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Patients Completing Core Protocol (CAMN107A2103), Exhibiting Stable Disease (SD), Partial Response (PR) or Complete Response (CR) to Nilotinib in Combination With Imatinib

Primary Purpose

Gastrointestinal Stromal Tumors

Status

Completed

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

Nilotinib, Imatinib

About this trial

This is an interventional treatment trial for Gastrointestinal Stromal Tumors focused on measuring Oncology, Cancer, Imatinib-Resistant Gastrointestinal Stromal Tumors, GIST, Nilotinib, Imatinib-Resistant Gastrointestinal Stromal Tumors (GIST)

Eligibility Criteria

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

Inclusion criteria:

Documented Complete Response, Partial Response, or Stable Disease at the time of entry to extension study and/or possible benefit from continuing treatment in the view of the investigator.
Normal organ and marrow function as defined in core protocol (CAMN107A2103).
Extension protocol written informed consent.

Exclusion criteria:

Inability to swallow the medication.
Any unresolved adverse events related to participation in the core protocol (CAMN107A2103).
A history of noncompliance to medical regimens or inability or unwillingness to return for all scheduled visits.

Other protocol defined inclusion/exclusion criteria may apply.

Sites / Locations

Dana Farber Cancer Institute
Fox Chase Cancer Center
Novartis Investigative Site
Novartis Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Monotherapy: AMN107

Combination Therapy: AMN107 + Imatinib

Arm Description

initial dose of imatinib (dose level 1) was 400 mg bid was administered orally on a continuous daily schedule and was not escalated during the study

six possible doses of Nilotinib (100 mg once daily (qd), 200 mg qd, 400 mg qd, 200 mg bid, 300 mg bid, and 400 mg bid). four possible doses of Imatinib (0 mg, 400 mg qd, 600 mg qd, and 400 mg bid).the initial dose of nilotinib (dose level 1) was 200 mg qd and could have been escalated up to 400 mg bid

Outcomes

Primary Outcome Measures

Safety and tolerability of nilotinib either as single agent or in combination with Imatinib

Assessed by AE evaluation, including safety laboratory and cardiac safety (ECG, cardiac enzymes, ECHO) measures.

Secondary Outcome Measures

To assess any clinical responses in Imatinib-resistant GIST patients. Assessment of tumor response will be made based on modified RECIST criteria - to be assessed at the end of every cycle of treatment

Assessment of tumor response will be made based on modified RECIST criteria.

Full Information

NCT ID

NCT00441155

First Posted

February 26, 2007

Last Updated

May 9, 2013

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT00441155

Brief Title

Patients Completing Core Protocol (CAMN107A2103), Exhibiting Stable Disease (SD), Partial Response (PR) or Complete Response (CR) to Nilotinib in Combination With Imatinib

Official Title

An Extension to a Phase I Multicenter, Dose Escalation Study of Nilotinib 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

November 2006 (undefined)

Primary Completion Date

January 2011 (Actual)

Study Completion Date

January 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

5. Study Description

Brief Summary

To provide study drug to patients that benefit from treatment judged by the investigator - to obtain additional long-term safety and efficacy data of this combination regimen in GIST

6. Conditions and Keywords

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

Gastrointestinal Stromal Tumors

Keywords

Oncology, Cancer, Imatinib-Resistant Gastrointestinal Stromal Tumors, GIST, Nilotinib, Imatinib-Resistant Gastrointestinal Stromal Tumors (GIST)

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

14 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Monotherapy: AMN107

Arm Type

Experimental

Arm Description

initial dose of imatinib (dose level 1) was 400 mg bid was administered orally on a continuous daily schedule and was not escalated during the study

Arm Title

Combination Therapy: AMN107 + Imatinib

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Nilotinib, Imatinib

Intervention Description

Nilotinib 50 mg and 200 mg gelatin capsules and Imatinib 100 mg and 400 mg film-coated tablets in bottles.. Medication labels for each study drug complied with the legal requirements of each country, were printed in the local language.

Primary Outcome Measure Information:

Title

Safety and tolerability of nilotinib either as single agent or in combination with Imatinib

Description

Assessed by AE evaluation, including safety laboratory and cardiac safety (ECG, cardiac enzymes, ECHO) measures.

Time Frame

AE monitored continuously from day 1 cycle 1 to the study completion visit; safety laboratory and cardiac safety monitored every 3 treatment cycles (every 3 months) from day 1 cycle 1 to the study completion visit

Secondary Outcome Measure Information:

Title

Description

Assessment of tumor response will be made based on modified RECIST criteria.

Time Frame

every 3 months, at completion of every third treatment cycle prior to first dose of next cycle, at study completion visit

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria: Documented Complete Response, Partial Response, or Stable Disease at the time of entry to extension study and/or possible benefit from continuing treatment in the view of the investigator. Normal organ and marrow function as defined in core protocol (CAMN107A2103). Extension protocol written informed consent. Exclusion criteria: Inability to swallow the medication. Any unresolved adverse events related to participation in the core protocol (CAMN107A2103). A history of noncompliance to medical regimens or inability or unwillingness to return for all scheduled visits. 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

First Name & Middle Initial & Last Name & Degree

NovartisPharmaceuticals

Organizational Affiliation

Novartis Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Dana Farber Cancer Institute

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02115

Country

United States

Facility Name

Fox Chase Cancer Center

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

Milano

State/Province

ZIP/Postal Code

20133

Country

Italy

12. IPD Sharing Statement

Learn more about this trial

Patients Completing Core Protocol (CAMN107A2103), Exhibiting Stable Disease (SD), Partial Response (PR) or Complete Response (CR) to Nilotinib in Combination With Imatinib

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