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


Phase 1
18 Years
N/A
Open (Enrolling)
Male
Prostate Cancer

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Determine the maximum tolerated dose of PSMA ADC

Outcome Time Frame:

13 weeks

Safety Issue:

No

Principal Investigator

Robert J Israel, MD

Investigator Role:

Study Director

Investigator Affiliation:

Progenics Pharmaceuticals, Inc.

Authority:

United States: Food and Drug Administration

Study ID:

PSMA ADC 1301

NCT ID:

NCT01414283

Start Date:

October 2008

Completion Date:

May 2013

Related Keywords:

  • Prostate Cancer
  • Prostatic Neoplasms

Name

Location

Progenics Pharmaceuticals, Inc.Tarrytown, New York  10591