Phase III, Open-label Study of Nilotinib Versus Imatinib in GIST Patients - Tabular View

Tracking Information

First Received Date ^ICMJE

November 4, 2008

Last Updated Date

October 6, 2009

Start Date ^ICMJE

March 2009

Estimated Primary Completion Date

May 2021 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

To compare Progression Free Survival (PFS) of nilotinib and imatinib when used as initial therapy in patents with unresectable and/ or metastatic GIST. [ Time Frame: throughout the study ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

To compare Progression Free Survival (PFS) of nilotinib and imatinib when used as initial therapy in patents with unresectable and/ or metastatic GIST. [ Designated as safety issue: No ]

Change History

Complete list of historical versions of study NCT00785785 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

To compare disease control rate (DCR) of nilotinib and imatinib [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
To compare time to treatment failure (TTF) of nilotinib and imatinib [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
To compare overall survival (OS) of nilotinib and imatinib [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
To compare time to progression (TTP), response rate (RR), time to tumor response and assess duration of response of nilotinib and imatinib [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
To compare safety and tolerability of nilotinib and imatinib [ Time Frame: at month 1 and then every 3 months ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

To compare disease control rate (DCR) of nilotinib and imatinib [ Designated as safety issue: Yes ]
To compare time to treatment failure (TTF) of nilotinib and imatinib [ Designated as safety issue: Yes ]
To compare overall survival (OS) of nilotinib and imatinib [ Designated as safety issue: Yes ]

Descriptive Information

Brief Title ^ICMJE

Phase III, Open-label Study of Nilotinib Versus Imatinib in GIST Patients

Official Title ^ICMJE

A Randomized, Open Label, Multi-center Phase III Study to Evaluate the Efficacy and Safety of Nilotinib Versus Imatinib in Adult Patients With Unresectable or Metastatic Gastrointestinal Stromal Tumors (GIST)

Brief Summary

This study will evaluate efficacy and safety of nilotinib versus imatinib in adult patients with unresectable or metastatic gastrointestinal stromal tumors (GIST).

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Gastrointestinal Stromal Tumor (GIST)

Intervention ^ICMJE

Drug: Nilotinib (AMN107)
Drug: imatinib (STI571)

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

736

Completion Date

Estimated Primary Completion Date

May 2021 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Histologically confirmed diagnosis of GIST which is unresectable and/or metastatic and either:
- no prior therapy with imatinib or any investigational therapies (e.g .sunitinib). Note: newly diagnosed patients may have received up to 14 days imatinib treatment for disease management while awaiting study start.
- recurrent GIST after stopping adjuvant treatment with imatinib and no subsequent treatment with any other investigational therapies (for example sunitinib).
At least one measurable site of disease on CT/MRI scan
Performance status ≤ 2 (capable of self-care but unable to carry out any work)
Normal organ, electrolyte and marrow function

Exclusion Criteria:

Prior treatment with nilotinib or any other drug in this class or other targeted therapy agents with the exception of adjuvant imatinib.
Disease progression during adjuvant therapy with imatinib
Prior or concommitant malignancy that is currently clinically significant or currently requires active intervention.
Impaired cardiac function

Other protocol-defined inclusion/exclusion criteria may apply

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Novartis Pharmaceuticals

+1-800-340-6843

Location Countries ^ICMJE

United States, Argentina, Austria, Brazil, Canada, Colombia, Denmark, France, Israel, Japan, Netherlands, Singapore, South Africa, Spain, Thailand, United Kingdom

Administrative Information

NCT ID ^ICMJE

NCT00785785

Responsible Party

External Affairs, Novartis Pharmaceuticals

Study ID Numbers ^ICMJE

CAMN107G2301

Study Sponsor ^ICMJE

Novartis Pharmaceuticals

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Novartis Pharmaceuticals

Information Provided By

Novartis

Verification Date

October 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP