Study of INC280 in Patients With c-MET Dependent Advanced Solid Tumors
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.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
The study team can explain what participation involves.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Dec 19, 2020 · Source: ClinicalTrials.gov
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Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- Novartis Pharmaceuticals
- Interventions being studied
- Drug: INC280
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- 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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Highlands Oncology GroupFayetteville, Arkansas
- University of Chicago SCChicago, Illinois
- Karmanos Cancer Institute Wayne St KarmanosDetroit, Michigan
- Sarah Cannon Research Institute Dept of OncNashville, Tennessee
- University of Texas/MD Anderson Cancer Center Dept of OncHouston, Texas
- Novartis Investigative SiteWestmead, New South Wales
- Novartis Investigative SiteWoolloongabba, Queensland
- Novartis Investigative SiteOttawa, Ontario
- Novartis Investigative SiteToronto, Ontario
- Novartis Investigative SiteLa Tronche
- Novartis Investigative SiteLille Cédex
- Novartis Investigative SiteStrasbourg
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Dec 19, 2020. Always confirm current availability with the study team.