A Phase 2 Study of ARQ 197 in Patients with Microphthalmia Transciption Factor Assciated Tumors

The purpose of this study is to determine the overall response rate in patients with unresectable locally advanced or metastatic alveolar soft parts sarcoma, clear cell sarcoma or translocation associated renal cell carcinoma.  Since this study will allow patients over 13 years of age, it will also be evaluating the safety of ARQ 197 in adolescent and young adult patients with MiT tumors.  Patients will be followed for the effect of the drug in terms of side effects, how it affects their disease, and pharmacokinetic testing.  Pharmacokinetics (PKs) is a method to determine the levels of a drug in the blood and see how the body absorbs, distributes, metabolizes and eliminates it.  This is done by frequent blood draws on key days during the first 4 weeks of treatment.

ARQ 197 is an oral drug in the family of targeted therapies.  It is a c-Met inhibitor and is not approved by the FDA.  In this study, it is an investigational drug.

Eligibility*

Inclusion:

• Age > 13 years old
• Histologically or cytologically confirmed unresectable locally advanced or metastatic alveolar soft part sarcoma, clear cell sarcoma, or translocation associated renal cell carcinoma
• Measurable disease
• Adequate liver, kidney, and bone marrow function

Exclusion:

• Significant GI disorders that could interfere with the absorption of the study drug
• Known HIV, Hep B or C infection

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