cMET-dysregulated Advanced Solid TumorsPhase 1NCT02520752
A DDI Study to Assess the Effect of INC280 on the PK of Midazolam and Caffeine in Patients With cMET-dysregulated Advanced Solid Tumors
A Phase 1 study testing INC280, Midazolam and Caffeine in people with cMET-dysregulated Advanced Solid Tumors, run by Novartis Pharmaceuticals at 12 sites in 7 countries.
Trial summary
Drg-drug Interaction (DDI) study to assess the effect of INC280 on the pharmacokinetics of midazolam and caffeine 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-dysregulated Advanced Solid Tumors
- What is being tested?
- INC280, Midazolam and Caffeine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 12 sitesin 7 countries
- Study dates
- 10 Dec 2015to 12 Sep 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
- Patients must have:
- advanced solid tumors and have confirmed cMET dysregulation
- at least one measurable lesion as defined by RECIST 1.1.
- recovered from all toxicities related to prior anti-cancer therapies
- adequate organ function
- ECOG performance status (PS) of 0 or 1
Who cannot join
- Patients must not have:
- known hypersensitivity to any of the excipients of INC280 or to benzodiazepines or known intolerance and hypersensitivity to caffeine
- symptomatic central nervous system (CNS) metastases who are neurologically unstable
- presence or history of carcinomatous meningitis
- history of another primary malignancy that is currently clinically significant or currently requires active intervention
- Clinically significant, uncontrolled heart diseases, including QTcF ≥ 450 ms (male patients), ≥ 460 ms (female patients) on the screening ECG
Show all 12Show fewer
- Thoracic radiotherapy to lung fields ≤ 4 weeks prior to starting INC280
- Major surgery within 4 weeks prior to starting INC280
- Patients receiving unstable or increasing doses of corticosteroids.
- Impairment of GI function or GI disease that may significantly alter the absorption of INC280
- Patients who have received or consumed, or are expected to receive or consume midazolam or caffeine-containing products (e.g., tea, coffee, cola), within 2 days prior to Day 1 and during the whole duration of the DDI phase (i.e., from Day -2 to Day 12)
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
12 sites in 7 countries.
12 sites in 7 countries
Spain3 sites
Novartis Investigative Site
Barcelona, Catalonia, 08003
Novartis Investigative Site
Barcelona, Catalonia, 08035
Novartis Investigative Site
Santiago de Compostela, Galicia, 15706
United States2 sites
Emory University School of Medicine/Winship Cancer Institute SC-2
Atlanta, Georgia, 30322
Washington University School of Medicine
St Louis, Missouri, 63110
France2 sites
Novartis Investigative Site
Dijon, Cote D Or, 21034
Novartis Investigative Site
Pierre-Bénite, 69310
United Kingdom2 sites
Novartis Investigative Site
London, W12 0HS
Novartis Investigative Site
Manchester, M20 9BX
About this study
Official title: A Phase I, Multicenter, Open-label, Single-sequence Drug-drug Interaction Study to Assess the Effect of INC280 on the Pharmacokinetics of Midazolam and Caffeine in Patients With cMET-dysregulated Advanced Solid Tumors
Drg-drug Interaction (DDI) study to assess the effect of INC280 on the pharmacokinetics of midazolam and caffeine in patients with cMET-dysregulated advanced solid tumors
- Conditions
- cMET-dysregulated Advanced Solid Tumors
- Keywords
- cMET, INC280, caffeine, midazolam
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| INC280 | Experimental | Not described Receives: Drug: INC280; Drug: Midazolam; Drug: Caffeine |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUClast of midazolam and caffeine
midazolam and caffeine pharmacokinetic parameters
Measured: Up to 72 hours post midazolam and caffeine dose
AUCinf of midazolam and caffeine
midazolam and caffeine pharmacokinetic parameter
Measured: Up to 72 hours post midazolam and caffeine dose
Lambda_z of midazolam and caffeine
midazolam and caffeine pharmacokinetic parameter
Measured: Up to 72 hours post midazolam and caffeine dose
Cmax of midazolam and caffeine
midazolam and caffeine pharmacokinetic parameter
Measured: Up to 72 hours post midazolam and caffeine dose
Tmax of midazolam and caffeine
midazolam and caffeine pharmacokinetic parameter
Measured: Up to 72 hours post midazolam and caffeine dose
T1/2 of midazolam and caffeine
midazolam and caffeine pharmacokinetic parameter
Measured: Up to 72 hours post midazolam and caffeine dose
CL/F of midazolam and caffeine
midazolam and caffeine pharmacokinetic parameter
Measured: Up to 72 hours post midazolam and caffeine dose
Vz/F of midazolam and caffeine
midazolam and caffeine pharmacokinetic parameter
Measured: Up to 72 hours post midazolam and caffeine dose
Secondary outcomes (3)
Adverse events based on the CTCAE v4.03 grade (severity) and other safety data (e.g.,ECG, vital signs, laboratory results)
To assess safety and tolerability of INC280 in patients with cMET-dysregulated advanced solid tumors
Measured: From consent to 30 days post last dose
Overall response rate of patients treated with INC280
Overall response rate is defined as Complete Response and Partial Response calculated per RECIST 1.1, per investigator assessment
Measured: Baseline, every 6 weeks
Disease control rate of patients treated with INC280
Disease control rate is defined as calculated as the proportion of patients with best overall response of Complete Response, Partial Response, or Stable Disease calculated per RECIST 1.1, per investigator assessment
Measured: Baseline, every 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2015 (estimated)
- Study start10 Dec 2015
- Primary completion30 Jan 2017
- Study completion12 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for cMET-dysregulated 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
- 37 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
- NCT02520752
- Sponsor's protocol ID
- CINC280A2103
- Status last verified
- Jul 2020
- First submitted
- 9 Aug 2015
- Last updated
- 10 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Multicenter, Open-label, Single-sequence Drug-drug Interaction Study to Assess the Effect of INC280 on the Pharmacokinetics of Midazolam and Caffeine in Patients With cMET-dysregulated Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT02520752
- Acronym / sponsor ID
- CINC280A2103
- Conditions
- cMET-dysregulated Advanced Solid Tumors
- Keywords
- cMET, INC280, caffeine, midazolam
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 10 Dec 2015 (actual)
- Primary completion
- 30 Jan 2017 (actual)
- Study completion
- 12 Sep 2017 (actual)
- First posted
- 13 Aug 2015 (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.
Drg-drug Interaction (DDI) study to assess the effect of INC280 on the pharmacokinetics of midazolam and caffeine 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, Drug: Midazolam, Drug: Caffeine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- advanced solid tumors and have confirmed cMET dysregulation
- at least one measurable lesion as defined by RECIST 1.1.
- recovered from all toxicities related to prior anti-cancer therapies
- adequate organ function
- ECOG performance status (PS) of 0 or 1
Key exclusion criteria (12 listed)
- known hypersensitivity to any of the excipients of INC280 or to benzodiazepines or known intolerance and hypersensitivity to caffeine
- symptomatic central nervous system (CNS) metastases who are neurologically unstable
- presence or history of carcinomatous meningitis
- history of another primary malignancy that is currently clinically significant or currently requires active intervention
- Clinically significant, uncontrolled heart diseases, including QTcF ≥ 450 ms (male patients), ≥ 460 ms (female patients) on the screening ECG
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 |
| Midazolam | Drug | INC280 |
| Caffeine | Drug | INC280 |
Primary outcome
AUClast of midazolam and caffeine
Time frame: Up to 72 hours post midazolam and caffeine dose
midazolam and caffeine pharmacokinetic parameters
AUCinf of midazolam and caffeine
Time frame: Up to 72 hours post midazolam and caffeine dose
midazolam and caffeine pharmacokinetic parameter
Lambda_z of midazolam and caffeine
Time frame: Up to 72 hours post midazolam and caffeine dose
midazolam and caffeine pharmacokinetic parameter
Cmax of midazolam and caffeine
Time frame: Up to 72 hours post midazolam and caffeine dose
midazolam and caffeine pharmacokinetic parameter
Tmax of midazolam and caffeine
Time frame: Up to 72 hours post midazolam and caffeine dose
midazolam and caffeine pharmacokinetic parameter
T1/2 of midazolam and caffeine
Time frame: Up to 72 hours post midazolam and caffeine dose
midazolam and caffeine pharmacokinetic parameter
CL/F of midazolam and caffeine
Time frame: Up to 72 hours post midazolam and caffeine dose
midazolam and caffeine pharmacokinetic parameter
Vz/F of midazolam and caffeine
Time frame: Up to 72 hours post midazolam and caffeine dose
midazolam and caffeine pharmacokinetic parameter
3 secondary outcomes
Adverse events based on the CTCAE v4.03 grade (severity) and other safety data (e.g.,ECG, vital signs, laboratory results)
Time frame: From consent to 30 days post last dose
Overall response rate of patients treated with INC280
Time frame: Baseline, every 6 weeks
Disease control rate of patients treated with INC280
Time frame: Baseline, every 6 weeks
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 10 Dec 2020.
- Results for CINC280A2103 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
12 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing INC280, Midazolam and Caffeine in people with cMET-dysregulated Advanced Solid Tumors, run by Novartis Pharmaceuticals at 12 sites in 7 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 6 inclusion and 12 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 10 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 12 sites in Spain, United States, France, United Kingdom, Bulgaria and 2 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?
AUClast of midazolam and caffeine (time frame: Up to 72 hours post midazolam and caffeine dose). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Dec 2020.