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OpenTrials
Completed

NCT Number: NCT02925104

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

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

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Key information

Conditions

cMET Dysegulation Advanced Solid Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novartis Investigative Site, Salzburg, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

INC280

Drug

Primary outcomes

  1. Incidence of Dose limiting toxiticites (DLTs)

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

  2. Frequency of DLTs

    Time frame: During the first 28 days on INC280 treatment

  3. Category of DLTs

    Time frame: During the first 28 days on INC280 treatment

  4. AUClast for INC280

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

  5. AUCtau for INC280

    Time frame: C1D1, C1D7, C1D15, C2D1, C3D1

  6. Cmax for INC280

    Time frame: C1D1, C1D7, C1D15, C2D1, C3D1

  7. Tmax

    Time frame: 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).

    Time frame: Screening, until 30 days post-treatment

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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.

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Oct 5, 2016
Registry last updated
Dec 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.