Studienregister

Studienregister der Deutschen Gesellschaft für Urologie e.V.

TRITON 2_CO-338-052

AcronymISRCTNEudraCTClinicaltrials.govDRKS
CO-338-0522016-003162-13NCT02952534

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

Status: Active

Purpose / Objectives

Primary Outcome

  1. Objective Response Rate (ORR) [ Time Frame: From enrollment to primary completion of study (up to approximately 3 years) ]
  2. Prostate Specific Antigen (PSA) Response [ Time Frame: From enrollment to primary completion of study (up to approximately 3 years) ]

Secondary Outcomes

  1. Duration of Response (DOR) [ Time Frame: From enrollment to completion of study (up to approximately 3 years and 6 months) ]
  2. Radiologic Progression-free Survival (rPFS) [ Time Frame: From enrollment to completion of study (up to approximately 3 years and 6 months) ]
  3. Overall Survival (OS) [ Time Frame: From enrollment to completion of study (up to approximately 3 years and 6 months) ]
  4. Clinical Benefit Rate (CBR), defined as the percentage of patients with a complete response (CR), partial response (PR) or stable disease (SD) according to modified RECIST 1.1 with no progression in bone per PCWG3 criteria [ Time Frame: From enrollment to primary completion of study (up to approximately 3 years) ]
  5. Time to PSA Progression [ Time Frame: From enrollment to primary completion of study (up to approximately 3 years) ]
  6. Trough plasma PK (Cmin) of rucaparib based on sparse sampling [ Time Frame: From enrollment to completion of study (up to approximately 3 years and 6 months) ]
  7. Safety and tolerability of rucaparib assessed by AEs reported; clinical laboratory investigations; Vital signs; 12-lead ECGs; Physical examinations; and ECOG performance status [ Time Frame: From enrollment to completion of study (up to approximately 3 years and 6 months) ]
    This is a composite outcome. It will be assessed by incidence, type, seriousness, and severity of AEs reported; clinical laboratory investigations (hematology, serum chemistry and urinalysis); Vital signs (blood pressure, heart rate, and body temperature); 12 lead ECGs; Physical examinations; and ECOG performance status

Diagnosis

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.

Patient attributes

Stage

metastatic, castration resistant

Age

18-

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

 

Trial design

  • Phase II
  • Multicenter
  • Prospective
  • One-arm
  • Open Label

Intervention

Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

 

 

Documents (password protected)

Responsibilities in overall trial

Clovis Oncology, Inc.

  • Tel. 303 625 5000
  • Fax 303 245 0360

Sponsor representative

BSc, MB ChB, MRCP, FFPM Lindsey Rolfe

    National Coordinating Investigator

    PD Dr. Axel Merseburger

    Monitoring

    Novella Clinical

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