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

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Progenics Pharmaceuticals, Inc.

ClinicalTrials.gov Identifier:

NCT01414283

First received: August 9, 2011

Last updated: September 11, 2012

Last verified: September 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

August 9, 2011

Last Updated Date

September 11, 2012

Start Date ^ICMJE

October 2008

Estimated Primary Completion Date

January 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Determine the maximum tolerated dose of PSMA ADC [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01414283 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

A Phase 1 Dose-escalation Study of PSMA ADC in Subjects With Progressive, Castration-resistant, Metastatic Prostate Cancer

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Prostate Cancer

Intervention ^ICMJE

Drug: PSMA ADC

PSMA ADC administered IV

Study Arm (s)

Experimental: Arm 1

Intervention: Drug: PSMA ADC

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

May 2013

Estimated Primary Completion Date

January 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

Clinically significant cardiac disease or severe debilitation pulmonary disease
Evidence of an active infection requiring ongoing antibiotic therapy
Any prior treatment with any other therapy targeting PSMA
History of drug and/or alcohol abuse

Gender

Male

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01414283

Other Study ID Numbers ^ICMJE

PSMA ADC 1301

Has Data Monitoring Committee

Responsible Party

Progenics Pharmaceuticals, Inc.

Study Sponsor ^ICMJE

Progenics Pharmaceuticals, Inc.

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Robert J Israel, MD

Progenics Pharmaceuticals, Inc.

Information Provided By

Progenics Pharmaceuticals, Inc.

Verification Date

September 2012

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

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