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

NCT01414296 | Completed Phase 1

• 1 other identifier: PSMA ADC 1301EXT
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Number of subjects with Adverse Events

  Safety and tolerability of PSMA ADC as measured by all adverse events, hematology, blood chemistry, and urine values, vital signs, electrocardiogram, and physical exam.

  39 weeks

Study Arms (1)

Arm 1

EXPERIMENTAL

Drug: PSMA ADC

Interventions

PSMA ADC DRUG

PSMA ADC administered IV

Arm 1

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Progenics Pharmaceuticals, Inc.: lead

Study Sites (1)

Progenics Pharmaceuticals, Inc.

Tarrytown, New York, 10591, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

PSMA ADC

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Robert J Israel, MD

  Progenics Pharmaceuticals, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2011
• First Posted: August 11, 2011
• Study Start: January 1, 2009
• Primary Completion: September 1, 2013
• Study Completion: November 1, 2013
• Last Updated: November 14, 2013

Record last verified: 2013-11

Locations

US (1)