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

Neoplasms Clinical Trial

Official title:

A Phase I Study of PT-523 in Patients With Solid Tumors

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00088023
• Other study ID #: 02-000
• Secondary ID: DFCI Legacy- 03-
• Status: Terminated
• Phase: Phase 1
• First received: July 19, 2004
• Last updated: March 27, 2014
• Start date: March 2004
• Est. completion date: December 2005

Study information

• Verified date: March 2014
• Source: Spectrum Pharmaceuticals, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 40
• Est. completion date: December 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neoplasms

Intervention

Drug:
• PT-523 for Injection

Locations

Country	Name	City	State
United States	Beth Isreal Deaconess Medical Center	Boston	Massachusetts
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Spectrum Pharmaceuticals, Inc	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,