cMET Dysegulation Advanced Solid TumorsPhase 1NCT02925104
A Dose Escalation Study to Assess PK, Safety and Tolerability of INC280 When Taken With Food in cMET Dysregulated Advanced Solid Tumors.
A Phase 1 study testing INC280 in people with cMET Dysegulation Advanced Solid Tumors, run by Novartis Pharmaceuticals at 17 sites in 8 countries.
Trial summary
Dose escalation study to assess PK, safety and tolerability of INC280 when taken with food in patients with cMET dysregulated advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- cMET Dysegulation Advanced Solid Tumors
- What is being tested?
- INC280
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 17 sitesin 8 countries
- Study dates
- 14 Dec 2016to 16 May 2018
- 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
- cMET dysregulated advanced solid tumor
- At least one measurable lesion as defined by RECIST 1.1
- Recovered from all toxicities related to prior anti-cancer therapies to grade ≤ 1
- Adequate organ function
- ECOG performance status (PS) ≤ 1
Who cannot join
- Prior treatment with crizotinib or any other cMET or HGF inhibitor
- Known hypersensitivity to any of the excipients of INC280
- Symptomatic central nervous system (CNS) metastases who are neurologically unstable
- Presence or history of a malignant disease other than the study related cancer
- Clinically significant, uncontrolled heart diseases
- Thoracic radiotherapy to lung fields ≤ 4 weeks prior to starting INC280 or patients who have not recovered from radiotherapy-related toxicities
Show all 11Show fewer
- Major surgery within 4 weeks prior to starting INC280
- Impairment of GI function
- Patients receiving unstable or increasing doses of corticosteroids
- Patients receiving treatment with any enzyme-inducing anticonvulsant
- Pregnant or nursing (lactating) women Other protocol-related inclusion/exclusion criteria may apply
Trial locations and contacts
17 sites in 8 countries.
17 sites in 8 countries
Spain5 sites
Novartis Investigative Site
Barcelona, 08041
Novartis Investigative Site
Madrid, 28040
Novartis Investigative Site
Málaga, Andalusia, 29010
Novartis Investigative Site
Santiago de Compostela, Galicia, 15706
Novartis Investigative Site
Zaragoza, 50009
Sweden4 sites
Novartis Investigative Site
Gothenburg, 413 45
Novartis Investigative Site
Lund, SE-221 85
Novartis Investigative Site
Stockholm, 171 76
Novartis Investigative Site
Uppsala, SE-751 85
Germany2 sites
Novartis Investigative Site
Dresden, 01307
Novartis Investigative Site
Mainz, 55131
United Kingdom2 sites
Novartis Investigative Site
London, W1G 6AD
Novartis Investigative Site
Manchester, M20 4BX
United States1 site
Indiana University Simon Cancer Center SC
Indianapolis, Indiana, 46202
About this study
Official title: A Multicenter, Open Label, Phase 1 Dose Escalation Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of INC280 Tablet Formulation With Food in Patients With cMET Dysregulated Advanced Solid Tumors.
Dose escalation study to assess PK, safety and tolerability of INC280 when taken with food in patients with cMET dysregulated advanced solid tumors.
- Conditions
- cMET Dysegulation Advanced Solid Tumors
- Being tested
- INC280
- Keywords
- cMET, INC280, food,
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 of Dose limiting toxiticites (DLTs)
Measured: During the first 28 days on INC280 treatment; cycle = 21 days
Frequency of DLTs
Measured: During the first 28 days on INC280 treatment
Category of DLTs
Measured: During the first 28 days on INC280 treatment
AUClast for INC280
Measured: Treatment Cycle 1 Day 1 (C1D1), C1D7, C1D15, C2D1, C3D1
AUCtau for INC280
Measured: C1D1, C1D7, C1D15, C2D1, C3D1
Cmax for INC280
Measured: C1D1, C1D7, C1D15, C2D1, C3D1
Tmax
Measured: C1D1, C1D7, C1D15, C2D1, C3D1
Secondary outcomes (1)
Adverse events based on CTCAE grading and other safety variables (e.g. EGC readings, physical examination, vital signs and laboratory results).
Measured: Screening, until 30 days post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2016 (estimated)
- Study start14 Dec 2016
- Primary completion16 May 2018
- Study completion16 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for cMET Dysegulation Advanced 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
- 36 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
- NCT02925104
- Sponsor's protocol ID
- CINC280A2108
- Other IDs
- 2016-001829-14, 2016
- Status last verified
- Feb 2020
- First submitted
- 4 Oct 2016
- 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
Moreno V, Greil R, Yachnin J, Majem M, Wermke M, Arkenau HT, Basque JR, Nidamarthy PK, Kapoor S, Cui X, Giovannini M. Pharmacokinetics and safety of capmatinib with food in patients with MET-dysregulated advanced solid tumors. Clin Ther. 2021 Jun;43(6):1092-1111. doi: 10.1016/j.clinthera.2021.04.006. Epub 2021 May 27.
PubMed 34053700
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 Multicenter, Open Label, Phase 1 Dose Escalation Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of INC280 Tablet Formulation With Food in Patients With cMET Dysregulated Advanced Solid Tumors.
- ClinicalTrials.gov ID
- NCT02925104
- Acronym / sponsor ID
- CINC280A2108
- Conditions
- cMET Dysegulation Advanced Solid Tumors
- Keywords
- cMET, INC280, food,
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 14 Dec 2016 (actual)
- Primary completion
- 16 May 2018 (actual)
- Study completion
- 16 May 2018 (actual)
- First posted
- 5 Oct 2016 (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.
Dose escalation study to assess PK, safety and tolerability of INC280 when taken with food in patients with cMET dysregulated advanced solid tumors.
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 (5 listed)
- cMET dysregulated advanced solid tumor
- At least one measurable lesion as defined by RECIST 1.1
- Recovered from all toxicities related to prior anti-cancer therapies to grade ≤ 1
- Adequate organ function
- ECOG performance status (PS) ≤ 1
Key exclusion criteria (11 listed)
- Prior treatment with crizotinib or any other cMET or HGF inhibitor
- Known hypersensitivity to any of the excipients of INC280
- Symptomatic central nervous system (CNS) metastases who are neurologically unstable
- Presence or history of a malignant disease other than the study related cancer
- Clinically significant, uncontrolled heart diseases
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 of Dose limiting toxiticites (DLTs)
Time frame: During the first 28 days on INC280 treatment; cycle = 21 days
Frequency of DLTs
Time frame: During the first 28 days on INC280 treatment
Category of DLTs
Time frame: During the first 28 days on INC280 treatment
AUClast for INC280
Time frame: Treatment Cycle 1 Day 1 (C1D1), C1D7, C1D15, C2D1, C3D1
AUCtau for INC280
Time frame: C1D1, C1D7, C1D15, C2D1, C3D1
Cmax for INC280
Time frame: C1D1, C1D7, C1D15, C2D1, C3D1
Tmax
Time frame: C1D1, C1D7, C1D15, C2D1, C3D1
1 secondary outcome
Adverse events based on CTCAE grading and other safety variables (e.g. EGC readings, physical examination, vital signs and laboratory results).
Time frame: Screening, until 30 days post-treatment
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 34053700Moreno V, Greil R, Yachnin J, Majem M, Wermke M, Arkenau HT, Basque JR, Nidamarthy PK, Kapoor S, Cui X, Giovannini M. Pharmacokinetics and safety of capmatinib with food in patients with MET-dysregulated advanced solid tumors. Clin Ther. 2021 Jun;43(6):1092-1111. doi: 10.1016/j.clinthera.2021.04.006. Epub 2021 May 27.
- Results for CINC280A2108 can be found on the Novartis Clinical Trial Results WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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
17 sites in 8 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 cMET Dysegulation Advanced Solid Tumors, run by Novartis Pharmaceuticals at 17 sites in 8 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 5 inclusion and 11 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 17 sites in Spain, Sweden, Germany, United Kingdom, United States and 3 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 of Dose limiting toxiticites (DLTs) (time frame: During the first 28 days on INC280 treatment; cycle = 21 days). The study lists 7 primary outcomes in all. 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 NCT02925104, which also lists 1 linked publication.
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.