NCT00135005

Brief Summary

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
59

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Aug 2005

Geographic Reach
4 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2005

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

August 23, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 25, 2005

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2006

Completed
Last Updated

December 8, 2020

Status Verified

May 1, 2013

Enrollment Period

1.3 years

First QC Date

August 23, 2005

Last Update Submit

December 6, 2020

Conditions

Gastrointestinal Stromal Tumors

Keywords

GISTAMN107Gastrointestinal Stromal Tumors

Outcome Measures

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

    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

    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

Secondary Outcomes (2)

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

    From day 1 cycle to the study completion visit

  • patients showing progression of disease on Imatinib. The patient will be followed-up for at least 4 cycles (28 days for one cycle)

    up to 4 cycles after disease profression on imatinib

Study Arms (1)

AMN107 + STI571

EXPERIMENTAL
Drug: AMN107, STI571

Interventions

AMN107, STI571DRUG
AMN107 + STI571

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Novartis Investigative Site

Boston, Massachusetts, 02115, United States

Location

Novartis Investigative Site

Philadelphia, Pennsylvania, 19111-2497, United States

Location

Novartis Investigative Site

Lyon, 69373, France

Location

Novartis Investigative Site

Berlin, 13125, Germany

Location

Novartis Investigative Site

Milan, MI, 20133, Italy

Location

Related Links

MeSH Terms

Conditions

Gastrointestinal Stromal Tumors

Interventions

nilotinibImatinib Mesylate

Condition Hierarchy (Ancestors)

Neoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal Diseases

Intervention Hierarchy (Ancestors)

BenzamidesAmidesOrganic ChemicalsBenzoatesAcids, CarbocyclicCarboxylic AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrimidines

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2005

First Posted

August 25, 2005

Study Start

August 1, 2005

Primary Completion

November 1, 2006

Study Completion

November 1, 2006

Last Updated

December 8, 2020

Record last verified: 2013-05

Locations

US(2)FR(1)IT(1)DE(1)