AGS-1C4D4 in Patients With Advanced Hormone Refractory Prostate Cancer

Phase 1CompletedNCT00519233

Astellas Pharma Inc13 enrolled

Overview

The present study will investigate the safety, tolerability and spectrum of side effects of AGS-1C4D4. As such, this study will characterize the dose limiting toxicities (DLT) and potentially the maximum tolerated dose (MTD) of AGS-1C4D4 in patients with advanced HRPC.

Cohorts of 1-6 patients will be administered AGS-1C404 in sequentially rising dose levels. Dose escalation will continue until the MTD of AGS-1C4D4 is established or the maximum planned dose is reached.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Prostate Cancer

Interventions

AGS-1C4D4DRUG

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patient has hormone-refractory metastatic prostate cancer Exclusion Criteria: * Patient has had chemotherapy, radiotherapy, or biological therapy within the past 4 weeks or has not recovered from side effects * Patient is currently participating or has participated in an investigational study within the past 30 days * Patient has illness or circumstance that could limit compliance with the study requirements * Patient uses illicit drugs or had a recent history of drug or alcohol abuse within the last year * Patient has Hepatitis B or C

Locations (2)

Unnamed facility

Baltimore, Maryland, United States

Unnamed facility

New York, New York, United States

Outcomes

Primary Outcomes

Safety, tolerability and side effects of AGS-1C4D4 in adult patients with advanced HRPC.

Time frame: 3 Months

Secondary Outcomes

The pharmacokinetic profile of AGS-1C4D4 in adult patients with advanced HRPC.

Time frame: 3 Months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.