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

NCT ID: NCT01414296

Last Updated: 2013-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2013-11-30

Brief Summary

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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

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Conditions

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Prostate Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm 1

Group Type EXPERIMENTAL

PSMA ADC

Intervention Type DRUG

PSMA ADC administered IV

Interventions

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PSMA ADC

PSMA ADC administered IV

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. 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.
2. A diagnosis of progressive, castration-resistant, metastatic prostate cancer.
3. Prior chemotherapy regimens, one of which contains taxane.
4. 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. History of drug and/or alcohol abuse
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Progenics Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Robert J Israel, MD

Role: STUDY_DIRECTOR

Progenics Pharmaceuticals, Inc.

Locations

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Progenics Pharmaceuticals, Inc.

Tarrytown, New York, United States

Site Status

Countries

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United States

Other Identifiers

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PSMA ADC 1301EXT

Identifier Type: -

Identifier Source: org_study_id