NCT02925104

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Dec 2016

Geographic Reach
8 countries

17 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 4, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 5, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

December 14, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 16, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 16, 2018

Completed
Last Updated

December 19, 2020

Status Verified

February 1, 2020

Enrollment Period

1.4 years

First QC Date

October 4, 2016

Last Update Submit

December 16, 2020

Conditions

cMET Dysegulation Advanced Solid Tumors

Keywords

cMET, INC280, food,

Outcome Measures

Primary Outcomes (7)

  • Incidence of Dose limiting toxiticites (DLTs)

    During the first 28 days on INC280 treatment; cycle = 21 days

  • Frequency of DLTs

    During the first 28 days on INC280 treatment

  • Category of DLTs

    During the first 28 days on INC280 treatment

  • AUClast for INC280

    Treatment Cycle 1 Day 1 (C1D1), C1D7, C1D15, C2D1, C3D1

  • AUCtau for INC280

    C1D1, C1D7, C1D15, C2D1, C3D1

  • Cmax for INC280

    C1D1, C1D7, C1D15, C2D1, C3D1

  • Tmax

    C1D1, C1D7, C1D15, C2D1, C3D1

Secondary Outcomes (1)

  • Adverse events based on CTCAE grading and other safety variables (e.g. EGC readings, physical examination, vital signs and laboratory results).

    Screening, until 30 days post-treatment

Study Arms (1)

INC280

EXPERIMENTAL
Drug: INC280

Interventions

INC280DRUG
INC280

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

Indiana University Simon Cancer Center SC

Indianapolis, Indiana, 46202, United States

Location

Novartis Investigative Site

Salzburg, 5020, Austria

Location

Novartis Investigative Site

Herlev, 2730, Denmark

Location

Novartis Investigative Site

Dresden, 01307, Germany

Location

Novartis Investigative Site

Mainz, 55131, Germany

Location

Novartis Investigative Site

Nijmegen, 6500 HB, Netherlands

Location

Novartis Investigative Site

Málaga, Andalusia, 29010, Spain

Location

Novartis Investigative Site

Santiago de Compostela, Galicia, 15706, Spain

Location

Novartis Investigative Site

Barcelona, 08041, Spain

Location

Novartis Investigative Site

Madrid, 28040, Spain

Location

Novartis Investigative Site

Zaragoza, 50009, Spain

Location

Novartis Investigative Site

Gothenburg, 413 45, Sweden

Location

Novartis Investigative Site

Lund, SE-221 85, Sweden

Location

Novartis Investigative Site

Stockholm, 171 76, Sweden

Location

Novartis Investigative Site

Uppsala, SE-751 85, Sweden

Location

Novartis Investigative Site

London, W1G 6AD, United Kingdom

Location

Novartis Investigative Site

Manchester, M20 4BX, United Kingdom

Location

Related Publications (1)

  • Moreno V, Greil R, Yachnin J, Majem M, Wermke M, Arkenau HT, Basque JR, Nidamarthy PK, Kapoor S, Cui X, Giovannini M. Pharmacokinetics and safety of capmatinib with food in patients with MET-dysregulated advanced solid tumors. Clin Ther. 2021 Jun;43(6):1092-1111. doi: 10.1016/j.clinthera.2021.04.006. Epub 2021 May 27.

    PMID: 34053700DERIVED

Related Links

MeSH Terms

Interventions

capmatinib

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 4, 2016

First Posted

October 5, 2016

Study Start

December 14, 2016

Primary Completion

May 16, 2018

Study Completion

May 16, 2018

Last Updated

December 19, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)DE(2)ES(5)US(1)SE(4)GB(2)NL(1)DK(1)