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A Phase 1a/1b Study to Evaluate the Safety of EZN-4176, in Adult Patients With Castration-Resistant Prostate Cancer

NCT01337518 · Status: SUSPENDED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2012-12-18

No results posted yet for this study

Summary

This study will evaluate an experimental drug called EZN-4176 to determine the anticancer effects when it is given to patients with an advanced form of prostate cancer called castration-resistant prostate cancer (CRPC). Goals of this phase I study include finding out the dose of EZN-4176 that can be safely given without serious side effects and to determine the amount of EZN-4176 that should be given in future studies.

Conditions

  • Prostatic Neoplasm

Interventions

DRUG

EZN-4176

EZN-4176 can be administered as a weekly one-hour i.v. infusion; weekly for 3 weeks followed by a 1 week rest; or 1 out of 2 weeks (every other week)

Sponsors & Collaborators

  • Enzon Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Aby Buchbinder, MD · Enzon Pharmaceuticals, Inc.

  • Daniel Danila, MD · Memorial Sloan Kettering Cancer Center

  • Johann de Bono, MD · Institute of Cancer Research, Royal Marsden Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2013-12-31
Completion
2013-12-31

Countries

  • United States
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01337518 on ClinicalTrials.gov