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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01546428
First received: February 27, 2012
Last updated: August 13, 2014
Last verified: August 2014
  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: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Study of INC280 in Japanese Patients With Advanced Solid Tumors

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Incidence of Dose Limiting Toxicities (DLT) in the dose escalation part [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Tumor responses will be measured according to RECIST 1.1 or MacDonald criteria for GBM


Estimated Enrollment: 50
Study Start Date: February 2012
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: INC280 Drug: INC280

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01546428

Contacts
Contact: Novartis Pharmaceuticals +81337978748
Contact: Novartis Pharmaceuticals

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

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01546428     History of Changes
Other Study ID Numbers: CINC280X1101
Study First Received: February 27, 2012
Last Updated: August 13, 2014
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Novartis:
c-MET
Advanced solid tumor

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on November 27, 2014