A Study of Oral AMN107 in Adults With Chronic Myelogenous Leukemia (CML) or Other Hematologic Malignancies

Sponsor
Novartis Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT00109707
Collaborator
(none)
507
Enrollment
101
Locations
3
Arms
89
Actual Duration (Months)
5
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this trial is to assess the efficacy, safety, tolerability, biologic activity, and pharmacokinetics of AMN107 in six groups of patients with one of the following conditions:

Relapsed/refractory Ph+ Acute lymphoblastic leukemia (ALL) (arm 1)

Group A - Imatinib failure only (arms 2, 3 and 4)

  • imatinib-resistant or intolerant CML - Chronic Phase (CP)

  • imatinib-resistant or intolerant CML - Accelerated Phase (AP)

  • imatinib-resistant or intolerant CML - Blast Crisis (BC)

Group B - Imatinib and other TKI failure (arms 2, 3 and 4)

  • imatinib-resistant or intolerant CML - Chronic Phase (CP)

  • imatinib-resistant or intolerant CML - Accelerated Phase (AP)

  • imatinib-resistant or intolerant CML - Blast Crisis (BC)

Hypereosinophilic syndrome/chronic eosinophilic leukemia (HES/CEL) (arm 5)

Systemic mastocytosis (Sm) (arm 6)

Study Design

Study Type:
Interventional
Actual Enrollment :
507 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase IA/II Multicenter, Dose-escalation Study of Oral AMN107 on a Continuous Daily Dosing Schedule in Adult Patients With Imatinib-resistant/Intolerant CML in Chronic or Accelerated Phase or Blast Crisis, Relapsed/Refractory Ph+ ALL, and Other Hematologic Malignancies.
Actual Study Start Date :
Apr 1, 2005
Actual Primary Completion Date :
Sep 1, 2012
Actual Study Completion Date :
Sep 1, 2012

Arms and Interventions

ArmIntervention/Treatment
Experimental: CML-CP With Prior Imatinib Only

Imatinib-resistant / intolerant PH+ CML-CP patients

Drug: Nilotinib

Experimental: CML-AP With Prior Imatinib Onl

Imatinib-resistant / intolerant PH+ CML-AP patients

Drug: Nilotinib

Experimental: CML-CP

Imatinib-resistant / intolerant PH+ CML-CP patients

Drug: Nilotinib

Outcome Measures

Primary Outcome Measures

  1. Number of Participants With Major Cytogenetic Response (MCyR) [Up to End of the Treatment (Approximately 7.5 years)]

    Major Cytogenetic Response (MCyR) is defined as Complete Cytogenetic Response (CCyR: 0% Ph-chromosome-positive cells in metaphase in bone marrow) or Partial Cytogenetic Response (PCyR: 1-35% Ph-chromosome-positive cells in metaphase in bone marrow).

  2. Number of Participants Confirmed Overall Hematological Response (Phase II) [Up to End of the Treatment (Approximately 7.5 years)]

    Hematologic response is defined as the percentage of participants in complete hematologic response (defined as the following present for at least 4 weeks: WBC count <10 x 109/L, Platelet count <450 x 109/L, Basophils <5%, No blasts and promyelocytes in peripheral blood, Myelocytes + metamyelocytes < 5% in peripheral blood, No evidence of extramedullary disease, including spleen and liver). Hematological response was a primary outcome measure for Arm CML-AP with prior imatinib only.

Secondary Outcome Measures

  1. Number of Participants With Overall Major Cytogenetic Responses (Phase II) [Up to End of the Treatment (Approximately 7.5 years)]

    Cytogenetic responses (CyRs) in CML are based on the percentage of Ph+ metaphases in bone marrow; a value of 0% Ph+ metaphases defines a complete cytogenetic response (CCyR) and >0% to 35% defines a major cytogenetic response (MCyR). Achievement of CCyR is associated with a significant survival advantage in participants with CML-CP. MCyR was categorized as either CCyR or partial cytogenetic response (PCyR).

  2. Number of Participants With Complete Hematologic Response (Phase II) [Up to End of the Treatment (Approximately 7.5 years)]

    A Complete Hematologic Response (CHR) is obtained when all the following criteria are met: WBC ≤ institutional ULN; platelets ≤ 450,000/mm3; ≤20% basophils in peripheral blood; no blasts or promyelocytes in PB cells; < 5% myelocytes plus metamyelocytes in PB cells; no extra-medullary involvement including no hepatomegaly or splenomegaly.

  3. Participants With (MMR) Major Molecular Response (Phase II) [Up to End of the Treatment (Approximately 7.5 years)]

    MMR was defined for participants who demonstrated a reduction in BCR-ABL/control gene % transcripts to ≤0.1% based on international scale. The control gene used may have been either BCR or ABL.

  4. Time to Progression (TTP) (Phase II) [Up to End of the Treatment (Approximately 7.5 years)]

    Time to Progression was defined as the time from the start of nilotinib to the earliest date of Disease Progression (PD), discontinuation due to PD or death. Disease progression was defined as an increase in the number of circulating leukemic cells via cytogenetic assessment using real-time quantitative reverse transcriptase polymerase chain reaction (PCR).

  5. Overall Survival (OS) (Phase II) [Up to End of the Treatment (Approximately 7.5 years)]

    OS was calculated for all participants as the time between the start of nilotinib and death. Participants were followed for survival after discontinuation, every 3 months, and were included in the analysis of OS. Censoring was at the date of the last contact for discontinued participants and followed up for survival.

  6. Number of Participants With Adverse Events and Serious Adverse Events to Evaluate Long Term Safety [From First Participant First Visit to Last Participant Last Visit (Approximately 7.5 years)]

    Adverse events (AEs) were defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events (SAEs) were defined as any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgement of investigators represent significant hazards.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
Main inclusion criteria include:
  • Patients with CML in blast crisis, CML in accelerated phase defined as never in blast crisis phase, or CML in chronic phase defined as never been in blast crisis phase or accelerated phase who have: *developed progressive disease during therapy with at least 600 mg of imatinib per day, -OR- *patients with CML on imatinib therapy, at any dose, developing progressive disease and the presence of a genetic mutation likely to result in imatinib resistance -OR- *have developed an intolerance to imatinib

  • Relapsed or refractory Ph+ ALL

  • Hypereosinophilic syndrome/chronic eosinophilic leukemia.

  • Systemic mastocytosis who have a clinical indication for treatment.

  • Prior imatinib therapy for patients with Ph+ ALL, HES/CEL and SM is permitted but is not required

  • CML patients who have been treated with an investigational tyrosine kinase inhibitor who otherwise meet the definition of imatinib-resistance or intolerance are eligible

  • Written informed consent prior to any study procedures being performed

Exclusion Criteria:
  • Impaired cardiac function

  • Patients with severe/chronic or uncontrolled medical conditions (including but not limited to diabetes, infections, GI impairment, CNS infiltration, liver and kidney disease)

  • Prior and concomitant use of certain medications (including but not limited to warfarin, chemotherapy, hematopoietic colony-stimulating growth factors, medications that can affect electrocardiogram test results, other investigational drugs )

  • Women who are pregnant or breastfeeding

  • Patients with a history of another primary malignancy that is currently clinically significant or currently requires active intervention.

  • Patients unwilling to comply with the protocol.

  • Known diagnosis of human immunodeficiency virus (HIV) infection

Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1City of Hope National Medical CenterDuarteCaliforniaUnited States91010
2Stanford University Medical CenterStanfordCaliforniaUnited States94305-5750
3University of Colorado HospitalAuroraColoradoUnited States80045
4H. Lee Moffitt Cancer Center & Research Institute Dept.of H. Lee MoffittTampaFloridaUnited States33612
5University of Chicago Medical Center Dept. of U. of Chicago Hosp(3)ChicagoIllinoisUnited States60637
6University of Illinois at Chicago Divisionof Hematology/OncologyChicagoIllinoisUnited States
7Indiana Blood and Marrow Institute Dept of Indiana Blood&Mar (2)Beech GroveIndianaUnited States46107
8Ochsner Clinic FoundationNew OrleansLouisianaUnited States70121
9Sidney Kimmel Comprehensive Cancer Center/Johns Hopkins Med. Div.of Hematologic MalignancieBaltimoreMarylandUnited States21231
10Dana Farber Cancer InstituteBostonMassachusettsUnited States02115
11University of Michigan Health System Clinical Trials OfficeAnn ArborMichiganUnited States48109
12Wayne State UniversityDetroitMichiganUnited States48201
13Mayo Clinic - RochesterRochesterMinnesotaUnited States55905
14Hackensack University Medical CenterHackensackNew JerseyUnited States07601
15Roswell Park Cancer Institute Rosewell SCBuffaloNew YorkUnited States14263
16Memorial Sloan Kettering Cancer CenterNew YorkNew YorkUnited States10017
17University of Rochester Medical CenterRochesterNew YorkUnited States14642
18Duke University Medical CenterDurhamNorth CarolinaUnited States27710
19Wake Forest University Baptist Medical CenterWinston-SalemNorth CarolinaUnited States27157
20Oregon Health Sciences UniversityPortlandOregonUnited States97239
21The Jones ClinicGermantownTennesseeUnited States38138
22Vanderbilt University Medical Center, Clinical Trials Center Investigational Drug ServicesNashvilleTennesseeUnited States37212
23MD Anderson Cancer Center/University of TexasHoustonTexasUnited States77030
24Swedish Cancer InstituteSeattleWashingtonUnited States98104
25Novartis Investigative SiteSt. LeonardsNew South WalesAustralia2065
26Novartis Investigative SiteAdelaideSouth AustraliaAustralia5000
27Novartis Investigative SitePrahranVictoriaAustralia3181
28Novartis Investigative SiteWienAustriaA-1090
29Novartis Investigative SiteBruxellesBelgium1000
30Novartis Investigative SiteHaine-saint-PaulBelgium7100
31Novartis Investigative SiteLeuvenBelgium3000
32Novartis Investigative SiteYvoirBelgium5530
33Novartis Investigative SiteVancouverBritish ColumbiaCanadaV5Z 4E3
34Novartis Investigative SiteTorontoOntarioCanadaM5G 2M9
35Novartis Investigative SiteMontrealQuebecCanadaH1T 2M4
36Novartis Investigative SiteMontrealQuebecCanadaH3A 1A1
37Novartis Investigative SiteVejleDenmarkDK-7100
38Novartis Investigative SiteHUS HelsinkiFinlandFIN-00029
39Novartis Investigative SiteBordeaux CedexFrance33076
40Novartis Investigative SiteCréteilFrance94010
41Novartis Investigative SiteDijonFrance21034
42Novartis Investigative SiteLilleFrance59037
43Novartis Investigative SiteLimoges cedexFrance87042
44Novartis Investigative SiteLyonFrance69437
45Novartis Investigative SiteMarseilleFrance13273
46Novartis Investigative SitePoitiersFrance86021
47Novartis Investigative SiteRennesFrance35019
48Novartis Investigative SiteVandoeuvre les NancyFrance54511
49Novartis Investigative SiteBerlinGermany13353
50Novartis Investigative SiteDuesseldorfGermany40225
51Novartis Investigative SiteFrankfurt/MGermany60590
52Novartis Investigative SiteHamburgGermany20246
53Novartis Investigative SiteLeipzigGermany04103
54Novartis Investigative SiteMainzGermany55131
55Novartis Investigative SiteMannheimGermany68169
56Novartis Investigative SiteMuenchenGermany81675
57Novartis Investigative SitePokfulamHong Kong
58Novartis Investigative SiteBergamoBGItaly24128
59Novartis Investigative SiteBolognaBOItaly40138
60Novartis Investigative SiteGenovaGEItaly16132
61Novartis Investigative SiteMonzaMBItaly20900
62Novartis Investigative SiteMilanoMIItaly20162
63Novartis Investigative SitePescaraPEItaly65124
64Novartis Investigative SitePaviaPVItaly27100
65Novartis Investigative SiteReggio CalabriaRCItaly89124
66Novartis Investigative SiteRomaRMItaly00144
67Novartis Investigative SiteRomaRMItaly00161
68Novartis Investigative SiteRomaRMItaly00168
69Novartis Investigative SiteOrbassanoTOItaly10043
70Novartis Investigative SiteNapoliItaly80131
71Novartis Investigative SiteHwasun-gunJeollanam-doKorea, Republic of519-809
72Novartis Investigative SiteSeoulKoreaKorea, Republic of05505
73Novartis Investigative SiteSeoulKoreaKorea, Republic of137-701
74Novartis Investigative SiteTaeguKorea, Republic of700 - 721
75Novartis Investigative SiteAmsterdamNetherlands1081 HV
76Novartis Investigative SiteRotterdamNetherlands
77Novartis Investigative SiteGraftonAucklandNew Zealand
78Novartis Investigative SiteOsloNorwayNO-0310
79Novartis Investigative SiteKatowicePoland40-635
80Novartis Investigative SiteLodzPoland90-153
81Novartis Investigative SiteWarszawaPoland02-097
82Novartis Investigative SiteWarszawaPoland02-776
83Novartis Investigative SiteWroclawPoland50-367
84Novartis Investigative SiteSingaporeSingapore169608
85Novartis Investigative SiteBarcelonaCatalunyaSpain08036
86Novartis Investigative SiteHospitalet de LLobregatCatalunyaSpain08907
87Novartis Investigative SiteGöteborgSwedenSE-413 45
88Novartis Investigative SiteLinköpingSwedenSE-581 85
89Novartis Investigative SiteLundSwedenSE-221 85
90Novartis Investigative SiteUppsalaSwedenSE-751 85
91Novartis Investigative SiteBaselSwitzerland4031
92Novartis Investigative SiteGenèveSwitzerland1211
93Novartis Investigative SiteNiaosong TownshipTaiwan83301
94Novartis Investigative SiteBirminghamUnited KingdomB15 2TH
95Novartis Investigative SiteCambridgeUnited KingdomCB2 2QQ
96Novartis Investigative SiteGlasgow - ScotlandUnited KingdomG12 OYN
97Novartis Investigative SiteLeedsUnited KingdomLS9 7TF
98Novartis Investigative SiteLiverpoolUnited KingdomL7 8XP
99Novartis Investigative SiteLondonUnited KingdomSE5 9RS
100Novartis Investigative SiteLondonUnited KingdomW12 0NN
101Novartis Investigative SiteNewcastle upon TyneUnited KingdomNE1 4LP

Sponsors and Collaborators

  • Novartis Pharmaceuticals

Investigators

  • Study Director: Novartis Pharmaceuticlas, Novartis Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00109707
Other Study ID Numbers:
  • CAMN107A2101
First Posted:
May 3, 2005
Last Update Posted:
Jun 29, 2021
Last Verified:
Jun 1, 2021

Study Results

Participant Flow

Recruitment DetailsThe study was conducted at 100 centers in 22 countries.
Pre-assignment DetailA total of 507 participants were randomized in the core study, out of which 136 participants entered the extension study.
Arm/Group TitleCML-CP With Prior Imatinib OnlyCML-AP With Prior Imatinib OnlyCML-CP
Arm/Group DescriptionAdult participants PH+ CML-CP ( Chronic Phase Chronic Myeloid Leukemia) without prior TKI treatment with either resistant / intolerant to Imatinib received 400 mg Nilotinib orally twice daily up to the end of treatment (September-2012).Adult participants PH+ CML-AP (Accelerated Phase Chronic Myeloid Leukemia) without prior TKI treatment with either resistant / intolerant to Imatinib received 400 mg Nilotinib orally twice daily up to the end of treatment (September-2012).Adult participants PH+ CML-CP in addition to prior TKI treatment with either resistant / intolerant to Imatinib received 400 mg Nilotinib orally twice daily up to the end of treatment (September-2012).
Period Title: Overall Study
STARTED32113749
Entered Extension Study1061515
COMPLETED6788
NOT COMPLETED25412941

Baseline Characteristics

Arm/Group TitleCML-CP With Prior Imatinib OnlyCML-AP With Prior Imatinib OnlyCML-CPTotal
Arm/Group DescriptionAdult participants PH+ CML-CP without prior TKI treatment with either resistant / intolerant to Imatinib received 400 mg Nilotinib orally twice daily up to the end of treatment (September-2012).Adult participants PH+ CML-AP without prior TKI treatment with either resistant / intolerant to Imatinib received 400 mg Nilotinib orally twice daily up to the end of treatment (September-2012).Adult participants PH+ CML-CP in addition to prior TKI treatment with either resistant / intolerant to Imatinib received 400 mg Nilotinib orally twice daily up to the end of treatment (September-2012).Total of all reporting groups
Overall Participants32113749507
Age, Customized (Count of Participants)
<35 years
22
6.9%
8
5.8%
3
6.1%
33
6.5%
≥35 to <55 years
104
32.4%
49
35.8%
16
32.7%
169
33.3%
≥55 to <65 years
97
30.2%
39
28.5%
12
24.5%
148
29.2%
≥65 years
98
30.5%
41
29.9%
18
36.7%
157
31%
Sex: Female, Male (Count of Participants)
Female
159
49.5%
61
44.5%
25
51%
245
48.3%
Male
162
50.5%
76
55.5%
24
49%
262
51.7%

Outcome Measures

1. Primary Outcome
TitleNumber of Participants With Major Cytogenetic Response (MCyR)
DescriptionMajor Cytogenetic Response (MCyR) is defined as Complete Cytogenetic Response (CCyR: 0% Ph-chromosome-positive cells in metaphase in bone marrow) or Partial Cytogenetic Response (PCyR: 1-35% Ph-chromosome-positive cells in metaphase in bone marrow).
Time FrameUp to End of the Treatment (Approximately 7.5 years)

Outcome Measure Data

Analysis Population Description
Full Analysis Set (FAS): All participants who received at least one dose of study medication
Arm/Group TitleCML-CP With Prior Imatinib OnlyCML-AP With Prior Imatinib OnlyCML-CP
Arm/Group DescriptionAdult participants PH+ CML-CP without prior TKI treatment with either resistant / intolerant to Imatinib received 400 mg Nilotinib orally twice daily up to the end of treatment (September-2012).Adult participants PH+ CML-AP (Accelerated Phase Chronic Myeloid Leukemia) without prior TKI treatment with either resistant / intolerant to Imatinib received 400 mg Nilotinib orally twice daily up to the end of treatment (September-2012).Adult participants Ph+ CML-CP in addition to prior TKI treatment with either resistant / intolerant to Imatinib received 400 mg Nilotinib orally twice daily up to the end of treatment (September-2012).
Measure Participants32113749
Count of Participants [Participants]
191
59.5%
44
32.1%
22
44.9%
2. Primary Outcome
TitleNumber of Participants Confirmed Overall Hematological Response (Phase II)
DescriptionHematologic response is defined as the percentage of participants in complete hematologic response (defined as the following present for at least 4 weeks: WBC count <10 x 109/L, Platelet count <450 x 109/L, Basophils <5%, No blasts and promyelocytes in peripheral blood, Myelocytes + metamyelocytes < 5% in peripheral blood, No evidence of extramedullary disease, including spleen and liver). Hematological response was a primary outcome measure for Arm CML-AP with prior imatinib only.
Time FrameUp to End of the Treatment (Approximately 7.5 years)

Outcome Measure Data

Analysis Population Description
Full Analysis Set (FAS): All participants who received at least one dose of study medication.
Arm/Group TitleCML-AP With Prior Imatinib Only
Arm/Group DescriptionAdult participants Ph+ CML-AP without prior TKI treatment with either resistant / intolerant to Imatinib received 400 mg Nilotinib orally twice daily up to the end of treatment (September-2012).
Measure Participants137
Count of Participants [Participants]
76
23.7%
3. Secondary Outcome
TitleNumber of Participants With Overall Major Cytogenetic Responses (Phase II)
DescriptionCytogenetic responses (CyRs) in CML are based on the percentage of Ph+ metaphases in bone marrow; a value of 0% Ph+ metaphases defines a complete cytogenetic response (CCyR) and >0% to 35% defines a major cytogenetic response (MCyR). Achievement of CCyR is associated with a significant survival advantage in participants with CML-CP. MCyR was categorized as either CCyR or partial cytogenetic response (PCyR).
Time FrameUp to End of the Treatment (Approximately 7.5 years)

Outcome Measure Data

Analysis Population Description
Full Analysis Set (FAS): All participants who received at least one dose of study medication
Arm/Group TitleCML-CP With Prior Imatinib OnlyCML-AP With Prior Imatinib OnlyCML-CP
Arm/Group DescriptionAdult participants PH+ CML-CP without prior TKI treatment with either resistant / intolerant to Imatinib received 400 mg Nilotinib orally twice daily up to the end of treatment (September-2012).Adult participants Ph+ CML-AP without prior TKI treatment with either resistant / intolerant to Imatinib received 400 mg Nilotinib orally twice daily up to the end of treatment (September-2012).Adult participants Ph+ CML-CP in addition to prior TKI treatment with either resistant / intolerant to Imatinib received 400 mg Nilotinib orally twice daily up to the end of treatment (September-2012).
Measure Participants32113749
Number [participants]
191
59.5%
44
32.1%
22
44.9%
4. Secondary Outcome
TitleNumber of Participants With Complete Hematologic Response (Phase II)
DescriptionA Complete Hematologic Response (CHR) is obtained when all the following criteria are met: WBC ≤ institutional ULN; platelets ≤ 450,000/mm3; ≤20% basophils in peripheral blood; no blasts or promyelocytes in PB cells; < 5% myelocytes plus metamyelocytes in PB cells; no extra-medullary involvement including no hepatomegaly or splenomegaly.
Time FrameUp to End of the Treatment (Approximately 7.5 years)

Outcome Measure Data

Analysis Population Description
Full Analysis Set (FAS): All participants who received at least one dose of study medication
Arm/Group TitleCML-CP With Prior Imatinib OnlyCML-AP With Prior Imatinib OnlyCML-CP
Arm/Group DescriptionAdult participants PH+ CML-CP without prior TKI treatment with either resistant / intolerant to Imatinib received 400 mg Nilotinib orally twice daily up to the end of treatment (September-2012).Adult participants Ph+ CML-AP without prior TKI treatment with either resistant / intolerant to Imatinib received 400 mg Nilotinib orally twice daily up to the end of treatment (September-2012).Adult participants Ph+ CML-CP in addition to prior TKI treatment with either resistant / intolerant to Imatinib received 400 mg Nilotinib orally twice daily up to the end of treatment (September-2012).
Measure Participants32113735
Number [participants]
158
49.2%
76
55.5%
27
55.1%
5. Secondary Outcome
TitleParticipants With (MMR) Major Molecular Response (Phase II)
DescriptionMMR was defined for participants who demonstrated a reduction in BCR-ABL/control gene % transcripts to ≤0.1% based on international scale. The control gene used may have been either BCR or ABL.
Time FrameUp to End of the Treatment (Approximately 7.5 years)

Outcome Measure Data

Analysis Population Description
Full Analysis Set (FAS): All participants who received at least one dose of study medication. Major molecular response was not an efficacy variable for participants who received the CML-CP with prior imatinib and other TKI (Group B E8)
Arm/Group TitleCML-CP With Prior Imatinib OnlyCML-AP With Prior Imatinib Only
Arm/Group DescriptionAdult participants PH+ CML-CP without prior TKI treatment with either resistant / intolerant to Imatinib received 400 mg Nilotinib orally twice daily up to the end of treatment (September-2012).Adult participants Ph+ CML-AP without prior TKI treatment with either resistant / intolerant to Imatinib received 400 mg Nilotinib orally twice daily up to the end of treatment (September-2012).
Measure Participants299122
Count of Participants [Participants]
106
33%
18
13.1%
6. Secondary Outcome
TitleTime to Progression (TTP) (Phase II)
DescriptionTime to Progression was defined as the time from the start of nilotinib to the earliest date of Disease Progression (PD), discontinuation due to PD or death. Disease progression was defined as an increase in the number of circulating leukemic cells via cytogenetic assessment using real-time quantitative reverse transcriptase polymerase chain reaction (PCR).
Time FrameUp to End of the Treatment (Approximately 7.5 years)

Outcome Measure Data

Analysis Population Description
Full Analysis Set (FAS): All participants who received at least one dose of study medication. Time to progression was not an efficacy variable for participants who received the CML-CP with prior imatinib and other TKI (Group B E8).
Arm/Group TitleCML-CP With Prior Imatinib OnlyCML-AP With Prior Imatinib Only
Arm/Group DescriptionAdult participants PH+ CML-CP without prior TKI treatment with either resistant / intolerant to Imatinib received 400 mg Nilotinib orally twice daily up to the end of treatment (September-2012).Adult participants Ph+ CML-AP without prior TKI treatment with either resistant / intolerant to Imatinib received 400 mg Nilotinib orally twice daily up to the end of treatment (September-2012).
Measure Participants321137
Median (Full Range) [Months]
55.6
15.9
7. Secondary Outcome
TitleOverall Survival (OS) (Phase II)
DescriptionOS was calculated for all participants as the time between the start of nilotinib and death. Participants were followed for survival after discontinuation, every 3 months, and were included in the analysis of OS. Censoring was at the date of the last contact for discontinued participants and followed up for survival.
Time FrameUp to End of the Treatment (Approximately 7.5 years)

Outcome Measure Data

Analysis Population Description
Full Analysis Set (FAS): All participants who received at least one dose of study medication.
Arm/Group TitleCML-CP With Prior Imatinib OnlyCML-AP With Prior Imatinib OnlyCML-CP
Arm/Group DescriptionAdult participants PH+ CML-CP without prior TKI treatment with either resistant / intolerant to Imatinib received 400 mg Nilotinib orally twice daily up to the end of treatment (September-2012).Adult participants Ph+ CML-AP without prior TKI treatment with either resistant / intolerant to Imatinib received 400 mg Nilotinib orally twice daily up to the end of treatment (September-2012).Adult participants Ph+ CML-CP in addition to prior TKI treatment with either resistant / intolerant to Imatinib received 400 mg Nilotinib orally twice daily up to the end of treatment (September-2012).
Measure Participants32113749
Median (95% Confidence Interval) [months]
NA
47.54
NA
8. Secondary Outcome
TitleNumber of Participants With Adverse Events and Serious Adverse Events to Evaluate Long Term Safety
DescriptionAdverse events (AEs) were defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events (SAEs) were defined as any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgement of investigators represent significant hazards.
Time FrameFrom First Participant First Visit to Last Participant Last Visit (Approximately 7.5 years)

Outcome Measure Data

Analysis Population Description
Safety set: All participants who received at least one dose of study medication and had at least one post baseline safety assessment.
Arm/Group TitleCML-CP With Prior Imatinib OnlyCML-AP With Prior Imatinib OnlyCML-CP
Arm/Group DescriptionAdult participants PH+ CML-CP ( Chronic Phase Chronic Myeloid Leukemia) without prior TKI treatment with either resistant / intolerant to Imatinib received 400 mg Nilotinib orally twice daily up to the end of treatment (September-2012).Adult participants PH+ CML-AP (Accelerated Phase Chronic Myeloid Leukemia) without prior TKI treatment with either resistant / intolerant to Imatinib received 400 mg Nilotinib orally twice daily up to the end of treatment (September-2012).Adult participants PH+ CML-CP in addition to prior TKI treatment with either resistant / intolerant to Imatinib received 400 mg Nilotinib orally twice daily up to the end of treatment (September-2012).
Measure Participants32113749
Serious Adverse Events
61
19%
26
19%
5
10.2%
Adverse Events
57
17.8%
17
12.4%
7
14.3%

Adverse Events

Time FrameFrom First Participant First Visit to Last Participant Last Visit (Approximately 7.5 years)
Adverse Event Reporting Description Safety set: All participants who received at least one dose of study medication and had at least one post baseline safety assessment.
Arm/Group TitleCML-CP With Prior Imatinib OnlyCML-AP With Prior Imatinib OnlyCML-CP
Arm/Group DescriptionAdult participants PH+ CML-CP without prior TKI treatment with either resistant / intolerant to Imatinib received 400 mg Nilotinib orally twice daily up to the end of treatment (September-2012).Adult participants Ph+ CML-AP without prior TKI treatment with either resistant / intolerant to Imatinib received 400 mg Nilotinib orally twice daily up to the end of treatment (September-2012).Adult participants Ph+ CML-CP in addition to prior TKI treatment with either resistant / intolerant to Imatinib received 400 mg Nilotinib orally twice daily up to the end of treatment (September-2012).
All Cause Mortality
CML-CP With Prior Imatinib OnlyCML-AP With Prior Imatinib OnlyCML-CP
Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total13/321 (4%) 14/137 (10.2%) 0/49 (0%)
Serious Adverse Events
CML-CP With Prior Imatinib OnlyCML-AP With Prior Imatinib OnlyCML-CP
Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total146/321 (45.5%) 55/137 (40.1%) 21/49 (42.9%)
Blood and lymphatic system disorders
Thrombocytopenia11/321 (3.4%) 11/137 (8%) 3/49 (6.1%)
Neutropenia7/321 (2.2%) 8/137 (5.8%) 0/49 (0%)
Anaemia4/321 (1.2%) 3/137 (2.2%) 3/49 (6.1%)
Febrile neutropenia4/321 (1.2%) 3/137 (2.2%) 2/49 (4.1%)
Leukocytosis0/321 (0%) 4/137 (2.9%) 0/49 (0%)
Leukopenia0/321 (0%) 2/137 (1.5%) 0/49 (0%)
Pancytopenia0/321 (0%) 0/137 (0%) 1/49 (2%)
Cardiac disorders
Angina pectoris12/321 (3.7%) 0/137 (0%) 0/49 (0%)
Myocardial infarction7/321 (2.2%) 5/137 (3.6%) 0/49 (0%)
Acute myocardial infarction6/321 (1.9%) 0/137 (0%) 0/49 (0%)
Atrial fibrillation5/321 (1.6%) 0/137 (0%) 1/49 (2%)
Coronary artery disease5/321 (1.6%) 0/137 (0%) 0/49 (0%)
Acute coronary syndrome3/321 (0.9%) 0/137 (0%) 0/49 (0%)
Palpitations3/321 (0.9%) 0/137 (0%) 0/49 (0%)
Cardiac failure congestive2/321 (0.6%) 0/137 (0%) 0/49 (0%)
Coronary artery stenosis2/321 (0.6%) 0/137 (0%) 0/49 (0%)
Pericardial effusion2/321 (0.6%) 0/137 (0%) 0/49 (0%)
Pericarditis2/321 (0.6%) 0/137 (0%) 0/49 (0%)
Angina pectoris0/321 (0%) 2/137 (1.5%) 0/49 (0%)
Cardiac arrest0/321 (0%) 2/137 (1.5%) 0/49 (0%)
Atrial flutter0/321 (0%) 0/137 (0%) 1/49 (2%)
Myocardial infarction0/321 (0%) 0/137 (0%) 1/49 (2%)
Ear and labyrinth disorders
Vertigo3/321 (0.9%) 0/137 (0%) 0/49 (0%)
Eye disorders
Catarac2/321 (0.6%) 0/137 (0%) 0/49 (0%)
Diplopia2/321 (0.6%) 0/137 (0%) 0/49 (0%)
Gastrointestinal disorders
Pancreatitis6/321 (1.9%) 0/137 (0%) 0/49 (0%)
Abdominal pain4/321 (1.2%) 3/137 (2.2%) 0/49 (0%)
Vomiting3/321 (0.9%) 0/137 (0%) 0/49 (0%)
Diarrhoea2/321 (0.6%) 2/137 (1.5%) 0/49 (0%)
Nausea0/321 (0%) 2/137 (1.5%) 0/49 (0%)
Gastric ulcer0/321 (0%) 0/137 (0%) 1/49 (2%)
Gastrointestinal haemorrhage0/321 (0%) 0/137 (0%) 1/49 (2%)
General disorders
Pyrexia9/321 (2.8%) 6/137 (4.4%) 2/49 (4.1%)
Chest pain4/321 (1.2%) 0/137 (0%) 0/49 (0%)
Malaise2/321 (0.6%) 0/137 (0%) 0/49 (0%)
Asthenia0/321 (0%) 0/137 (0%) 0/49 (0%)
Hepatobiliary disorders
Cholelithiasis3/321 (0.9%) 0/137 (0%) 1/49 (2%)
Infections and infestations
Lower respiratory tract infection4/321 (1.2%) 0/137 (0%) 0/49 (0%)
Cellulitis2/321 (0.6%) 0/137 (0%) 0/49 (0%)
Peritonitis2/321 (0.6%) 0/137 (0%) 0/49 (0%)
Pneumonia2/321 (0.6%) 7/137 (5.1%) 4/49 (8.2%)
Sepsis2/321 (0.6%) 0/137 (0%) 0/49 (0%)
Urinary tract infection2/321 (0.6%) 0/137 (0%) 0/49 (0%)
Abdominal abscess0/321 (0%) 0/137 (0%) 1/49 (2%)
Erysipelas0/321 (0%) 0/137 (0%) 1/49 (2%)
Herpes zoster0/321 (0%) 0/137 (0%) 0/49 (0%)
Injury, poisoning and procedural complications
Subdural haemorrhage2/321 (0.6%) 0/137 (0%) 0/49 (0%)
Hip fracture0/321 (0%) 0/137 (0%) 1/49 (2%)
Nerve injury0/321 (0%) 0/137 (0%) 1/49 (2%)
Investigations
Lipase increased3/321 (0.9%) 2/137 (1.5%) 0/49 (0%)
White blood cell count increased0/321 (0%) 3/137 (2.2%) 2/49 (4.1%)
Electrocardiogram QT prolonged0/321 (0%) 0/137 (0%) 1/49 (2%)
Haemoglobin decreased0/321 (0%) 0/137 (0%) 1/49 (2%)
Metabolism and nutrition disorders
Hyperglycaemia2/321 (0.6%) 0/137 (0%) 0/49 (0%)
Dehydration0/321 (0%) 0/137 (0%) 1/49 (2%)
Musculoskeletal and connective tissue disorders
Bone pain4/321 (1.2%) 3/137 (2.2%) 0/49 (0%)
Pain in extremity4/321 (1.2%) 0/137 (0%) 0/49 (0%)
Arthralgia3/321 (0.9%) 0/137 (0%) 0/49 (0%)
Intervertebral disc protrusion2/321 (0.6%) 0/137 (0%) 0/49 (0%)
Muscular weakness2/321 (0.6%) 0/137 (0%) 0/49 (0%)
Musculoskeletal chest pain0/321 (0%) 2/137 (1.5%) 0/49 (0%)
Flank pain0/321 (0%) 0/137 (0%) 1/49 (2%)
Intervertebral disc disorder0/321 (0%) 0/137 (0%) 1/49 (2%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Back pain4/321 (1.2%) 0/137 (0%) 1/49 (2%)
Prostate cancer2/321 (0.6%) 0/137 (0%) 0/49 (0%)
Prostatic adenoma0/321 (0%) 0/137 (0%) 1/49 (2%)
Rectal adenocarcinoma0/321 (0%) 0/137 (0%) 1/49 (2%)
Nervous system disorders
Cerebrovascular accident4/321 (1.2%) 0/137 (0%) 0/49 (0%)
Dizziness4/321 (1.2%) 0/137 (0%) 0/49 (0%)
Brain oedema2/321 (0.6%) 0/137 (0%) 0/49 (0%)
Cerebral infarction2/321 (0.6%) 0/137 (0%) 0/49 (0%)
Cerebral ischaemia2/321 (0.6%) 0/137 (0%) 0/49 (0%)
Headache2/321 (0.6%) 0/137 (0%) 0/49 (0%)
Loss of consciousness2/321 (0.6%) 0/137 (0%) 0/49 (0%)
Peripheral sensory neuropathy2/321 (0.6%) 0/137 (0%) 0/49 (0%)
Presyncope2/321 (0.6%) 0/137 (0%) 0/49 (0%)
Cerebral haemorrhage0/321 (0%) 3/137 (2.2%) 1/49 (2%)
Aphasia0/321 (0%) 2/137 (1.5%) 0/49 (0%)
Syncope0/321 (0%) 2/137 (1.5%) 0/49 (0%)
Renal and urinary disorders
Renal failure3/321 (0.9%) 0/137 (0%) 1/49 (2%)
Urinary retention0/321 (0%) 0/137 (0%) 1/49 (2%)
Respiratory, thoracic and mediastinal disorders
Dyspnoea5/321 (1.6%) 3/137 (2.2%) 0/49 (0%)
Pleural effusion4/321 (1.2%) 0/137 (0%) 0/49 (0%)
Interstitial lung disease2/321 (0.6%) 0/137 (0%) 0/49 (0%)
Pleurisy2/321 (0.6%) 0/137 (0%) 0/49 (0%)
Pulmonary oedema2/321 (0.6%) 0/137 (0%) 0/49 (0%)
Pneumonitis0/321 (0%) 2/137 (1.5%) 1/49 (2%)
Respiratory failure0/321 (0%) 2/137 (1.5%) 0/49 (0%)
Cough0/321 (0%) 0/137 (0%) 5/49 (10.2%)
Productive cough0/321 (0%) 0/137 (0%) 1/49 (2%)
Skin and subcutaneous tissue disorders
Skin necrosis0/321 (0%) 0/137 (0%) 1/49 (2%)
Vascular disorders
Deep vein thrombosis2/321 (0.6%) 0/137 (0%) 0/49 (0%)
Haematoma2/321 (0.6%) 0/137 (0%) 1/49 (2%)
Temporal arteritis2/321 (0.6%) 0/137 (0%) 0/49 (0%)
Other (Not Including Serious) Adverse Events
CML-CP With Prior Imatinib OnlyCML-AP With Prior Imatinib OnlyCML-CP
Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total319/321 (99.4%) 136/137 (99.3%) 48/49 (98%)
Blood and lymphatic system disorders
Thrombocytopenia107/321 (33.3%) 60/137 (43.8%) 16/49 (32.7%)
Anaemia71/321 (22.1%) 61/137 (44.5%) 9/49 (18.4%)
Neutropenia57/321 (17.8%) 39/137 (28.5%) 15/49 (30.6%)
Leukopenia16/321 (5%) 11/137 (8%) 3/49 (6.1%)
Thrombocytosis16/321 (5%) 0/137 (0%) 0/49 (0%)
Lymphadenopathy0/321 (0%) 7/137 (5.1%) 0/49 (0%)
Febrile neutropenia0/321 (0%) 7/137 (5.1%) 0/49 (0%)
Leukocytosis0/321 (0%) 9/137 (6.6%) 0/49 (0%)
Cardiac disorders
Tachycardia0/321 (0%) 7/137 (5.1%) 0/49 (0%)
Ventricular extrasystoles0/321 (0%) 0/137 (0%) 3/49 (6.1%)
Eye disorders
Conjunctivitis20/321 (6.2%) 0/137 (0%) 0/49 (0%)
Gastrointestinal disorders
Nausea121/321 (37.7%) 41/137 (29.9%) 13/49 (26.5%)
Diarrhoea93/321 (29%) 34/137 (24.8%) 6/49 (12.2%)
Vomiting92/321 (28.7%) 30/137 (21.9%) 7/49 (14.3%)
Constipation88/321 (27.4%) 31/137 (22.6%) 10/49 (20.4%)
Abdominal pain47/321 (14.6%) 17/137 (12.4%) 8/49 (16.3%)
Abdominal pain upper46/321 (14.3%) 21/137 (15.3%) 6/49 (12.2%)
Dyspepsia33/321 (10.3%) 0/137 (0%) 7/49 (14.3%)
Stomatitis0/321 (0%) 14/137 (10.2%) 3/49 (6.1%)
Haemorrhoids0/321 (0%) 7/137 (5.1%) 3/49 (6.1%)
General disorders
Fatigue105/321 (32.7%) 28/137 (20.4%) 13/49 (26.5%)
Pyrexia66/321 (20.6%) 49/137 (35.8%) 8/49 (16.3%)
Oedema peripheral55/321 (17.1%) 27/137 (19.7%) 5/49 (10.2%)
Asthenia53/321 (16.5%) 24/137 (17.5%) 12/49 (24.5%)
Chest pain19/321 (5.9%) 0/137 (0%) 4/49 (8.2%)
Pain19/321 (5.9%) 10/137 (7.3%) 4/49 (8.2%)
Chills0/321 (0%) 15/137 (10.9%) 1/49 (2%)
Inflammation0/321 (0%) 0/137 (0%) 3/49 (6.1%)
Hepatobiliary disorders
Hyperbilirubinaemia32/321 (10%) 10/137 (7.3%) 0/49 (0%)
Hyperbilirubinaemia0/321 (0%) 0/137 (0%) 4/49 (8.2%)
Infections and infestations
Nasopharyngitis80/321 (24.9%) 0/137 (0%) 0/49 (0%)
Upper respiratory tract infection41/321 (12.8%) 7/137 (5.1%) 5/49 (10.2%)
Urinary tract infection28/321 (8.7%) 0/137 (0%) 4/49 (8.2%)
Bronchitis26/321 (8.1%) 0/137 (0%) 4/49 (8.2%)
Sinusitis22/321 (6.9%) 0/137 (0%) 5/49 (10.2%)
Influenza21/321 (6.5%) 0/137 (0%) 0/49 (0%)
Rhinitis16/321 (5%) 0/137 (0%) 3/49 (6.1%)
Pneumonia0/321 (0%) 7/137 (5.1%) 3/49 (6.1%)
Nasopharyngitis0/321 (0%) 0/137 (0%) 8/49 (16.3%)
Herpes simplex0/321 (0%) 0/137 (0%) 3/49 (6.1%)
Herpes zoster0/321 (0%) 0/137 (0%) 3/49 (6.1%)
Periodontitis0/321 (0%) 0/137 (0%) 3/49 (6.1%)
Injury, poisoning and procedural complications
Procedural pain17/321 (5.3%) 0/137 (0%) 0/49 (0%)
Investigations
Lipase increased55/321 (17.1%) 8/137 (5.8%) 10/49 (20.4%)
Alanine aminotransferase increased39/321 (12.1%) 14/137 (10.2%) 8/49 (16.3%)
Weight decreased30/321 (9.3%) 15/137 (10.9%) 2/49 (4.1%)
Blood bilirubin increased29/321 (9%) 14/137 (10.2%) 4/49 (8.2%)
Aspartate aminotransferase increased24/321 (7.5%) 7/137 (5.1%) 5/49 (10.2%)
Blood creatine phosphokinase increased19/321 (5.9%) 0/137 (0%) 3/49 (6.1%)
Gamma-glutamyltransferase increased19/321 (5.9%) 0/137 (0%) 0/49 (0%)
Amylase increased18/321 (5.6%) 0/137 (0%) 3/49 (6.1%)
White blood cell count decreased0/321 (0%) 11/137 (8%) 0/49 (0%)
Haemoglobin decreased0/321 (0%) 9/137 (6.6%) 0/49 (0%)
Haemoglobin decreased0/321 (0%) 7/137 (5.1%) 0/49 (0%)
Platelet count decreased0/321 (0%) 7/137 (5.1%) 0/49 (0%)
Weight increased0/321 (0%) 0/137 (0%) 5/49 (10.2%)
Blood glucose increased0/321 (0%) 0/137 (0%) 4/49 (8.2%)
Metabolism and nutrition disorders
Decreased appetite50/321 (15.6%) 12/137 (8.8%) 7/49 (14.3%)
Hyperglycaemia27/321 (8.4%) 12/137 (8.8%) 3/49 (6.1%)
Hypokalaemia25/321 (7.8%) 22/137 (16.1%) 6/49 (12.2%)
Hypophosphataemia22/321 (6.9%) 10/137 (7.3%) 5/49 (10.2%)
Hypomagnesaemia19/321 (5.9%) 10/137 (7.3%) 0/49 (0%)
Hypocalcaemia17/321 (5.3%) 15/137 (10.9%) 0/49 (0%)
Hyperkalaemia0/321 (0%) 0/137 (0%) 3/49 (6.1%)
Musculoskeletal and connective tissue disorders
Arthralgia86/321 (26.8%) 20/137 (14.6%) 10/49 (20.4%)
Myalgia63/321 (19.6%) 0/137 (0%) 7/49 (14.3%)
Pain in extremity63/321 (19.6%) 18/137 (13.1%) 9/49 (18.4%)
Back pain60/321 (18.7%) 19/137 (13.9%) 7/49 (14.3%)
Muscle spasms45/321 (14%) 9/137 (6.6%) 8/49 (16.3%)
Bone pain43/321 (13.4%) 14/137 (10.2%) 4/49 (8.2%)
Musculoskeletal pain32/321 (10%) 0/137 (0%) 3/49 (6.1%)
Neck pain16/321 (5%) 0/137 (0%) 3/49 (6.1%)
Musculoskeletal chest pain0/321 (0%) 7/137 (5.1%) 1/49 (2%)
Nervous system disorders
Headache114/321 (35.5%) 0/137 (0%) 11/49 (22.4%)
Dizziness35/321 (10.9%) 0/137 (0%) 5/49 (10.2%)
Paraesthesia17/321 (5.3%) 0/137 (0%) 0/49 (0%)
Psychiatric disorders
Insomnia40/321 (12.5%) 0/137 (0%) 2/49 (4.1%)
Depression28/321 (8.7%) 0/137 (0%) 3/49 (6.1%)
Anxiety20/321 (6.2%) 0/137 (0%) 3/49 (6.1%)
Renal and urinary disorders
Pollakiuria17/321 (5.3%) 0/137 (0%) 0/49 (0%)
Respiratory, thoracic and mediastinal disorders
Cough91/321 (28.3%) 21/137 (15.3%) 0/49 (0%)
Dyspnoea51/321 (15.9%) 14/137 (10.2%) 9/49 (18.4%)
Oropharyngeal pain39/321 (12.1%) 16/137 (11.7%) 2/49 (4.1%)
Dyspnoea exertional21/321 (6.5%) 0/137 (0%) 0/49 (0%)
Epistaxis16/321 (5%) 17/137 (12.4%) 2/49 (4.1%)
Skin lesion19/321 (5.9%) 0/137 (0%) 3/49 (6.1%)
Pleural effusion0/321 (0%) 10/137 (7.3%) 4/49 (8.2%)
Skin and subcutaneous tissue disorders
Rash118/321 (36.8%) 39/137 (28.5%) 20/49 (40.8%)
Pruritus104/321 (32.4%) 18/137 (13.1%) 9/49 (18.4%)
Night sweats37/321 (11.5%) 7/137 (5.1%) 3/49 (6.1%)
Dry skin36/321 (11.2%) 0/137 (0%) 4/49 (8.2%)
Alopecia34/321 (10.6%) 8/137 (5.8%) 1/49 (2%)
Erythema30/321 (9.3%) 0/137 (0%) 4/49 (8.2%)
Hyperhidrosis26/321 (8.1%) 7/137 (5.1%) 3/49 (6.1%)
Petechiae0/321 (0%) 9/137 (6.6%) 0/49 (0%)
Vascular disorders
Hypertension37/321 (11.5%) 0/137 (0%) 5/49 (10.2%)
Haematoma0/321 (0%) 10/137 (7.3%) 0/49 (0%)
Hypotension0/321 (0%) 10/137 (7.3%) 1/49 (2%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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 (ie, data from all sites) in the clinical trial.

Results Point of Contact

Name/TitleStudy Director
OrganizationNovartisPharmaceuticals
Phone862-778-8300
Emailnovartis.email@novartis.com
Responsible Party:
Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00109707
Other Study ID Numbers:
  • CAMN107A2101
First Posted:
May 3, 2005
Last Update Posted:
Jun 29, 2021
Last Verified:
Jun 1, 2021