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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
  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
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Progenics Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01414283     History of Changes
Other Study ID Numbers: PSMA ADC 1301
Study First Received: August 9, 2011
Last Updated: October 31, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on November 25, 2014