Nilotinib Roll-over Protocol for Patients in Novartis-sponsored Nilotinib Study and Benefiting From Nilotinib Treatment
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
1 other identifier
interventional
15
1 country
11
Brief Summary
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 Clinical Development \& Medical Affairs study and are benefiting from the treatment as judged by the investigator.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Jun 2013
Longer than P75 for phase_2
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 23, 2013
CompletedFirst Posted
Study publicly available on registry
May 29, 2013
CompletedStudy Start
First participant enrolled
June 25, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 2, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
October 2, 2023
CompletedResults Posted
Study results publicly available
August 19, 2024
CompletedAugust 19, 2024
July 1, 2024
10.3 years
May 23, 2013
July 26, 2024
July 26, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Number of participants with adverse events (AEs) (any AE regardless of seriousness), serious adverse events (SAEs), Fatal SAEs and treatment related AEs.
Adverse events were reported from enrolment until 30 days after last dose of study treatment, up to approximately 10.3 years.
Study Arms (1)
nilotinib
EXPERIMENTALThe starting dose of nilotinib was same as the last dose given in the parent nilotinib study. After this, the dose of nilotinib was based on the investigator's judgment. The total daily dose was up to 800 mg.
Interventions
Nilotinib was administered daily as hard gelatin capsules for oral use. The starting dose of nilotinib was same as the last dose given in the parent nilotinib study. After this, the dose of nilotinib was based on the investigator's judgment. The total daily dose was up to 800 mg.
Eligibility Criteria
You may qualify if:
- Patient is currently enrolled in a Novartis-sponsored, Clinical study receiving nilotinib and benefiting from the treatment with nilotinib, as determined by the investigator
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
Novartis Investigative Site
Nagoya, Aichi-ken, 464 8681, Japan
Novartis Investigative Site
Kashiwa, Chiba, 277 8577, Japan
Novartis Investigative Site
Gifu, Gifu, 501-1194, Japan
Novartis Investigative Site
Sapporo, Hokkaido, 060 8648, Japan
Novartis Investigative Site
Yokohama, Kanagawa, 241-8515, Japan
Novartis Investigative Site
Kumamoto, Kumamoto, 860-8556, Japan
Novartis Investigative Site
Sendai, Miyagi, 980 8574, Japan
Novartis Investigative Site
Kurashiki, Okayama-ken, 701-0192, Japan
Novartis Investigative Site
Osaka, Osaka, 540-0006, Japan
Novartis Investigative Site
Suita, Osaka, 565 0871, Japan
Novartis Investigative Site
Chuo Ku, Tokyo, 104 0045, Japan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Novartis Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 23, 2013
First Posted
May 29, 2013
Study Start
June 25, 2013
Primary Completion
October 2, 2023
Study Completion
October 2, 2023
Last Updated
August 19, 2024
Results First Posted
August 19, 2024
Record last verified: 2024-07
Data Sharing
- IPD Sharing
- Will share
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.