Clinical trial NCT02925104: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: cMET Dysegulation Advanced Solid Tumors
Keywords: cMET, INC280, food,
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2016-10-05
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Incidence of Dose limiting toxiticites (DLTs)
timeFrame: During the first 28 days on INC280 treatment; cycle = 21 days
measure: Frequency of DLTs
timeFrame: During the first 28 days on INC280 treatment
measure: Category of DLTs
timeFrame: During the first 28 days on INC280 treatment
measure: AUClast for INC280
timeFrame: Treatment Cycle 1 Day 1 (C1D1), C1D7, C1D15, C2D1, C3D1
measure: AUCtau for INC280
timeFrame: C1D1, C1D7, C1D15, C2D1, C3D1
measure: Cmax for INC280
timeFrame: C1D1, C1D7, C1D15, C2D1, C3D1
measure: Tmax
timeFrame: C1D1, C1D7, C1D15, C2D1, C3D1
Secondary outcomes:
measure: Adverse events based on CTCAE grading and other safety variables (e.g. EGC readings, physical examination, vital signs and laboratory results).
timeFrame: Screening, until 30 days post-treatment
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University Simon Cancer Center SC
state: Indiana
city: Salzburg
country: Austria
facility: Novartis Investigative Site
city: Herlev
country: Denmark
facility: Novartis Investigative Site
city: Dresden
country: Germany
facility: Novartis Investigative Site
city: Mainz
country: Germany
facility: Novartis Investigative Site
city: Nijmegen
country: Netherlands
facility: Novartis Investigative Site
city: Malaga
country: Spain
facility: Novartis Investigative Site
state: Andalucia
city: Santiago de Compostela
country: Spain
facility: Novartis Investigative Site
state: Galicia
city: Barcelona
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Zaragoza
country: Spain
facility: Novartis Investigative Site
city: Goteborg
country: Sweden
facility: Novartis Investigative Site
city: Lund
country: Sweden
facility: Novartis Investigative Site
city: Stockholm
country: Sweden
facility: Novartis Investigative Site
city: Uppsala
country: Sweden
facility: Novartis Investigative Site
city: London
country: United Kingdom
facility: Novartis Investigative Site
city: Manchester
country: United Kingdom
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: 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.