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Completed

NCT Number: NCT00135005

Study of AMN107 With Imatinib in 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.

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Key information

Conditions

Gastrointestinal Stromal Tumors Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novartis Investigative Site, Lyon, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AMN107, STI571

Drug

Primary outcomes

  1. 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

    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 outcomes

  1. To characterize safety and tolerability of AMN107 in combination with Imatinib in GIST

    Time frame: From day 1 cycle to the study completion visit

  2. 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

    cycle = 28 days

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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)

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Aug 25, 2005
Registry last updated
Dec 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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