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NCT01324479 Clinical Trial

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

Solid Tumors Clinical Trial

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 Details — Status: Completed

Administrative data
NCT number NCT01324479
Other study ID # CINC280X2102
Secondary ID 2010-024101-12
Status Completed
Phase Phase 1
First received
Last updated
Start date February 29, 2012
Est. completion date July 4, 2017

Study information
Verified date April 2019
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 131
Est. completion date July 4, 2017
Est. primary completion date July 4, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• INC280

Locations
Country Name City State
Australia Novartis Investigative Site Westmead New South Wales
Australia Novartis Investigative Site Woolloongabba Queensland
Canada Novartis Investigative Site Ottawa Ontario
Canada Novartis Investigative Site Toronto Ontario
France Novartis Investigative Site La Tronche
France Novartis Investigative Site LILLE Cédex
France Novartis Investigative Site Strasbourg Cedex
Germany Novartis Investigative Site Essen
Germany Novartis Investigative Site Frankfurt
Germany Novartis Investigative Site Freiburg
Germany Novartis Investigative Site Gottingen
Germany Novartis Investigative Site Hannover
Germany Novartis Investigative Site Oldenburg
Hong Kong Novartis Investigative Site Hong Kong
Hong Kong Novartis Investigative Site Shatin, New Territories
Israel Novartis Investigative Site Haifa
Israel Novartis Investigative Site Kfar Saba
Israel Novartis Investigative Site Ramat Gan
Israel Novartis Investigative Site Tel Aviv
Italy Novartis Investigative Site Ancona AN
Italy Novartis Investigative Site Meldola FC
Italy Novartis Investigative Site Milano MI
Italy Novartis Investigative Site Milano MI
Italy Novartis Investigative Site Reggio Emilia RE
Korea, Republic of Novartis Investigative Site Gyeonggi do Korea
Korea, Republic of Novartis Investigative Site Seoul Korea
Korea, Republic of Novartis Investigative Site Seoul Korea
Korea, Republic of Novartis Investigative Site Seoul Seocho Gu
Korea, Republic of Novartis Investigative Site Seoul Gyeonggi Do
Netherlands Novartis Investigative Site Amsterdam
Netherlands Novartis Investigative Site Rotterdam
Netherlands Novartis Investigative Site Utrecht The Netherlands
Norway Novartis Investigative Site Oslo
Singapore Novartis Investigative Site Singapore
Spain Novartis Investigative Site Barcelona Catalunya
Spain Novartis Investigative Site Granada Andalucia
Spain Novartis Investigative Site Madrid
Spain Novartis Investigative Site Oviedo Asturias
Spain Novartis Investigative Site Zaragoza
Taiwan Novartis Investigative Site Tainan Taiwan ROC
Taiwan Novartis Investigative Site Taipei Taiwan ROC
Thailand Novartis Investigative Site Songkhla Hat Yai
United States University of Chicago SC Chicago Illinois
United States Karmanos Cancer Institute Wayne St Karmanos Detroit Michigan
United States Highlands Oncology Group Fayetteville Arkansas
United States University of Texas/MD Anderson Cancer Center Dept of Onc Houston Texas
United States Sarah Cannon Research Institute Dept of Onc Nashville Tennessee

Sponsors (1)
Lead Sponsor Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Australia,  Canada,  France,  Germany,  Hong Kong,  Israel,  Italy,  Korea, Republic of,  Netherlands,  Norway,  Singapore,  Spain,  Taiwan,  Thailand, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence rate of dose-limiting toxicities and adverse events 2 years
Secondary Objective response by local investigator assessment 2 years
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