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Nilotinib in Newly Diagnosed Adult Philadelphia Chromosome & /or BCR-ABL Positive Chronic Myeloid Leukaemia in Chronic Phase (`MACS1252)

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ClinicalTrials.gov Identifier: NCT01061177
Recruitment Status : Completed
First Posted : February 2, 2010
Results First Posted : February 24, 2017
Last Update Posted : February 24, 2017
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition CML in Chronic Phase
Intervention Drug: Nilotinib
Enrollment 1090
Recruitment Details  
Pre-assignment Details ITT: intent to treat; b3a2 & b2a2 +ve are categories of BCR-ABL transcripts (BCR-ABL1 is an abnormal gene found in chronic myeloid leukemia and acute lymphoblastic leukemia patients; CyR (Ph+ Patients Only) = cytogenic response for Philadelphia positive patients only.
Arm/Group Title Nilotinib
Hide Arm/Group Description This was a single-arm study; therefore all participants received nilotinib (AMN107) 300 mg bid given as two 150 mg capsules twice daily.
Period Title: Overall Study
Started 1089
ITT_MR (b2a2 &/or b3a2 +ve Pts Only) 1056
ITT_CyR (Ph+ Patients Only) 983
Completed 881
Not Completed 208
Reason Not Completed
Adverse Event             117
Withdrawal by Subject             27
Disease progression             17
Protocol Violation             11
Lost to Follow-up             9
New cancer therapy             9
Abnormal laboratory values             6
Abnormal test procedure results             4
Administratie problems             4
Death             4
Arm/Group Title Nilotinib
Hide Arm/Group Description This was a single-arm study; therefore all participants received nilotinib (AMN107) 300 mg bid given as two 150 mg capsules twice daily.
Overall Number of Baseline Participants 1089
Hide Baseline Analysis Population Description
The intent-to-treat (ITT) population consisted of all participants who received at least one dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1089 participants
51.6  (14.87)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1089 participants
Female
447
  41.0%
Male
642
  59.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1089 participants
Caucacian 1045
Black 6
Oriental 5
Native American 2
Other 31
Weight at baseline  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 1089 participants
77.47  (15.730)
ECOG performance score   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1089 participants
No restrictions (0) 867
Only light work (1) 199
Only self care (2) 21
Limited self care (3) 0
Completely disabled (4) 0
Missing 2
[1]
Measure Description: ECOG = Eastern Cooperative Oncology Group
1.Primary Outcome
Title Percentage of Participants With Molecular Response (MR4^0) at 18 Months
Hide Description MR4^0 was defined as either (i) detectable disease ≤ 0.01% BCR-ABL ratio (international scale (IS)) with mean ABL transcripts ≥ 10 000 or (ii) undetectable disease in complementary deoxyribonucleic acid (cDNA) with ≥ 10 000 ABL transcripts.
Time Frame at 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat_Molecular (ITT_MR) analysis set was a subset of the ITT population including the patients with typical BCR-ABL transcript at screening.
Arm/Group Title Nilotinib
Hide Arm/Group Description:
This was a single-arm study; therefore all participants received nilotinib (AMN107) 300 mg bid given as two 150 mg capsules twice daily.
Overall Number of Participants Analyzed 1056
Measure Type: Number
Unit of Measure: Percentage of Participants
38.3
2.Secondary Outcome
Title Percentage of Participants Free From Progression to Accelerated Phase/Blast Crisis (AP/BC) at 12 and 24 Months
Hide Description

The following events were considered disease progression to AP/BC: Death due to disease under study; AP, as defined by any of the following: ≥ 15% blasts in the peripheral blood or bone marrow, but < 30% blasts in both the peripheral blood and bone marrow, ≥ 30% blasts plus promyelocytes in peripheral blood or bone marrow, ≥ 20% basophils in the peripheral blood, Thrombocytopenia (< 100 × 109/L) that was unrelated to therapy, Evidence of clonal evolution, as determined by medical review with consensus of the SSMC/DMC.

BC was defined as: ≥ 30% blasts in peripheral blood or bone marrow, Appearance of extramedullary involvement other than hepatosplenomegaly proven by biopsy.

Time Frame at 12 and 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population consisted of all patients who received at least one dose of study drug.
Arm/Group Title Nilotinib
Hide Arm/Group Description:
This was a single-arm study; therefore all participants received nilotinib (AMN107) 300 mg bid given as two 150 mg capsules twice daily.
Overall Number of Participants Analyzed 1089
Measure Type: Number
Unit of Measure: Percentage of participants
Pts free from progression to AP/BC at 12 months 99.4
Pts free from progression to AP/BC at 24 months 99.4
3.Secondary Outcome
Title Rate of Event Free Survival at 12 and 24 Months
Hide Description EFS was defined as the time from the date of Day 1 (first treatment) + 1 day to the first occurrence of any of the following: Loss of complete hematologic response (CHR), Loss of CCyR, Death from any cause, Progression to the AP or BC of CML, Not achieving CHR up to 3 months (ie, 91 + 15 days), Not achieving CCyR up to 18 months (ie, 548 + 15 days), whichever is earlier.
Time Frame at 12 and 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population consisted of all patients who received at least one dose of study drug.
Arm/Group Title Nilotinib
Hide Arm/Group Description:
This was a single-arm study; therefore all participants received nilotinib (AMN107) 300 mg bid given as two 150 mg capsules twice daily.
Overall Number of Participants Analyzed 1089
Measure Type: Number
Unit of Measure: Percentage of participants
Percentage of participants with EFS at 12 months 71.7
Percentage of participants with EFS at 24 months 69.1
4.Secondary Outcome
Title Percentage of Participants With Major Molecular Response (MMR) at, as Well as by, 12 and 24 Months
Hide Description MMR was defined as BCR-ABL ratio (IS) ≤ 0.1% in a peripheral blood sample. BCR-ABL1 is an abnormal gene found in chronic myeloid leukemia (CML) and acute lymphoblastic leukemia (ALL). The chromosomal defect in the Philadelphia chromosome is a translocation, in which parts of two chromosomes, 9 and 22, swap places. The result is that a fusion gene is created by juxtapositioning the Abl1 gene on chromosome 9 to a part of the BCR ("breakpoint cluster region") gene on chromosome 22. Depending upon the breakpoints on the BCR gene, there are several forms of fusion proteins.
Time Frame 12 months, 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat_Molecular (ITT_MR) analysis set was a subset of the ITT population including the patients with typical BCR-ABL transcript at screening.
Arm/Group Title Nilotinib
Hide Arm/Group Description:
This was a single-arm study; therefore all participants received nilotinib (AMN107) 300 mg bid given as two 150 mg capsules twice daily.
Overall Number of Participants Analyzed 1056
Measure Type: Number
Unit of Measure: Percentage of participants
at 12 months 56.2
at 24 months 61.1
by 12 months 68.8
by 24 months 80.3
5.Secondary Outcome
Title Percentage of Participants With Complete Cytogenetic Response (CCyR) at, as Well as by, 12 and 24 Months
Hide Description CCyR parameters were defined as 0% Philadelphia positive (Ph+) metaphases. Loss of CCyR was defined as a patient exceeding the CCyR criteria (ie, > 0% Ph+ metaphases) at a subsequent visit after the patient had achieved CCyR.
Time Frame 12 and 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT_CyR population was a subset of the ITT population including the Ph+ patients at screening was considered. Patients who had either no metaphases recorded at screening bone marrow or only negative metaphases recorded at screening bone marrow but had Ph+ metaphases at any visits after screening were also part of this population.
Arm/Group Title Nilotinib
Hide Arm/Group Description:
This was a single-arm study; therefore all participants received nilotinib (AMN107) 300 mg bid given as two 150 mg capsules twice daily.
Overall Number of Participants Analyzed 983
Measure Type: Number
Unit of Measure: Percentage of participants
at 12 months 72.4
at 24 months 65.6
By Month 12 82.5
By Month 24 89.0
6.Secondary Outcome
Title Percentage of Participants With Major Cytogenetic Response (MCyR) at, as Well as by, 12 and 24 Months
Hide Description Major cytogenetic response (MCyR) parameters were defined as 0 to 35% Philadelphia positive (Ph+) metaphases.
Time Frame 12 and 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT_CyR population was a subset of the ITT population including the Ph+ patients at screening was considered. Patients who had either no metaphases recorded at screening bone marrow or only negative metaphases recorded at screening bone marrow but had Ph+ metaphases at any visits after screening were also part of this population.
Arm/Group Title Nilotinib
Hide Arm/Group Description:
This was a single-arm study; therefore all participants received nilotinib (AMN107) 300 mg bid given as two 150 mg capsules twice daily.
Overall Number of Participants Analyzed 983
Measure Type: Number
Unit of Measure: Percentage of participants
at 12 months 73.8
at 24 months 66.2
by 12 months 86.7
by 24 months 91.4
7.Secondary Outcome
Title Percentage of Participants Free From Progression to AP/BC With MR4^0 at 12 Months
Hide Description

The following events were considered disease progression to AP/BC: Death due to disease under study; AP, as defined by any of the following: ≥ 15% blasts in the peripheral blood or bone marrow, but < 30% blasts in both the peripheral blood and bone marrow, ≥ 30% blasts plus promyelocytes in peripheral blood or bone marrow, ≥ 20% basophils in the peripheral blood, Thrombocytopenia (< 100 × 109/L) that was unrelated to therapy, Evidence of clonal evolution, as determined by medical review with consensus of the SSMC/DMC.

BC was defined as: ≥ 30% blasts in peripheral blood or bone marrow, Appearance of extramedullary involvement other than hepatosplenomegaly proven by biopsy.

Time Frame at 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population consisted of all patients who received at least one dose of study drug.
Arm/Group Title Nilotinib
Hide Arm/Group Description:
This was a single-arm study; therefore all participants received nilotinib (AMN107) 300 mg bid given as two 150 mg capsules twice daily.
Overall Number of Participants Analyzed 400
Measure Type: Number
Unit of Measure: Percentage of participants
100.0
8.Secondary Outcome
Title Percentage of Participants With Event Free Survival in Participants Achieving MR4^0 at 12 Months
Hide Description EFS was defined as the time from the date of Day 1 (first treatment) + 1 day to the first occurrence of any of the following: Loss of complete hematologic response (CHR), Loss of CCyR, Death from any cause, Progression to the AP or BC of CML, Not achieving CHR up to 3 months (i.e. 91 + 15 days).
Time Frame at 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population consisted of all patients who received at least one dose of study drug.
Arm/Group Title Nilotinib
Hide Arm/Group Description:
This was a single-arm study; therefore all participants received nilotinib (AMN107) 300 mg bid given as two 150 mg capsules twice daily.
Overall Number of Participants Analyzed 400
Measure Type: Number
Unit of Measure: Percentage of participants
87.0
9.Secondary Outcome
Title Percentage of Participants With Progression Free Survival (PFS) at 12 and 24 Months
Hide Description PFS was defined by the study protocol as the time from the date of start of study drug to the date of earliest progression to AP/BC, or the date of death from any cause.
Time Frame 12 months, 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population consisted of all patients who received at least one dose of study drug.
Arm/Group Title Nilotinib
Hide Arm/Group Description:
This was a single-arm study; therefore all participants received nilotinib (AMN107) 300 mg bid given as two 150 mg capsules twice daily.
Overall Number of Participants Analyzed 1089
Measure Type: Number
Unit of Measure: Percentage of participants
at 12 months 99.2
at 24 months 99.0
10.Secondary Outcome
Title Rate of Molecular Response (MR4^0) at, as Well as by, 12 and 24 Months
Hide Description MR4^0 was defined as either (i) detectable disease ≤ 0.01% BCR-ABL ratio (international scale (IS)) with mean ABL transcripts ≥ 10 000 or (ii) undetectable disease in complementary deoxyribonucleic acid (cDNA) with ≥ 10 000 ABL transcripts.
Time Frame 12 and 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT_MR population was a subset of the ITT population including the patients with typical BCR-ABL transcript at screening ie, b3a2 and/or b2a2 were considered. This population was referred to as ITT_MR.
Arm/Group Title Nilotinib
Hide Arm/Group Description:
This was a single-arm study; therefore all participants received nilotinib (AMN107) 300 mg bid given as two 150 mg capsules twice daily.
Overall Number of Participants Analyzed 1056
Measure Type: Number
Unit of Measure: Percentage of participants
at 12 months 30.7
at 24 months 40.2
by month 12 36.9
by month 24 55.0
11.Secondary Outcome
Title Rate of Molecular Response (MR4^5) at, as Well as by, 12 and 24 Months
Hide Description MR4^5 was defined as either (i) detectable disease ≤ 0.0032% BCR-ABL ratio (IS) with mean ABL transcripts ≥ 32 000 or (ii) undetectable disease in cDNA with ≥ 32 000 ABL transcripts).
Time Frame 12 and 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT_MR population was a subset of the ITT population including the patients with typical BCR-ABL transcript at screening ie, b3a2 and/or b2a2 were considered.
Arm/Group Title Nilotinib
Hide Arm/Group Description:
This was a single-arm study; therefore all participants received nilotinib (AMN107) 300 mg bid given as two 150 mg capsules twice daily.
Overall Number of Participants Analyzed 1056
Measure Type: Number
Unit of Measure: Percentage of participants
at 12 months 15.2
at 24 months 21.9
by 12 months 20.6
by 24 months 38.4
12.Secondary Outcome
Title Rate of Complete Hematologic Response (CHR) at, as Well as by, 12 and 24 Months
Hide Description CHR was defined as all of the following present for ≥ 4 weeks in the peripheral blood: WBC count < 10 x 109/L, Platelet count < 450 x 109/L, No circulating peripheral blood blasts, promyelocytes, myelocytes, or metamyelocytes in the peripheral blood, The presence of < 5% basophils, No evidence of disease-related symptoms and extramedullary disease, including spleen and liver. Loss of CHR was defined as the appearance of any of the following after having achieved a CHR confirmed by a second determination ≥ 4 weeks later (unless associated with progression to AP/BC or death, which was considered to be a confirmed loss of CHR event on its own): WBC count that increased to > 20.0 x 109/L, Platelet count that increased to ≥ 600 x 109/L, Any palpable spleen, defined as size of spleen below costal margin > 5 cm, Appearance of > 5% myelocytes plus metamyelocytes, or any promyelocytes or blasts in the peripheral blood.
Time Frame 12 months, 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population consisted of all patients who received at least one dose of study drug.
Arm/Group Title Nilotinib
Hide Arm/Group Description:
This was a single-arm study; therefore all participants received nilotinib (AMN107) 300 mg bid given as two 150 mg capsules twice daily.
Overall Number of Participants Analyzed 1089
Measure Type: Number
Unit of Measure: Percentage of prticipants
by Month 24 89.1
at 12 months 82.7
at 24 months 75.5
by Month12 86.2
13.Secondary Outcome
Title Percentage of Participants With Overall Survival at 12 and 24 Months
Hide Description OS was defined as the time between the date of Day 1 (first treatment) and the date of death from any cause. Deaths which occurred after the 24-month time window and which were occasionally reported by some Investigators were excluded from the analysis. This is in agreement with the protocol stating that patients were to be followed for survival and progression to AP/BC up to 24 months after the participants treatment start.
Time Frame 12 months, 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population consisted of all patients who received at least one dose of study drug.
Arm/Group Title Nilotinib
Hide Arm/Group Description:
This was a single-arm study; therefore all participants received nilotinib (AMN107) 300 mg bid given as two 150 mg capsules twice daily.
Overall Number of Participants Analyzed 1089
Measure Type: Number
Unit of Measure: Percentage of participants
at 12 months 99.6
at 24 months 98.9
14.Secondary Outcome
Title Rate of Molecular Response (MR4^0) by 18 Months
Hide Description

MR4^0 was defined as either (i) detectable disease ≤ 0.01% BCR-ABL ratio (international scale (IS)) with mean ABL transcripts ≥ 10 000 or (ii) undetectable disease in complementary deoxyribonucleic acid (cDNA) with ≥ 10 000 ABL transcripts.

BCR = Breakpoint Cluster Region gene/BCR gene product

BCR-ABL is fusion gene formed from the ABL gene from chromosome 9 fusing with the BCR gene on chromosome 22, the gene product is BCR-ABL tyrosine kinase

Time Frame by 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT_MR population was a subset of the ITT population including the patients with typical BCR-ABL transcript at screening ie, b3a2 and/or b2a2 were considered. This population was referred to as ITT_MR.
Arm/Group Title Nilotinib
Hide Arm/Group Description:
This was a single-arm study; therefore all participants received nilotinib (AMN107) 300 mg bid given as two 150 mg capsules twice daily.
Overall Number of Participants Analyzed 1056
Measure Type: Number
Unit of Measure: Percentage of participants
48.5
15.Secondary Outcome
Title Rate of Molecular Response (MR4^5) by 18 Months
Hide Description

MR4^5 was defined as either (i) detectable disease ≤ 0.0032% BCR-ABL ratio (IS) with mean ABL transcripts ≥ 32 000 or (ii) undetectable disease in cDNA with ≥ 32 000 ABL transcripts).

BCR = Breakpoint Cluster Region gene/BCR gene product

BCR-ABL is fusion gene formed from the ABL gene from chromosome 9 fusing with the BCR gene on chromosome 22, the gene product is BCR-ABL tyrosine kinase

Time Frame by 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT_MR population was a subset of the ITT population including the patients with typical BCR-ABL transcript at screening ie, b3a2 and/or b2a2 were considered.
Arm/Group Title Nilotinib
Hide Arm/Group Description:
This was a single-arm study; therefore all participants received nilotinib (AMN107) 300 mg bid given as two 150 mg capsules twice daily.
Overall Number of Participants Analyzed 1056
Measure Type: Number
Unit of Measure: Percentage of participants
31.6
16.Secondary Outcome
Title Percentage of Participants With Progression Free Survival in Participants Achieving MR4^0 at 12 Months
Hide Description PFS was defined by the study protocol as the time from the date of start of study drug to the date of earliest progression to AP/BC, or the date of death from any cause.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population consisted of all patients who received at least one dose of study drug.
Arm/Group Title Nilotinib
Hide Arm/Group Description:
This was a single-arm study; therefore all participants received nilotinib (AMN107) 300 mg bid given as two 150 mg capsules twice daily.
Overall Number of Participants Analyzed 400
Measure Type: Number
Unit of Measure: Percentage of participants
at 12 months 99.2
at 24 months 99.0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Nilotinib
Hide Arm/Group Description This was a single-arm study; therefore all participants received nilotinib (AMN107) 300 mg bid given as two 150 mg capsules twice daily.
All-Cause Mortality
Nilotinib
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Nilotinib
Affected / at Risk (%)
Total   207/1089 (19.01%) 
Blood and lymphatic system disorders   
Anaemia  1  5/1089 (0.46%) 
Haemolytic anaemia  1  1/1089 (0.09%) 
Haemorrhagic anaemia  1  1/1089 (0.09%) 
Leukopenia  1  1/1089 (0.09%) 
Neutropenia  1  2/1089 (0.18%) 
Pancytopenia  1  1/1089 (0.09%) 
Splenic infarction  1  1/1089 (0.09%) 
Thrombocytopenia  1  3/1089 (0.28%) 
Cardiac disorders   
Acute coronary syndrome  1  3/1089 (0.28%) 
Acute myocardial infarction  1  4/1089 (0.37%) 
Angina pectoris  1  6/1089 (0.55%) 
Angina unstable  1  2/1089 (0.18%) 
Aortic valve stenosis  1  1/1089 (0.09%) 
Arteriosclerosis coronary artery  1  2/1089 (0.18%) 
Atrial fibrillation  1  13/1089 (1.19%) 
Atrial flutter  1  2/1089 (0.18%) 
Cardiac failure  1  1/1089 (0.09%) 
Cardiac failure congestive  1  3/1089 (0.28%) 
Coronary artery disease  1  7/1089 (0.64%) 
Coronary artery stenosis  1  1/1089 (0.09%) 
Coronary artery thrombosis  1  1/1089 (0.09%) 
Mitral valve disease  1  1/1089 (0.09%) 
Mitral valve incompetence  1  1/1089 (0.09%) 
Myocardial infarction  1  4/1089 (0.37%) 
Myocardial ischaemia  1  3/1089 (0.28%) 
Pericardial effusion  1  1/1089 (0.09%) 
Pericarditis  1  1/1089 (0.09%) 
Prinzmetal angina  1  1/1089 (0.09%) 
Sick sinus syndrome  1  1/1089 (0.09%) 
Supraventricular tachycardia  1  1/1089 (0.09%) 
Congenital, familial and genetic disorders   
Atrial septal defect  1  1/1089 (0.09%) 
Ear and labyrinth disorders   
Deafness  1  1/1089 (0.09%) 
Vertigo  1  1/1089 (0.09%) 
Endocrine disorders   
Goitre  1  1/1089 (0.09%) 
Hyperthyroidism  1  1/1089 (0.09%) 
Inappropriate antidiuretic hormone secretion  1  1/1089 (0.09%) 
Thyroiditis subacute  1  1/1089 (0.09%) 
Eye disorders   
Conjunctival disorder  1  1/1089 (0.09%) 
Diabetic retinopathy  1  1/1089 (0.09%) 
Eye haemorrhage  1  1/1089 (0.09%) 
Gastrointestinal disorders   
Abdominal hernia  1  1/1089 (0.09%) 
Abdominal pain  1  4/1089 (0.37%) 
Abdominal pain lower  1  2/1089 (0.18%) 
Colitis  1  1/1089 (0.09%) 
Constipation  1  3/1089 (0.28%) 
Diarrhoea  1  2/1089 (0.18%) 
Duodenal ulcer haemorrhage  1  1/1089 (0.09%) 
Dysphagia  1  1/1089 (0.09%) 
Gastric ulcer perforation  1  1/1089 (0.09%) 
Gastritis  1  2/1089 (0.18%) 
Gastrooesophageal reflux disease  1  1/1089 (0.09%) 
Gastrooesophageal sphincter insufficiency  1  1/1089 (0.09%) 
Haemorrhoids  1  2/1089 (0.18%) 
Haemorrhoids thrombosed  1  1/1089 (0.09%) 
Ileus  1  1/1089 (0.09%) 
Inguinal hernia  1  2/1089 (0.18%) 
Intestinal obstruction  1  1/1089 (0.09%) 
Nausea  1  1/1089 (0.09%) 
Pancreatic disorder  1  1/1089 (0.09%) 
Pancreatitis  1  6/1089 (0.55%) 
Pancreatitis acute  1  2/1089 (0.18%) 
Small intestinal haemorrhage  1  1/1089 (0.09%) 
Umbilical hernia  1  1/1089 (0.09%) 
Vomiting  1  5/1089 (0.46%) 
General disorders   
Chest pain  1  1/1089 (0.09%) 
Device dislocation  1  1/1089 (0.09%) 
Drug resistance  1  1/1089 (0.09%) 
Fatigue  1  2/1089 (0.18%) 
Localised oedema  1  1/1089 (0.09%) 
Non-cardiac chest pain  1  4/1089 (0.37%) 
Oedema peripheral  1  1/1089 (0.09%) 
Pyrexia  1  6/1089 (0.55%) 
Soft tissue inflammation  1  1/1089 (0.09%) 
Hepatobiliary disorders   
Cholangitis  1  1/1089 (0.09%) 
Cholecystitis  1  2/1089 (0.18%) 
Cholelithiasis  1  1/1089 (0.09%) 
Gallbladder enlargement  1  1/1089 (0.09%) 
Hepatic fibrosis  1  1/1089 (0.09%) 
Hepatic steatosis  1  1/1089 (0.09%) 
Hepatotoxicity  1  1/1089 (0.09%) 
Jaundice  1  1/1089 (0.09%) 
Immune system disorders   
Drug hypersensitivity  1  1/1089 (0.09%) 
Infections and infestations   
Abdominal abscess  1  1/1089 (0.09%) 
Appendicitis  1  1/1089 (0.09%) 
Bronchitis  1  2/1089 (0.18%) 
Bronchopneumonia  1  1/1089 (0.09%) 
Corneal abscess  1  1/1089 (0.09%) 
Diverticulitis  1  1/1089 (0.09%) 
Epididymitis  1  1/1089 (0.09%) 
Gangrene  1  1/1089 (0.09%) 
Infection  1  1/1089 (0.09%) 
Lung infection  1  1/1089 (0.09%) 
Perirectal abscess  1  1/1089 (0.09%) 
Phlebitis infective  1  1/1089 (0.09%) 
Pneumonia  1  4/1089 (0.37%) 
Rectal abscess  1  1/1089 (0.09%) 
Respiratory tract infection  1  1/1089 (0.09%) 
Urinary tract infection  1  1/1089 (0.09%) 
Urinary tract infection bacterial  1  1/1089 (0.09%) 
Viral pericarditis  1  1/1089 (0.09%) 
Injury, poisoning and procedural complications   
Cervical vertebral fracture  1  1/1089 (0.09%) 
Clavicle fracture  1  1/1089 (0.09%) 
Coronary artery restenosis  1  2/1089 (0.18%) 
Exposure via father  1  1/1089 (0.09%) 
Femoral neck fracture  1  1/1089 (0.09%) 
Overdose  1  1/1089 (0.09%) 
Post procedural inflammation  1  1/1089 (0.09%) 
Rib fracture  1  1/1089 (0.09%) 
Road traffic accident  1  1/1089 (0.09%) 
Sternal injury  1  1/1089 (0.09%) 
Tendon rupture  1  1/1089 (0.09%) 
Investigations   
Amylase increased  1  2/1089 (0.18%) 
Blood creatine phosphokinase increased  1  2/1089 (0.18%) 
Blood pressure increased  1  1/1089 (0.09%) 
C-reactive protein increased  1  1/1089 (0.09%) 
Electrocardiogram QT prolonged  1  3/1089 (0.28%) 
Lipase increased  1  1/1089 (0.09%) 
Platelet count decreased  1  3/1089 (0.28%) 
Transaminases increased  1  1/1089 (0.09%) 
Metabolism and nutrition disorders   
Decreased appetite  1  2/1089 (0.18%) 
Diabetes mellitus  1  3/1089 (0.28%) 
Diabetes mellitus inadequate control  1  1/1089 (0.09%) 
Failure to thrive  1  1/1089 (0.09%) 
Hypercholesterolaemia  1  1/1089 (0.09%) 
Hyperglycaemia  1  2/1089 (0.18%) 
Hyponatraemia  1  1/1089 (0.09%) 
Hypophosphataemia  1  1/1089 (0.09%) 
Musculoskeletal and connective tissue disorders   
Arthralgia  1  2/1089 (0.18%) 
Arthropathy  1  1/1089 (0.09%) 
Back pain  1  5/1089 (0.46%) 
Bone pain  1  1/1089 (0.09%) 
Intervertebral disc protrusion  1  2/1089 (0.18%) 
Muscular weakness  1  1/1089 (0.09%) 
Musculoskeletal pain  1  3/1089 (0.28%) 
Neck pain  1  1/1089 (0.09%) 
Pain in extremity  1  2/1089 (0.18%) 
Rotator cuff syndrome  1  1/1089 (0.09%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Bladder neoplasm  1  1/1089 (0.09%) 
Blast cell crisis  1  2/1089 (0.18%) 
Breast cancer  1  1/1089 (0.09%) 
Cervix carcinoma  1  1/1089 (0.09%) 
Cholangiocarcinoma  1  1/1089 (0.09%) 
Colon adenoma  1  1/1089 (0.09%) 
Colorectal cancer  1  1/1089 (0.09%) 
Duodenal neoplasm  1  1/1089 (0.09%) 
Endometrial cancer  1  1/1089 (0.09%) 
Non-Hodgkin's lymphoma  1  1/1089 (0.09%) 
Prostate cancer  1  2/1089 (0.18%) 
Retroperitoneal cancer  1  1/1089 (0.09%) 
Skin cancer  1  2/1089 (0.18%) 
Squamous cell carcinoma  1  1/1089 (0.09%) 
Urinary bladder adenoma  1  1/1089 (0.09%) 
Uterine leiomyoma  1  1/1089 (0.09%) 
Nervous system disorders   
Aphasia  1  1/1089 (0.09%) 
Carotid artery occlusion  1  1/1089 (0.09%) 
Carotid artery stenosis  1  1/1089 (0.09%) 
Carpal tunnel syndrome  1  1/1089 (0.09%) 
Cerebral haemorrhage  1  1/1089 (0.09%) 
Cerebral ischaemia  1  1/1089 (0.09%) 
Cerebrovascular accident  1  2/1089 (0.18%) 
Cranial nerve disorder  1  1/1089 (0.09%) 
Facial paresis  1  1/1089 (0.09%) 
Headache  1  5/1089 (0.46%) 
Hyperaesthesia  1  1/1089 (0.09%) 
Intracranial aneurysm  1  1/1089 (0.09%) 
Ischaemic stroke  1  2/1089 (0.18%) 
Lethargy  1  1/1089 (0.09%) 
Memory impairment  1  1/1089 (0.09%) 
Motor neurone disease  1  1/1089 (0.09%) 
Neuropathy peripheral  1  1/1089 (0.09%) 
Occipital neuralgia  1  1/1089 (0.09%) 
Sciatica  1  1/1089 (0.09%) 
Subarachnoid haemorrhage  1  1/1089 (0.09%) 
Transient ischaemic attack  1  2/1089 (0.18%) 
VIIth nerve paralysis  1  1/1089 (0.09%) 
Psychiatric disorders   
Anxiety  1  1/1089 (0.09%) 
Bipolar disorder  1  1/1089 (0.09%) 
Confusional state  1  1/1089 (0.09%) 
Depression  1  4/1089 (0.37%) 
Depression suicidal  1  1/1089 (0.09%) 
Suicide attempt  1  3/1089 (0.28%) 
Renal and urinary disorders   
Dysuria  1  1/1089 (0.09%) 
Haematuria  1  1/1089 (0.09%) 
Incontinence  1  1/1089 (0.09%) 
Nephrolithiasis  1  2/1089 (0.18%) 
Renal colic  1  1/1089 (0.09%) 
Renal cyst  1  1/1089 (0.09%) 
Renal failure  1  1/1089 (0.09%) 
Renal failure acute  1  2/1089 (0.18%) 
Renal impairment  1  1/1089 (0.09%) 
Urinary retention  1  1/1089 (0.09%) 
Reproductive system and breast disorders   
Benign prostatic hyperplasia  1  1/1089 (0.09%) 
Genital pain  1  1/1089 (0.09%) 
Genital swelling  1  1/1089 (0.09%) 
Menorrhagia  1  1/1089 (0.09%) 
Metrorrhagia  1  2/1089 (0.18%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnoea  1  5/1089 (0.46%) 
Epistaxis  1  2/1089 (0.18%) 
Hyperventilation  1  1/1089 (0.09%) 
Pleural effusion  1  1/1089 (0.09%) 
Pneumonitis  1  1/1089 (0.09%) 
Pulmonary embolism  1  1/1089 (0.09%) 
Sleep apnoea syndrome  1  1/1089 (0.09%) 
Skin and subcutaneous tissue disorders   
Diabetic foot  1  1/1089 (0.09%) 
Dry gangrene  1  1/1089 (0.09%) 
Photosensitivity reaction  1  1/1089 (0.09%) 
Skin haemorrhage  1  1/1089 (0.09%) 
Surgical and medical procedures   
Hysterectomy  1  1/1089 (0.09%) 
Skin neoplasm excision  1  1/1089 (0.09%) 
Vascular disorders   
Aneurysm ruptured  1  1/1089 (0.09%) 
Aortic stenosis  1  2/1089 (0.18%) 
Arterial disorder  1  1/1089 (0.09%) 
Arterial haemorrhage  1  1/1089 (0.09%) 
Arterial occlusive disease  1  1/1089 (0.09%) 
Deep vein thrombosis  1  1/1089 (0.09%) 
Haemorrhage  1  1/1089 (0.09%) 
Hypertension  1  1/1089 (0.09%) 
Hypertensive crisis  1  1/1089 (0.09%) 
Leriche syndrome  1  1/1089 (0.09%) 
Peripheral arterial occlusive disease  1  2/1089 (0.18%) 
Peripheral artery stenosis  1  1/1089 (0.09%) 
Peripheral ischaemia  1  1/1089 (0.09%) 
Raynaud's phenomenon  1  1/1089 (0.09%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Nilotinib
Affected / at Risk (%)
Total   841/1089 (77.23%) 
Blood and lymphatic system disorders   
Anaemia  1  65/1089 (5.97%) 
Thrombocytopenia  1  111/1089 (10.19%) 
Gastrointestinal disorders   
Abdominal pain  1  79/1089 (7.25%) 
Abdominal pain upper  1  88/1089 (8.08%) 
Constipation  1  65/1089 (5.97%) 
Diarrhoea  1  93/1089 (8.54%) 
Nausea  1  122/1089 (11.20%) 
Vomiting  1  62/1089 (5.69%) 
General disorders   
Asthenia  1  97/1089 (8.91%) 
Fatigue  1  150/1089 (13.77%) 
Infections and infestations   
Nasopharyngitis  1  113/1089 (10.38%) 
Investigations   
Alanine aminotransferase increased  1  86/1089 (7.90%) 
Blood bilirubin increased  1  80/1089 (7.35%) 
Lipase increased  1  76/1089 (6.98%) 
Metabolism and nutrition disorders   
Hypophosphataemia  1  77/1089 (7.07%) 
Musculoskeletal and connective tissue disorders   
Arthralgia  1  96/1089 (8.82%) 
Back pain  1  78/1089 (7.16%) 
Muscle spasms  1  93/1089 (8.54%) 
Myalgia  1  99/1089 (9.09%) 
Nervous system disorders   
Headache  1  163/1089 (14.97%) 
Psychiatric disorders   
Insomnia  1  55/1089 (5.05%) 
Respiratory, thoracic and mediastinal disorders   
Cough  1  56/1089 (5.14%) 
Skin and subcutaneous tissue disorders   
Alopecia  1  115/1089 (10.56%) 
Dry skin  1  93/1089 (8.54%) 
Pruritus  1  180/1089 (16.53%) 
Rash  1  233/1089 (21.40%) 
Vascular disorders   
Hypertension  1  64/1089 (5.88%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
Results Point of Contact
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: 862-778-8300
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01061177     History of Changes
Other Study ID Numbers: CAMN107EIC01
2009-017775-19 ( EudraCT Number )
First Submitted: February 1, 2010
First Posted: February 2, 2010
Results First Submitted: August 3, 2015
Results First Posted: February 24, 2017
Last Update Posted: February 24, 2017