Nilotinib Roll-over Protocol for Patients in Novartis-sponsored Nilotinib Study and Benefiting From Nilotinib Treatment

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01863745
First received: May 23, 2013
Last updated: August 25, 2014
Last verified: August 2014
  Purpose

The purpose of this study is to collect and assess long-term safety of nilotinib in patients who are on nilotinib treatment in a Novartis-sponsored, Oncology CD&MA study and are benefiting from the treatment as judged by the investigator.


Condition Intervention Phase
Gastrointestinal Stromal Tumors
Drug: nilotinib
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label, Multi-center Nilotinib Roll-over Protocol for Patients Who Have Completed a Previous Novartis-sponsored Nilotinib Study and Are Judged by the Investigator to Benefit From Continued Nilotinib Treatment

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Frequency and nature of adverse events [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    To collect and assess long-term safety of nilotinib in patients receiving nilotinib and are benefiting from treatment with nilotinib n a Novartis-sponsored Oncology study which had reached its objectives.


Enrollment: 15
Study Start Date: June 2013
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: nilotinib
16 patients who are currently enrolled in a Novartis- sponsored, Oncology Clinical Development & Medical Affairs (CD&MA) study receiving nilotinib and has fulfilled all their requirements in the parent study will be enrolled.
Drug: nilotinib
Nilotinib can be provided as 200 mg and 150 mg hard gelatin capsules. The starting dose of nilotinib should be the same as the last dose that was given in the parent nilotinib study. After this, the dose of nilotinib is based on the investigator's judgment.

  Eligibility

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

Inclusion Criteria:

  • Patient is currently enrolled in a Novartis-sponsored, Oncology CD&MA study receiving nilotinib and benefiting from the treatment with nilotinib, as determined by the investigator.

Exclusion Criteria:

  • Patient has been permanently discontinued from nilotinib treatment in the parent study due to unacceptable toxicity, non-compliance to study procedures, withdrawal of consent or any other reason.

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: NCT01863745

Locations
Japan
Novartis Investigative Site
Nagoya, Aichi, Japan, 464-8681
Novartis Investigative Site
Kashiwa, Chiba, Japan
Novartis Investigative Site
Sapporo-city, Hokkaido, Japan, 060-8648
Novartis Investigative Site
Yokohama, Kanagawa, Japan, 241-8515
Novartis Investigative Site
Kumamoto City, Kumamoto, Japan, 860-8556
Novartis Investigative Site
Sendai-city, Miyagi, Japan, 980-8574
Novartis Investigative Site
Kurashiki, Okayama, Japan, 701-0192
Novartis Investigative Site
Suita-city, Osaka, Japan, 565-0871
Novartis Investigative Site
Chuo-ku, Tokyo, Japan
Novartis Investigative Site
Gifu, Japan, 501-1194
Novartis Investigative Site
Osaka, Japan, 540-0006
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01863745     History of Changes
Other Study ID Numbers: CAMN107A1201
Study First Received: May 23, 2013
Last Updated: August 25, 2014
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Novartis:
ggastrointestinal stromal tumors
gastrointestinal,
stromal,
tumors,
GIST,
AMN107,
nilotinib

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

ClinicalTrials.gov processed this record on August 28, 2014