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:
NCT01414283
First received: August 9, 2011
Last updated: September 11, 2012
Last verified: September 2012
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Purpose
Prostate-specific Membrane Antigen Antibody-Drug Conjugate (PSMA ADC) 1301 is an open-label, dose-escalation phase 1 study of PSMA ADC administered IV in subjects with progressive, castration-resistant, metastatic prostate cancer that has progressed after prior taxane therapy. For all subjects, PSMA ADC will be administered in four repeating cycles.
| 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: | A Phase 1 Dose-escalation Study of PSMA ADC 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:
- Determine the maximum tolerated dose of PSMA ADC [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 70 |
| Study Start Date: | October 2008 |
| Estimated Study Completion Date: | May 2013 |
| Estimated Primary Completion Date: | January 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:
- 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
- Any prior treatment with any other therapy targeting PSMA
- History of drug and/or alcohol abuse
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01414283
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: | NCT01414283 History of Changes |
| Other Study ID Numbers: | PSMA ADC 1301 |
| Study First Received: | August 9, 2011 |
| Last Updated: | September 11, 2012 |
| 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 19, 2013