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Safety Study of PT-523 in Cancer Patients to Treat Solid Tumors Including a Preliminary Assessment of Effectiveness

This study has been terminated.
National Cancer Institute (NCI)
Information provided by:
Spectrum Pharmaceuticals, Inc Identifier:
First received: July 19, 2004
Last updated: March 27, 2014
Last verified: March 2014
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.

Condition Intervention Phase
Drug: PT-523 for Injection
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Study of PT-523 in Patients With Solid Tumors

Further study details as provided by Spectrum Pharmaceuticals, Inc:

Estimated Enrollment: 40
Study Start Date: March 2004
Estimated Study Completion Date: December 2005
Detailed Description:

The primary objectives of this study are 1) to evaluate the safety of a short intravenous infusion of PT-523 when administered on days 1, 8, and 15 of a 28-day cycle to patients with solid tumors who have failed curative or survival prolonging therapy or for whom no such therapies exist; and 2) to establish the maximum tolerated dose (MTD) and identify the dose limiting toxicities (DLT) of PT-523.

The secondary objectives of this study are to determine the pharmacokinetics and to evaluate preliminary efficacy of PT-523.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

There are no limitations on the extent or type of prior therapy received by the patient other than the time intervals indicated above, as long as the patient has demonstrated complete recovery from any adverse effects, and fulfills all relevant inclusion criteria.

  Contacts and Locations
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Please refer to this study by its identifier: NCT00088023

United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Beth Isreal Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Spectrum Pharmaceuticals, Inc
National Cancer Institute (NCI)
Principal Investigator: Joseph Paul Eder, M.D. Dana-Farber Cancer Institute
  More Information

Additional Information: Identifier: NCT00088023     History of Changes
Other Study ID Numbers: 02-000
DFCI Legacy- 03-183
CTEP Grant No.- UO1-CA62490-09
NSC No.- 712783
Study First Received: July 19, 2004
Last Updated: March 27, 2014

Keywords provided by Spectrum Pharmaceuticals, Inc:
Solid tumors processed this record on May 25, 2017