Trial Information

Summary: A Phase I Study of TRC102 in Combination with Alimta in Patients with Advanced Solid Tumors

The purpose of this study is to determine the safety and tolerability of TRC102 when given in combination with Alimta. The study will assess the effects of this drug combination on patients and their cancers by assessing the patients' side effects and through pharmacokinetics. Pharmacokinetics (PKs) is a way to determine the amount of drug in the patient's blood and to see how the body processes, distributes, metabolizes and eliminates the drug. This is done by frequent blood draws during the first four weeks of treatment.

Pemetrexed (Alimta) is an FDA-approved drug for the treatment of non-small lung cancer and mesothelioma. Alimta is an antifolate, antineoplastic drug. Because it is being used in this study in combination with TRC102, it is considered investigational. TRC102 is an oral, targeted therapy that covalently binds to AP sites in the DNA fromed during the process of base excision repair. This is a mechanism cancer cells use to repair the DNA after damage from chemotherapy. TRC102 is not approved by the FDA and is investigational.

Patient Inclusion Criteria:

• ECOG 0-1
• Resolution of all toxicities to
• INR < 1.5 x ULN

Patient Exclusion Criteria:

• Prior bone marrow transplant
• Clinically significant pericardial, pleural or peritoneal effusions within the past 3 months

Not all eligibility criteria are listed. Additional criteria must be met in order to be eligible.

If you would like to learn more about participating in this study, please send an e-mail message using the form below.