Trial Information

Summary: A Phase I Study of XL518 in Subjects with Advanced Solid Tumors

The purpose of this study is to evaluate the safety and tolerability of daily oral administration of XL518 in subjects with solid tumors. The study will also determine the maximum dose of XL518 that can be given to patients while assessing the drug's effect on the patient and his or her cancer. Pharmacokinetics (PKs) will be done to determine levels of XL518 in the blood and to study how the body processes the drug by looking at how the body absorbs, distributes, metabolizes, and eliminates it.

XL518 is an oral targeted therapy that works by inhibiting the MEK pathway within the cancer cell. XL518 is not approved by the FDA and is considered an investigational drug.

Patient Inclusion Criteria:

• Patients who have received > 3 cytotoxic chemotherapy regimens or > 2 biologic regimens will be reviewed with sponsor for suitability to participate in the study
• Cortisol level > 20 after ACTH Stimulation Test

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

Patient Exclusion Criteria:

• Radiation of > 3000 cGy to 25% of the bone marrow
• Prolonged QTc interval on EKG
• Currently on anticoagulation

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