Study of INC280 in Patients With c-MET Dependent Advanced Solid Tumors
- Conditions
- Solid Tumors
- Interventions
- Drug: INC280
- Registration Number
- NCT01324479
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 131
- 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
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description INC280 INC280 -
- Primary Outcome Measures
Name Time Method Incidence rate of dose-limiting toxicities and adverse events 2 years
- Secondary Outcome Measures
Name Time Method Objective response by local investigator assessment 2 years
Trial Locations
- Locations (6)
Highlands Oncology Group
🇺🇸Fayetteville, Arkansas, United States
Karmanos Cancer Institute Wayne St Karmanos
🇺🇸Detroit, Michigan, United States
Novartis Investigative Site
🇹🇭Songkhla, Hat Yai, Thailand
University of Texas/MD Anderson Cancer Center Dept of Onc
🇺🇸Houston, Texas, United States
Sarah Cannon Research Institute Dept of Onc
🇺🇸Nashville, Tennessee, United States
University of Chicago SC
🇺🇸Chicago, Illinois, United States