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OpenTrials
Completed

NCT Number: NCT01546428

A Phase I Study of INC280 in Japanese Patients With Advanced Solid Tumors

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

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Key information

Conditions

Advanced Solid Tumor

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novartis Investigative Site, Kashiwa, Chiba, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Other protocol-defined inclusion/exclusion criteria may apply

Treatment and study plan

INC280

Drug

Primary outcomes

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

    Time frame: 4 weeks

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

Secondary outcomes

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

    Time frame: 4 months

    Incidence and severity of adverse events and serious adverse events, changes in laboratory values will be measured during the treatment.

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

    Time frame: 1 month

    Plasma concentration of INC280 and derived PK parameters of INC280 will be measured with serial plasma samples during treatment for first months.

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

    Time frame: 4 months

    Tumor responses will be measured according to RECIST 1.1 or MacDonald criteria for GBM

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Mar 7, 2012
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.

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