- Hematology/Medical Oncology
Area of focus i
- Kidney cancer (renal cancer)
Accepting New Patients
Experimental: Arm A - vismodegib
Patients receive vismodegib PO QD. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Intervention: Drug: vismodegib
Experimental: Arm B - GSK2256098
Patients receive FAK inhibitor GSK2256098 PO BID. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Intervention: Drug: GSK2256098
* A female of childbearing potential is a sexually mature female who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months)Eastern Cooperative Oncology Group (ECOG) performance status =< 2 Patient history: Patients with history of neurofibromatosis (NF) may have other stable central nervous system (CNS) tumors (schwannoma, acoustic neuroma or ependymoma) if lesions have been stable for 6 months No metastatic meningiomas (as defined by extracranial meningiomas) allowed No history of allergic reactions attributed to compounds of similar or biologic composition to assigned study drug No known active hepatitis B or C No current Child Pugh class B or C liver disease No uncontrolled gastric ulcer disease (grade 3 gastric ulcer disease within 28 days of registration) No uncontrolled diabetes defined as a known diabetic with hemoglobin A1C (HBA1C) > 7.5 OR fasting glucose > 140 No uncontrolled hypertension defined as blood pressure (BP) > 140/90 No abdominal fistula, gastrointestinal (GI) perforation, or intra-abdominal abscess within 28 days prior to registration Concomitant medications: Chronic concomitant treatment with strong inhibitors of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors must discontinue the drug for 14 days prior to registration on the study for patients with NF2 mutation enrolled to GSK2256098 Chronic concomitant treatment with strong CYP3A4 inducers is not allowed; patients must discontinue the drug 14 days prior to the start of study treatment for patients with NF2 mutation enrolled to GSK2256098 Absolute neutrophil count (ANC) >= 1,500/mm^3 Platelet count >= 100,000/mm^3 Creatinine OR =< 1.5 mg/dl x upper limit of normal (ULN) OR calculated (calc.) creatinine clearance > 45 mL/min Urine protein:creatinine ratio (UPC) =< 45 mg/mmol; ONLY APPLICABLE for patients with NF2 mutation (GSK2256098) Total bilirubin =< 1.5 x upper limit of normal (ULN); except in case of Gilbert's disease Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 2.5 x upper limit of normal (ULN) Fasting triglyceride =< 200 mg/dL; ONLY APPLICABLE for patients with NF2 mutation (GSK2256098) Fasting cholesterol =< 240 mg/dL; ONLY APPLICABLE for patients with NF2 mutation (GSK2256098) Corrected QC interval calculated using Fridericia's formula (QTcF) =< 500 msec; ONLY APPLICABLE for patients with NF2 mutation (GSK2256098)