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

NCT ID: NCT01324479

Last Updated: 2020-12-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 131 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2017-07-04

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.

Conditions

Solid Tumors

Keywords

Non-small cell lung cancer,; hepatocellular,; gastric,; renal cell,; c-MET,; refractory,; glioblastoma,; breast,; nasopharyngeal,; confirmed evidence of c-MET dysregulation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

INC280

Group Type: EXPERIMENTAL

INC280

Intervention Type: DRUG

Interventions

INC280

Intervention Type: DRUG

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.

• 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.

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

Highlands Oncology Group

Fayetteville, Arkansas, United States

University of Chicago SC

Chicago, Illinois, United States

Karmanos Cancer Institute Wayne St Karmanos

Detroit, Michigan, United States

Sarah Cannon Research Institute Dept of Onc

Nashville, Tennessee, United States

University of Texas/MD Anderson Cancer Center Dept of Onc

Houston, Texas, United States

Novartis Investigative Site

Westmead, New South Wales, Australia

Novartis Investigative Site

Woolloongabba, Queensland, Australia

Novartis Investigative Site

Ottawa, Ontario, Canada

Novartis Investigative Site

Toronto, Ontario, Canada

Novartis Investigative Site

La Tronche, , France

Novartis Investigative Site

Lille Cédex, , France

Novartis Investigative Site

Strasbourg, , France

Novartis Investigative Site

Essen, , Germany

Novartis Investigative Site

Frankfurt, , Germany

Novartis Investigative Site

Freiburg im Breisgau, , Germany

Novartis Investigative Site

Göttingen, , Germany

Novartis Investigative Site

Hanover, , Germany

Novartis Investigative Site

Oldenburg, , Germany

Novartis Investigative Site

Shatin, New Territories, Hong Kong, Hong Kong

Novartis Investigative Site

Hong Kong, , Hong Kong

Novartis Investigative Site

Haifa, , Israel

Novartis Investigative Site

Kfar Saba, , Israel

Novartis Investigative Site

Ramat Gan, , Israel

Novartis Investigative Site

Tel Aviv, , Israel

Novartis Investigative Site

Ancona, AN, Italy

Novartis Investigative Site

Meldola, FC, Italy

Novartis Investigative Site

Milan, MI, Italy

Novartis Investigative Site

Milan, MI, Italy

Novartis Investigative Site

Reggio Emilia, RE, Italy

Novartis Investigative Site

Utrecht, The Netherlands, Netherlands

Novartis Investigative Site

Amsterdam, , Netherlands

Novartis Investigative Site

Rotterdam, , Netherlands

Novartis Investigative Site

Oslo, , Norway

Novartis Investigative Site

Singapore, , Singapore

Novartis Investigative Site

Seoul, Gyeonggi-do, South Korea

Novartis Investigative Site

Gyeonggi-do, Korea, South Korea

Novartis Investigative Site

Seoul, Korea, South Korea

Novartis Investigative Site

Seoul, Korea, South Korea

Novartis Investigative Site

Seoul, Seocho Gu, South Korea

Novartis Investigative Site

Granada, Andalusia, Spain

Novartis Investigative Site

Barcelona, Catalonia, Spain

Novartis Investigative Site

Oviedo, Principality of Asturias, Spain

Novartis Investigative Site

Madrid, , Spain

Novartis Investigative Site

Zaragoza, , Spain

Novartis Investigative Site

Tainan City, Taiwan ROC, Taiwan

Novartis Investigative Site

Taipei, Taiwan ROC, Taiwan

Novartis Investigative Site

Songkhla, Hat Yai, Thailand

Countries

United States; Australia; Canada; France; Germany; Hong Kong; Israel; Italy; Netherlands; Norway; Singapore; South Korea; Spain; Taiwan; Thailand

References

Schuler M, Berardi R, Lim WT, de Jonge M, Bauer TM, Azaro A, Gottfried M, Han JY, Lee DH, Wollner M, Hong DS, Vogel A, Delmonte A, Akimov M, Ghebremariam S, Cui X, Nwana N, Giovannini M, Kim TM. Molecular correlates of response to capmatinib in advanced non-small-cell lung cancer: clinical and biomarker results from a phase I trial. Ann Oncol. 2020 Jun;31(6):789-797. doi: 10.1016/j.annonc.2020.03.293. Epub 2020 Mar 30.

Reference Type: DERIVED

PMID: 32240796 (View on PubMed)

Bang YJ, Su WC, Schuler M, Nam DH, Lim WT, Bauer TM, Azaro A, Poon RTP, Hong D, Lin CC, Akimov M, Ghebremariam S, Zhao S, Giovannini M, Ma B. Phase 1 study of capmatinib in MET-positive solid tumor patients: Dose escalation and expansion of selected cohorts. Cancer Sci. 2020 Feb;111(2):536-547. doi: 10.1111/cas.14254. Epub 2019 Dec 30.

Reference Type: DERIVED

PMID: 31778267 (View on PubMed)

Related Links

https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=17178

Results for INC280X2102 can be found on the Novartis Clinical Trial Results Website

Other Identifiers

2010-024101-12

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CINC280X2102

Identifier Type: -

Identifier Source: org_study_id