Actively Recruiting
Phase I Study of Talazoparib with Radiation Therapy for Locally Recurrent Gynecologic Cancers
Led by M.D. Anderson Cancer Center · Updated on 2026-03-11
24
Participants Needed
2
Research Sites
N/A
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
Researchers are evaluating the combination of talazoparib and radiation therapy in treating patients with gynecologic cancers that have returned after previous treatments. This phase I trial focuses on determining the best dose and side effects of talazoparib given with radiation therapy in patients with ovarian, fallopian tube, primary peritoneal, cervical, vaginal, or endometrial cancer. Talazoparib may work by blocking enzymes needed for tumor cell growth, while radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Participants receive talazoparib orally once daily starting about 7 to 10 days before radiation therapy and continuing for up to 8 weeks, unless the disease worsens or side effects become unacceptable. Radiation therapy is given five days a week (Monday to Friday) for up to 7 weeks. After treatment, patients are followed for 1 year with visits at 1, 3, 6, 9, and 12 months, then every 6 months for another year. During the study, patients undergo regular assessments to monitor safety, side effects, and the dose patients can tolerate. Researchers also evaluate tumor response and control, time to disease progression, survival, and quality of life, including gastrointestinal side effects. Blood tests, imaging scans, and tumor biopsies may be collected to explore biomarkers and treatment effects. Participation can last up to 2 years for outcome assessments and follow-up.
CONDITIONS
Brief 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 study procedures
- Histologically confirmed recurrent ovarian, fallopian tube, primary peritoneal, endometrial, vaginal, or cervical cancer in abdomen and pelvis
- Stage IV disease allowed if no new or stable disease outside radiation area for at least 3 months
- Willingness to stop other cancer treatments at least 3 weeks before starting study therapy
- Hemoglobin level of 10.0 g/dL or higher with no blood transfusions in past 28 days
- Absolute neutrophil count of at least 1.5 x 10^9/L
- No signs of myelodysplastic syndrome or acute myeloid leukemia in blood
- White blood cell count over 3 x 10^9/L
- Platelet count of at least 100 x 10^9/L
- Total bilirubin less than or equal to 1.5 times the normal limit
- Liver enzymes AST and ALT less than or equal to 2.5 times normal, or up to 5 times if liver metastases present
- Serum creatinine less than or equal to 1.5 times normal
- ECOG performance status 0 or 1, or life expectancy of at least 16 weeks if ECOG is not met
- Negative pregnancy test for women of childbearing potential and use of effective birth control methods
- Ability and willingness to follow study procedures and visits
- At least one measurable lesion not previously irradiated (≥10 mm or lymph nodes ≥15 mm)
- Consent for tumor biopsy for biomarker studies (optional)
You will not qualify if you...
- Presence of ascites, peritoneal carcinomatosis, or liver metastases
- Prior radiation therapy in planned treatment area
- Use of chemotherapy, radiotherapy, endocrine therapy, immunotherapy, or investigational agents within 3 weeks before study
- Previous enrollment in this study
- Participation in another clinical trial with investigational product within last 4 weeks
- Second primary cancer except certain treated types with no disease for 5+ years
- Current systemic chemotherapy or radiotherapy
- Use of certain CYP3A4 or P-gp inhibitors or inducers
- Persistent side effects grade 2 or higher from previous cancer treatment except hair loss
- Abnormal ECG with prolonged QT interval or family history of long QT syndrome
- Myelodysplastic syndrome or acute myeloid leukemia
- Symptomatic uncontrolled brain metastases
- Major surgery within 14 days before study treatment
- Serious uncontrolled medical conditions or infections
- Inability to swallow oral medication or gastrointestinal absorption issues
- Breastfeeding women
- Known allergies to talazoparib or its ingredients
- Uncontrolled seizures
- Need for pelvic and para-aortic radiotherapy
- Isolated vaginal relapse without other pelvic or abdominal disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) to assess eligibility
Duration - 3 to 4 days
Participants begin taking talazoparib orally once daily starting 7 to 10 days before radiation therapy begins.
Daily oral medication before radiation therapy starts
Duration - Up to 8 weeks
Participants receive talazoparib orally once daily for up to 8 weeks while undergoing radiation therapy 5 days a week (Monday through Friday) for up to 7 weeks.
Radiation therapy visits 5 days per week (Monday-Friday) plus daily oral medication
Duration - Up to 2 years
Participants are monitored after completing treatment to assess safety and cancer status.
Visits at 1, 3, 6, 9, and 12 months, then every 6 months up to 2 years
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
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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