<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/NCT04496999</url>
  </required_header>
  <id_info>
    <org_study_id>HDMM</org_study_id>
    <nct_id>NCT04496999</nct_id>
  </id_info>
  <brief_title>HDM201 and Midostaurin (HDMM) in Relapsed/Refractory AML With FLT3mut and TP53wt.</brief_title>
  <acronym>HDMM</acronym>
  <official_title>HDM201 and Midostaurin (HDMM) in Relapsed/Refractory AML With FLT3mut and TP53wt; a Phase I Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Insel Gruppe AG, University Hospital Bern</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Insel Gruppe AG, University Hospital Bern</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>
      This is a non-randomized prospective open-label single-arm clinical phase I trial&#xD;
      investigating dose finding, feasibility and safety of the combined treatment of HDM201 and&#xD;
      midostaurin in patients with relapsed/refractory acute myeloid leukemia (AML) with FLT3mut&#xD;
      applying an accelerated titration design.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background and Rationale:&#xD;
&#xD;
      Acute myeloid leukemia (AML) is a clonal hematopoietic malignant disease characterized by&#xD;
      genetic and epigenetic alterations leading to inactivation of the tumor suppressor p53. This&#xD;
      contributes to a block in normal differentiation of the various blood type lineages and to an&#xD;
      accumulation of leukemic blasts in the blood and bone marrow. The disease variants have been&#xD;
      grouped into favorable, intermediate and poor risk categories. The largest group of poor risk&#xD;
      AML is characterized by the genetic alterations of the FLT3 receptor gene termed FLT3-ITD or&#xD;
      FLT3-TKD. The prognosis for this specific subset which comprises 25-35% of all AML patients&#xD;
      is generally poor, particularly in elderly or in relapsed patients, highlighting the unmet&#xD;
      need for novel treatments.&#xD;
&#xD;
      Targeting the mutated FLT3 receptor is a promising approach to treat this specific poor risk&#xD;
      AML subset. Midostaurin is particularly effective to induce cell death in FLT3-ITD/-TKD and&#xD;
      TP53wt cells. Targeting MDM2 is a novel approach to restore the crucial p53 tumor suppressor&#xD;
      function in AML cells. Preliminary data indicate that the MDM2 inhibitor HDM201 is active in&#xD;
      AML cell lines in vitro and in vivo. Like midostaurin HDM201 is specifically effective to&#xD;
      induce cell death in FLT3-ITD and TP53wt cells. The combination of midostaurin and HDM201&#xD;
      targets FLT3-ITD AML cells, with little effect on FLT3 wt cells and healthy blood cells. Both&#xD;
      compounds induce apoptosis and cell death in a dose-dependent manner in FLT3-ITD TP53wt AML&#xD;
      cells, with enhanced effects in the combination treatment. The combination treatment with&#xD;
      midostaurin and HDM201 ought to be superior to the current best available treatment which&#xD;
      utilizes intensive genotoxic induction therapy. In order to confirm inhibition of mutated&#xD;
      FLT3 receptor and restoration of p53 tumor suppressor function, blood samples will be&#xD;
      analyzed in this trial before, during and after treatment with HDM201 and midostaurin for&#xD;
      changes in the expression of FLT3 and p53 target genes as well as induction of pro- apoptotic&#xD;
      genes. These gene expression levels will be correlated with clinical response and outcome.&#xD;
&#xD;
      Objectives:&#xD;
&#xD;
      Primary objective:&#xD;
&#xD;
      The primary objective of this trial is to establish the recommended dose for a subsequent&#xD;
      phase II (RP2D) of HDM201 in combination with midostaurin in patients with relapsed or&#xD;
      refractory FLT3mut TP53wt AML.&#xD;
&#xD;
      Secondary objectives:&#xD;
&#xD;
      The secondary objectives are to determine the safety and tolerability of HDM201 in&#xD;
      combination with midostaurin and to assess the preliminary antitumor activity of HDM201 in&#xD;
      combination with midostaurin in patients with relapsed or refractory FLT3mut TP53wt AML and&#xD;
      in newly diagnosed AML with FLT3mut and TP53wt.&#xD;
&#xD;
      Study Duration:&#xD;
&#xD;
      The trial study duration encompasses the time from when the first participant signs the&#xD;
      informed consent until the last protocol-specific procedure of the last patient in the trial&#xD;
      has been completed.&#xD;
&#xD;
      This phase I trial involves a minimum of 3 and a maximum of 24 subjects. Accordingly, the&#xD;
      Investigator anticipate a duration of recruitment of between 3 and 18 months.&#xD;
&#xD;
      All patients will be followed up for up to 12 months after end of treatment, adding to a&#xD;
      total study duration of between 15 and 33 months depending on the effective number of&#xD;
      patients in the various dose cohorts.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Insufficient recruitment&#xD;
  </why_stopped>
  <start_date type="Actual">July 13, 2020</start_date>
  <completion_date type="Actual">September 9, 2022</completion_date>
  <primary_completion_date type="Actual">September 9, 2022</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Non-randomized prospective open-label single-arm clinical phase I trial investigating dose finding, feasibility and safety of the combined treatment of HDM201 and midostaurin</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Dose finding</measure>
    <time_frame>30 days</time_frame>
    <description>to identify the incidence of dose limiting toxicities (DLT) at each dose level and to determine the maximum tolerated dose (MTD) of HDM201 and its recommended dose that will be used in a later phase II study (recommended phase II dose; RP2D) when added to midostaurin</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall response rate (ORR)</measure>
    <time_frame>60 days</time_frame>
    <description>CR, CRi, CRp, PR including assessment of minimal residual disease by molecular diagnostics and flowcytometry after cycles 1 and 2.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse Events</measure>
    <time_frame>33 months</time_frame>
    <description>Number of patients experiencing adverse events and severity of the adverse events</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression free survival</measure>
    <time_frame>33 months</time_frame>
    <description>Time from end of treatment (after bone marrow assessment after cycle 2) until progression of disease or death as a result of any cause.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>33 months</time_frame>
    <description>Time from end of treatment (after bone marrow assessment after cycle 2) until death as a result of any cause.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infectious complications of study treatment</measure>
    <time_frame>33 months</time_frame>
    <description>Assessment of the number of febrile episodes requiring antibiotic/antifungal treatment as well as assessment of identified causing germs.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">2</enrollment>
  <condition>AML, Adult</condition>
  <arm_group>
    <arm_group_label>Midostaurin with HDM201 dose escalation.</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Midostaurin 50mg bid d1-28 (morning, evening) and HDM201</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>HDM201</intervention_name>
    <description>Dose level 0: HDM201 40 mg QD d1,2 (midday)/ Dose level 1: HDM201 40 mg QD d1,2,3 (midday) = Starting dose/ Dose level 2: HDM201 40 mg QD d1,2,3,4,5 (midday)/ Dose level 3: HDM201 60 mg QD d1,2,3,4,5 (midday)/ Dose level 4: HDM201 80 mg QD d1,2,3,4,5 (midday)</description>
    <arm_group_label>Midostaurin with HDM201 dose escalation.</arm_group_label>
    <other_name>Dose finding</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Midostaurin</intervention_name>
    <description>Midostaurin 50mg bid d1-28 (morning, evening)</description>
    <arm_group_label>Midostaurin with HDM201 dose escalation.</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  AML with FLT3-ITD or FLT3-TKD and TP53wt.&#xD;
&#xD;
          -  Age over 18 years&#xD;
&#xD;
          -  Patient must give written informed consent before registration indicating that the&#xD;
             patient understands the purpose of the procedures required for the trial and is&#xD;
             willing to participate in the trial.&#xD;
&#xD;
          -  Patients with relapsed/refractory disease must have morphologic proof (from bone&#xD;
             marrow aspirate, smears or touch preps of bone marrow biopsy) of AML with &gt;= 10%&#xD;
             blasts within two weeks (14 days) prior to initiation of therapy.&#xD;
&#xD;
          -  Patients must demonstrate one of the following: Relapse after first complete remission&#xD;
             or refractory to conventional induction chemotherapy with or without Midostaurin&#xD;
             (failure to respond to 1 or more cycles of daunorubicin and cytarabine) or to&#xD;
             re-induction.&#xD;
&#xD;
          -  Patients with relapse after HSCT (non-preventive) and pretransplant treatment with&#xD;
             Midostaurin (FLT3-ITD or FLT3-TKD at diagnosis) or without Midostaurin (acquired FLT3&#xD;
             mutation).&#xD;
&#xD;
          -  Laboratory values that indicate adequate organ function assessed locally at the&#xD;
             screening visit:&#xD;
&#xD;
               -  AST ≤ 3 times ULN&#xD;
&#xD;
               -  Alanine aminotransferase (ALT) ≤ 3 times ULN&#xD;
&#xD;
               -  Serum total bilirubin ≤ 1.5 times ULN, unless in case of hyperbilirubinemia due&#xD;
                  to an isolated Gilbert syndrome&#xD;
&#xD;
               -  Estimated (by Cockcroft-Gault) creatinine clearance ≥ 30ml/min&#xD;
&#xD;
          -  ECOG score performance status 0-2.&#xD;
&#xD;
          -  Patients may have received therapy for other malignancies, as long as they have&#xD;
             completed therapy at least 6 months prior to study entry.&#xD;
&#xD;
          -  Subjects must have a life expectancy of 3 or more months.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  AML with FLT3wt or TP53mut&#xD;
&#xD;
          -  Ongoing adverse event drug-induced neuropathy of prior therapy grade ≥2 (according to&#xD;
             CTCAE criteria Version 5.0) at registration&#xD;
&#xD;
          -  Previous malignancy within 2 years with the exception of adequately treated in situ&#xD;
             cervical cancer or localized non-melanoma skin cancer.&#xD;
&#xD;
          -  Evidence of ongoing uncontrolled systemic infections.&#xD;
&#xD;
          -  Major surgery within 4 weeks prior to trial registration&#xD;
&#xD;
          -  Concurrent treatment with other experimental drugs or treatment in a clinical trial&#xD;
             within 30 days prior to trial registration.&#xD;
&#xD;
          -  Treatment with chemotherapy and radiotherapy within 3 weeks prior to trial&#xD;
             registration&#xD;
&#xD;
          -  Vaccinated with live, attenuated vaccines within 4 weeks prior to trial registration&#xD;
&#xD;
          -  History of stroke or intracranial hemorrhage within 6 months prior to trial&#xD;
             registration.&#xD;
&#xD;
          -  Clinically significant cardiovascular disease such as congestive heart failure NYHA&#xD;
             III or IV (as defined by the New York Heart Association Functional Classification),&#xD;
             uncontrolled or symptomatic arrhythmias, unstable angina pectoris, myocardial&#xD;
             infarction within 6 months of prior to registration&#xD;
&#xD;
          -  Prior solid organ transplantation&#xD;
&#xD;
          -  Any life-threatening illness, medical condition, or organ system dysfunction which, in&#xD;
             the investigator's opinion,&#xD;
&#xD;
               -  could impair the ability of the patient to participate in the trial&#xD;
&#xD;
               -  could compromise the patient's safety,&#xD;
&#xD;
               -  could interfere with the absorption or metabolism of midostaurin or HDM201,&#xD;
&#xD;
               -  could put the trial outcomes at undue risk,&#xD;
&#xD;
               -  could prevent compliance with trial treatment.&#xD;
&#xD;
          -  Psychiatric disorder precluding understanding of trial information, giving informed&#xD;
             consent, or interfering with compliance for oral drug intake.&#xD;
&#xD;
          -  Known hypersensitivity to trial drug(s) or hypersensitivity to any other component of&#xD;
             the trial drugs.&#xD;
&#xD;
          -  Any concomitant drugs contraindicated for use with the trial drugs according to the&#xD;
             approved product information.&#xD;
&#xD;
          -  Any psychological, familial, sociological or geographical condition potentially&#xD;
             hampering compliance with the trial protocol and follow-up.&#xD;
&#xD;
          -  Impairment of gastrointestinal (GI) function or GI disease that might alter&#xD;
             significantly the absorption of midostaurin and/or HDM201.&#xD;
&#xD;
          -  Known confirmed diagnosis of HIV infection or active viral hepatitis (testing is not&#xD;
             mandatory to exclude these viral infections).&#xD;
&#xD;
          -  Pregnant or nursing (lactating) women&#xD;
&#xD;
          -  Women of child-bearing potential, defined as all women physiologically capable of&#xD;
             becoming pregnant, unless they are using highly effective methods of contraception&#xD;
             during dosing and for at least 12 months after stopping medication. Highly effective&#xD;
             contraception methods include:&#xD;
&#xD;
               -  Total abstinence (when this is in line with the preferred and usual lifestyle of&#xD;
                  the subject). Periodic abstinence (e.g., calendar, ovulation, symptothermal,&#xD;
                  post-ovulation methods) and withdrawal are not acceptable methods of&#xD;
                  contraception&#xD;
&#xD;
               -  Female sterilization (have had surgical bilateral oophorectomy with or without&#xD;
                  hysterectomy), total hysterectomy, or tubal ligation at least six weeks before&#xD;
                  taking study treatment. In case of oophorectomy alone, only when the reproductive&#xD;
                  status of the woman has been confirmed by follow up hormone level assessment&#xD;
&#xD;
               -  Male sterilization (at least 12 months prior to screening). The vasectomized male&#xD;
                  partner should be the sole partner for that subject&#xD;
&#xD;
               -  Use of oral, injected or implanted hormonal methods of contraception or placement&#xD;
                  of an intrauterine device (IUD) or intrauterine system (IUS), or other forms of&#xD;
                  hormonal contraception that have comparable efficacy (failure rate &lt;1%), for&#xD;
                  example hormone vaginal ring or transdermal hormone contraception.&#xD;
&#xD;
               -  Midostaurin may reduce the effectiveness of hormonal contraceptives; therefore,&#xD;
                  females using systemically active hormonal contraceptives should add a barrier&#xD;
                  method of contraception.&#xD;
&#xD;
        Women are considered post-menopausal and not of child bearing potential if they have had 2&#xD;
        years of natural (spontaneous) amenorrhea with an appropriate clinical profile (i.e., age&#xD;
        appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy&#xD;
        (with or without hysterectomy), total hysterectomy, or tubal ligation at least six weeks&#xD;
        ago. In the case of oophorectomy alone, only when the reproductive status of the woman has&#xD;
        been confirmed by follow up hormone level assessment is she considered not of child bearing&#xD;
        potential.&#xD;
&#xD;
          -  Sexually active males unless they use a condom during intercourse while taking the&#xD;
             drug during treatment, and for at least 12 months after stopping treatment and should&#xD;
             not father a child in this period. A condom is required to be used also by&#xD;
             vasectomized men as well as during intercourse with a male partner in order to prevent&#xD;
             delivery of the drug via semen.&#xD;
&#xD;
          -  Unwillingness or inability to comply with the protocol.&#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>Thomas Pabst, Prof</last_name>
    <role>Study Chair</role>
    <affiliation>Department of Medical Oncology, University Hospital Bern Switzerland</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Departement of Medical Oncology, University Hospital Berne</name>
      <address>
        <city>Berne</city>
        <zip>3010</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>July 29, 2020</study_first_submitted>
  <study_first_submitted_qc>July 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 4, 2020</study_first_posted>
  <last_update_submitted>October 3, 2022</last_update_submitted>
  <last_update_submitted_qc>October 3, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 6, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>AML with FLT3-ITD or FLT3-TKD and TP53wt</keyword>
  <keyword>relapsed/refractory AML</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Midostaurin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</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/NCT04496999
org study id: HDMM
nct id: NCT04496999
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a non-randomized prospective open-label single-arm clinical phase I trial
      investigating dose finding, feasibility and safety of the combined treatment of HDM201 and
      midostaurin in patients with relapsed/refractory acute myeloid leukemia (AML) with FLT3mut
      applying an accelerated titration design.
Background and Rationale:

      Acute myeloid leukemia (AML) is a clonal hematopoietic malignant disease characterized by
      genetic and epigenetic alterations leading to inactivation of the tumor suppressor p53. This
      contributes to a block in normal differentiation of the various blood type lineages and to an
      accumulation of leukemic blasts in the blood and bone marrow. The disease variants have been
      grouped into favorable, intermediate and poor risk categories. The largest group of poor risk
      AML is characterized by the genetic alterations of the FLT3 receptor gene termed FLT3-ITD or
      FLT3-TKD. The prognosis for this specific subset which comprises 25-35% of all AML patients
      is generally poor, particularly in elderly or in relapsed patients, highlighting the unmet
      need for novel treatments.

      Targeting the mutated FLT3 receptor is a promising approach to treat this specific poor risk
      AML subset. Midostaurin is particularly effective to induce cell death in FLT3-ITD/-TKD and
      TP53wt cells. Targeting MDM2 is a novel approach to restore the crucial p53 tumor suppressor
      function in AML cells. Preliminary data indicate that the MDM2 inhibitor HDM201 is active in
      AML cell lines in vitro and in vivo. Like midostaurin HDM201 is specifically effective to
      induce cell death in FLT3-ITD and TP53wt cells. The combination of midostaurin and HDM201
      targets FLT3-ITD AML cells, with little effect on FLT3 wt cells and healthy blood cells. Both
      compounds induce apoptosis and cell death in a dose-dependent manner in FLT3-ITD TP53wt AML
      cells, with enhanced effects in the combination treatment. The combination treatment with
      midostaurin and HDM201 ought to be superior to the current best available treatment which
      utilizes intensive genotoxic induction therapy. In order to confirm inhibition of mutated
      FLT3 receptor and restoration of p53 tumor suppressor function, blood samples will be
      analyzed in this trial before, during and after treatment with HDM201 and midostaurin for
      changes in the expression of FLT3 and p53 target genes as well as induction of pro- apoptotic
      genes. These gene expression levels will be correlated with clinical response and outcome.

      Objectives:

      Primary objective:

      The primary objective of this trial is to establish the recommended dose for a subsequent
      phase II (RP2D) of HDM201 in combination with midostaurin in patients with relapsed or
      refractory FLT3mut TP53wt AML.

      Secondary objectives:

      The secondary objectives are to determine the safety and tolerability of HDM201 in
      combination with midostaurin and to assess the preliminary antitumor activity of HDM201 in
      combination with midostaurin in patients with relapsed or refractory FLT3mut TP53wt AML and
      in newly diagnosed AML with FLT3mut and TP53wt.

      Study Duration:

      The trial study duration encompasses the time from when the first participant signs the
      informed consent until the last protocol-specific procedure of the last patient in the trial
      has been completed.

      This phase I trial involves a minimum of 3 and a maximum of 24 subjects. Accordingly, the
      Investigator anticipate a duration of recruitment of between 3 and 18 months.

      All patients will be followed up for up to 12 months after end of treatment, adding to a
      total study duration of between 15 and 33 months depending on the effective number of
      patients in the various dose cohorts.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Non-randomized prospective open-label single-arm clinical phase I trial investigating dose finding, feasibility and safety of the combined treatment of HDM201 and midostaurin
primary purpose: Treatment
masking: None (Open Label)
measure: Dose finding
time frame: 30 days
description: to identify the incidence of dose limiting toxicities (DLT) at each dose level and to determine the maximum tolerated dose (MTD) of HDM201 and its recommended dose that will be used in a later phase II study (recommended phase II dose; RP2D) when added to midostaurin
measure: Overall response rate (ORR)
time frame: 60 days
description: CR, CRi, CRp, PR including assessment of minimal residual disease by molecular diagnostics and flowcytometry after cycles 1 and 2.
measure: Adverse Events
time frame: 33 months
description: Number of patients experiencing adverse events and severity of the adverse events
measure: Progression free survival
time frame: 33 months
description: Time from end of treatment (after bone marrow assessment after cycle 2) until progression of disease or death as a result of any cause.
measure: Overall survival
time frame: 33 months
description: Time from end of treatment (after bone marrow assessment after cycle 2) until death as a result of any cause.
measure: Infectious complications of study treatment
time frame: 33 months
description: Assessment of the number of febrile episodes requiring antibiotic/antifungal treatment as well as assessment of identified causing germs.
arm group label: Midostaurin with HDM201 dose escalation.
arm group type: Experimental
description: Midostaurin 50mg bid d1-28 (morning, evening) and HDM201
intervention type: Drug
intervention name: HDM201
description: Dose level 0: HDM201 40 mg QD d1,2 (midday)/ Dose level 1: HDM201 40 mg QD d1,2,3 (midday) = Starting dose/ Dose level 2: HDM201 40 mg QD d1,2,3,4,5 (midday)/ Dose level 3: HDM201 60 mg QD d1,2,3,4,5 (midday)/ Dose level 4: HDM201 80 mg QD d1,2,3,4,5 (midday)
arm group label: Midostaurin with HDM201 dose escalation.
other name: Dose finding
intervention type: Drug
intervention name: Midostaurin
description: Midostaurin 50mg bid d1-28 (morning, evening)
arm group label: Midostaurin with HDM201 dose escalation.
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Thomas Pabst, Prof
role: Study Chair
affiliation: Department of Medical Oncology, University Hospital Bern Switzerland
facility: 
country: Switzerland
responsible party type: Sponsor
mesh term: Midostaurin
sharing ipd: Yes