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Study of INC280 in Patients With c-MET Dependent Advanced Solid Tumors

Study 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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT01324479
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Novartis Pharmaceuticals
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Novartis Pharmaceuticals
Principal Investigator Affiliation Novartis Pharmaceuticals
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Completed
Countries Australia, Canada, France, Germany, Hong Kong, Israel, Italy, Korea, Republic of, Netherlands, Norway, Singapore, Spain, Taiwan, Thailand, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Solid Tumors
Study Website: View Trial Website
Arms & Interventions

Arms

Experimental: INC280

Interventions

Drug: - INC280

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Highlands Oncology Group, Fayetteville, Arkansas

Status

Address

Highlands Oncology Group

Fayetteville, Arkansas, 72703

University of Chicago SC, Chicago, Illinois

Status

Address

University of Chicago SC

Chicago, Illinois, 60637

Detroit, Michigan

Status

Address

Karmanos Cancer Institute Wayne St Karmanos

Detroit, Michigan, 48201

Nashville, Tennessee

Status

Address

Sarah Cannon Research Institute Dept of Onc

Nashville, Tennessee, 37203

Houston, Texas

Status

Address

University of Texas/MD Anderson Cancer Center Dept of Onc

Houston, Texas, 77030-4009

International Sites

Novartis Investigative Site, Amsterdam, Netherlands

Status

Address

Novartis Investigative Site

Amsterdam, , 1066 CX

Novartis Investigative Site, Rotterdam, Netherlands

Status

Address

Novartis Investigative Site

Rotterdam, , 3075 EA

Novartis Investigative Site, Oslo, Norway

Status

Address

Novartis Investigative Site

Oslo, , NO-0424

Novartis Investigative Site, Singapore, Singapore

Status

Address

Novartis Investigative Site

Singapore, , 169610

Novartis Investigative Site, Granada, Andalucia, Spain

Status

Address

Novartis Investigative Site

Granada, Andalucia, 18014

Novartis Investigative Site, Oviedo, Asturias, Spain

Status

Address

Novartis Investigative Site

Oviedo, Asturias, 33006

Novartis Investigative Site, Barcelona, Catalunya, Spain

Status

Address

Novartis Investigative Site

Barcelona, Catalunya, 08035

Novartis Investigative Site, Madrid, Spain

Status

Address

Novartis Investigative Site

Madrid, , 28046

Novartis Investigative Site, Zaragoza, Spain

Status

Address

Novartis Investigative Site

Zaragoza, , 50009

Novartis Investigative Site, Tainan, Taiwan ROC, Taiwan

Status

Address

Novartis Investigative Site

Tainan, Taiwan ROC, 70403

Novartis Investigative Site, Taipei, Taiwan ROC, Taiwan

Status

Address

Novartis Investigative Site

Taipei, Taiwan ROC, 10041

Novartis Investigative Site, Songkhla, Hat Yai, Thailand

Status

Address

Novartis Investigative Site

Songkhla, Hat Yai, 90110

Novartis Investigative Site, Westmead, New South Wales, Australia

Status

Address

Novartis Investigative Site

Westmead, New South Wales, 2145

Novartis Investigative Site, Woolloongabba, Queensland, Australia

Status

Address

Novartis Investigative Site

Woolloongabba, Queensland, 4102

Novartis Investigative Site, Ottawa, Ontario, Canada

Status

Address

Novartis Investigative Site

Ottawa, Ontario, K1H 8L6

Novartis Investigative Site, Toronto, Ontario, Canada

Status

Address

Novartis Investigative Site

Toronto, Ontario, M5G 2M9

Novartis Investigative Site, La Tronche, France

Status

Address

Novartis Investigative Site

La Tronche, , 38700

Novartis Investigative Site, LILLE Cédex, France

Status

Address

Novartis Investigative Site

LILLE Cédex, , 59037

Novartis Investigative Site, Strasbourg Cedex, France

Status

Address

Novartis Investigative Site

Strasbourg Cedex, , 67091

Novartis Investigative Site, Essen, Germany

Status

Address

Novartis Investigative Site

Essen, , 45147

Novartis Investigative Site, Frankfurt, Germany

Status

Address

Novartis Investigative Site

Frankfurt, , 60590

Novartis Investigative Site, Freiburg, Germany

Status

Address

Novartis Investigative Site

Freiburg, , 79106

Novartis Investigative Site, Gottingen, Germany

Status

Address

Novartis Investigative Site

Gottingen, , 37075

Novartis Investigative Site, Hannover, Germany

Status

Address

Novartis Investigative Site

Hannover, , 30625

Novartis Investigative Site, Oldenburg, Germany

Status

Address

Novartis Investigative Site

Oldenburg, , 26121

Novartis Investigative Site, Hong Kong, Hong Kong

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Address

Novartis Investigative Site

Hong Kong, ,

Novartis Investigative Site, Shatin, New Territories, Hong Kong

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Address

Novartis Investigative Site

Shatin, New Territories, ,

Novartis Investigative Site, Haifa, Israel

Status

Address

Novartis Investigative Site

Haifa, , 3525408

Novartis Investigative Site, Kfar Saba, Israel

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Address

Novartis Investigative Site

Kfar Saba, , 4428164

Novartis Investigative Site, Ramat Gan, Israel

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Address

Novartis Investigative Site

Ramat Gan, , 5265601

Novartis Investigative Site, Tel Aviv, Israel

Status

Address

Novartis Investigative Site

Tel Aviv, , 6423906

Novartis Investigative Site, Ancona, AN, Italy

Status

Address

Novartis Investigative Site

Ancona, AN, 60126

Novartis Investigative Site, Meldola, FC, Italy

Status

Address

Novartis Investigative Site

Meldola, FC, 47014

Novartis Investigative Site, Milano, MI, Italy

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Address

Novartis Investigative Site

Milano, MI, 20133

Novartis Investigative Site, Milano, MI, Italy

Status

Address

Novartis Investigative Site

Milano, MI, 20162

Novartis Investigative Site, Reggio Emilia, RE, Italy

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Address

Novartis Investigative Site

Reggio Emilia, RE, 42123

Novartis Investigative Site, Seoul, Gyeonggi Do, Korea, Republic of

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Address

Novartis Investigative Site

Seoul, Gyeonggi Do, 03080

Novartis Investigative Site, Gyeonggi do, Korea, Korea, Republic of

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Address

Novartis Investigative Site

Gyeonggi do, Korea, 10408

Novartis Investigative Site, Seoul, Korea, Korea, Republic of

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Address

Novartis Investigative Site

Seoul, Korea, 05505

Novartis Investigative Site, Seoul, Korea, Korea, Republic of

Status

Address

Novartis Investigative Site

Seoul, Korea, 06351

Novartis Investigative Site, Seoul, Seocho Gu, Korea, Republic of

Status

Address

Novartis Investigative Site

Seoul, Seocho Gu, 06591

Novartis Investigative Site, Utrecht, The Netherlands, Netherlands

Status

Address

Novartis Investigative Site

Utrecht, The Netherlands, 3508 GA