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

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT03968406
Phase
PHASE1
Status
Recruiting
Apply to this trial

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Quality-of-Life Assessment — OTHER
    Ancillary studies
  • Radiation Therapy — RADIATION
    Undergo radiation therapy
  • Talazoparib — DRUG
    Given PO

Study Details

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.

Key Dates

Start date
Sep 26, 2019
Status verified
Mar 2026
Primary completion
Oct 1, 2027
Completion
Oct 1, 2027

Study Design

Enrollment
24 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (talazoparib, radiation therapy)
    Patients receive talazoparib PO QD beginning on days -10 to -7 and continuing for up to 8 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo radiation therapy 5 days a week (Monday-Friday) for up to 7 weeks.

Primary Outcome Measure

Maximum tolerated dose (MTD) [ Time Frame: Up to 30 days ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Johns Hopkins University/Sidney Kimmel Cancer CenterBaltimoreMaryland21287
Jessica Leitzel
[email protected]
410-502-9242
Stéphanie Gaillard, MD PhD (PRINCIPAL_INVESTIGATOR)
M D Anderson Cancer CenterHoustonTexas77030
Lilie L. Lin
[email protected]
713-563-2300
Lilie L. Lin (PRINCIPAL_INVESTIGATOR)

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By research site
Johns Hopkins University/Sidney Kimmel Cancer Center· Baltimore, MDM D Anderson Cancer Center· Houston, TX

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