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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

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ClinicalTrials.gov Identifier: NCT02626234
Recruitment Status : Completed
First Posted : December 10, 2015
Last Update Posted : December 10, 2020
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Description
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Brief 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

Condition or disease Intervention/treatment Phase
cMET-dysregulated Advanced Solid Tumors Drug: INC280 Drug: digoxin Drug: rosuvastatin Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : December 8, 2015
Actual Primary Completion Date : February 28, 2017
Actual Study Completion Date : April 28, 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: INC280 Drug: INC280
Drug: digoxin
Drug: rosuvastatin


Outcome Measures
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Primary Outcome Measures :
  1. AUClast of digoxin and rosuvastatin [ Time Frame: Up to 240 hours post digoxin and rosuvastatin dose ]
    digoxin and rosuvastatin pharmacokinetics parameters

  2. AUCinf of digoxin and rosuvastatin [ Time Frame: Up to 240 hours post digoxin and rosuvastatin dose ]
    digoxin and rosuvastatin pharmacokinetics parameters

  3. Lambda_z of digoxin and rosuvastatin [ Time Frame: Up to 240 hours post digoxin and rosuvastatin dose ]
    digoxin and rosuvastatin pharmacokinetics parameters

  4. Cmax of digoxin and rosuvastatin [ Time Frame: Up to 240 hours post digoxin and rosuvastatin dose ]
    digoxin and rosuvastatin pharmacokinetics parameters

  5. Tmax of digoxin and rosuvastatin [ Time Frame: Up to 240 hours post digoxin and rosuvastatin dose ]
    digoxin and rosuvastatin pharmacokinetics parameters

  6. T1/2 of digoxin and rosuvastatin [ Time Frame: Up to 240 hours post digoxin and rosuvastatin dose ]
    digoxin and rosuvastatin pharmacokinetics parameters

  7. CL/F of digoxin and rosuvastatin [ Time Frame: Up to 240 hours post digoxin and rosuvastatin dose ]
    digoxin and rosuvastatin pharmacokinetics parameters

  8. Vz/F of digoxin and rosuvastatin [ Time Frame: Up to 240 hours post digoxin and rosuvastatin dose ]
    digoxin and rosuvastatin pharmacokinetics parameters


Secondary Outcome Measures :
  1. 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 ]
    To assess safety and tolerability of INC280 in patients with cMET-dysregulated advanced solid tumors

  2. Overall response rate of patients treated with INC280 [ Time Frame: Up to 12 months ]
    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

  3. Disease control rate of patients treated with INC280 [ Time Frame: Up to 12 months ]
    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

  4. Concentration of INC280 during DDI phase [ Time Frame: Day 22, Cycle 2 Day 1 ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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
  • 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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02626234


Locations
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United States, Georgia
Emory University School of Medicine/Winship Cancer Institute Phase 1 Working Group
Atlanta, Georgia, United States, 30322
United States, New Hampshire
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
Austria
Novartis Investigative Site
Vienna, Austria, A-1090
Belgium
Novartis Investigative Site
Edegem, Antwerpen, Belgium, 2650
Czechia
Novartis Investigative Site
Brno, Czechia, 65653
Greece
Novartis Investigative Site
Ioannina, GR, Greece, 455 00
Novartis Investigative Site
Athens, Greece, 18547
Italy
Novartis Investigative Site
Milano, MI, Italy, 20141
Novartis Investigative Site
Candiolo, TO, Italy, 10060
Novartis Investigative Site
Bologna, Italy, 40138
Novartis Investigative Site
Napoli, Italy, 80131
Spain
Novartis Investigative Site
Madrid, Spain, 28034
Novartis Investigative Site
Madrid, Spain, 28222
United Kingdom
Novartis Investigative Site
London, United Kingdom, W1G 6AD
Novartis Investigative Site
Manchester, United Kingdom, M20 9BX
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
More Information
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Additional Information:

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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02626234    
Other Study ID Numbers: CINC280A2105
First Posted: December 10, 2015    Key Record Dates
Last Update Posted: December 10, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
cMET, INC280, rosuvastatin, digoxin
Additional relevant MeSH terms:
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Neoplasms
Digoxin
Rosuvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
 Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Anti-Arrhythmia Agents
Cardiotonic Agents
Protective Agents
Physiological Effects of Drugs