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

Phase 1
18 Years
Not Enrolling

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Trial Information

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

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.

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.

Type of Study:


Study Design:

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

Principal Investigator

Joseph Paul Eder, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute


United States: Food and Drug Administration

Study ID:




Start Date:

March 2004

Completion Date:

December 2005

Related Keywords:

  • Neoplasms
  • Solid tumors
  • Neoplasms



Dana-Farber Cancer Institute Boston, Massachusetts  02115
Massachusetts General Hospital Boston, Massachusetts  02114-2617
Beth Isreal Deaconess Medical Center Boston, Massachusetts  02215