patients With Locally Recurrent Gynecologic Cancers
Led by M.D. Anderson Cancer Center · Updated on 2026-03-11
24
Participants Needed
2
Research Sites
418 weeks
Total Duration
On this page
Sponsors
M
M.D. Anderson Cancer Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Talazoparib and Radiation Therapy in Treating Patients With Locally Recurrent Gynecologic Cancers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent before any study procedures
- Histologically confirmed recurrent ovarian, fallopian tube, primary peritoneal, endometrial, vaginal, or cervical cancer in abdomen or pelvis
- Stage IV disease allowed if disease outside radiation area is undetectable or stable for at least 3 months and immediate chemotherapy is not needed
- Willing to stop chemotherapy, immunotherapy, biologic therapy, and targeted therapies at least 3 weeks before starting study treatment
- Hemoglobin 10.0 g/dL or higher with no blood transfusions in past 28 days
- Absolute neutrophil count (ANC) 1.5 x 10^9/L or higher
- No signs of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML) on blood smear
- White blood cell count over 3 x 10^9/L
- Platelet count 100 x 10^9/L or higher
- Total bilirubin less than or equal to 1.5 times institutional upper limit of normal (ULN)
- AST and ALT less than or equal to 2.5 times ULN, or up to 5 times ULN if liver metastases present
- Serum creatinine less than or equal to 1.5 times ULN
- ECOG performance status 0-1 or minimum life expectancy of 16 weeks if ECOG 2 or higher
- Life expectancy of at least 16 weeks
- Non-childbearing status confirmed by negative pregnancy test within 28 days before treatment
- Women of childbearing potential willing to use two forms of effective birth control
- Willing and able to follow study protocol including treatment and scheduled visits
- At least one measurable lesion not previously irradiated, suitable for repeated measurement
- Consent to tumor biopsies for biomarker studies (optional)
You will not qualify if you...
- Presence of ascites, peritoneal carcinomatosis, or liver metastases
- Prior radiotherapy to planned radiation area
- Chemotherapy, radiotherapy, endocrine therapy, immunotherapy, or investigational agents within 3 weeks before treatment
- Previous participation in this study
- Participation in another investigational study within last 4 weeks
- Second primary cancer except certain treated skin, cervical, or solid tumors without evidence of disease for 5 or more years
- Receiving any systemic chemotherapy or radiotherapy
- Current use of CYP3A4 inhibitors or P-glycoprotein (P-gp) inhibitors/inducers or breast cancer resistance protein (BCRP) inhibitors
- Persistent toxicities grade 2 or higher from previous cancer therapy except hair loss
- Abnormal ECG with prolonged QT interval or family history of long QT syndrome
- Diagnosis of myelodysplastic syndrome or acute myeloid leukemia
- Symptomatic uncontrolled brain metastases
- Major surgery within 14 days before starting study treatment
- Serious uncontrolled medical conditions or active infections
- Unable to swallow oral medication or gastrointestinal disorders affecting absorption
- Breastfeeding women
- Known allergy to talazoparib or its ingredients
- Uncontrolled seizures
- Need for pelvic and para-aortic radiotherapy
- Isolated vaginal relapse without pelvic or abdominal disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, United States, 21287
Actively Recruiting
2
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
L
Lilie Lin
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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