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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01414283
First Posted: August 11, 2011
Last Update Posted: November 1, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Progenics Pharmaceuticals, Inc.
  Purpose
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.

Condition Intervention Phase
Prostate Cancer Drug: PSMA ADC Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Dose-escalation Study of PSMA ADC in Subjects With Progressive, Castration-resistant, Metastatic Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Progenics Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Determine the maximum tolerated dose of PSMA ADC [ Time Frame: 13 weeks ]

Enrollment: 52
Study Start Date: October 2008
Study Completion Date: September 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: PSMA ADC
PSMA ADC administered IV

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01414283


Locations
United States, New York
Progenics Pharmaceuticals, Inc.
Tarrytown, New York, United States, 10591
Sponsors and Collaborators
Progenics Pharmaceuticals, Inc.
Investigators
Study Director: Robert J Israel, MD Progenics Pharmaceuticals, Inc.
  More Information

Responsible Party: Progenics Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01414283     History of Changes
Other Study ID Numbers: PSMA ADC 1301
First Submitted: August 9, 2011
First Posted: August 11, 2011
Last Update Posted: November 1, 2013
Last Verified: October 2013

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases