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

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

August 9, 2011
August 11, 2011
November 14, 2013
January 2009
September 2013   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01414296 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Extended Study of Prostate-specific Membrane Antigen Antibody-Drug Conjugate in Subjects With Prostate Cancer
Extended 39-Week Study of PSMA ADC Following the Initial 12-Week Dose-escalation Study in Subjects With Progressive, Castration-resistant, Metastatic Prostate Cancer
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.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Prostate Cancer
Drug: PSMA ADC
PSMA ADC administered IV
Experimental: Arm 1
Intervention: Drug: PSMA ADC
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
70
November 2013
September 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Male
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01414296
PSMA ADC 1301EXT
No
Not Provided
Not Provided
Progenics Pharmaceuticals, Inc.
Progenics Pharmaceuticals, Inc.
Not Provided
Study Director: Robert J Israel, MD Progenics Pharmaceuticals, Inc.
Progenics Pharmaceuticals, Inc.
November 2013

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