MACS0999: An Exploratory Trial to Assess the Improvement of Adverse Events in Chronic Myelogenous Leukemia Patients Treated With Imatinib When Switched to Nilotinib Treatment

Sponsor
Novartis Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT00980018
Collaborator
(none)
52
Enrollment
23
Locations
1
Arm
36
Duration (Months)
2.3
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this exploratory study will be to examine changes in chronic low grade chronic adverse events, measured by Common Terminology Criteria for Adverse Events (CTCAE) grading, when patients are switched from imatinib to nilotinib therapy.

Condition or DiseaseIntervention/TreatmentPhase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
52 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Exploratory Trial to Assess the Improvement of Chronic Low-grade Non-hematologic Adverse Events Experienced by Patients With Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP) Treated With Imatinib When Switched to Nilotinib Treatment
Study Start Date :
Dec 1, 2009
Actual Primary Completion Date :
Dec 1, 2012
Actual Study Completion Date :
Dec 1, 2012

Arms and Interventions

ArmIntervention/Treatment
Experimental: nilotinib

Participants received two 150 [a total of 300 mg at each dosing] mg nilotinib capsules twice daily (bid) orally every morning and every evening approximately 12 hours apart and two 200 mg capsules [a total of 400 mg at each dosing] for patients enrolled prior to Protocol Amendment 1).

Drug: Nilotinib
Participants received two 150 [a total of 300 mg at each dosing] mg nilotinib capsules twice daily (bid) orally every morning and every evening approximately 12 hours apart and two 200 mg capsules [a total of 400 mg at each dosing] for patients enrolled prior to Protocol Amendment 1).
Other Names:
  • Tasigna, nilotinib, AMN107,
  • Outcome Measures

    Primary Outcome Measures

    1. Percentage of Participants With Improvement in Imatinib Related Chronic Low Grade Non Hematologic Adverse Event (AE) After Switch to Treatment With Nilotinib at End of Cycle 3 [End of Cycles 1, 2, and 3]

      A patient was considered improved if 50% or more of the chronic imatinib-related chronic low grade nonhematologic AEs showed improvement (a decrease in CTCAE [Common Terminology Criteria for Adverse Events] grade or complete resolution).

    Secondary Outcome Measures

    1. Percentage of Participants Achieving Complete Cytogenetic Response (CCyR) After Switching to Nilotinib for Participants Not Reporting CCyR at Baseline [Cycles 1, 2, 6, 9, and 12]

      Time to complete cytogenetic response is defined as time from baseline to first time of CCyR as documented by bone marrow cytogenetics. Cytogenetic response was assessed as applicable by bone marrow cytogenetics 6, 12, and 18 months after starting imatinib therapy. Assess CCyR by bone marrow cytogenics

    2. Percentage of Participants Achieving Major Molecular Response (MMR) After the Switch in the Therapy for Participants Not Reporting MMR at Baseline [Cycles 1,2,3,6,9,12]

      Major Molecular Response (MMR) value at Molecular MD is designated a percentage, which is equivalent to a 3-log reduction from a standardized baseline value from the International Randomized Interferon versus STI571 (IRIS) study or 0.1% per International Scale (IS). Time to MMR is defined as time from baseline to first time of MMR as documented by RQ-PCR

    3. Log Change in BCR-Abl Transcript Level From Baseline After the Switch Therapy [Cycles 1,2,3,6,9, and 12]

      Levels of BCR-ABL transcripts were determined by quantitative RQ-PCR testing of peripheral blood and analyzed at a central testing laboratory. Log reduction in BCR-ABL transcripts levels from the standardized baseline value will be calculated for each sample from the reported percent ratio of BCR-ABL transcripts versus control gene transcripts converted to a reference standard.

    4. Duration of Complete Cytogenetic Response [18 months of follow up from the first documented response]

      Duration of Complete Cytogenetic Response is defined as the time from first CCyR to first loss of CCyR as documented by bone marrow cytogenetics, or by FISH assay, whichever is earlier. The duration of CCyR begins on the day of enrollment for patients reporting CCyR at baseline.

    5. Time to Complete Cytogenetic Response in Participants Not Reporting at Baseline [Cycle 12]

      For time to CCyR, an event is defined as achievement of CCyR documented by bone marrow cytogenetics.

    6. Duration of Major Molecular Response [18 months of follow up from the first documented response]

      Duration of Major Molecular Response is defined as the time from first MMR to first loss of MMR as documented by RQ-PCR. The duration of MMR begins on the day of enrollment for patients reporting MMR at baseline.

    7. Time to Major Molecular Response (MMR) in Participants With MMR Absent at Baseline [Cycles 1,2,3,6,9,12]

      For time to MMR, an event is defined as achievement of MMR documented by RQ-PCR. Patients with MMR at the Screening RQ-PCR assay are counted as having time to MMR equal to 0.

    8. Time to Optimal Imatinib-related Adverse Event Improvement [18 months of follow up from the date of the first dose of study drug to the time to maximum decrease in CTCAE grade of these events]

      Time to optimal improvement is defined as the time when the sum of the total CTCAE toxicity grades for a patient's chronic low-grade imatinib-related adverse events reaches its minimum value.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    1. Male or female patients ≥ 18 years of age

    2. Eastern Cooperative Oncology Group (ECOG) 0, 1, or 2

    3. Diagnosis of CML-CP associated with Bcr-Abl quantifiable by RQ-PCR (IS)

    4. Patients must be an imatinib responder and achieved the following efficacy milestones as appropriate for the length of time on imatinib therapy as per protocol

    5. CML-CP patients initiated on any dose of imatinib

    6. Ability to provide written informed consent prior to any study related screening procedures being done

    Exclusion Criteria:
    1. Loss of CHR or cytogenetic response

    2. Prior accelerated phase or blast phase CML

    3. Previously documented T315I mutation

    4. Presence of chromosomal abnormalities (trisomy 8) and/or clonal evolution other than Ph+.

    5. Previous treatment with any other tyrosine kinase inhibitor except for imatinib.

    6. Treatment with other investigational agents within 30 days of Day 1.

    7. History of non-compliance to medical regimens or inability to grant consent.

    8. Women who are pregnant, breast feeding, or of childbearing potential without a negative serum test at baseline. Male or female patients of childbearing potential unwilling to use contraceptive precautions throughout the trial and 3 months following discontinuation of study drug. Post-menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential. Women of childbearing potential must have a negative serum pregnancy test prior to the first dose of nilotinib.

    Other protocol-defined inclusion/exclusion criteria may apply

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Highlands Oncology GroupFayettevilleArkansasUnited States72703
    2Hematology Oncology Services of Arkansas SCLittle RockArkansasUnited States72205
    3USC Norris Cancer Center LAC & USC Medical CenterLos AngelesCaliforniaUnited States90033
    4Southwest Cancer Care MurrietaPowayCaliforniaUnited States92064
    5Rocky Mountain Cancer Centers RMCC - AuroraGreenwood VillageColoradoUnited States
    6Florida Cancer InstituteNew Port RicheyFloridaUnited States34655
    7Cancer Centers of Florida PA Cancer Centers of FL-Orlando-4OcoeeFloridaUnited States*see dep*
    8Stroger Cook County Hospital John H. Stroger HospitalChicagoIllinoisUnited States60612
    9St. Francis Hospital and Health Centers IndianaBlood&MarrowTransplantnBeech GroveIndianaUnited States46107
    10St. Agnes HospitalBaltimoreMarylandUnited States21229
    11St. Louis University Cancer CenterSaint LouisMissouriUnited States63110
    12Northwest Cancer Specialists Salmon Creek OfficePortlandOregonUnited States97210
    13Oregon Health Sciences UniversityPortlandOregonUnited States97239
    14The Jones ClinicGermantownTennesseeUnited States38138
    15Texas Oncology, P.A.BedfordTexasUnited States76022
    16Presbyterian Hospital of Dallas TexasOncology@PresbyterianHospDallasTexasUnited States75231
    17Texas Oncology Texas Oncology - Sugar LandDallasTexasUnited States75246
    18MD Anderson Cancer Center/University of TexasHoustonTexasUnited States77031
    19Cancer Care Centers of South Texas / HOAST CCC of So. TX- San Antonio(2)San AntonioTexasUnited States78229
    20Novartis Investigative SiteBramptonOntarioCanadaL6R 3J7
    21Novartis Investigative SiteTorontoOntarioCanadaM5G 2M9
    22Novartis Investigative SiteMontrealQuebecCanadaH1T 2M4
    23Novartis Investigative SiteMontrealQuebecCanadaH3A 1A1

    Sponsors and Collaborators

    • Novartis Pharmaceuticals

    Investigators

    • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Novartis Pharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT00980018
    Other Study ID Numbers:
    • CAMN107AUS17
    First Posted:
    Sep 18, 2009
    Last Update Posted:
    Jul 1, 2021
    Last Verified:
    Jun 1, 2021

    Study Results

    Participant Flow

    Recruitment DetailsThe study was conducted at 15 centers in US and 4 centers in Canada from 10-December-2009 (first patient first visit) to 27-December-2012 (last patient last visit).
    Pre-assignment DetailA total of 68 patients were screened out of which 52 enrolled and 40 completed the full duration of treatment.
    Arm/Group TitleNilotinib
    Arm/Group DescriptionParticipants received two 150 [a total of 300 mg at each dosing] mg nilotinib capsules twice daily (bid) orally every morning and every evening approximately 12 hours apart and two 200 mg capsules [a total of 400 mg at each dosing] for patients enrolled prior to Protocol Amendment 1).
    Period Title: Overall Study
    STARTED52
    COMPLETED40
    NOT COMPLETED12

    Baseline Characteristics

    Arm/Group TitleNilotinib
    Arm/Group DescriptionParticipants received two 150 [a total of 300 mg at each dosing] mg nilotinib capsules twice daily (bid) orally every morning and every evening approximately 12 hours apart and two 200 mg capsules [a total of 400 mg at each dosing] for patients enrolled prior to Protocol Amendment 1).
    Overall Participants52
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    51.7
    (10.76)
    Sex: Female, Male (Count of Participants)
    Female
    26
    50%
    Male
    26
    50%

    Outcome Measures

    1. Primary Outcome
    TitlePercentage of Participants With Improvement in Imatinib Related Chronic Low Grade Non Hematologic Adverse Event (AE) After Switch to Treatment With Nilotinib at End of Cycle 3
    DescriptionA patient was considered improved if 50% or more of the chronic imatinib-related chronic low grade nonhematologic AEs showed improvement (a decrease in CTCAE [Common Terminology Criteria for Adverse Events] grade or complete resolution).
    Time FrameEnd of Cycles 1, 2, and 3

    Outcome Measure Data

    Analysis Population Description
    Full Analysis Set (FAS): All participants who received at least one dose of study drug.
    Arm/Group TitleNilotinib
    Arm/Group DescriptionParticipants received two 150 [a total of 300 mg at each dosing] mg nilotinib capsules twice daily (bid) orally every morning and every evening approximately 12 hours apart and two 200 mg capsules [a total of 400 mg at each dosing] for patients enrolled prior to Protocol Amendment 1).
    Measure Participants52
    End of Cycle 1
    37
    71.2%
    End of Cycle 2
    43
    82.7%
    End of Cycle 3
    44
    84.6%
    2. Secondary Outcome
    TitlePercentage of Participants Achieving Complete Cytogenetic Response (CCyR) After Switching to Nilotinib for Participants Not Reporting CCyR at Baseline
    DescriptionTime to complete cytogenetic response is defined as time from baseline to first time of CCyR as documented by bone marrow cytogenetics. Cytogenetic response was assessed as applicable by bone marrow cytogenetics 6, 12, and 18 months after starting imatinib therapy. Assess CCyR by bone marrow cytogenics
    Time FrameCycles 1, 2, 6, 9, and 12

    Outcome Measure Data

    Analysis Population Description
    FAS : All participants who received at least one dose of study drug.
    Arm/Group TitleNilotinib
    Arm/Group DescriptionParticipants received two 150 [a total of 300 mg at each dosing] mg nilotinib capsules twice daily (bid) orally every morning and every evening approximately 12 hours apart and two 200 mg capsules [a total of 400 mg at each dosing] for patients enrolled prior to Protocol Amendment 1).
    Measure Participants7
    Cycle 1
    2
    3.8%
    Cycle 2
    3
    5.8%
    Cycle 3
    0
    0%
    Cycle 6
    2
    3.8%
    Cycle 9
    0
    0%
    Cycle 12
    0
    0%
    3. Secondary Outcome
    TitlePercentage of Participants Achieving Major Molecular Response (MMR) After the Switch in the Therapy for Participants Not Reporting MMR at Baseline
    DescriptionMajor Molecular Response (MMR) value at Molecular MD is designated a percentage, which is equivalent to a 3-log reduction from a standardized baseline value from the International Randomized Interferon versus STI571 (IRIS) study or 0.1% per International Scale (IS). Time to MMR is defined as time from baseline to first time of MMR as documented by RQ-PCR
    Time FrameCycles 1,2,3,6,9,12

    Outcome Measure Data

    Analysis Population Description
    FAS : All participants who received at least one dose of study drug.
    Arm/Group TitleNilotinib
    Arm/Group DescriptionParticipants received two 150 [a total of 300 mg at each dosing] mg nilotinib capsules twice daily (bid) orally every morning and every evening approximately 12 hours apart and two 200 mg capsules [a total of 400 mg at each dosing] for patients enrolled prior to Protocol Amendment 1).
    Measure Participants18
    Cycle 1
    2
    3.8%
    Cycle 2
    6
    11.5%
    Cycle 3
    3
    5.8%
    Cycle 6
    2
    3.8%
    Cycle 9
    2
    3.8%
    Cycle 12
    0
    0%
    4. Secondary Outcome
    TitleLog Change in BCR-Abl Transcript Level From Baseline After the Switch Therapy
    DescriptionLevels of BCR-ABL transcripts were determined by quantitative RQ-PCR testing of peripheral blood and analyzed at a central testing laboratory. Log reduction in BCR-ABL transcripts levels from the standardized baseline value will be calculated for each sample from the reported percent ratio of BCR-ABL transcripts versus control gene transcripts converted to a reference standard.
    Time FrameCycles 1,2,3,6,9, and 12

    Outcome Measure Data

    Analysis Population Description
    FAS: All participants who received at least one dose of study drug.
    Arm/Group TitleNilotinib
    Arm/Group DescriptionParticipants received two 150 [a total of 300 mg at each dosing] mg nilotinib capsules twice daily (bid) orally every morning and every evening approximately 12 hours apart and two 200 mg capsules [a total of 400 mg at each dosing] for patients enrolled prior to Protocol Amendment 1).
    Measure Participants52
    Cycle 1
    -0.177
    (0.3665)
    Cycle 2
    -0.407
    (0.5748)
    Cycle 3
    -0.540
    (0.6960)
    Cycle 6
    -0.718
    (0.9313)
    Cycle 9
    -0.844
    (0.9130)
    Cycle 12
    -0.902
    (0.9913)
    5. Secondary Outcome
    TitleDuration of Complete Cytogenetic Response
    DescriptionDuration of Complete Cytogenetic Response is defined as the time from first CCyR to first loss of CCyR as documented by bone marrow cytogenetics, or by FISH assay, whichever is earlier. The duration of CCyR begins on the day of enrollment for patients reporting CCyR at baseline.
    Time Frame18 months of follow up from the first documented response

    Outcome Measure Data

    Analysis Population Description
    FAS: All participants who received at least one dose of study drug.
    Arm/Group TitleNilotinib
    Arm/Group DescriptionParticipants received two 150 [a total of 300 mg at each dosing] mg nilotinib capsules twice daily (bid) orally every morning and every evening approximately 12 hours apart and two 200 mg capsules [a total of 400 mg at each dosing] for patients enrolled prior to Protocol Amendment 1).
    Measure Participants52
    Participants with CCyR at baseline
    319.7
    (143.03)
    Participants achieving CCyR on study
    266.3
    (86.73)
    6. Secondary Outcome
    TitleTime to Complete Cytogenetic Response in Participants Not Reporting at Baseline
    DescriptionFor time to CCyR, an event is defined as achievement of CCyR documented by bone marrow cytogenetics.
    Time FrameCycle 12

    Outcome Measure Data

    Analysis Population Description
    FAS: All participants who received at least one dose of study drug.
    Arm/Group TitleNilotinib
    Arm/Group DescriptionParticipants received two 150 [a total of 300 mg at each dosing] mg nilotinib capsules twice daily (bid) orally every morning and every evening approximately 12 hours apart and two 200 mg capsules [a total of 400 mg at each dosing] for patients enrolled prior to Protocol Amendment 1).
    Measure Participants7
    Median (95% Confidence Interval) [months]
    1.9
    7. Secondary Outcome
    TitleDuration of Major Molecular Response
    DescriptionDuration of Major Molecular Response is defined as the time from first MMR to first loss of MMR as documented by RQ-PCR. The duration of MMR begins on the day of enrollment for patients reporting MMR at baseline.
    Time Frame18 months of follow up from the first documented response

    Outcome Measure Data

    Analysis Population Description
    FAS : All participants who received at least one dose of study drug.
    Arm/Group TitleNilotinib
    Arm/Group DescriptionParticipants received two 150 [a total of 300 mg at each dosing] mg nilotinib capsules twice daily (bid) orally every morning and every evening approximately 12 hours apart and two 200 mg capsules [a total of 400 mg at each dosing] for patients enrolled prior to Protocol Amendment 1).
    Measure Participants49
    Participants with MMR at baseline
    277.6
    (166.88)
    Participants achieving MMR on study
    208.3
    (123.61)
    8. Secondary Outcome
    TitleTime to Major Molecular Response (MMR) in Participants With MMR Absent at Baseline
    DescriptionFor time to MMR, an event is defined as achievement of MMR documented by RQ-PCR. Patients with MMR at the Screening RQ-PCR assay are counted as having time to MMR equal to 0.
    Time FrameCycles 1,2,3,6,9,12

    Outcome Measure Data

    Analysis Population Description
    FAS : All participants who received at least one dose of study drug.
    Arm/Group TitleNilotinib
    Arm/Group DescriptionParticipants received two 150 [a total of 300 mg at each dosing] mg nilotinib capsules twice daily (bid) orally every morning and every evening approximately 12 hours apart and two 200 mg capsules [a total of 400 mg at each dosing] for patients enrolled prior to Protocol Amendment 1).
    Measure Participants18
    Median (95% Confidence Interval) [months]
    2.8
    9. Secondary Outcome
    TitleTime to Optimal Imatinib-related Adverse Event Improvement
    DescriptionTime to optimal improvement is defined as the time when the sum of the total CTCAE toxicity grades for a patient's chronic low-grade imatinib-related adverse events reaches its minimum value.
    Time Frame18 months of follow up from the date of the first dose of study drug to the time to maximum decrease in CTCAE grade of these events

    Outcome Measure Data

    Analysis Population Description
    FAS: All participants who received at least one dose of study drug.
    Arm/Group TitleNilotinib
    Arm/Group DescriptionParticipants received two 150 [a total of 300 mg at each dosing] mg nilotinib capsules twice daily (bid) orally every morning and every evening approximately 12 hours apart and two 200 mg capsules [a total of 400 mg at each dosing] for patients enrolled prior to Protocol Amendment 1).
    Measure Participants52
    Median (95% Confidence Interval) [months]
    1.9

    Adverse Events

    Time Frame18 months of follow up from the date of the first dose of study drug to the time to maximum decrease in CTCAE grade of these events
    Adverse Event Reporting Description The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
    Arm/Group TitleNilotinib
    Arm/Group DescriptionParticipants received two 150 [a total of 300 mg at each dosing] mg nilotinib capsules twice daily (bid) orally every morning and every evening approximately 12 hours apart and two 200 mg capsules [a total of 400 mg at each dosing] for patients enrolled prior to Protocol Amendment 1).
    All Cause Mortality
    Nilotinib
    Affected / at Risk (%)# Events
    Total0/52 (0%)
    Serious Adverse Events
    Nilotinib
    Affected / at Risk (%)# Events
    Total9/52 (17.3%)
    Cardiac disorders
    Cardiac arrest1/52 (1.9%)
    Coronary artery disease1/52 (1.9%)
    Gastrointestinal disorders
    Pancreatitis1/52 (1.9%)
    Pancreatitis acute1/52 (1.9%)
    General disorders
    Pain1/52 (1.9%)
    Hepatobiliary disorders
    Cholecystitis acute1/52 (1.9%)
    Infections and infestations
    Bronchitis1/52 (1.9%)
    Gastroenteritis1/52 (1.9%)
    Vulval cellulitis1/52 (1.9%)
    Wound infection bacterial1/52 (1.9%)
    Wound infection staphylococcal1/52 (1.9%)
    Injury, poisoning and procedural complications
    Cartilage injury1/52 (1.9%)
    Scapula fracture1/52 (1.9%)
    Musculoskeletal and connective tissue disorders
    Arthralgia1/52 (1.9%)
    Nervous system disorders
    Facial palsy1/52 (1.9%)
    Reproductive system and breast disorders
    Ovarian torsion1/52 (1.9%)
    Respiratory, thoracic and mediastinal disorders
    Pleural effusion1/52 (1.9%)
    Vascular disorders
    Arteriosclerosis1/52 (1.9%)
    Hypotension1/52 (1.9%)
    Other (Not Including Serious) Adverse Events
    Nilotinib
    Affected / at Risk (%)# Events
    Total49/52 (94.2%)
    Eye disorders
    Dry eye4/52 (7.7%)
    Gastrointestinal disorders
    Abdominal pain8/52 (15.4%)
    Constipation14/52 (26.9%)
    Diarrhoea8/52 (15.4%)
    Dry mouth4/52 (7.7%)
    Dyspepsia6/52 (11.5%)
    Nausea11/52 (21.2%)
    General disorders
    Chest pain3/52 (5.8%)
    Chills5/52 (9.6%)
    Fatigue17/52 (32.7%)
    Pyrexia3/52 (5.8%)
    Infections and infestations
    Sinusitis3/52 (5.8%)
    Upper respiratory tract infection6/52 (11.5%)
    Investigations
    Lipase increased3/52 (5.8%)
    Weight decreased5/52 (9.6%)
    Metabolism and nutrition disorders
    Anorexia7/52 (13.5%)
    Decreased appetite3/52 (5.8%)
    Hyperglycaemia4/52 (7.7%)
    Hypokalaemia3/52 (5.8%)
    Hypophosphataemia3/52 (5.8%)
    Musculoskeletal and connective tissue disorders
    Arthralgia12/52 (23.1%)
    Bone pain3/52 (5.8%)
    Muscle spasms8/52 (15.4%)
    Myalgia4/52 (7.7%)
    Pain in extremity5/52 (9.6%)
    Nervous system disorders
    Dizziness4/52 (7.7%)
    Headache17/52 (32.7%)
    Hypoaesthesia3/52 (5.8%)
    Psychiatric disorders
    Depression3/52 (5.8%)
    Insomnia6/52 (11.5%)
    Respiratory, thoracic and mediastinal disorders
    Cough5/52 (9.6%)
    Dysphonia3/52 (5.8%)
    Dyspnoea9/52 (17.3%)
    Skin and subcutaneous tissue disorders
    Alopecia7/52 (13.5%)
    Dry skin7/52 (13.5%)
    Night sweats5/52 (9.6%)
    Pruritus12/52 (23.1%)
    Rash17/52 (32.7%)
    Skin lesion4/52 (7.7%)
    Vascular disorders
    Hot flush5/52 (9.6%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

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

    There is NOT 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.

    Results Point of Contact

    Name/TitleStudy Director
    OrganizationNovartis Pharmaceuticals
    Phone862-778-8300
    EmailNovartis.email@novartis.com
    Responsible Party:
    Novartis Pharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT00980018
    Other Study ID Numbers:
    • CAMN107AUS17
    First Posted:
    Sep 18, 2009
    Last Update Posted:
    Jul 1, 2021
    Last Verified:
    Jun 1, 2021