Prostate Cancer Biomarker Enrichment and Treatment Selection

Sponsor
Canadian Cancer Trials Group
Study ID
NCT03385655
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • Adavosertib — DRUG
    250mg, may dose escalate to 300mg if no drug-related GI tox in cycle 1
  • Savolitinib — DRUG
    600mg once daily, orally.
  • Darolutamide — DRUG
    600mg twice daily, orally.
  • CFI-400945 — DRUG
    Dose level assigned at enrollment, starting at 32mg/day on Days 1-7 and 15-21 or 15-28 depending on toxicity experienced.
  • Ipatasertib — DRUG
    400mg daily 3 weeks on, 1 week off
  • Durvalumab and Tremelimumab — DRUG
    Durvalumab 1500mg day 1 every 4 weeks; Tremelimumab 225mg day 1 cycle 1
  • Carboplatin — DRUG
    AUC 5 IV 60min Day 1 q 21 days

Study Details

The purpose of the pre-study screening is to test for DNA abnormalities or biomarkers.

Key Dates

Start date
Aug 1, 2018
Status verified
Aug 2025
Primary completion
Oct 7, 2024
Completion
Dec 31, 2025

Study Design

Enrollment
200 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: WEE-1 inhibitor - ARM CLOSED
  • Experimental: cMET inhibitor
  • Experimental: novel non-steroidal androgen receptor (AR) antagonist
  • Experimental: CFI400945 PLK4 inhibitor - ARM CLOSED
  • Experimental: Ipatasertib AKT inhibitor
  • Experimental: Durvalumab and Tremelimumab immunotherapy
  • Experimental: Carboplatin platinum based chemotherapy

Primary Outcome Measure

Clinical benefit rate defined as proportion of patients who had PSA decline ≥ 50%, complete or partial objective response, or Stable disease for ≥ 12 weeks. [ Time Frame: 2 years ]

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