<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01730248</url>
  </required_header>
  <id_info>
    <org_study_id>CINC424A2104</org_study_id>
    <nct_id>NCT01730248</nct_id>
  </id_info>
  <brief_title>A Study to Find the Maximum Tolerated Dose of the Experimental Combination of the Drugs INC424 and BKM120 in Patients With Primary or Secondary Myelofibrosis</brief_title>
  <official_title>A Phase Ib, Open-label, Multi-center, Two-arm, Dose-finding Study to Assess Safety and Efficacy of the Oral Combination or INC424 (INC424) and BKM120 in Patients With Primary Myelofibrosis (PMF), Postpolycythemia Vera-myelofibrosis (PPV-MF), or Post-essential Thrombocythemia-myelofibrosis (PET-MF)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Novartis Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Incyte Corporation</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Novartis</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this phase Ib clinical trial is to evaluate the safety of the combination of&#xD;
      INC424 and BKM120 in the myelofibrosis population and to establish the maximum tolerated dose&#xD;
      and or the Recommended Phase II dose of the combination guided by the Bayesian dose&#xD;
      escalation model. INC424 has shown efficacy in myelofibrosis (MF) and is approved in the US&#xD;
      and EU for the treatment of MF. BKM120 is a PI3K inhibitor. Preclinical and early clinical&#xD;
      experience support inhibition of the PI3K/mTOR pathway in MF as aberrant activation of the&#xD;
      pathway has been observed in MF models and may contribute to the pathogenesis of the disease.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Decision by Sponsor to to terminate the study early.&#xD;
  </why_stopped>
  <start_date type="Actual">December 18, 2012</start_date>
  <completion_date type="Actual">September 28, 2017</completion_date>
  <primary_completion_date type="Actual">September 28, 2017</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of dose limiting toxicities</measure>
    <time_frame>baseline, when the maximum tolerated dose is established.</time_frame>
    <description>The incidence of dose limiting toxicities will be analyzed to establish the maximum tolerated dose. To assess the maximum tolerated dose, labs and adverse events are monitored.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Frequency of adverse events</measure>
    <time_frame>after each cohort is enrolled at baseline until the maximum tolerated dose is established</time_frame>
    <description>Adverse Events are monitored at each study visit and 30 days post last dose of study drug</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of serious adverse events</measure>
    <time_frame>after each cohort is enrolled at baseline until the maximum tolerated dose is established</time_frame>
    <description>Serious Adverse events monitored at each study visit and 30 days post last dose of study drug</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Abnormalities in vital signs</measure>
    <time_frame>baseline, days 2, 8, 15, 22 of cycle 1, day 1 and 15 at Cycle 2, Day 1 from cycle 3 to 12, day 28 on Cycle 12 and every 12 weeks from Week 60 to 96 and at End of treatment</time_frame>
    <description>cycle = 28 days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Laboratory test values including Imaging (electrocardiograms (ECGs), abdominal MRI/CT, ECHO/MUGA</measure>
    <time_frame>Day 1, 2, 5, 8, 11, 18, 22, 25 of cycle 1, weekly in cycle 2, then at every scheduled visit including End of treatment visit</time_frame>
    <description>ECGs are performed baseline, days 2, 8, 15, 22 of cycle 1 then day 1 from Cycle 2 to cycle 12, and at cycle 12 day 28 and every 12 weeks and end of treatment. Magnetic resonance imaging (MRI) or Cat Scan (CT) performed at baseline, cycle 4 day 1, cycle 7 day 1, cycle 12 day 28, then every 24 weeks , and end of treatment if not done in past 12 weeks. Echocardiography (ECHO) or Multiple Gated Acquisition (MUGA) is performed at baseline and then every 4 cycles until cycle 12, then every 24 weeks therafter or as clinically indicated until Week 96. Hematology is performed at baseline and days 2, 5, 8, 11, 15, 18, 22, 25 of cycle 1, weekly in cycle 2, then on every scheduled visit (D1 of Cycle 3 to 12, at Cycle 12 Day 28 ,then every 12 weeks) and end of treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum plasma concentration (Cmax)</measure>
    <time_frame>pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 hours on days 1, 2, and 8</time_frame>
    <description>To characterize the pharmacokinetics (PK) of INC424 alone or in combination with BKM120</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum plasma concentration time (Tmax)</measure>
    <time_frame>pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 hours on days 1, 2, and 8</time_frame>
    <description>To characterize the pharmacokinetics (PK) of INC424 alone or in combination with BKM120</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the plasma concentration time curve (AUC)</measure>
    <time_frame>pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 hours on days 1, 2, and 8</time_frame>
    <description>To characterize the pharmacokinetics (PK) of INC424 alone or in combination with BKM120</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum plasma concentration (Cmax)</measure>
    <time_frame>pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 24 hours on days 2 and 8</time_frame>
    <description>To characterize the pharmacokinetics (PK) of BKM120 alone or in combination with INC424</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum plasma concentration time (Tmax)</measure>
    <time_frame>pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 24 hours on days 2 and 8</time_frame>
    <description>To characterize the pharmacokinetics (PK) of BKM120 alone or in combination with INC424</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the plasma concentration time curve (AUC)</measure>
    <time_frame>pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 24 hours on days 2 and 8</time_frame>
    <description>To characterize the pharmacokinetics (PK) of BKM120 alone or in combination with INC424</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of adverse events</measure>
    <time_frame>after each cohort is enrolled at baseline until the maximum tolerated dose is established</time_frame>
    <description>Adverse Events are monitored at each study visit and 30 days post last dose of study drug</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Severity of adverse events</measure>
    <time_frame>after each cohort is enrolled at baseline until the maximum tolerated dose is established</time_frame>
    <description>Adverse Events are monitored at each study visit and 30 days post last dose of study drug</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Severity of serious adverse events</measure>
    <time_frame>after each cohort is enrolled at baseline until the maximum tolerated dose is established</time_frame>
    <description>Serious Adverse events monitored at each study visit and 30 days post last dose of study drug</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of serious adverse events</measure>
    <time_frame>after each cohort is enrolled at baseline until the maximum tolerated dose is established</time_frame>
    <description>Adverse Events are monitored at each study visit and 30 days post last dose of study drug</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">63</enrollment>
  <condition>Myelofibrosis</condition>
  <arm_group>
    <arm_group_label>JAK Inhibitor Naive</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Two treatment periods applicable to all patients; Treatment Period (6 cycles / 28 days per cycle) and Extension Period ( 6 or more cycles of 28 days, with visits every 28days for 6 cycles and then visits every 12 weeks) following the treatment period dependent on patient continued eligibility. Two Study Phases: Dose Escalation Phase to determine maximum tolerated dose (MTD) / Recommended Phase II dose (RPIID) &amp; an Expansion Phase</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Prior JAK Inhibitor</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Two treatment periods applicable to all patients; Treatment Period (6 cycles / 28 days per cycle) and Extension Period (6 or more cycles of 28 days, with visits every 28 days for 6 cycles then visits every 12 weeks) following the treatment period dependent on patient continued eligibility. Two Study Phases: Dose Escalation Phase to determine MTD / RPIID &amp; an Expansion Phase</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>INC424</intervention_name>
    <description>5 mg tablets administered orally twice daily</description>
    <arm_group_label>JAK Inhibitor Naive</arm_group_label>
    <arm_group_label>Prior JAK Inhibitor</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BKM120</intervention_name>
    <description>10 mg and 50 mg hard gelatin capsules administered orally once daily</description>
    <arm_group_label>JAK Inhibitor Naive</arm_group_label>
    <arm_group_label>Prior JAK Inhibitor</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosed with PMF, PPV-MF or PET-MF irrespective of JAK2 mutation status&#xD;
&#xD;
          -  Myelofibrosis patients requiring therapy must be classified as intermediate risk level&#xD;
             1 )1 or more prognostic factors defined by IWG) with at least one criteria other than&#xD;
             age&#xD;
&#xD;
          -  Must have palpable spleen of at least 5 cm from the costal margin to the point of&#xD;
             greatest splenic profusion at Screening&#xD;
&#xD;
          -  Must have active symptoms of MF (one symptom score of at least 5 or two symptom scores&#xD;
             of at least 3 at Screening) (per MFSSF 0-10)&#xD;
&#xD;
          -  PLT counts &gt; or = 75X 10^9/L at Screening or Cycle 1 Day 1 (not with aid of&#xD;
             transfusions&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant or nursing women&#xD;
&#xD;
          -  WOCBP not using highly effective methods of contraception&#xD;
&#xD;
          -  Sexually active males who refuse condom use&#xD;
&#xD;
          -  Previous Treatment with one of the following: PI3 K inhibitors and AKT inhibitors; JAK&#xD;
             inhibitors that resulted in clinically significant toxicities per the Investigator;&#xD;
&#xD;
          -  Patients who have had splenic irradiation within 12 months prior to Screening&#xD;
&#xD;
          -  Patients with specific mood disorders&#xD;
&#xD;
          -  Any history of bleeding diathesis&#xD;
&#xD;
          -  Patients receiving the following treatments / medications:&#xD;
&#xD;
        EIAED within 2 wks. prior to study treatment; medication known to prolong QT interval or&#xD;
        induce Torsades de Pointes; treatment with potent systemic systemic inhibitor or systemic&#xD;
        inducer of CYP3A4; any use of drug that interferes with coagulation or inhibits PLT&#xD;
        function&#xD;
&#xD;
        -current and willing candidates for a stem cell transplantation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Novartis Pharmaceuticals</last_name>
    <role>Study Director</role>
    <affiliation>Novartis Pharmaceuticals</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Herston</city>
        <state>Queensland</state>
        <zip>4029</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Melbourne</city>
        <state>Victoria</state>
        <zip>3000</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Vienna</city>
        <zip>A-1090</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Paris</city>
        <zip>75010</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Berlin</city>
        <zip>13353</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Rostock</city>
        <zip>18057</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Jerusalem</city>
        <zip>91120</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Ramat Gan</city>
        <zip>5265601</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Firenze</city>
        <state>FI</state>
        <zip>50134</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Varese</city>
        <state>VA</state>
        <zip>21100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Singapore</city>
        <zip>169608</zip>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Madrid</city>
        <zip>28041</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Edgbaston</city>
        <state>Birmingham</state>
        <zip>B15 2WB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>London</city>
        <zip>NW1 2BU</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>London</city>
        <zip>SE1 9RT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Austria</country>
    <country>France</country>
    <country>Germany</country>
    <country>Israel</country>
    <country>Italy</country>
    <country>Singapore</country>
    <country>Spain</country>
    <country>United Kingdom</country>
  </location_countries>
  <link>
    <url>https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=17230</url>
    <description>Results for INC424A2104 can be found on the Novartis Clinical Trial Results Website</description>
  </link>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>November 12, 2012</study_first_submitted>
  <study_first_submitted_qc>November 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2012</study_first_posted>
  <last_update_submitted>December 16, 2020</last_update_submitted>
  <last_update_submitted_qc>December 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 19, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Myelofibrosis,</keyword>
  <keyword>PMF,</keyword>
  <keyword>PPV-MF,</keyword>
  <keyword>PET-MF,</keyword>
  <keyword>Primary Myelofibrosis,</keyword>
  <keyword>Post-polycythemia vera myelofibrosis,</keyword>
  <keyword>Post-essential thrombocythemia myelofibrosis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Primary Myelofibrosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01730248
org study id: CINC424A2104
nct id: NCT01730248
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this phase Ib clinical trial is to evaluate the safety of the combination of
      INC424 and BKM120 in the myelofibrosis population and to establish the maximum tolerated dose
      and or the Recommended Phase II dose of the combination guided by the Bayesian dose
      escalation model. INC424 has shown efficacy in myelofibrosis (MF) and is approved in the US
      and EU for the treatment of MF. BKM120 is a PI3K inhibitor. Preclinical and early clinical
      experience support inhibition of the PI3K/mTOR pathway in MF as aberrant activation of the
      pathway has been observed in MF models and may contribute to the pathogenesis of the disease.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Incidence of dose limiting toxicities
time frame: baseline, when the maximum tolerated dose is established.
description: The incidence of dose limiting toxicities will be analyzed to establish the maximum tolerated dose. To assess the maximum tolerated dose, labs and adverse events are monitored.
measure: Frequency of adverse events
time frame: after each cohort is enrolled at baseline until the maximum tolerated dose is established
description: Adverse Events are monitored at each study visit and 30 days post last dose of study drug
measure: Frequency of serious adverse events
time frame: after each cohort is enrolled at baseline until the maximum tolerated dose is established
description: Serious Adverse events monitored at each study visit and 30 days post last dose of study drug
measure: Abnormalities in vital signs
time frame: baseline, days 2, 8, 15, 22 of cycle 1, day 1 and 15 at Cycle 2, Day 1 from cycle 3 to 12, day 28 on Cycle 12 and every 12 weeks from Week 60 to 96 and at End of treatment
description: cycle = 28 days
measure: Laboratory test values including Imaging (electrocardiograms (ECGs), abdominal MRI/CT, ECHO/MUGA
time frame: Day 1, 2, 5, 8, 11, 18, 22, 25 of cycle 1, weekly in cycle 2, then at every scheduled visit including End of treatment visit
description: ECGs are performed baseline, days 2, 8, 15, 22 of cycle 1 then day 1 from Cycle 2 to cycle 12, and at cycle 12 day 28 and every 12 weeks and end of treatment. Magnetic resonance imaging (MRI) or Cat Scan (CT) performed at baseline, cycle 4 day 1, cycle 7 day 1, cycle 12 day 28, then every 24 weeks , and end of treatment if not done in past 12 weeks. Echocardiography (ECHO) or Multiple Gated Acquisition (MUGA) is performed at baseline and then every 4 cycles until cycle 12, then every 24 weeks therafter or as clinically indicated until Week 96. Hematology is performed at baseline and days 2, 5, 8, 11, 15, 18, 22, 25 of cycle 1, weekly in cycle 2, then on every scheduled visit (D1 of Cycle 3 to 12, at Cycle 12 Day 28 ,then every 12 weeks) and end of treatment.
measure: Maximum plasma concentration (Cmax)
time frame: pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 hours on days 1, 2, and 8
description: To characterize the pharmacokinetics (PK) of INC424 alone or in combination with BKM120
measure: Maximum plasma concentration time (Tmax)
time frame: pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 hours on days 1, 2, and 8
description: To characterize the pharmacokinetics (PK) of INC424 alone or in combination with BKM120
measure: Area under the plasma concentration time curve (AUC)
time frame: pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 hours on days 1, 2, and 8
description: To characterize the pharmacokinetics (PK) of INC424 alone or in combination with BKM120
measure: Maximum plasma concentration (Cmax)
time frame: pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 24 hours on days 2 and 8
description: To characterize the pharmacokinetics (PK) of BKM120 alone or in combination with INC424
measure: Maximum plasma concentration time (Tmax)
time frame: pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 24 hours on days 2 and 8
description: To characterize the pharmacokinetics (PK) of BKM120 alone or in combination with INC424
measure: Area under the plasma concentration time curve (AUC)
time frame: pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 24 hours on days 2 and 8
description: To characterize the pharmacokinetics (PK) of BKM120 alone or in combination with INC424
measure: Duration of adverse events
time frame: after each cohort is enrolled at baseline until the maximum tolerated dose is established
description: Adverse Events are monitored at each study visit and 30 days post last dose of study drug
measure: Severity of adverse events
time frame: after each cohort is enrolled at baseline until the maximum tolerated dose is established
description: Adverse Events are monitored at each study visit and 30 days post last dose of study drug
measure: Severity of serious adverse events
time frame: after each cohort is enrolled at baseline until the maximum tolerated dose is established
description: Serious Adverse events monitored at each study visit and 30 days post last dose of study drug
measure: Duration of serious adverse events
time frame: after each cohort is enrolled at baseline until the maximum tolerated dose is established
description: Adverse Events are monitored at each study visit and 30 days post last dose of study drug
arm group label: JAK Inhibitor Naive
arm group type: Experimental
description: Two treatment periods applicable to all patients; Treatment Period (6 cycles / 28 days per cycle) and Extension Period ( 6 or more cycles of 28 days, with visits every 28days for 6 cycles and then visits every 12 weeks) following the treatment period dependent on patient continued eligibility. Two Study Phases: Dose Escalation Phase to determine maximum tolerated dose (MTD) / Recommended Phase II dose (RPIID) & an Expansion Phase
arm group label: Prior JAK Inhibitor
arm group type: Experimental
description: Two treatment periods applicable to all patients; Treatment Period (6 cycles / 28 days per cycle) and Extension Period (6 or more cycles of 28 days, with visits every 28 days for 6 cycles then visits every 12 weeks) following the treatment period dependent on patient continued eligibility. Two Study Phases: Dose Escalation Phase to determine MTD / RPIID & an Expansion Phase
intervention type: Drug
intervention name: INC424
description: 5 mg tablets administered orally twice daily
arm group label: JAK Inhibitor Naive
arm group label: Prior JAK Inhibitor
intervention type: Drug
intervention name: BKM120
description: 10 mg and 50 mg hard gelatin capsules administered orally once daily
arm group label: JAK Inhibitor Naive
arm group label: Prior JAK Inhibitor
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Novartis Pharmaceuticals
role: Study Director
affiliation: Novartis Pharmaceuticals
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Australia
country: Austria
country: France
country: Germany
country: Israel
country: Italy
country: Singapore
country: Spain
country: United Kingdom
url: https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=17230
description: Results for INC424A2104 can be found on the Novartis Clinical Trial Results Website
responsible party type: Sponsor
mesh term: Primary Myelofibrosis
sharing ipd: No