ABOUT THIS STUDY
- Dose Escalation Population: Histological or cytological diagnosis of advanced/metastatic solid tumor that is resistant to standard therapy or for which no standard therapy is available. Lesions may be measurable or non measurable.
- Expansion Population 1: Patients with histologically confirmed metastatic renal cell cancer with no prior systemic therapy directed at the malignant tumor.
- Expansion Population 2: Patients with histologically confirmed metastatic renal cell cancer whose prior systemic therapy directed at the malignant tumor was single agent VEGF inhibitor and who now have acquired resistance to this treatment. Resistance is defined as progression following an initial response (complete or partial), or stable disease for at least 6 months on single agent VEGF inhibitor.
- Expansion Population 3: Patients with histologically confirmed glioblastoma whose disease has failed on previous therapy, and which must have included treatment with external beam radiation and temozolomide chemotherapy, and who now have radiographically recurrent or progressive disease.
- Expansion Population 4: Patients with histologically confirmed advanced-stage (unresectable or metastatic) hepatocellular carcinoma who have not received previous systemic therapy directed at the malignant tumor will be eligible to receive crizotinib plus sorafenib, should this combination be tested. Eligibility criteria also include normal hepatic function or Child-Pugh hepatic function class A.
- Patients with hemorrhagic brain metastases or with known symptomatic brain metastases
- Major surgery within 4 weeks of starting study treatment.
- Radiation therapy within 2 weeks of starting study treatment.
- Hypertension that cannot be controlled with medications (>150/90 mmHg despite optimal
- For glioblastoma patients: Prior treatment of glioblastoma with Gliadel wafers,
stereotactic radiation, or brachytherapy unless there is pathological or definitive
radiological evidence (PET scan or perfusion MRI) of recurrent tumor or unless there
is new enhancement outside of the radiation field. History of Grade 2 or greater acute
intracranial hemorrhage. Radiation therapy (RT) for glioblastoma within 3 months
unless there is either: a) histopathologic confirmation of recurrent tumor, or b) new
enhancement on MRI outside of the RT treatment field.Concomitant treatment with
therapeutic doses of anticoagulants (low dose warfarin (Coumadin) up to 2 mg PO daily
for deep vein thrombosis prophylaxis is allowed).
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