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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01546428
First Posted: March 7, 2012
Last Update Posted: June 20, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
  Purpose
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

Condition Intervention Phase
Advanced Solid Tumor Drug: INC280 Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Study of INC280 in Japanese Patients With Advanced Solid Tumors

Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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.

  • 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.

  • 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


Enrollment: 44
Study Start Date: February 2012
Study Completion Date: January 2016
Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: INC280 Drug: INC280

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01546428


Locations
Japan
Novartis Investigative Site
Kashiwa, Chiba, Japan, 277-8577
Novartis Investigative Site
Fukuoka, Japan, 811-1395
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01546428     History of Changes
Other Study ID Numbers: CINC280X1101
First Submitted: February 27, 2012
First Posted: March 7, 2012
Last Update Posted: June 20, 2016
Last Verified: June 2016

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
c-MET
Advanced solid tumor