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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2009-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Prostate Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1.AGS-1C4D4

Group Type EXPERIMENTAL

AGS-1C4D4

Intervention Type DRUG

IV

Interventions

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AGS-1C4D4

IV

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No