NCT01546428

Brief Summary

INC280 will be administered to Japanese patients with advanced soid tumors whose disease has progressed despite standard therapy or for whom no standard therapy exists. The trial will assess the safety and tolerability and determine the maximum tolerated dose (MTD) on INC280

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Feb 2012

Longer than P75 for phase_1

Geographic Reach
1 country

2 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

Study Start

First participant enrolled

February 1, 2012

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

February 27, 2012

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 7, 2012

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

December 19, 2020

Status Verified

June 1, 2016

Enrollment Period

3.9 years

First QC Date

February 27, 2012

Last Update Submit

December 16, 2020

Conditions

Advanced Solid Tumor

Keywords

c-METAdvanced solid tumor

Outcome Measures

Primary Outcomes (1)

  • Incidence of Dose Limiting Toxicities (DLT) in the dose escalation part

    Incidence and frequency of DLT during the first cycle of INC280 treatment in the dose escalation part according to the CTCAE.

    4 weeks

Secondary Outcomes (3)

  • Incidence and severity of adverse events and serious adverse events, changes in laboratory values

    4 months

  • Plasma concentration of INC280 and derived PK parameters of INC280 such as Tmax, AUC and T1/2

    1 month

  • Preliminary tumor responses according to RECIST 1.1 or MacDonald criteria for GBM

    4 months

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:

  • Advanced solid tumors that are refractory to currently available therapies or for which no effective treatment is available.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2
  • Good organ (hepatic, kidney, BM) function at screening/baseline visit.

You may not qualify if:

  • Symptomatic CNS metastases that are neurologically unstable or requiring increasing doses of steroids to control CNS disease.
  • Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of INC280.
  • Undergone a bone marrow or solid organ transplant.
  • Women who are pregnant or breast feeding.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Novartis Investigative Site

Kashiwa, Chiba, 277-8577, Japan

Location

Novartis Investigative Site

Fukuoka, 811-1395, Japan

Location

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

February 27, 2012

First Posted

March 7, 2012

Study Start

February 1, 2012

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

December 19, 2020

Record last verified: 2016-06

Locations

JP(2)