Boston, Massachusetts 02215

  • Neoplasms

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.


Study summary:

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.


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.


Study is Available At:


Original ID:

02-000


NCT ID:

NCT00088023


Secondary ID:

DFCI Legacy- 03-183


Study Acronym:


Brief Title:

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


Official Title:

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


Overall Status:

Terminated


Study Phase:

Phase 1


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Spectrum Pharmaceuticals, Inc


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Non-Randomized, Endpoint Classificatio


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

40


Enrollment Type:


Overall Contact Information

Official Name:Joseph Paul Eder, M.D.
Principal Investigator
Dana-Farber Cancer Institute

Study Dates

Start Date:March 2004
Completion Date:December 2005
Verification Date:March 2014
Last Changed Date:March 27, 2014
First Received Date:July 19, 2004

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Drug
Name:PT-523 for Injection

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Spectrum Pharmaceuticals, Inc
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Cancer Institute (NCI)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: April 03, 2020

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