Prostate-specific Membrane Antigen Antibody-Drug Conjugate in Subjects With Prostate Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Progenics Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01414283
First received: August 9, 2011
Last updated: October 31, 2013
Last verified: October 2013

August 9, 2011
October 31, 2013
October 2008
April 2013   (final data collection date for primary outcome measure)
Determine the maximum tolerated dose of PSMA ADC [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01414283 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Prostate-specific Membrane Antigen Antibody-Drug Conjugate in Subjects With Prostate Cancer
A Phase 1 Dose-escalation Study of PSMA ADC in Subjects With Progressive, Castration-resistant, Metastatic Prostate Cancer

Prostate-specific Membrane Antigen Antibody-Drug Conjugate (PSMA ADC) 1301 is an open-label, dose-escalation phase 1 study of PSMA ADC administered IV in subjects with progressive, castration-resistant, metastatic prostate cancer that has progressed after prior taxane therapy. For all subjects, PSMA ADC will be administered in four repeating cycles.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Prostate Cancer
Drug: PSMA ADC
PSMA ADC administered IV
Experimental: Arm 1
Intervention: Drug: PSMA ADC
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
52
September 2013
April 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. A diagnosis of progressive, castration-resistant, metastatic prostate cancer.
  2. Prior chemotherapy regimens, one of which contains taxane.
  3. Eastern Cooperative Oncology Group status of 0 or 1

Exclusion Criteria:

  1. Clinically significant cardiac disease or severe debilitation pulmonary disease
  2. Evidence of an active infection requiring ongoing antibiotic therapy
  3. Any prior treatment with any other therapy targeting PSMA
  4. History of drug and/or alcohol abuse
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01414283
PSMA ADC 1301
No
Progenics Pharmaceuticals, Inc.
Progenics Pharmaceuticals, Inc.
Not Provided
Study Director: Robert J Israel, MD Progenics Pharmaceuticals, Inc.
Progenics Pharmaceuticals, Inc.
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP