Trial Information
A Phase 1 Dose-escalation Study of PSMA ADC in Subjects With Progressive, Castration-resistant, Metastatic Prostate Cancer
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Determine the maximum tolerated dose of PSMA ADC
Outcome Time Frame:
13 weeks
Safety Issue:
No
Principal Investigator
Robert J Israel, MD
Investigator Role:
Study Director
Investigator Affiliation:
Progenics Pharmaceuticals, Inc.
Authority:
United States: Food and Drug Administration
Study ID:
PSMA ADC 1301
NCT ID:
NCT01414283
Start Date:
October 2008
Completion Date:
May 2013
Related Keywords:
- Prostate Cancer
- Prostatic Neoplasms
Name | Location |
Progenics Pharmaceuticals, Inc. |
Tarrytown, New York 10591 |