Clinical Trials/NCT03385655

NCT03385655

Active, Not Recruiting

Phase 2

Prostate Cancer Biomarker Enrichment and Treatment Selection (PC-BETS) Study

Canadian Cancer Trials Group11 sites in 1 country200 target enrollmentAugust 1, 2018

ConditionsProstate Cancer

InterventionsCFI-400945 Ipatasertib Adavosertib Savolitinib Darolutamide Durvalumab and Tremelimumab Carboplatin

DrugsAdavosertib Savolitinib Darolutamide CFI-400945 Ipatasertib Durvalumab and Tremelimumab Carboplatin

Overview

Phase: Phase 2
Intervention: CFI-400945
Conditions: Prostate Cancer
Sponsor: Canadian Cancer Trials Group
Enrollment: 200
Locations: 11
Primary Endpoint: Clinical benefit rate defined as proportion of patients who had PSA decline ≥ 50%, complete or partial objective response, or Stable disease for ≥ 12 weeks.
Status: Active, Not Recruiting
Last Updated: 8 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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

Detailed Description

This testing will be done on a samples of blood to see whether or not patients are eligible to take part in one of the sub-studies. Each study will be looking at what effects a new drug or drugs has on prostate cancer and will also be looking at the side effects of treatment. The purpose of the main studies is to see if the biomarkers that were identified screening samples can help predict which patients are most likely to be helped by that drug or drugs and to see how the cancer cells respond to treatment.

Registry

clinicaltrials.gov

Start Date

August 1, 2018

End Date

December 31, 2025

Last Updated

8 months ago

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

Canadian Cancer Trials Group

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•The following will be required prior to REGISTRATION:
•Patients must have histologically confirmed adenocarcinoma of the prostate without pathologic or clinical evidence (e.g. PSA \< 2.0 μg/L with liver metastases) of small cell neuroendocrine differentiation.
•Patients must consent prior to blood collection for screening correlative testing by a central reference laboratory. The screening blood sample cannot be sent for analysis prior to screening registration.
•All patients must have consented to the release of a tumour block from their primary or metastatic tumour. The centre/pathologist must have agreed to the submission of the specimen(s). Contact CCTG if no archival tissue is available.
•Patients must have evidence of castrate resistance with either biochemical or radiological disease progression in the setting of surgical or medical castration:
•PSA Progression:
•Minimum of two rising PSA values from a baseline measurement with an interval of ≥ 1 week between each measurement
•PSA must be ≥ 2.0 µg/L (ng/mL)
•Objective progression:
•RECIST 1.1, or

Exclusion Criteria

•Patients with a history of other malignancies, except: adequately treated non-melanoma skin cancer, or other solid tumours curatively treated with no evidence of disease for ≥ 2 years.
•Patients with central nervous system (CNS) involvement unless at least 4 weeks from prior therapy completion (including radiation and/or surgery) AND clinically stable and not receiving steroids and/or enzyme-inducing anti-epileptic medications for brain metastases. Patients with epilepsy not due to CNS metastases are eligible as long as no contraindication or concern with drug interactions.
•Patients with serious illnesses or medical conditions which could cause unacceptable safety risks or would not permit the patient to be managed according to the protocol. This includes but is not limited to:
•active infection requiring systemic therapy;
•active or known human immunodeficiency virus (HIV) with detectable viral load;
•uncontrolled or recent clinically significant cardiac disease, including:
•angina pectoris, symptomatic pericarditis, coronary artery bypass grafting, coronary angioplasty, or stenting, or myocardial infarction in the previous 12 months;
•history of documented congestive heart failure (New York Heart Association functional classification III-IV) or cardiomyopathy;
•history of any cardiac arrhythmias, e.g. ventricular, supraventricular, nodal arrhythmias, or conduction abnormality in the previous 12 months;
•patients with uncontrolled hypertension.

Arms & Interventions

CFI400945 PLK4 inhibitor - ARM CLOSED

Intervention: CFI-400945

Ipatasertib AKT inhibitor

Intervention: Ipatasertib

WEE-1 inhibitor - ARM CLOSED

Intervention: Adavosertib

cMET inhibitor

Intervention: Savolitinib

novel non-steroidal androgen receptor (AR) antagonist

Intervention: Darolutamide

Durvalumab and Tremelimumab immunotherapy

Intervention: Durvalumab and Tremelimumab

Carboplatin platinum based chemotherapy

Intervention: Carboplatin

Outcomes

Primary Outcomes

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