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Treating Metastatic Solid Tumors with an Inherited or Acquired Gene Mutation Using the PARP Inhibitor Talazoparib

Clinicaltrials.gov identifier:
NCT04550494

Treatment
Treatment study for people with advanced solid tumors

Study Contact Information:

Lead Researcher: A.P. Chen, MD
Contact: chenali@mail.nih.gov 
National Cancer Institute Developmental Therapeutics Clinic
Bethesda, MD

Treating Metastatic Solid Tumors with an Inherited or Acquired Gene Mutation Using the PARP Inhibitor Talazoparib

About the Study

This study is looking whether the drug (also known as ) is safe and effective for treating people with advanced solid cancers (including breast, gastric, ovarian, pancreatic, or other ) in people with an (found through genetic testing) or an acquired mutation (found with testing) in , ATR, , , , BAP1, , CDK12, CHEK1, , IDH1, IDH2, MRE11A, , , , RAD51, RAD51B, , , RAD54L or other genes. is a type of known as a . 

This study is open to people who have previously been treated with a treatment and people who have not been previously treated with a . 

What the Study Involves

Participants will receive orally once daily for 28 days. This cycle will be repeated every 28 days as long as there isn’t disease progression or unacceptable side effects. Participants will undergo biopsy at the start of the study and 4 hours after dose on day 1 of cycle 2. Participants can elect to have another biopsy, either at the start of the next cycle or at the time of disease progression.

Study Locations

Florida

  • Gainesville
    University of Florida Health Science Center - Gainesville
    Lead Researcher: Thomas George, MD
    Contact: cancer-center@ufl.edu 

Maryland

  • Bethesda
    National Cancer Institute Developmental Therapeutics Clinic
    Lead Researcher: A.P. Chen, MD
    Contact: chenali@mail.nih.gov 

Oklahoma

  • Oklahoma City
    University of Oklahoma Health Sciences Center
    Lead Researcher: Abdul Rafeh Naqash, MD 
    Contact:  ou-clinical-trials@ouhsc.edu 
This Study is Open To:

Adults with the following may be eligible:

  • (tumor site must be able to be biopsied) and documented inherited or tumor mutations in genes involved in repair, such as:
    • or , , ATR, , BAP1, , CDK12, CHEK1, , IDH1, IDH2, MRE11A, , , , RAD51, RAD51B, , , RAD54L, ARID1A, OR
    •  FANCA, FANCB, FANCC, FANCD2, FANCE, FANCF, FANCG, FANCI, FANCJ, FANCL, FANCM, FANCN
  • Recurrent, locally advanced, or disease; disease has progressed after at least one standard therapy OR no acceptable standard treatment option exists
  • Able to swallow oral medications (tablets or capsules). 
  • Life expectancy > 3 months
  • Patients with ovarian cancer:
    • Should have one prior platinum-based therapy
  • Patients with pancreatic cancer:
    • Should have received prior platinum-containing therapy
  • Patients with breast cancer:
    • Patients with HER2+ breast cancer should have had 2 prior therapies for cancer, including anti-HER2 therapy
    • Patients who are eligible for a must have had prior treatment (except - patients who have previously received are ineligible for the study)
  • Patients with gastric cancer:
    • Patients with HER2+ gastric cancer should have had received anti-HER2 therapy for cancer
  • Patients with cancer:
    • Patients who are eligible for a must have had prior treatment (except - patients who have previously received are ineligible for the study)
This Study is Not Open To:

People with the following may not be eligible: 

  • people must wait 4 weeks after chemotherapy or radiation to start the study or 6 weeks for nitrosoureas or mitomycin C.
    • Must be at least 2 weeks since any prior administration of a study drug in another trial and be at least 1 week from palliative radiation therapy.
    • Patients who have had prior monoclonal antibody therapy must have completed that therapy at least 6 weeks prior to enrollment in the study.
  • had prior treatment with .
  • receiving any other investigational agents.
  • active brain metastases or carcinomatous meningitis.
  • illnesses such as ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness.
  • pregnant people and people who are currently lactating.
  • people who require the use of anticoagulants such as warfarin.
  • history of prior cancer within the past 3 years (other than certain types of skin cancers that have been controlled).
  • HIV-infected patients on effective antiretroviral therapy with undetected viral load within 6 months are eligible.