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CompletedNCT00718562Updated Feb 23, 2017

Efficacy and Safety of AMN107 in Patients With GastroIntestinal Stromal Tumors (GIST) Who Have Failed Both Imatinib and Sunitinib

A Phase 2 interventional study of AMN107 in Gastrointestinal Stromal Tumors, sponsored by Novartis Pharmaceuticals. Completed at 8 sites in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2017-02-23.

Sponsored by Novartis Pharmaceuticals · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
35
Allocation
Not applicable
Ages
20 Years and older
Sex
All
01

Study summary

This study will evaluate the efficacy and safety of nilotinib in gastrointestinal stromal tumors patients who failed imatinib and sunitinib therapy.

02

Conditions studied

  • Gastrointestinal Stromal Tumors

Keywords

  • nilotinib
  • AMN107
  • Sunitinib
  • Sunitinib malate
  • Imatinib
  • Imatinib mesylate
  • Tyrosine
03

In context

Gastrointestinal Stromal Tumors

333 studies on the registry are indexed under Gastrointestinal Stromal Tumors; 61 are open to participants now.

This study's enrollment of 35 is below the median of 50 across 243 interventional studies indexed under Gastrointestinal Stromal Tumors.

Browse Gastrointestinal Stromal Tumors studies →

Lead sponsor

Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.

Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Documented disease progression during imatinib and sunitinib therapy OR intolerance to imatinib and/or sunitinib
  • At least one measurable site of disease on CT/MRI scan
  • PS≤2
  • Normal organ, electrolyte, and bone marrow function

Exclusion criteria

Exclusion Criteria:

  • Previous treatment with nilotinib or any other drug in this class or other targeted therapy
  • Treatment with any cytotoxic and/or investigational drug ≤ 4 weeks prior to study entry
  • Impaired cardiac function
  • Use of coumarin derivatives (i.e. warfarin)
  • Women who are pregnant or lactating

Other protocol-defined inclusion/exclusion criteria may apply.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
35 participants (actual)

Study arms

  • Experimental
    Nilotinib

    Drug: AMN107

Interventions

  • DrugAMN107
06

What researchers measure

Primary outcomes

  1. Disease Control Rate (DCR) in all patients with either sunitinib-resistant GIST or in patients with GIST who are intolerant of sunitinib

    Time frame: 24 weeks

Secondary outcomes

  1. DCR in patients with sunitinib-resistant GIST, Progression free survival (PFS), overall survival (OS), Objective response rate (ORR)

    Time frame: 24 weeks

  2. Safety

    Time frame: 24 weeks

  3. PK profile

    Time frame: 24 weeks

07

Study locations

8 sites
  • Novartis Investigative Site
    Nagoya, Aichi 464-8681, Japan
  • Novartis Investigative Site
    Kashiwa, Chiba 277-8577, Japan
  • Novartis Investigative Site
    Fukuoka-city, Fukuoka 812-8582, Japan
  • Novartis Investigative Site
    Sapporo-city, Hokkaido 060-8648, Japan
  • Novartis Investigative Site
    Niigata-city, Niigata 951-8520, Japan
  • Novartis Investigative Site
    Suita-city, Osaka 565-0871, Japan
  • Novartis Investigative Site
    Sunto-gun, Shizuoka 411-8777, Japan
  • Novartis Investigative Site
    Chuo-ku, Tokyo 104-0045, Japan
08

References and documents

Publications

  • Sawaki A, Nishida T, Doi T, Yamada Y, Komatsu Y, Kanda T, Kakeji Y, Onozawa Y, Yamasaki M, Ohtsu A. Phase 2 study of nilotinib as third-line therapy for patients with gastrointestinal stromal tumor. Cancer. 2011 Oct 15;117(20):4633-41. doi: 10.1002/cncr.26120. Epub 2011 Mar 31. PubMed 21456006 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 23, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00718562
Lead sponsor
Novartis Pharmaceuticals
Responsible party
Sponsor
First posted
Jul 18, 2008
Start date
Sep 2008
Primary completion
Jul 2013
Completion
Jul 2013
Last update
Feb 23, 2017

Study contacts

Novartis Pharmaceuticals
study director · Novartis Pharmaceuticals

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.

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