cMET-dysregulated Advanced Solid TumorsPhase 1NCT02626234
A Drug-drug Interaction (DDI) Study to Assess the Effect of INC280 on the Pharmacokinetics of Digoxin and Rosuvastatin in Patients With cMET-dysregulated Advanced Solid Tumors
A Phase 1 study testing INC280, digoxin and rosuvastatin in people with cMET-dysregulated Advanced Solid Tumors, run by Novartis Pharmaceuticals at 15 sites in 8 countries.
Trial summary
the study aim to assess the effect of INC280 on the pharmacokinetics of digoxin and rosuvastatin 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, digoxin and rosuvastatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 15 sitesin 8 countries
- Study dates
- 8 Dec 2015to 28 Apr 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
- prior treatment with cMET or HGF-targeting inhibitor
- known hypersensitivity to digoxin or rosuvastatin or its excipients
- symptomatic central nervous system (CNS) metastases who are neurologically unstable
- presence or history of carcinomatous meningitis
Show all 14Show fewer
- history of another primary malignancy that is currently clinically significant or currently requires active intervention
- Clinically significant, uncontrolled heart diseases, including QTcF ≥ 450 msec (male patients), ≥ 460 msec (female patients) on the screening ECG
- 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 are expected to receive digoxin or rosuvastatin within 21 days prior to the beginning of the DDI phase (Day 1) and for the duration of the DDI phase.
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
15 sites in 8 countries.
15 sites in 8 countries
Italy4 sites
Novartis Investigative Site
Bologna, 40138
Novartis Investigative Site
Candiolo, TO, 10060
Novartis Investigative Site
Milan, MI, 20141
Novartis Investigative Site
Naples, 80131
United States2 sites
Emory University School of Medicine/Winship Cancer Institute Phase 1 Working Group
Atlanta, Georgia, 30322
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756
Greece2 sites
Novartis Investigative Site
Athens, 18547
Novartis Investigative Site
Ioannina, GR, 455 00
Spain2 sites
Novartis Investigative Site
Madrid, 28034
Novartis Investigative Site
Madrid, 28222
United Kingdom2 sites
Novartis Investigative Site
London, W1G 6AD
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 Digoxin and Rosuvastatin in Patients With cMET-dysregulated Advanced Solid Tumors
the study aim to assess the effect of INC280 on the pharmacokinetics of digoxin and rosuvastatin in patients with cMET-dysregulated advanced solid tumors
- Conditions
- cMET-dysregulated Advanced Solid Tumors
- Being tested
- INC280, digoxin, rosuvastatin
- Keywords
- cMET, INC280, rosuvastatin, digoxin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INC280Drug
digoxinDrug
rosuvastatinDrug
| Study group | Role | What they receive |
|---|---|---|
| INC280 | Experimental | Not described Receives: Drug: INC280; Drug: digoxin; Drug: rosuvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUClast of digoxin and rosuvastatin
digoxin and rosuvastatin pharmacokinetics parameters
Measured: Up to 240 hours post digoxin and rosuvastatin dose
AUCinf of digoxin and rosuvastatin
digoxin and rosuvastatin pharmacokinetics parameters
Measured: Up to 240 hours post digoxin and rosuvastatin dose
Lambda_z of digoxin and rosuvastatin
digoxin and rosuvastatin pharmacokinetics parameters
Measured: Up to 240 hours post digoxin and rosuvastatin dose
Cmax of digoxin and rosuvastatin
digoxin and rosuvastatin pharmacokinetics parameters
Measured: Up to 240 hours post digoxin and rosuvastatin dose
Tmax of digoxin and rosuvastatin
digoxin and rosuvastatin pharmacokinetics parameters
Measured: Up to 240 hours post digoxin and rosuvastatin dose
T1/2 of digoxin and rosuvastatin
digoxin and rosuvastatin pharmacokinetics parameters
Measured: Up to 240 hours post digoxin and rosuvastatin dose
CL/F of digoxin and rosuvastatin
digoxin and rosuvastatin pharmacokinetics parameters
Measured: Up to 240 hours post digoxin and rosuvastatin dose
Vz/F of digoxin and rosuvastatin
digoxin and rosuvastatin pharmacokinetics parameters
Measured: Up to 240 hours post digoxin and rosuvastatin dose
Secondary outcomes (4)
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 from Day 1 until date of progression or death whichever comes first
Measured: Up to 12 months
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 from Day 1 until date of progression or death whichever comes first
Measured: Up to 12 months
Concentration of INC280 during DDI phase
INC280 concentrations collected on Day 22 during DDI phase and Cycle 2 Day 1 during post DDI phase along with a listing of individual values.
Measured: Day 22, Cycle 2 Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2015 (estimated)
- Study start8 Dec 2015
- Primary completion28 Feb 2017
- Study completion28 Apr 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
- 32 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
- NCT02626234
- Sponsor's protocol ID
- CINC280A2105
- Status last verified
- Jul 2020
- First submitted
- 13 Oct 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 Digoxin and Rosuvastatin in Patients With cMET-dysregulated Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT02626234
- Acronym / sponsor ID
- CINC280A2105
- Conditions
- cMET-dysregulated Advanced Solid Tumors
- Keywords
- cMET, INC280, rosuvastatin, digoxin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 8 Dec 2015 (actual)
- Primary completion
- 28 Feb 2017 (actual)
- Study completion
- 28 Apr 2017 (actual)
- First posted
- 10 Dec 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.
the study aim to assess the effect of INC280 on the pharmacokinetics of digoxin and rosuvastatin 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: digoxin, Drug: rosuvastatin |
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 (14 listed)
- known hypersensitivity to any of the excipients of INC280
- prior treatment with cMET or HGF-targeting inhibitor
- known hypersensitivity to digoxin or rosuvastatin or its excipients
- symptomatic central nervous system (CNS) metastases who are neurologically unstable
- presence or history of carcinomatous meningitis
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 |
| digoxin | Drug | INC280 |
| rosuvastatin | Drug | INC280 |
Primary outcome
AUClast of digoxin and rosuvastatin
Time frame: Up to 240 hours post digoxin and rosuvastatin dose
digoxin and rosuvastatin pharmacokinetics parameters
AUCinf of digoxin and rosuvastatin
Time frame: Up to 240 hours post digoxin and rosuvastatin dose
digoxin and rosuvastatin pharmacokinetics parameters
Lambda_z of digoxin and rosuvastatin
Time frame: Up to 240 hours post digoxin and rosuvastatin dose
digoxin and rosuvastatin pharmacokinetics parameters
Cmax of digoxin and rosuvastatin
Time frame: Up to 240 hours post digoxin and rosuvastatin dose
digoxin and rosuvastatin pharmacokinetics parameters
Tmax of digoxin and rosuvastatin
Time frame: Up to 240 hours post digoxin and rosuvastatin dose
digoxin and rosuvastatin pharmacokinetics parameters
T1/2 of digoxin and rosuvastatin
Time frame: Up to 240 hours post digoxin and rosuvastatin dose
digoxin and rosuvastatin pharmacokinetics parameters
CL/F of digoxin and rosuvastatin
Time frame: Up to 240 hours post digoxin and rosuvastatin dose
digoxin and rosuvastatin pharmacokinetics parameters
Vz/F of digoxin and rosuvastatin
Time frame: Up to 240 hours post digoxin and rosuvastatin dose
digoxin and rosuvastatin pharmacokinetics parameters
4 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: Up to 12 months
Disease control rate of patients treated with INC280
Time frame: Up to 12 months
Concentration of INC280 during DDI phase
Time frame: Day 22, Cycle 2 Day 1
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 CINC280A2105 can be found Novartis Clinical trials 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
15 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, digoxin and rosuvastatin in people with cMET-dysregulated Advanced Solid Tumors, run by Novartis Pharmaceuticals at 15 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 6 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 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 15 sites in Italy, United States, Greece, Spain, United Kingdom 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?
AUClast of digoxin and rosuvastatin (time frame: Up to 240 hours post digoxin and rosuvastatin 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.