A Study of Rucaparib in Patients With Metastatic Castration-resistant Prostate Cancer and Homologous Recombination Gene Deficiency

  • Interventional
  • Not Recruiting
  • NCT02952534
Eligibility Details Visit Clinicaltrials.gov

TRITON2: A Multicenter, Open-label Phase 2 Study of Rucaparib in Patients With Metastatic Castration-resistant Prostate Cancer Associated With Homologous Recombination Deficiency

The purpose of this study is to determine how patients with metastatic castration-resistant prostate cancer, and evidence of a homologous recombination gene deficiency, respond to treatment with rucaparib.

Gender
Male

Age Group
18 Years and up

Accepting Healthy Volunteers?
No

Inclusion Criteria:

         - Be 18 years old at the time the informed consent form is signed

         - Have a histologically or cytologically confirmed adenocarcinoma or poorly differentiated carcinoma of the prostate

         - Be surgically or medically castrated, with serum testosterone levels of ≤ 50 ng/dL (1.73 nM)

         - Experienced disease progression after having received at least 1 but no more than 2 prior next-generation androgen receptor-targeted therapies, and 1 prior taxane-based chemotherapy, for castration-resistant disease

         - Have a deleterious mutation in BRCA1/2 or ATM, or molecular evidence of other homologous recombination deficiency

        Exclusion Criteria:

         - Active second malignancy, with the exception of curatively treated non-melanoma skin cancer, carcinoma in situ, or superficial bladder cancer

         - Prior treatment with any PARP inhibitor, mitoxantrone, cyclophosphamide or any platinum-based chemotherapy

         - Symptomatic and/or untreated central nervous system metastases

         - Pre-existing duodenal stent and/or any gastrointestinal disorder or defect that would, in the opinion of the investigator, interfere with absorption of rucaparib

At a Glance

National Government IDNCT02952534

IRB#IRB16-1507

Lead SponsorClovis Oncology, Inc.

Lead PhysicianAkash Patnaik

Collaborator(s)N/A

EligibilityMale
18 Years and up
Not Recruiting