NCT00088023

Brief Summary

The purpose of this study is to determine the safety of a short intravenous infusion of PT-523 to patients with solid tumors who have failed curative or survival prolonging therapy or for whom no such therapies exist.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Mar 2004

Geographic Reach
1 country

3 active sites

Status
terminated

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

March 1, 2004

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 19, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 20, 2004

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
Last Updated

March 31, 2014

Status Verified

March 1, 2014

First QC Date

July 19, 2004

Last Update Submit

March 27, 2014

Conditions

Neoplasms

Keywords

Solid tumors

Interventions

PT-523 for InjectionDRUG

Eligibility Criteria

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

You may qualify if:

  • Presence of metastatic or inoperable malignancy, other than leukemia or a primary central nervous system (CNS) tumor, for which there is no known curative or survival prolonging palliative therapy, or failure of these therapies .
  • Age greater than or equal to 18 years.
  • Life expectancy greater than or equal to 2 months.
  • ECOG performance status 0 - 2.
  • Adequate organ function and bone marrow reserve.
  • Use of appropriate contraceptive method.
  • Sign patient informed consent.

You may not qualify if:

  • Active brain metastases.
  • Presence of third-space fluid collections (pleural effusion, ascites).
  • Major surgery within 3 weeks prior to dosing.
  • Prior chemotherapy or radiation therapy within 3 weeks prior to dosing (6 weeks for nitrosoureas or mitomycin-C). Prior antifolate therapy is permitted, as long as it has not been administered within 3 weeks prior to dosing with PT-523.
  • Prior bone marrow transplantation.
  • Presence of uncontrolled serious medical or psychiatric illness.
  • Patients requiring radiation therapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Beth Isreal Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Related Links

MeSH Terms

Conditions

Neoplasms

Interventions

N(alpha)-(4-amino-4-deoxypteroyl)-N(delta)-hemiphthaloyl-L-ornithineInjections

Intervention Hierarchy (Ancestors)

Drug Administration RoutesDrug TherapyTherapeutics

Study Officials

  • Joseph Paul Eder, M.D.

    Dana-Farber Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

July 19, 2004

First Posted

July 20, 2004

Study Start

March 1, 2004

Study Completion

December 1, 2005

Last Updated

March 31, 2014

Record last verified: 2014-03

Locations

US(3)