study of inc280 in patients with c-met dependent advanced solid tumors

Conditions: Solid Tumors

Summary: this study will assess the safety and efficacy of inc280 in patients with solid tumors that are refractory to current treatment or for which there is not a current standard of care and whose tumors have dysregulation of the c-met pathway.


Eligibility criteria:
inclusion criteria: * 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 1.1 exclusion criteria: 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 study drug. 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 mitomycin-c) * biologic therapy (e.g., antibodies): ≤4 weeks * non-cytotoxic small molecule therapeutics: ≤5 half-lives or ≤2 weeks (whichever is longer) * 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.

Keywords: non-small cell lung cancer, hepatocellular, gastric, renal cell, c-met, refractory, glioblastoma, breast, nasopharyngeal, confirmed evidence of c-met dysregulation