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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00441155
First received: February 26, 2007
Last updated: May 9, 2013
Last verified: May 2013
  Purpose

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


Condition Intervention Phase
Gastrointestinal Stromal Tumors
Drug: Nilotinib, Imatinib
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Safety and tolerability of nilotinib either as single agent or in combination with Imatinib [ 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 ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: every 3 months, at completion of every third treatment cycle prior to first dose of next cycle, at study completion visit ] [ Designated as safety issue: No ]
    Assessment of tumor response will be made based on modified RECIST criteria.


Enrollment: 14
Study Start Date: November 2006
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Monotherapy: AMN107
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
Drug: Nilotinib, Imatinib
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.
Active Comparator: Combination Therapy: AMN107 + Imatinib
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
Drug: Nilotinib, Imatinib
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00441155

Locations
United States, Massachusetts
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
United States, Pennsylvania
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111-2497
France
Novartis Investigative Site
Lyon Cedex, France, 69373
Italy
Novartis Investigative Site
Milano, MI, Italy, 20133
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Study Director: NovartisPharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00441155     History of Changes
Other Study ID Numbers: CAMN107A2103E1
Study First Received: February 26, 2007
Last Updated: May 9, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Oncology
Cancer
Imatinib-Resistant Gastrointestinal Stromal Tumors
GIST
Nilotinib
Imatinib-Resistant Gastrointestinal Stromal Tumors (GIST)

Additional relevant MeSH terms:
Gastrointestinal Stromal Tumors
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Imatinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2014