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

Astellas

Status and phase: Completed; Phase 1

Conditions: Prostate Cancer

Treatments: Drug: AGS-1C4D4

Study type: Interventional

Funder types: Industry

Identifiers

NCT00519233

MK4721-003

2007_535

2007001

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 13 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

13 participants in 1 patient group

1.AGS-1C4D4

Experimental group

Treatment:

Drug: AGS-1C4D4