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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01324479




Registration number
NCT01324479
Ethics application status
Date submitted
25/03/2011
Date registered
29/03/2011
Date last updated
19/12/2020

Titles & IDs
Public title
Study of INC280 in Patients With c-MET Dependent Advanced Solid Tumors
Scientific 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
Secondary ID [1] 0 0
2010-024101-12
Secondary ID [2] 0 0
CINC280X2102
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Solid Tumors 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - INC280

Experimental: INC280 -


Treatment: Drugs: INC280
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence rate of dose-limiting toxicities and adverse events
Timepoint [1] 0 0
2 years
Secondary outcome [1] 0 0
Objective response by local investigator assessment
Timepoint [1] 0 0
2 years

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
29/02/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
4/07/2017
Sample size
Target
Accrual to date
Final
131
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 0 0
Novartis Investigative Site - Westmead
Recruitment hospital [2] 0 0
Novartis Investigative Site - Woolloongabba
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment postcode(s) [2] 0 0
4102 - Woolloongabba
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arkansas
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United States of America
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Illinois
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United States of America
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Michigan
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United States of America
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Tennessee
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United States of America
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Texas
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Canada
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Ontario
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France
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La Tronche
Country [8] 0 0
France
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LILLE Cédex
Country [9] 0 0
France
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Strasbourg Cedex
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Germany
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Essen
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Germany
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Frankfurt
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Germany
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Freiburg
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Germany
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Gottingen
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Germany
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Hannover
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Germany
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Oldenburg
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Hong Kong
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Hong Kong
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Hong Kong
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Shatin, New Territories
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Israel
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Haifa
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Israel
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Kfar Saba
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Israel
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Ramat Gan
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Israel
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Tel Aviv
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Italy
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AN
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Italy
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FC
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Italy
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MI
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Italy
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RE
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Korea, Republic of
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Gyeonggi Do
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Korea, Republic of
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Korea
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Korea, Republic of
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Seocho Gu
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Netherlands
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The Netherlands
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Netherlands
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Amsterdam
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Netherlands
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Rotterdam
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Norway
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Oslo
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Singapore
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Singapore
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Spain
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Andalucia
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Spain
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Asturias
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Spain
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Catalunya
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Spain
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Madrid
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Spain
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Zaragoza
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Taiwan
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Taiwan ROC
Country [40] 0 0
Thailand
State/province [40] 0 0
Hat Yai

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01324479
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01324479