Extended 39-Week Study of PSMA ADC Following the Initial 12-Week Dose-escalation Study in Subjects With Progressive, Castration-resistant, Metastatic Prostate Cancer
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
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:
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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.
Outcome Time Frame:
Robert J Israel, MD
Progenics Pharmaceuticals, Inc.
United States: Food and Drug Administration
PSMA ADC 1301EXT
- Prostate Cancer
- Prostatic Neoplasms
|Progenics Pharmaceuticals, Inc.||Tarrytown, New York 10591|