Extended 39-Week Study of PSMA ADC Following the Initial 12-Week Dose-escalation Study in Subjects With Progressive, Castration-resistant, Metastatic Prostate Cancer
Phase 1
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Male
Prostate Cancer
Male
Prostate Cancer
Trial Information
Extended 39-Week Study of PSMA ADC Following the Initial 12-Week Dose-escalation Study in Subjects With Progressive, Castration-resistant, Metastatic Prostate Cancer
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
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:
Number of subjects with Adverse Events
Outcome 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.
Outcome Time Frame:
39 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 1301EXT
NCT ID:
NCT01414296
Start Date:
January 2009
Completion Date:
October 2013
Related Keywords:
- Prostate Cancer
- Prostatic Neoplasms
Name | Location |
|---|---|
| Progenics Pharmaceuticals, Inc. | Tarrytown, New York 10591 |
