Extended Study of Prostate-specific Membrane Antigen Antibody-Drug Conjugate in Subjects With Prostate Cancer
This study is ongoing, but not recruiting participants.
Sponsor:
Progenics Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Progenics Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01414296
First received: August 9, 2011
Last updated: January 25, 2013
Last verified: January 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Drug: PSMA ADC |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Extended 39-Week Study of PSMA ADC Following the Initial 12-Week Dose-escalation Study in Subjects With Progressive, Castration-resistant, Metastatic Prostate Cancer |
Resource links provided by NLM:
Further study details as provided by Progenics Pharmaceuticals, Inc.:
Primary Outcome Measures:
- Number of subjects with Adverse Events [ Time Frame: 39 weeks ] [ Designated as safety issue: No ]Safety and tolerability of PSMA ADC as measured by all adverse events, hematology, blood chemistry, and urine values, vital signs, electrocardiogram, and physical exam.
| Estimated Enrollment: | 70 |
| Study Start Date: | January 2009 |
| Estimated Study Completion Date: | October 2013 |
| Estimated Primary Completion Date: | October 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Arm 1 |
Drug: PSMA ADC
PSMA ADC administered IV
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01414296
Locations
| United States, New York | |
| Progenics Pharmaceuticals, Inc. | |
| Tarrytown, New York, United States, 10591 | |
Sponsors and Collaborators
Progenics Pharmaceuticals, Inc.
Investigators
| Study Director: | Robert J Israel, MD | Progenics Pharmaceuticals, Inc. |
More Information
No publications provided
| Responsible Party: | Progenics Pharmaceuticals, Inc. |
| ClinicalTrials.gov Identifier: | NCT01414296 History of Changes |
| Other Study ID Numbers: | PSMA ADC 1301EXT |
| Study First Received: | August 9, 2011 |
| Last Updated: | January 25, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male |
Prostatic Diseases Antibodies, Monoclonal Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 21, 2013