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

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.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02925104

Enrollment

Registered

2016-10-05

Start date

2016-12-14

Completion date

2018-05-16

Last updated

2020-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cMET Dysegulation Advanced Solid Tumors

Keywords

cMET, INC280, food,

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.

Interventions

DRUGINC280

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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/

Design outcomes

Primary

Measure	Time frame
Tmax	C1D1, C1D7, C1D15, C2D1, C3D1
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

Secondary

Measure	Time frame
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

Countries

Austria, Denmark, Germany, Netherlands, Spain, Sweden, United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026