Efficacy and Safety of AMN107 in Patients With GastroIntestinal Stromal Tumors (GIST) Who Have Failed Both Imatinib and Sunitinib

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00718562
First received: July 16, 2008
Last updated: March 27, 2014
Last verified: March 2014
  Purpose

This study will evaluate the efficacy and safety of nilotinib in gastrointestinal stromal tumors patients who failed imatinib and sunitinib therapy.


Condition Intervention Phase
Gastrointestinal Stromal Tumors
Drug: AMN107
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multi-center Phase II Study to Evaluate the Efficacy and Safety of AMN107 (Nilotinib) in Patients With Gastrointestinal Stromal Tumors Who Have Progressed on or Are Intolerant to Both Imatinib and Sunitinib

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Disease Control Rate (DCR) in all patients with either sunitinib-resistant GIST or in patients with GIST who are intolerant of sunitinib [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • DCR in patients with sunitinib-resistant GIST, Progression free survival (PFS), overall survival (OS), Objective response rate (ORR) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Safety [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • PK profile [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Enrollment: 35
Study Start Date: September 2008
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nilotinib Drug: AMN107

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Documented disease progression during imatinib and sunitinib therapy OR intolerance to imatinib and/or sunitinib
  • At least one measurable site of disease on CT/MRI scan
  • PS≤2
  • Normal organ, electrolyte, and bone marrow function

Exclusion Criteria:

  • Previous treatment with nilotinib or any other drug in this class or other targeted therapy
  • Treatment with any cytotoxic and/or investigational drug ≤ 4 weeks prior to study entry
  • Impaired cardiac function
  • Use of coumarin derivatives (i.e. warfarin)
  • Women who are pregnant or lactating

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: NCT00718562

Locations
Japan
Novartis Investigative Site
Nagoya, Aichi, Japan, 464-8681
Novartis Investigative Site
Kashiwa, Chiba, Japan, 277-8577
Novartis Investigative Site
Fukuoka-city, Fukuoka, Japan, 812-8582
Novartis Investigative Site
Sapporo-city, Hokkaido, Japan, 060-8648
Novartis Investigative Site
Niigata-city, Niigata, Japan, 951-8520
Novartis Investigative Site
Suita-city, Osaka, Japan, 565-0871
Novartis Investigative Site
Sunto-gun, Shizuoka, Japan, 411-8777
Novartis Investigative Site
Chuo-ku, Tokyo, Japan, 104-0045
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: NCT00718562     History of Changes
Other Study ID Numbers: CAMN107D1201
Study First Received: July 16, 2008
Last Updated: March 27, 2014
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Novartis:
nilotinib
AMN107
Sunitinib
Sunitinib malate
Imatinib
Imatinib mesylate
Tyrosine

Additional relevant MeSH terms:
Gastrointestinal Stromal Tumors
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Imatinib
Sunitinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on September 16, 2014