Prostate-specific Membrane Antigen Antibody-Drug Conjugate in Subjects With Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

A Phase 1 Dose-escalation Study of PSMA ADC in Subjects With Progressive, Castration-resistant, Metastatic Prostate Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01414283
• Other study ID #: PSMA ADC 1301
• Status: Completed
• Phase: Phase 1
• First received: August 9, 2011
• Last updated: October 31, 2013
• Start date: October 2008
• Est. completion date: September 2013

Study information

• Verified date: October 2013
• Source: Progenics Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: September 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. A diagnosis of progressive, castration-resistant, metastatic prostate cancer.

2. Prior chemotherapy regimens, one of which contains taxane.

3. 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. Any prior treatment with any other therapy targeting PSMA

4. History of drug and/or alcohol abuse

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• PSMA ADC
PSMA ADC administered IV

Locations

Country	Name	City	State
United States	Progenics Pharmaceuticals, Inc.	Tarrytown	New York

Sponsors (1)

Lead Sponsor	Collaborator
Progenics Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine the maximum tolerated dose of PSMA ADC		13 weeks	No