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

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. Identifier: NCT01414283
Recruitment Status : Completed
First Posted : August 11, 2011
Last Update Posted : November 1, 2013
Information provided by (Responsible Party):
Progenics Pharmaceuticals, Inc.

Brief Summary:
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 or disease Intervention/treatment Phase
Prostate Cancer Drug: PSMA ADC Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
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
Study Start Date : October 2008
Primary Completion Date : April 2013
Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Arm 1 Drug: PSMA ADC
PSMA ADC administered IV

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

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

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

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 identifier (NCT number): NCT01414283

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

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

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