Description:
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.
Title
- Brief Title: Study of INC280 in Patients With c-MET Dependent Advanced Solid Tumors
- Official Title: A Phase I Open-label Dose Escalation Study With Expansion to Assess the Safety and Tolerability of INC280 in Patients With c-MET Dependent Advanced Solid Tumors
Clinical Trial IDs
- ORG STUDY ID:
CINC280X2102
- SECONDARY ID:
2010-024101-12
- NCT ID:
NCT01324479
Conditions
Interventions
Drug | Synonyms | Arms |
---|
INC280 | | INC280 |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
INC280 | Experimental | | |
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.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Incidence rate of dose-limiting toxicities and adverse events |
Time Frame: | 2 years |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | Objective response by local investigator assessment |
Time Frame: | 2 years |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Completed |
Lead Sponsor: | Novartis Pharmaceuticals |
Trial Keywords
- Non-small cell lung cancer,
- hepatocellular,
- gastric,
- renal cell,
- c-MET,
- refractory,
- glioblastoma,
- breast,
- nasopharyngeal,
- confirmed evidence of c-MET dysregulation
Last Updated
December 19, 2020