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

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.