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A Dose Escalation Study to Assess PK, Safety and Tolerability of INC280 When Taken With Food in cMET Dysregulated Advanced Solid Tumors.

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ClinicalTrials.gov Identifier: NCT02925104
Recruitment Status : Completed
First Posted : October 5, 2016
Last Update Posted : July 11, 2018
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Description
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Brief Summary:
Dose escalation study to assess PK, safety and tolerability of INC280 when taken with food in patients with cMET dysregulated advanced solid tumors.

Condition or disease Intervention/treatment Phase
cMET Dysegulation Advanced Solid Tumors Drug: INC280 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Actual Study Start Date : December 14, 2016
Actual Primary Completion Date : May 16, 2018
Actual Study Completion Date : May 16, 2018
Arms and Interventions
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Arm Intervention/treatment
Experimental: INC280 Drug: INC280


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of Dose limiting toxiticites (DLTs) [ Time Frame: During the first 28 days on INC280 treatment; cycle = 21 days ]
  2. Frequency of DLTs [ Time Frame: During the first 28 days on INC280 treatment ]
  3. Category of DLTs [ Time Frame: During the first 28 days on INC280 treatment ]
  4. AUClast for INC280 [ Time Frame: Treatment Cycle 1 Day 1 (C1D1), C1D7, C1D15, C2D1, C3D1 ]
  5. AUCtau for INC280 [ Time Frame: C1D1, C1D7, C1D15, C2D1, C3D1 ]
  6. Cmax for INC280 [ Time Frame: C1D1, C1D7, C1D15, C2D1, C3D1 ]
  7. Tmax [ Time Frame: C1D1, C1D7, C1D15, C2D1, C3D1 ]

Secondary Outcome Measures :
  1. 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 ]

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:

  • 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

Exclusion Criteria:

  • 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
  • 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
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): NCT02925104


Locations
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United States, Indiana
Indiana University Simon Cancer Center SC
Indianapolis, Indiana, United States, 46202
Austria
Novartis Investigative Site
Salzburg, Austria, 5020
Denmark
Novartis Investigative Site
Herlev, Denmark, 2730
Germany
Novartis Investigative Site
Dresden, Germany, 01307
Novartis Investigative Site
Mainz, Germany, 55131
Netherlands
Novartis Investigative Site
Nijmegen, Netherlands, 6500 HB
Spain
Novartis Investigative Site
Malaga, Andalucia, Spain, 29010
Novartis Investigative Site
Santiago de Compostela, Galicia, Spain, 15706
Novartis Investigative Site
Barcelona, Spain, 08041
Novartis Investigative Site
Madrid, Spain, 28040
Novartis Investigative Site
Zaragoza, Spain, 50009
Sweden
Novartis Investigative Site
Goteborg, Sweden, 413 45
Novartis Investigative Site
Lund, Sweden, SE-221 85
Novartis Investigative Site
Stockholm, Sweden, 171 76
Novartis Investigative Site
Uppsala, Sweden, SE-751 85
United Kingdom
Novartis Investigative Site
London, United Kingdom, W1G 6AD
Novartis Investigative Site
Manchester, United Kingdom, M20 4BX
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
More Information
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02925104     History of Changes
Other Study ID Numbers: CINC280A2108
2016-001829-14 ( EudraCT Number )
First Posted: October 5, 2016    Key Record Dates
Last Update Posted: July 11, 2018
Last Verified: July 2018
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, food,