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

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Novartis

Status and phase

Completed
Phase 1

Conditions

Gastrointestinal Stromal Tumors

Treatments

Drug: AMN107, STI571

Study type

Interventional

Funder types

Industry

Identifiers

NCT00135005
2005-000561-18 (EudraCT Number)
CAMN107A2103

Details and patient eligibility

About

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.

Enrollment

59 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

59 participants in 1 patient group

AMN107 + STI571
Experimental group
Treatment:
Drug: AMN107, STI571

Trial contacts and locations

5

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Data sourced from clinicaltrials.gov

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