Study of AMN107 With Imatinib in Gastrointestinal Stromal Tumors (GIST)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00135005
First received: August 23, 2005
Last updated: May 9, 2013
Last verified: May 2013
  Purpose

This study is an open-label, multicenter, Phase I dose-escalation study of the combination of AMN107 and imatinib (STI571) in patients with imatinib-resistant GIST. This study is designed to determine the Phase II dose of AMN107 and imatinib when administered together in patients with imatinib-resistant GIST, and to characterize the safety, tolerability and pharmacokinetic (PK) profile of this combination.


Condition Intervention Phase
Gastrointestinal Stromal Tumors
Drug: AMN107, STI571
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Multicenter, Dose Escalation Study of AMN107 in Combination With Imatinib on a Continuous Daily Dosing Schedule in Adult Patients With Imatinib-resistant Gastrointestinal Stromal Tumors (GIST)

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • To determine the MTD which will be the Phase II dose of AMN107 when given in combination with Imatinib. The MTD is defined to be the highest dose of AMN107 in combination with Imatinib given for at least 21 days in the first treatment cycle [ Time Frame: From day 1 cycle 1 until at least six subjects have been treated at the recommended dose level and observed for at least 21 days ] [ Designated as safety issue: Yes ]
    MTD is defined to be the highest dose of AMN in combination with imatinib given for at least 21 days in the first treatment cycle


Secondary Outcome Measures:
  • To characterize safety and tolerability of AMN107 in combination with Imatinib in GIST [ Time Frame: From day 1 cycle to the study completion visit ] [ Designated as safety issue: Yes ]
  • patients showing progression of disease on Imatinib. The patient will be followed-up for at least 4 cycles (28 days for one cycle) [ Time Frame: up to 4 cycles after disease profression on imatinib ] [ Designated as safety issue: No ]
    cycle = 28 days


Enrollment: 59
Study Start Date: August 2005
Study Completion Date: November 2006
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AMN107 + STI571 Drug: AMN107, STI571

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with gastrointestinal stromal tumor (GIST).
  • Patients who have had disease progression during imatinib therapy with 800 mg.
  • Ability to understand and willingness to sign a written informed consent document.

Exclusion Criteria:

  • Patients with prior or concomitant malignancies other than GIST with the exception of previous or concomitant basal cell skin cancer or previous cervical carcinoma in situ.
  • A history of impaired cardiac function or uncontrolled cardiovascular disease.
  • Severe and/or uncontrolled concurrent disease that could cause unacceptable safety risks such as impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of AMN107.
  • Currently taking certain medications that could affect an electrocardiogram result.
  • Women who are pregnant or breast feeding.
  • Patients unwilling or unable to comply with the protocol.

NOTE: Additional inclusion and/ or exclusion criteria may apply.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00135005

Locations
United States, Massachusetts
Novartis Investigative Site
Boston, Massachusetts, United States, 02115
United States, Pennsylvania
Novartis Investigative Site
Philadelphia, Pennsylvania, United States, 19111-2497
France
Novartis Investigative Site
Lyon Cedex, France, 69373
Germany
Novartis Investigative Site
Berlin, Germany, 13125
Italy
Novartis Investigative Site
Milano, MI, Italy, 20133
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Additional Information:
No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00135005     History of Changes
Other Study ID Numbers: CAMN107A2103, 2005-000561-18
Study First Received: August 23, 2005
Last Updated: May 9, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
GIST
AMN107
Gastrointestinal Stromal Tumors

Additional relevant MeSH terms:
Gastrointestinal Stromal Tumors
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Imatinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 20, 2014