Solid TumorsPhase 1NCT01324479
Study of INC280 in Patients With c-MET Dependent Advanced Solid Tumors
A Phase 1 study testing INC280 in people with Solid Tumors, run by Novartis Pharmaceuticals at 47 sites in 15 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors
- What is being tested?
- INC280
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 131 participants
- Where
- 47 sitesin 15 countries
- Study dates
- 29 Feb 2012to 4 Jul 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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
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- 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 locations and contacts
47 sites in 15 countries.
47 sites in 15 countries
Germany6 sites
Novartis Investigative Site
Essen, 45147
Novartis Investigative Site
Frankfurt, 60590
Novartis Investigative Site
Freiburg im Breisgau, 79106
Novartis Investigative Site
Göttingen, 37075
Novartis Investigative Site
Hanover, 30625
Novartis Investigative Site
Oldenburg, 26121
United States5 sites
University of Chicago SC
Chicago, Illinois, 60637
Karmanos Cancer Institute Wayne St Karmanos
Detroit, Michigan, 48201
Highlands Oncology Group
Fayetteville, Arkansas, 72703
University of Texas/MD Anderson Cancer Center Dept of Onc
Houston, Texas, 77030-4009
Sarah Cannon Research Institute Dept of Onc
Nashville, Tennessee, 37203
Italy5 sites
Novartis Investigative Site
Ancona, AN, 60126
Novartis Investigative Site
Meldola, FC, 47014
Novartis Investigative Site
Milan, MI, 20133
Novartis Investigative Site
Milan, MI, 20162
Novartis Investigative Site
Reggio Emilia, RE, 42123
South Korea5 sites
Novartis Investigative Site
Gyeonggi-do, Korea, 10408
Novartis Investigative Site
Seoul, Gyeonggi-do, 03080
Novartis Investigative Site
Seoul, Korea, 05505
Novartis Investigative Site
Seoul, Korea, 06351
Novartis Investigative Site
Seoul, Seocho Gu, 06591
Spain5 sites
Novartis Investigative Site
Barcelona, Catalonia, 08035
Novartis Investigative Site
Granada, Andalusia, 18014
Novartis Investigative Site
Madrid, 28046
Novartis Investigative Site
Oviedo, Principality of Asturias, 33006
Novartis Investigative Site
Zaragoza, 50009
Israel4 sites
Novartis Investigative Site
Haifa, 3525408
Novartis Investigative Site
Kfar Saba, 4428164
Novartis Investigative Site
Ramat Gan, 5265601
Novartis Investigative Site
Tel Aviv, 6423906
France3 sites
Novartis Investigative Site
La Tronche, 38700
Novartis Investigative Site
Lille Cédex, 59037
Novartis Investigative Site
Strasbourg, 67091
Netherlands3 sites
Novartis Investigative Site
Amsterdam, 1066 CX
Novartis Investigative Site
Rotterdam, 3075 EA
Novartis Investigative Site
Utrecht, The Netherlands, 3508 GA
Australia2 sites
Novartis Investigative Site
Westmead, New South Wales, 2145
Novartis Investigative Site
Woolloongabba, Queensland, 4102
Canada2 sites
Novartis Investigative Site
Ottawa, Ontario, K1H 8L6
Novartis Investigative Site
Toronto, Ontario, M5G 2M9
Hong Kong2 sites
Novartis Investigative Site
Hong Kong
Novartis Investigative Site
Shatin, New Territories, Hong Kong
Taiwan2 sites
Novartis Investigative Site
Tainan, Taiwan ROC, 70403
Novartis Investigative Site
Taipei, Taiwan ROC, 10041
About this study
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
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
- Being tested
- INC280
- Keywords
- Non-small cell lung cancer,, hepatocellular,, gastric,, renal cell,, c-MET,, refractory,, glioblastoma,, breast,, nasopharyngeal,, confirmed evidence of c-MET dysregulation
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INC280Drug
| Study group | Role | What they receive |
|---|---|---|
| INC280 | Experimental | Not described Receives: Drug: INC280 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence rate of dose-limiting toxicities and adverse events
Measured: 2 years
Secondary outcomes (1)
Objective response by local investigator assessment
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2011 (estimated)
- Study start29 Feb 2012
- Primary completion4 Jul 2017
- Study completion4 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Solid TumorsStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01324479
- Sponsor's protocol ID
- CINC280X2102
- Other IDs
- 2010-024101-12
- Status last verified
- Apr 2019
- First submitted
- 25 Mar 2011
- Last updated
- 19 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32240796Bang 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.
PubMed 31778267
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01324479
- Acronym / sponsor ID
- CINC280X2102
- Conditions
- Solid Tumors
- Keywords
- Non-small cell lung cancer,, hepatocellular,, gastric,, renal cell,, c-MET,, refractory,, glioblastoma,, breast,
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 29 Feb 2012 (actual)
- Primary completion
- 4 Jul 2017 (actual)
- Study completion
- 4 Jul 2017 (actual)
- First posted
- 29 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| INC280 | Experimental | Drug: INC280 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| INC280 | Drug | INC280 |
Primary outcome
Incidence rate of dose-limiting toxicities and adverse events
Time frame: 2 years
1 secondary outcome
Objective response by local investigator assessment
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2020.
- Derived from this study: PubMed 32240796Schuler 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.
- Derived from this study: PubMed 31778267Bang 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.
- Results for INC280X2102 can be found on the Novartis Clinical Trial Results WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
47 sites in 15 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing INC280 in people with Solid Tumors, run by Novartis Pharmaceuticals at 47 sites in 15 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 47 sites in Germany, United States, Italy, South Korea, Spain and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence rate of dose-limiting toxicities and adverse events (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01324479, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2020.