Extended Study of Prostate-specific Membrane Antigen Antibody-Drug Conjugate in Subjects With Prostate Cancer
| Status: | Completed |
|---|---|
| Conditions: | Prostate Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 11/18/2012 |
| Start Date: | January 2009 |
| End Date: | October 2013 |
| Contact: | Sandra Narain |
| Email: | snarain@progenics.com |
| Phone: | 914-784-1887 |
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.
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
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