Terminated/Withdrawn
Sponsor ID
20190505

Safety and Efficacy of Therapies for Metastatic Castration-resistant Prostate Cancer (mCRPC)

Sponsor ID
20190505
Clinicaltrials.gov ID
NCT04631601
EUCTIS ID
N/A
EudraCT ID
2020-001305-23

Study Details

This is a master protocol designed to evaluate the safety and efficacy of investigational therapies in participants with metastatic castration-resistant prostate cancer (mCRPC).

Additional Study Details

Phase
Phase 1/Phase 2
Product
AMG 160
Type
Interventional
Masking
None (Open Label)
Enrollment
55
Additional Study Details

Protocol Summary

Primary Outcome Measures

Dose exploration only: Number of participants who experience dose limiting toxicities (DLTs)

Timeframe: Up to 3 years

Number of participants who experience one or more treatment-emergent adverse events (TEAEs)

Timeframe: Up to 3 years

Number of participants who experience one or more treatment-related adverse events

Timeframe: Up to 3 years

Number of participants who experience a clinically significant change in vital signs

Timeframe: Up to 3 years

Number of participants who experience a clinically significant change in clinical laboratory tests

Timeframe: Up to 3 years

Secondary Outcome Measures

Objective response rate per response evaluation criteria in solid tumors (RECIST) 1.1 with prostate cancer working group 3 (PCWG3) modifications

Timeframe: Up to 3 years

Number of participants who experience circulating tumor cell (CTC) response

Timeframe: Up to 3 years

Number of participants who experience prostate-specific antigen (PSA) response rate

Timeframe: Up to 3 years

Duration of response

Timeframe: Up to 3 years

Overall survival (OS)

Timeframe: Up to 3 years

Progression-free survival

Timeframe: Up to 3 years

Time to progression

Timeframe: Up to 3 years

Time to subsequent therapy

Timeframe: Up to 3 years

Maximum plasma concentration (Cmax)

Timeframe: Up to 3 years

Minimum plasma concentration (Cmin)

Timeframe: Up to 3 years

Area under the concentration-time curve (AUC)

Timeframe: Up to 3 years

Accumulation ratio based on area under the concentration-time curve (AUC)

Timeframe: Up to 3 years

Half-life (t1/2)

Timeframe: Up to 3 years

Change from baseline in prostate-specific membrane antigen (PSMA)-positive tumor burden assessed using gallium (GA) 68-labelled PSMA-11 positron emission tomography/computed tomography (PET/CT)

Timeframe: Baseline up to 3 years

Change from baseline in prostate-specific membrane antigen (PSMA)-negative disease burden assessed using 18F-fluorodeoxyglucose (F-FDG) positron emission tomography/computed tomography (PET/CT)

Timeframe: Baseline to 3 years

Time to symptomatic skeletal events

Timeframe: Up to 3 years

Concentration of alkaline phosphatase

Timeframe: Up to 3 years

Concentration of lactate dehydrogenase (LDH)

Timeframe: Up to 3 years

Concentration of hemoglobin

Timeframe: Up to 3 years

Neutrophil-to-lymphocyte ratio

Timeframe: Up to 3 years

Concentration of N-telopeptide in the urine

Timeframe: Up to 3 years

Locations

Location
Status
Contact Us
Location
University of Texas MD Anderson Cancer Center
Houston, TX, United States, 77030
Status
Recruiting
Location
Norton Cancer Institute
Louisville, KY, United States, 40207
Status
Recruiting
Location
Clinica Universidad de Navarra
Pamplona, Navarra, Spain, 31008
Status
Recruiting
Location
Akademiska sjukhuset
Uppsala, Sweden, 75185
Status
Recruiting
Location
Rigshospitalet
Kobenhavn O, Denmark, 2100
Status
Recruiting
Location
St Vincents Hospital Sydney
Darlinghurst, NSW, Australia, 2010
Status
Recruiting
Showing {first} - {last} of {total} Results