Study to Allow Access to Nilotinib for Patients Who Are on Nilotinib Treatment in a Novartis-sponsored Study
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
2 other identifiers
interventional
57
16 countries
33
Brief Summary
The purpose of this study was to allow continued use of nilotinib in patients who were on nilotinib treatment in a Novartis-sponsored, Oncology Clinical Development \& Medical Affairs (CD\&MA) study and were 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 P25-P50 for phase_4
Started Mar 2013
Longer than P75 for phase_4
33 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 14, 2012
CompletedFirst Posted
Study publicly available on registry
November 28, 2012
CompletedStudy Start
First participant enrolled
March 29, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 7, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
July 7, 2023
CompletedResults Posted
Study results publicly available
February 8, 2024
CompletedFebruary 8, 2024
February 1, 2024
10.3 years
November 14, 2012
December 19, 2023
February 6, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Adverse Events and Serious Adverse Events
An Adverse Event (AE) is any untoward medical occurrence (eg any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product. Serious adverse event (SAE) case data were collected in the Safety Database. Adverse event (AE) data (both non-serious and serious) were collected in the Clinical database. Max. = Maximum Yrs = Years Approx. = Approximately eCRF = electronic Case Report Form Time = timeframe
SAE case data were collected the entire study duration after first dose of study treatment up to a max. time of approx. 10 yrs. AEs (both non-serious and serious) were collected in the eCRF 3 yrs after study initiation up to a max. time of approx. 7 yrs.
Secondary Outcomes (1)
Number of Participants With Clinical Benefit From Nilotinib
Clinical benefit data were first collected 3 years after study initiation and are reported at baseline, Weeks 24, 48, 72, 96, 144, 192, 240, 288, 336, 384, 432, 480, and 528.
Study Arms (1)
Nilotinib
EXPERIMENTALPatients who were on nilotinib treatment in a Novartis-sponsored study (parent study) and were benefiting from nilotinib treatment met the criteria for enrolment into the CAMN107A2409 study and to receive continued nilotinib treatment. The starting dose of nilotinib in the CAMN107A2409 study should have been the same as the last dose administered in the parent study. After the starting dose, the dose of nilotinib was based on the investigator's judgement. The dose of nilotinib should have been ≤ 800 mg/day for adult patients, 230mg/m2 body surface area (BSA) and ≤ 800 mg/day for pediatric patients.
Interventions
Patients who were on nilotinib treatment in a Novartis-sponsored study (parent study) and were benefiting from nilotinib treatment met the criteria for enrolment into the CAMN107A2409 study and to receive continued nilotinib treatment. The starting dose of nilotinib in the CAMN107A2409 study should have been the same as the last dose administered in the parent study. After the starting dose, the dose of nilotinib was based on the investigator's judgement. The dose of nilotinib should have been ≤ 800 mg/day for adult patients, 230mg/m2 body surface area (BSA) and ≤ 800 mg/day for pediatric patients.
Eligibility Criteria
You may qualify if:
- Patient is currently enrolled in a Novartis-sponsored, Oncology Clinical Development \& Medical Affairs study receiving nilotinib and has fulfilled all their requirements in the parent study -Patient is currently benefiting from the treatment with nilotinib, as determined by the investigator -Patient has demonstrated compliance, as assessed by the investigator, with the parent study protocol requirements -Willingness and ability to comply with scheduled visits, treatment plans and any other study procedures -Written informed consent obtained prior to enrolling in roll-over study
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 - Patient has participated in a Novartis sponsored combination trial where nilotinib was dispensed in combination with another study medication and patient is still receiving combination therapy -Patients who are currently receiving treatment with any medications that have the potential to prolong the QT interval or inducing Torsade de Pointes and the treatment cannot be either safely discontinued at least one week prior to nilotinib treatment or switched to a different medication prior to start of nilotinib treatment and for the duration of the study -Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hcG laboratory test. -Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during the study and for 30 days after the final dose of nilotinib.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (33)
Novartis Investigative Site
Albany, New York, 12208, United States
Novartis Investigative Site
Houston, Texas, 77030, United States
Novartis Investigative Site
Vienna, A 1090, Austria
Novartis Investigative Site
Vancouver, British Columbia, V5Z 4E6, Canada
Novartis Investigative Site
Halifax, Nova Scotia, B3H 1V7, Canada
Novartis Investigative Site
Hamilton, Ontario, L8V 5C2, Canada
Novartis Investigative Site
Toronto, Ontario, M5G1X5, Canada
Novartis Investigative Site
Lille, 59000, France
Novartis Investigative Site
Paris, 75571, France
Novartis Investigative Site
Hong Kong SAR, Hong Kong
Novartis Investigative Site
Budapest, 1062, Hungary
Novartis Investigative Site
Budapest, 1097, Hungary
Novartis Investigative Site
Haifa, 3109601, Israel
Novartis Investigative Site
Bologna, BO, 40138, Italy
Novartis Investigative Site
Genova, GE, 16147, Italy
Novartis Investigative Site
Modena, MO, 41124, Italy
Novartis Investigative Site
Roma, RM, 00161, Italy
Novartis Investigative Site
Candiolo, TO, 10060, Italy
Novartis Investigative Site
Amsterdam, 1081 HV, Netherlands
Novartis Investigative Site
Leiden, 2300 RC, Netherlands
Novartis Investigative Site
Moscow, 117198, Russia
Novartis Investigative Site
Singapore, 119228, Singapore
Novartis Investigative Site
Singapore, 169608, Singapore
Novartis Investigative Site
Bratislava, 833 10, Slovakia
Novartis Investigative Site
Suwon, Gyeonggi-do, 443380, South Korea
Novartis Investigative Site
Seoul, Korea, 05505, South Korea
Novartis Investigative Site
Seoul, 06351, South Korea
Novartis Investigative Site
Barcelona, 08041, Spain
Novartis Investigative Site
Malmo, SE-205 02, Sweden
Novartis Investigative Site
Cambridge, London, CB2 2QQ, United Kingdom
Novartis Investigative Site
London, SW3 6JJ, United Kingdom
Novartis Investigative Site
Manchester, M20 4BX, United Kingdom
Novartis Investigative Site
Newcastle upon Tyne, NE7 7DN, United Kingdom
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 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 14, 2012
First Posted
November 28, 2012
Study Start
March 29, 2013
Primary Completion
July 7, 2023
Study Completion
July 7, 2023
Last Updated
February 8, 2024
Results First Posted
February 8, 2024
Record last verified: 2024-02
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 https://www.clinicalstudydatarequest.com/.