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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.

NCT02925104

Description:

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

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Completed

Phase:

Phase 1

URL:

https://clinicaltrials.gov/show/NCT02925104

Trial Eligibility

Document

Title

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

Clinical Trial IDs

  • ORG STUDY ID: CINC280A2108
  • SECONDARY ID: 2016-001829-14
  • NCT ID: NCT02925104

Conditions

  • cMET Dysegulation Advanced Solid Tumors

Interventions

DrugSynonymsArms
INC280INC280

Purpose

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

Trial Arms

NameTypeDescriptionInterventions
INC280Experimental
  • INC280

Eligibility 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
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Incidence of Dose limiting toxiticites (DLTs)
Time Frame:During the first 28 days on INC280 treatment; cycle = 21 days
Safety Issue:
Description:

Secondary Outcome Measures

Measure: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
Safety Issue:
Description:

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Completed
Lead Sponsor:Novartis Pharmaceuticals

Trial Keywords

  • cMET, INC280, food,

Last Updated

December 19, 2020