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

NCT01324479 | Completed Phase 1 FDA Drug

• 2 other identifiers: CINC280X21022010-024101-12
• Study Type: interventional
• Target: 131
• Locations: 15 countries
• Sites: 47

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

Outcome Measures

Primary Outcomes (1)

• Incidence rate of dose-limiting toxicities and adverse events

  2 years

Secondary Outcomes (1)

• Objective response by local investigator assessment

  2 years

Study Arms (1)

INC280

EXPERIMENTAL

Drug: INC280

Interventions

INC280 DRUG

INC280

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (47)

Highlands Oncology Group

Fayetteville, Arkansas, 72703, United States

Location

University of Chicago SC

Chicago, Illinois, 60637, United States

Location

Karmanos Cancer Institute Wayne St Karmanos

Detroit, Michigan, 48201, United States

Location

Sarah Cannon Research Institute Dept of Onc

Nashville, Tennessee, 37203, United States

Location

University of Texas/MD Anderson Cancer Center Dept of Onc

Houston, Texas, 77030-4009, United States

Location

Novartis Investigative Site

Westmead, New South Wales, 2145, Australia

Location

Novartis Investigative Site

Woolloongabba, Queensland, 4102, Australia

Location

Novartis Investigative Site

Ottawa, Ontario, K1H 8L6, Canada

Location

Novartis Investigative Site

Toronto, Ontario, M5G 2M9, Canada

Location

Novartis Investigative Site

La Tronche, 38700, France

Location

Novartis Investigative Site

Lille Cédex, 59037, France

Location

Novartis Investigative Site

Strasbourg, 67091, France

Location

Novartis Investigative Site

Essen, 45147, Germany

Location

Novartis Investigative Site

Frankfurt, 60590, Germany

Location

Novartis Investigative Site

Freiburg im Breisgau, 79106, Germany

Location

Novartis Investigative Site

Göttingen, 37075, Germany

Location

Novartis Investigative Site

Hanover, 30625, Germany

Location

Novartis Investigative Site

Oldenburg, 26121, Germany

Location

Novartis Investigative Site

Shatin, New Territories, Hong Kong, Hong Kong

Location

Novartis Investigative Site

Hong Kong, Hong Kong

Location

Novartis Investigative Site

Haifa, 3525408, Israel

Location

Novartis Investigative Site

Kfar Saba, 4428164, Israel

Location

Novartis Investigative Site

Ramat Gan, 5265601, Israel

Location

Novartis Investigative Site

Tel Aviv, 6423906, Israel

Location

Novartis Investigative Site

Ancona, AN, 60126, Italy

Location

Novartis Investigative Site

Meldola, FC, 47014, Italy

Location

Novartis Investigative Site

Milan, MI, 20133, Italy

Location

Novartis Investigative Site

Milan, MI, 20162, Italy

Location

Novartis Investigative Site

Reggio Emilia, RE, 42123, Italy

Location

Novartis Investigative Site

Utrecht, The Netherlands, 3508 GA, Netherlands

Location

Novartis Investigative Site

Amsterdam, 1066 CX, Netherlands

Location

Novartis Investigative Site

Rotterdam, 3075 EA, Netherlands

Location

Novartis Investigative Site

Oslo, NO-0424, Norway

Location

Novartis Investigative Site

Singapore, 169610, Singapore

Location

Novartis Investigative Site

Seoul, Gyeonggi-do, 03080, South Korea

Location

Novartis Investigative Site

Gyeonggi-do, Korea, 10408, South Korea

Location

Novartis Investigative Site

Seoul, Korea, 05505, South Korea

Location

Novartis Investigative Site

Seoul, Korea, 06351, South Korea

Location

Novartis Investigative Site

Seoul, Seocho Gu, 06591, South Korea

Location

Novartis Investigative Site

Granada, Andalusia, 18014, Spain

Location

Novartis Investigative Site

Barcelona, Catalonia, 08035, Spain

Location

Novartis Investigative Site

Oviedo, Principality of Asturias, 33006, Spain

Location

Novartis Investigative Site

Madrid, 28046, Spain

Location

Novartis Investigative Site

Zaragoza, 50009, Spain

Location

Novartis Investigative Site

Tainan, Taiwan ROC, 70403, Taiwan

Location

Novartis Investigative Site

Taipei, Taiwan ROC, 10041, Taiwan

Location

Novartis Investigative Site

Songkhla, Hat Yai, 90110, Thailand

Location

Related Publications (2)

• 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.

  PMID: 32240796 DERIVED

• 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.

  PMID: 31778267 DERIVED

Related Links

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

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Glioblastoma

Interventions

capmatinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2011
• First Posted: March 29, 2011
• Study Start: February 29, 2012
• Primary Completion: July 4, 2017
• Study Completion: July 4, 2017
• Last Updated: December 19, 2020

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (2); NO (1); ES (5); SG (1); DE (6); KR (5); HK (2); AU (2); TH (1); FR (3); NL (3); IL (4); US (5); CA (2); IT (5)