Patient case: 68-year-old male with non-small cell carcinoma; genetic feature: MET

Clinical trial: Study of INC280 in Patients With c-MET Dependent Advanced 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: 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.

Relevance to patient case: possibly relevant