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

August 23, 2005
May 9, 2013
August 2005
November 2006   (final data collection date for primary outcome measure)
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
Not Provided
Complete list of historical versions of study NCT00135005 on ClinicalTrials.gov Archive Site
  • 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
Not Provided
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Study of AMN107 With Imatinib in Gastrointestinal Stromal Tumors (GIST)
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)

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.

Not Provided
Interventional
Phase 1
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Gastrointestinal Stromal Tumors
Drug: AMN107, STI571
Experimental: AMN107 + STI571
Intervention: Drug: AMN107, STI571
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
59
November 2006
November 2006   (final data collection date for primary outcome measure)

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.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   France,   Germany,   Italy
 
NCT00135005
CAMN107A2103, 2005-000561-18
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP