Back to resultsExtended Study of Prostate-specific Membrane Antigen Antibody-Drug Conjugate in Subjects With Prostate Cancer
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
PSMA ADC
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer
Eligibility Criteria
Inclusion Criteria:
- 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.
- 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
- History of drug and/or alcohol abuse
Sites / Locations
- Progenics Pharmaceuticals, Inc.
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Arm 1
Arm Description
Outcomes
Primary Outcome Measures
Number of subjects with Adverse Events
Safety and tolerability of PSMA ADC as measured by all adverse events, hematology, blood chemistry, and urine values, vital signs, electrocardiogram, and physical exam.
Secondary Outcome Measures
Full Information
NCT ID
NCT01414296
First Posted
August 9, 2011
Last Updated
November 12, 2013
Sponsor
Progenics Pharmaceuticals, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01414296
Brief Title
Extended Study of Prostate-specific Membrane Antigen Antibody-Drug Conjugate in Subjects With Prostate Cancer
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 Type
Interventional
2. Study Status
Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
November 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Progenics Pharmaceuticals, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
PSMA ADC
Intervention Description
PSMA ADC administered IV
Primary Outcome Measure Information:
Title
Number of subjects with Adverse Events
Description
Safety and tolerability of PSMA ADC as measured by all adverse events, hematology, blood chemistry, and urine values, vital signs, electrocardiogram, and physical exam.
Time Frame
39 weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
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
History of drug and/or alcohol abuse
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert J Israel, MD
Organizational Affiliation
Progenics Pharmaceuticals, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Progenics Pharmaceuticals, Inc.
City
Tarrytown
State/Province
New York
ZIP/Postal Code
10591
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Extended Study of Prostate-specific Membrane Antigen Antibody-Drug Conjugate in Subjects With Prostate Cancer
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