Vanderbilt-Ingram Cancer Center

This is an open label extension protocol for patients who have been treated in previous ARQ 197 studies that have reached their designated end-dates. Patients enrolled in this extension protocol will continue to receive either ARQ 197 as monotherapy or in combination with other drug(s) at the same dose(s), and same schedule(s) in which they were originally enrolled. This extension study is designed to further evaluate the safety and tolerability of ARQ 197 monotherapy or in combination with other drug(s) when given to patients who tolerated previous treatment well and may benefit from the continuing treatment.

Criteria
 Inclusion Criteria:

 • Signed written informed consent to Study ARQ 197-299

 • Male or female subjects of the age defined in the original protocol they were enrolled.

 • Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤3

 • Adequate bone marrow function:

 • Absolute neutrophil count (ANC) ≥1.5 x 10^9/L

 • Hemoglobin ≥8.0 g/dL

 • Enrollment within 14 days of the completion of End of Study Visit of the original study

 • Subjects, who participated in previous ARQ 197 studies that have reached their designated end-dates, who did not meet discontinuation criteria in their original study, and who may, in the opinion of the Investigator and the Sponsor, benefit from treatment

 • Women of childbearing potential must have a negative pregnancy test performed within 14 days of the start of study drug. Both men and women enrolled in this study must agree to use adequate birth control measures while on study

 Exclusion Criteria:

 • Known or suspected allergy to ARQ 197

 • Substance abuse, medical, psychological or social conditions that may interfere with the subject's participation in the study or evaluation of the study results

 • Any condition that is unstable or which could jeopardize the safety of the subject and his/her compliance in the study

 • A serious uncontrolled medical disorder/condition that in the opinion of the Investigator would impair the ability of the subject to receive protocol therapy

 • Requirement to receive other concurrent chemotherapy (excluding combination therapy defined in original protocol), immunotherapy, radiotherapy, or any other investigational drug while on study. Palliative radiotherapy is allowed provided that:

 • in the opinion of the Investigator, the subject does not have progressive disease

 • the radiation field does not encompass a target lesion

 • no more than 10% of the subject's bone marrow is irradiated