• Return to search results
• Start new search

Investigator(s):
Ramaprasad Srinivasan, M.D. Principal Investigator Phone: 301-496-6353 ramasrin@mail.nih.gov	W. Marston Linehan, M.D. Phone: 301-496-6353 linehanm@mail.nih.gov
Referral Contact(s):
Martha Ninos, R.N. Research Nurse Phone: 301-435-8897 mninos@mail.nih.gov

---

Primary Eligibility:

• Metastatic papillary renal cell carcinoma or bilateral multifocal papillary renal cell carcinoma localized to the kidneys
• Measurable disease defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan
• ≥ 18 years of age
• ECOG status ≤ 2
• Availability of unstained slides and /or paraffin block of tumor tissue (except subjects with documented germline c-Met mutations where tissue is not required)
• Serum cortisol level ≥ 20 µg/dL by adrenocorticotropic hormone stimulation test
• QTc < 470 msec
• ANC ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³
• Hemoglobin ≥ 9 g/dL
• Total bilirubin ≤ 1.5 mg/dL
• Creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 60 mL/min
• ALT and AST ≤ 2.5 x the upper limit of normal (ULN) (5 x ULN with liver involvement)
• ≥ 14 days since prior radiotherapy to ≥ 25% of bone marrow
• No more than one prior anticancer therapy
• No prior systemic anticancer therapy, including cytotoxic chemotherapy, anti-VEGF, anti-VEGFR agents, or investigational drugs within 14 days of the first dose of study drug
• No prior c-Met inhibitor therapy
• No other concurrent investigational or commercial agents or therapies
• No known brain metastasis
• No uncontrolled illness, including
• ongoing or active infection
• symptomatic congestive heart failure
• unstable angina pectoris
• cardiac arrhythmia
• systolic blood pressure (BP) > 140 mm Hg or diastolic BP > 90 mm Hg for > 24 hours or resulting in symptoms
• No psychiatric illness or social situations that would preclude study compliance
• Not pregnant or nursing
• Must use effective contraception
• No other malignancy within the past 5 years except nonmelanoma skin cancer; no current evidence of disease
• No concurrent antiviral therapy for HIV-positive patients
• No allergy or hypersensitivity to components of XL880

---

Treatment Plan:

This is a multicenter, open label, non-randomized, single-arm study. Patients are stratified according to c-Met germline mutations (present vs. absent).

• Patients receive oral GSK 1363089/ XL880 daily in 2-week cycles
• Patients may continue GSK 1363089 /XL880 for up to 2 years in the absence of disease progression or unacceptable toxicity, at the discretion of the investigator
• Blood samples are collected at baseline for c-Met germline mutational analysis
• Blood and tumor tissue samples may be collected periodically for pharmacodynamic, pharmacokinetic, and genetic and protein expression analysis
• During the study treatment period (first 8 weeks), patients will return to NIH for evaluation every week; during the treatment extension period (beyond the first 8 weeks), patients will be evaluated at NIH at least every 4 weeks

---

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: 12/4/08
Updated: 1/13/09