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Extended 39-Week Study of PSMA ADC Following the Initial 12-Week Dose-escalation Study 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

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


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

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:

Number of subjects with Adverse Events

Outcome Description:

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

Outcome Time Frame:

39 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 1301EXT

NCT ID:

NCT01414296

Start Date:

January 2009

Completion Date:

October 2013

Related Keywords:

  • Prostate Cancer
  • Prostatic Neoplasms

Name

Location

Progenics Pharmaceuticals, Inc.Tarrytown, New York  10591