- Must have evidence of c-MET dysregulation from either local data or the results of
molecular pre-screening evaluations.
- Confirmed diagnosis of a solid tumor.
- Measureable lesion.
- Refractory to currently available treatment or no therapies available.
- 18 years or older.
- ECOG performance status of 0, 1, or 2.
- Obtained written informed consent.
Additional inclusion criteria for NSCLC patients EGFRwt with high c-MET expression:
- Written documentation of EGFRwt NSCLC.
- Written documentation of c-MET positivity.
- Patients should not have received more than three prior lines of antineoplastic
therapy for NSCLC.
- Presence of at least one measurable lesion as determined by modified RECIST version
HCC with liver dysfunction greater than Child-Pugh A. Previous treatment with a c-MET
inhibitor or HGF-targeting therapy. Symptomatic CNS metastases that are neurologically
unstable or requiring increasing doses of steroids to control their CNS disease.
Any CNS deficits. For patients with GBM, CNS symptoms grade 2 or greater. Subjects with
significant or uncontrolled cardiovascular disease (eg, uncontrolled hypertension,
peripheral vascular disease, congestive heart failure, cardiac arrhythmia, or acute
coronary syndrome) within 6 months of starting study treatment or heart attack within 12
months of starting study treatment.
Receiving anti-epileptic drugs that are known to be strong inducers of CYP3A4. Prior or
current anti-angiogenic therapy for patients with GBM. Radiation therapy within 4 weeks
(< 12 for GBM) prior to the first dose of study drug or limited field radiotherapy within
2 weeks (< 12 weeks GBM) prior to the start of study treatment. Any persistent side
effect of prior radiotherapy must be resolved to Grade 1 prior to the first dose of
Additional exclusion criteria for NSCLC patients EGFRwt with high c-MET expression:
- Patients who have received more than three prior lines of antineoplastic therapies
- Any unresolved toxicity (CTCAE grade > 1) from previous anti-cancer therapy or
radiotherapy, except alopecia
- Patients have received anti-cancer therapies within the following time frames prior
to the first dose of study treatment:
- Conventional cytotoxic chemotherapy: 4 weeks (6 weeks for nitrosoureas and
- Biologic therapy (e.g., antibodies): 4 weeks
- Non-cytotoxic small molecule therapeutics: 5 half-lives or 2 weeks (whichever
- Other investigational agents: 4 weeks
- Radiation therapy (palliative setting is allowed.): 4 weeks
- Major surgery: 2 weeks
Other protocol-defined inclusion/exclusion criteria may apply.
Minimum Eligible Age: 18 Years
Maximum Eligible Age: N/A
Eligible Gender: Both