- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01414283
Prostate-specific Membrane Antigen Antibody-Drug Conjugate in Subjects With Prostate Cancer
October 31, 2013 updated by: Progenics Pharmaceuticals, Inc.
A Phase 1 Dose-escalation Study of PSMA ADC in Subjects With Progressive, Castration-resistant, Metastatic Prostate Cancer
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
52
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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New York
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Tarrytown, New York, United States, 10591
- Progenics Pharmaceuticals, Inc.
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm 1
|
PSMA ADC administered IV
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Determine the maximum tolerated dose of PSMA ADC
Time Frame: 13 weeks
|
13 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Robert J Israel, MD, Progenics Pharmaceuticals, Inc.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2008
Primary Completion (Actual)
April 1, 2013
Study Completion (Actual)
September 1, 2013
Study Registration Dates
First Submitted
August 9, 2011
First Submitted That Met QC Criteria
August 10, 2011
First Posted (Estimate)
August 11, 2011
Study Record Updates
Last Update Posted (Estimate)
November 1, 2013
Last Update Submitted That Met QC Criteria
October 31, 2013
Last Verified
October 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PSMA ADC 1301
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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