search
Back to results

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

Primary Purpose

Gastrointestinal Stromal Tumors

Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
AMN107
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastrointestinal Stromal Tumors focused on measuring nilotinib, AMN107, Sunitinib, Sunitinib malate, Imatinib, Imatinib mesylate, Tyrosine

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

  • 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.

Sites / Locations

  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Nilotinib

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
July 16, 2008
Last Updated
February 20, 2017
Sponsor
Novartis Pharmaceuticals
search

1. Study Identification

Unique Protocol Identification Number
NCT00718562
Brief Title
Efficacy and Safety of AMN107 in Patients With GastroIntestinal Stromal Tumors (GIST) Who Have Failed Both Imatinib and Sunitinib
Official Title
A Multi-center Phase II Study to Evaluate the Efficacy and Safety of AMN107 (Nilotinib) in Patients With Gastrointestinal Stromal Tumors Who Have Progressed on or Are Intolerant to Both Imatinib and Sunitinib
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrointestinal Stromal Tumors
Keywords
nilotinib, AMN107, Sunitinib, Sunitinib malate, Imatinib, Imatinib mesylate, Tyrosine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nilotinib
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
AMN107
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
DCR in patients with sunitinib-resistant GIST, Progression free survival (PFS), overall survival (OS), Objective response rate (ORR)
Time Frame
24 weeks
Title
Safety
Time Frame
24 weeks
Title
PK profile
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
464-8681
Country
Japan
Facility Name
Novartis Investigative Site
City
Kashiwa
State/Province
Chiba
ZIP/Postal Code
277-8577
Country
Japan
Facility Name
Novartis Investigative Site
City
Fukuoka-city
State/Province
Fukuoka
ZIP/Postal Code
812-8582
Country
Japan
Facility Name
Novartis Investigative Site
City
Sapporo-city
State/Province
Hokkaido
ZIP/Postal Code
060-8648
Country
Japan
Facility Name
Novartis Investigative Site
City
Niigata-city
State/Province
Niigata
ZIP/Postal Code
951-8520
Country
Japan
Facility Name
Novartis Investigative Site
City
Suita-city
State/Province
Osaka
ZIP/Postal Code
565-0871
Country
Japan
Facility Name
Novartis Investigative Site
City
Sunto-gun
State/Province
Shizuoka
ZIP/Postal Code
411-8777
Country
Japan
Facility Name
Novartis Investigative Site
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
104-0045
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
21456006
Citation
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.
Results Reference
result

Learn more about this trial

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

We'll reach out to this number within 24 hrs