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Investigator(s):
Shivaani Kummar, M.D. Principal Investigator Phone: 301-435-5402 kummars@mail.nih.gov
Referral Contact(s):
Janelle Bingham, R.N. Research Nurse Phone: 301-435-2715 Fax: 301-451-5433 jbingham@mail.nih.gov	Deborah Allen, R.N., O.C.N. Research Nurse Phone: 301-402-5640 Fax: 301-480-7281 allendeb@mail.nih.gov

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Primary Eligibility:

• Histologically documented solid tumors:
• Pheochromocytoma
• Follicular, medullary, or papillary thyroid
• Colorectal
• Non-small cell lung (excluding squamous cell histology)
• Hepatocellular
• Head and neck
• Renal cell
• Disease progression following prior treatment or disease for which standard curative measures do not exist
• Measurable disease
• Recovered from prior therapy
• Aged ≥ 18 years
• ECOG ≤ 2 (Karnofsky > 60%)
• Absolute neutrophil count ≥ 1,500/mcL
• Platelets ≥ 100,000/mcL
• Total bilirubin ≤ 1.5 institutional upper limit of normal (ULN)
• AST(SGOT)/ALT(SGPT) ≤ 2.5 x ULN
• Creatinine < 1.5 x ULN OR creatinine clearance ≥ 60 mL/min/1.73 m² for patients with creatinine levels ≥ 1.5 x ULN

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Study Outline:

This is an open-label Phase II study of R935788.

• Patients will receive R935788 orally twice a day in 28-day cycles without interruption
• Imaging studies will be obtained every two cycles

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Additional Information:

• This trial will be conducted at the NIH Clinical Center in Bethesda, MD. It is open to patients who meet the eligibility requirements, regardless of where they live in the United States.
• There is no charge for medical care received at NIH Clinical Center.
• FAQs about this study - provides information for patients about the trial such as frequency and duration of visits, costs, how to enroll, treatment plan.
• PDQ (Physicians Data Query) - provides additional details about this study for health care providers.

Reviewed: 9/9/09
Updated: 11/11/09