NCT01414283

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P50-P75 for phase_1 prostate-cancer

Timeline
Completed

Started Oct 2008

Typical duration for phase_1 prostate-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

August 9, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 11, 2011

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

November 1, 2013

Status Verified

October 1, 2013

Enrollment Period

4.5 years

First QC Date

August 9, 2011

Last Update Submit

October 31, 2013

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

  • Determine the maximum tolerated dose of PSMA ADC

    13 weeks

Study Arms (1)

Arm 1

EXPERIMENTAL
Drug: PSMA ADC

Interventions

PSMA ADCDRUG

PSMA ADC administered IV

Arm 1

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Progenics Pharmaceuticals, Inc.

Tarrytown, New York, 10591, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

PSMA ADC

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Robert J Israel, MD

    Progenics Pharmaceuticals, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 9, 2011

First Posted

August 11, 2011

Study Start

October 1, 2008

Primary Completion

April 1, 2013

Study Completion

September 1, 2013

Last Updated

November 1, 2013

Record last verified: 2013-10

Locations

US(1)