A Phase I Study of PT-523 in Patients With Solid Tumors
Data Collection
Treatment Study
Summary
Study start date: March 1, 2004
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.40 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.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 Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 3 locations
Dana-Farber Cancer Institute
Boston, United StatesBeth Isreal Deaconess Medical Center
Boston, United States