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

This study has been terminated.
Sponsor:
Collaborator:
Information provided by:
Spectrum Pharmaceuticals, Inc
ClinicalTrials.gov Identifier:
NCT00088023
First received: July 19, 2004
Last updated: March 27, 2014
Last verified: March 2014
  Purpose

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
Neoplasms
Drug: PT-523 for Injection
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
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

Resource links provided by NLM:


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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00088023

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

Additional Information:
No publications provided

ClinicalTrials.gov 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
Health Authority: United States: Food and Drug Administration

Keywords provided by Spectrum Pharmaceuticals, Inc:
Solid tumors

ClinicalTrials.gov processed this record on September 18, 2014