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

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Primary Purpose

Status

Completed

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

AMN107, STI571

About this trial

This is an interventional treatment trial for Gastrointestinal Stromal Tumors focused on measuring GIST, AMN107, Gastrointestinal Stromal Tumors

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

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

AMN107 + STI571

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

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

cycle = 28 days

Full Information

NCT ID

NCT00135005

First Posted

August 23, 2005

Last Updated

December 6, 2020

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT00135005

Brief Title

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

Official Title

A Phase I Multicenter, Dose Escalation Study of AMN107 in Combination With Imatinib on a Continuous Daily Dosing Schedule in Adult Patients With Imatinib-resistant Gastrointestinal Stromal Tumors (GIST)

Study Type

Interventional

2. Study Status

Record Verification Date

May 2013

Overall Recruitment Status

Completed

Study Start Date

August 2005 (undefined)

Primary Completion Date

November 2006 (Actual)

Study Completion Date

November 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gastrointestinal Stromal Tumors

Keywords

GIST, AMN107, Gastrointestinal Stromal Tumors

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

59 (Actual)

8. Arms, Groups, and Interventions

Arm Title

AMN107 + STI571

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

AMN107, STI571

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

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 Outcome Measure Information:

Title

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

Time Frame

From day 1 cycle to the study completion visit

Title

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

Description

cycle = 28 days

Time Frame

up to 4 cycles after disease profression on imatinib

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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.

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

Boston

State/Province

Massachusetts

ZIP/Postal Code

02115

Country

United States

Facility Name

Novartis Investigative Site

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19111-2497

Country

United States

Facility Name

Novartis Investigative Site

City

Lyon Cedex

ZIP/Postal Code

69373

Country

France

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

13125

Country

Germany

Facility Name

Novartis Investigative Site

City

Milano

State/Province

MI

ZIP/Postal Code

20133

Country

Italy

12. IPD Sharing Statement

Links:

URL

https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=2942

Description

Results for CAMN107A2103 can be found on the Novartis Clinical Trial Results Website

Gastrointestinal Stromal Tumors

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial