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Completed

NCT Number: NCT01414296

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

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.

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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

  • 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

Exclusion criteria

  • 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

Treatment and study plan

PSMA ADC

Drug

PSMA ADC administered IV

Primary outcomes

  1. Number of subjects with Adverse Events

    Time frame: 39 weeks

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

Sponsors and collaborators

Lead sponsor

Progenics Pharmaceuticals, Inc.

Industry

Registry information

Official study title

Extended 39-Week Study of PSMA ADC Following the Initial 12-Week Dose-escalation Study in Subjects With Progressive, Castration-resistant, Metastatic Prostate Cancer

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Aug 11, 2011
Registry last updated
Nov 14, 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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