Extended Study of Prostate-specific Membrane Antigen Antibody-Drug Conjugate in Subjects With Prostate Cancer
- Registration Number
- NCT01414296
- Lead Sponsor
- Progenics Pharmaceuticals, Inc.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 10
Inclusion Criteria
- 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.
- A diagnosis of progressive, castration-resistant, metastatic prostate cancer.
- Prior chemotherapy regimens, one of which contains taxane.
- Eastern Cooperative Oncology Group status of 0 or 1
Exclusion Criteria
- Clinically significant cardiac disease or severe debilitation pulmonary disease
- Evidence of an active infection requiring ongoing antibiotic therapy
- History of drug and/or alcohol abuse
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Arm 1 PSMA ADC -
- Primary Outcome Measures
Name Time Method Number of subjects with Adverse Events 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Progenics Pharmaceuticals, Inc.
🇺🇸Tarrytown, New York, United States