Prostate Cancer Biomarker Enrichment and Treatment Selection

Summary

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

Conditions

• Prostate Cancer

Interventions

DRUG

Adavosertib

250mg, may dose escalate to 300mg if no drug-related GI tox in cycle 1

DRUG

Savolitinib

600mg once daily, orally.

DRUG

Darolutamide

600mg twice daily, orally.

DRUG

CFI-400945

Dose level assigned at enrollment, starting at 32mg/day on Days 1-7 and 15-21 or 15-28 depending on toxicity experienced.

DRUG

Ipatasertib

400mg daily 3 weeks on, 1 week off

DRUG

Durvalumab and Tremelimumab

Durvalumab 1500mg day 1 every 4 weeks; Tremelimumab 225mg day 1 cycle 1

DRUG

Carboplatin

AUC 5 IV 60min Day 1 q 21 days

Sponsors & Collaborators

• Canadian Cancer Clinical Trials Network

  collaborator UNKNOWN

• BC Cancer Foundation

  collaborator OTHER

• Canadian Cancer Trials Group

  lead NETWORK

Principal Investigators

• Michael Kolinsky · Cross Cancer Institute, Edmonton, AB Canada

• Som Mukherjee · Juravinski Cancer Centre at Hamilton Health Sciences Centre, ON Canada

• Michael Ong · Ottawa Hospital Research Institute, Ottawa, ON Canada

• Kim Chi · BCCA - Vancouver Cancer Centre

• Aaron Hansen · University Health Network, Toronto, ON, Canada

• Sebastien Hotte · Juravinski Cancer Centre at Hamilton Health Sciences, Hamilton, ON Canada

• Zineb Hamilou · CHUM-Centre Hospitalier de l'Universite de Montreal

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-08-01

Primary Completion

2024-10-07

Completion

2025-12-31

Countries

• Canada

Study Locations