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Trial record 1 of 1 for:    NCT01735955
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Study to Allow Access to Nilotinib for Patients Who Are on Nilotinib Treatment in a Novartis-sponsored Study

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ClinicalTrials.gov Identifier: NCT01735955
Recruitment Status : Completed
First Posted : November 28, 2012
Results First Posted : February 8, 2024
Last Update Posted : February 8, 2024
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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

Condition or disease Intervention/treatment Phase
Chronic Myelogenous Leukemia (CML) Metastatic Gastrointestinal Stromal Tumors (GIST) Acute Lymphoblastic Leukemia (ALL) Receptor Tyrosine Kinase (KIT) Mutated Melanoma Drug: Nilotinib Phase 4

Detailed Description:

This was a multi-center, open label, single-arm, phase IV study to better characterize the long-term safety of nilotinib in patients treated in Novartis-sponsored studies and who benefited from treatment with nilotinib.

Patients who were enrolled in Novartis-sponsored nilotinib studies, had benefitted from treatment with nilotinib and fulfilled all requirements in the parent study could be enrolled into the current roll-over study.

There was no sample size estimation carried out for this study.

Patients returned to the study center on a quarterly basis (12 weeks ± 1 week) for scheduled visit. Adverse Events (AEs) (non-serious and serious AEs), clinical benefit assessment by investigator and study medication dispensing information were collected.

The original protocol of the current roll-over study was designed to provide continuation of treatment with nilotinib for patients enrolled in nilotinib studies. Therefore, the original protocol did not require AEs (non-serious and serious AEs) to be collected into the clinical database and only required serious adverse events (SAEs) to be collected in the Novartis safety database throughout the study duration.

The scheduled visit frequency was annually.

However, feedback from health authorities stated that all AEs should be collected. To account for this, the protocol was amended in 2016 (Protocol amendment 3 (PA 3)), with the primary objective changed to assess long-term safety of nilotinib. Consequently, PA 3 started to require all AEs (non-serious and serious AEs) to be entered into the clinical database, in addition to the continued SAE collection into the Novartis safety database. At the same time, the scheduled visit frequency was increased from annually to quarterly, and the protocol was also amended to require an investigator assessment of clinical benefit for patients.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 57 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Actual Study Start Date : March 29, 2013
Actual Primary Completion Date : July 7, 2023
Actual Study Completion Date : July 7, 2023


Arm Intervention/treatment
Experimental: Nilotinib
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.
Drug: Nilotinib
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.
Other Name: AMN107




Primary Outcome Measures :
  1. Number of Participants With Adverse Events and Serious Adverse Events [ Time Frame: 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. ]

    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



Secondary Outcome Measures :
  1. Number of Participants With Clinical Benefit From Nilotinib [ Time Frame: 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. ]

    Number of patients (pts) with clinical benefit as assessed by investigator.

    Clinical benefit data were first collected 3 years after study initiation and up to a maximum timeframe of approx. 7 years and 3 months at a patient level (up to Week 528 total at the study level).

    Pts who discontinued in the first 3 years after study initiation didn't have any clinical benefit data collected. Pts who enrolled in the first 3 years after study initiation only had clinical benefit data collected starting at approx. the third year of the study until the end of the patient's participation in the study. Pts who enrolled after the first 3 years after study initiation had all clinical benefit data collected until the end of the patient's participation in the study.

    Data for the earlier time points are provided only for later enrolled pts. Data for the later time points are provided only for the earlier enrolled pts.

    The time point per patient was calculated from the date of first drug intake.




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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

-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

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 - 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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01735955


Locations
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United States, New York
Novartis Investigative Site
Albany, New York, United States, 12208
United States, Texas
Novartis Investigative Site
Houston, Texas, United States, 77030
Austria
Novartis Investigative Site
Vienna, Austria, A 1090
Canada, British Columbia
Novartis Investigative Site
Vancouver, British Columbia, Canada, V5Z 4E6
Canada, Nova Scotia
Novartis Investigative Site
Halifax, Nova Scotia, Canada, B3H 1V7
Canada, Ontario
Novartis Investigative Site
Hamilton, Ontario, Canada, L8V 5C2
Novartis Investigative Site
Toronto, Ontario, Canada, M5G1X5
France
Novartis Investigative Site
Lille, France, 59000
Novartis Investigative Site
Paris, France, 75571
Hong Kong
Novartis Investigative Site
Hong Kong SAR, Hong Kong
Hungary
Novartis Investigative Site
Budapest, Hungary, 1062
Novartis Investigative Site
Budapest, Hungary, 1097
Israel
Novartis Investigative Site
Haifa, Israel, 3109601
Italy
Novartis Investigative Site
Bologna, BO, Italy, 40138
Novartis Investigative Site
Genova, GE, Italy, 16147
Novartis Investigative Site
Modena, MO, Italy, 41124
Novartis Investigative Site
Roma, RM, Italy, 00161
Novartis Investigative Site
Candiolo, TO, Italy, 10060
Korea, Republic of
Novartis Investigative Site
Suwon, Gyeonggi-do, Korea, Republic of, 443380
Novartis Investigative Site
Seoul, Korea, Korea, Republic of, 05505
Novartis Investigative Site
Seoul, Korea, Republic of, 06351
Netherlands
Novartis Investigative Site
Amsterdam, Netherlands, 1081 HV
Novartis Investigative Site
Leiden, Netherlands, 2300 RC
Russian Federation
Novartis Investigative Site
Moscow, Russian Federation, 117198
Singapore
Novartis Investigative Site
Singapore, Singapore, 119228
Novartis Investigative Site
Singapore, Singapore, 169608
Slovakia
Novartis Investigative Site
Bratislava, Slovakia, 833 10
Spain
Novartis Investigative Site
Barcelona, Spain, 08041
Sweden
Novartis Investigative Site
Malmö, Sweden, SE-205 02
United Kingdom
Novartis Investigative Site
Cambridge, London, United Kingdom, CB2 2QQ
Novartis Investigative Site
London, United Kingdom, SW3 6JJ
Novartis Investigative Site
Manchester, United Kingdom, M20 4BX
Novartis Investigative Site
Newcastle upon Tyne, United Kingdom, NE7 7DN
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  Study Documents (Full-Text)

Documents provided by Novartis ( Novartis Pharmaceuticals ):
Study Protocol  [PDF] August 30, 2018
Statistical Analysis Plan  [PDF] July 21, 2023

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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01735955    
Other Study ID Numbers: CAMN107A2409
2012-003902-28 ( EudraCT Number )
First Posted: November 28, 2012    Key Record Dates
Results First Posted: February 8, 2024
Last Update Posted: February 8, 2024
Last Verified: February 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

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/.

URL: https://clinicalstudydatarequest.com/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
metastatic gastrointestinal stromal tumors (GIST)
Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia in chronic phase (CML-CP),
adult
Chronic myelogenous leukemia (CML)
chronic myeloid leukemia (CML)
chronic myelocytic leukemia (CML)
Acute Lymphoblastic Leukemia (ALL)
Philadelphia chromosome positive
Acute Lymphoid Leukemia
suboptimal molecular response
Tasigna
CML
GIST
nilotinib
Additional relevant MeSH terms:
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Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Gastrointestinal Stromal Tumors
Neoplasms by Histologic Type
Neoplasms
Hematologic Diseases
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Myeloproliferative Disorders
Bone Marrow Diseases
Chronic Disease
Disease Attributes
Pathologic Processes
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Nilotinib
Tyrosine Kinase Inhibitors
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action