A Master Protocol Evaluating the Safety and Efficacy of Therapies for Metastatic Castration-resistant Prostate Cancer

Phase 1

Active, not recruiting

• Conditions: Metastatic Castration-resistant Prostate Cancer; MedDRA version: 21.1Level: LLTClassification code 10076506Term: Castration-resistant prostate cancerSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2020-001305-23-IT
• Lead Sponsor: AMGEN INC.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-08
• Last Update Posted: 9 January 2023

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: Male
• Target Recruitment: 105

Inclusion Criteria

All Subprotocols
- Subjects with mCRPC with histologically or cytologically confirmed adenocarcinoma of the prostate without pure neuroendocrine differentiation or small cell features
- Subjects should have undergone bilateral orchiectomy or should be on continuous androgen deprivation therapy with a gonadotropin releasing hormone agonist or antagonist
- Total serum testosterone should be <= 50 ng/dL (or 1.7 nmol/L)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 – 1
- Life expectancy of > 3 months

*Please refer to protocol for the full list
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 53
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 52

Exclusion Criteria

All Subprotocols
- Pathological finding consistent with pure small cell, neuroendocrine carcinoma of the prostate or any other histology different from adenocarcinoma
- CNS metastases or leptomeningeal disease
- Symptomatic peripheral sensory or motor neuropathy >= grade 3
- History or presence of clinically relevant CNS pathology
- Confirmed history/current autoimmune disease or other diseases resulting in permanent immunosuppression or requiring permanent immunosuppressive therapy
- Presence of fungal, bacterial, viral, or other infection requiring IV antimicrobials (Subprotocol A&B) / active fungal, bacterial, viral, or other infection requiring systemic therapy (Subprotocol C) within 7 days of dosing
- History/evidence of inflammatory bowel disease or any other GI disorder causing chronic nausea, vomiting, or diarrhea
- History of arterial or venous thrombosis within 12 months of first dose
- Myocardial infarction, uncontrolled hypertension (Subprotocol A&C), unstable angina, cardiac arrhythmia requiring medication, and/or symptomatic congestive heart failure (New York Heart Association > class II) within 12 months (Subprotocol A&B) / within 6 months (Subprotocol C) of first dose of AMG 160

*Please refer to protocol for the full list

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified