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Extended Study of 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.
ClinicalTrials.gov Identifier: NCT01414296
Recruitment Status : Completed
First Posted : August 11, 2011
Last Update Posted : November 14, 2013
Information provided by (Responsible Party):
Progenics Pharmaceuticals, Inc.

Brief Summary:
Prostate-specific Membrane Antigen Antibody-Drug Conjugate (PSMA ADC) 1301EXT is an open-label, nonrandomized, phase 1 extension study of PSMA ADC administered IV in subjects with progressive CMPC that has progressed after prior taxane therapy. Subjects who have participated in PSMA ADC 1301 and who, in the opinion of the PI, are likely to benefit from continued treatment with PSMA ADC will be enrolled in PSMA ADC 1301EXT.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Extended 39-Week Study of PSMA ADC Following the Initial 12-Week Dose-escalation Study in Subjects With Progressive, Castration-resistant, Metastatic Prostate Cancer
Study Start Date : January 2009
Primary Completion Date : September 2013
Study Completion Date : November 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. Number of subjects with Adverse Events [ Time Frame: 39 weeks ]
    Safety and tolerability of PSMA ADC as measured by all adverse events, hematology, blood chemistry, and urine values, vital signs, electrocardiogram, and physical exam.

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. Subjects who have completed the PSMA ADC 1301 study and who, in the opinion of the investigator, have derived benefit from treatment with PSMA ADC.
  2. A diagnosis of progressive, castration-resistant, metastatic prostate cancer.
  3. Prior chemotherapy regimens, one of which contains taxane.
  4. 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. 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 ClinicalTrials.gov identifier (NCT number): NCT01414296

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.
ClinicalTrials.gov Identifier: NCT01414296     History of Changes
Other Study ID Numbers: PSMA ADC 1301EXT
First Posted: August 11, 2011    Key Record Dates
Last Update Posted: November 14, 2013
Last Verified: November 2013

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