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Completed

NCT Number: NCT01414283

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

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Progenics Pharmaceuticals, Inc.

Tarrytown, New York, 10591, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PSMA ADC

Drug

PSMA ADC administered IV

Primary outcomes

  1. Determine the maximum tolerated dose of PSMA ADC

    Time frame: 13 weeks

Sponsors and collaborators

Lead sponsor

Progenics Pharmaceuticals, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2013
Study completion
2013
First posted
Aug 11, 2011
Registry last updated
Nov 1, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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