Phase 2 Study in Patients With MiT Tumors

Completed · Phase 2

Conditions studied: Renal Cell Carcinoma (RCC), Alveolar Soft Part Sarcoma (ASPS), Clear Cell Sarcoma (CCS)

In brief

This is a multi-center, single arm intended to evaluate the anti-tumor effect of ARQ 197 in patients with microphthalmia transcription factor associated (MiT) tumors. MiT tumors include clear cell sarcoma, alveolar soft parts sarcoma, and translocation associated renal cell carcinoma.

Key facts

Study ID

NCT00557609

Run by

ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)

People needed

47

Starts

2007-10-01

Expected to finish

2011-02-01

Last updated by the study team

2013-02-08

Who can join

Age: 13 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically or cytologically confirmed unresectable locally advanced or metastatic alveolar soft part sarcoma, clear cell sarcoma, or translocation associated renal cell carcinoma
• ≥13 years old
• Male or female patients of child-producing potential must agree to use double barrier contraception, oral contraceptives or avoidance of pregnancy measures during the study and for 30 days after the last ARQ 197 dose
• Females of childbearing potential must have a negative serum pregnancy test

You may not qualify if…

• Central nervous system metastasis unless it has been stable for ≥ 3 months after treatment and patient has no neural symptoms
• Pregnant or lactating
• Significant gastrointestinal disorder(s), in the opinion of a Investigator, could interfere with the absorption of ARQ 197 (e.g., Crohn's disease, ulcerative colitis, extensive gastric or small bowel resection)
• Unable or unwilling to swallow ARQ 197 capsules twice daily
• Known human immunodeficiency virus (HIV), Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
• Bradycardia at baseline or known history of arrhythmia
• Received ARQ 197 previously

Where it is running

• Study site — San Francisco, California, United States
• Study site — Santa Monica, California, United States
• Study site — Miami, Florida, United States
• Study site — Boston, Massachusetts, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Dallas, Texas, United States
• Study site — Houston, Texas, United States
• Study site — Toronto, Ontario, Canada
• Study site — London, United Kingdom

Full record on ClinicalTrials.gov

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