<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/NCT03755154</url>
  </required_header>
  <id_info>
    <org_study_id>CL1-65487-002</org_study_id>
    <secondary_id>2018-004170-97</secondary_id>
    <nct_id>NCT03755154</nct_id>
  </id_info>
  <brief_title>Study of a New Intravenous Drug, Called S65487, in Patients With Acute Myeloid Leukemia, Non Hodgkin Lymphoma, Multiple Myeloma or Chronic Lymphocytic Leukemia</brief_title>
  <official_title>Phase I, Open Label, Non-randomised, Non-comparative, Multi-center Study, Evaluating S65487, a Bcl-2 Inhibitor Intravenously Administered, in Patients With Relapsed or Refractory Acute Myeloid Leukemia, Non Hodgkin Lymphoma, Multiple Myeloma or Chronic Lymphocytic Leukemia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institut de Recherches Internationales Servier</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>ADIR, a Servier Group company</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Servier</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 first in human study is to assess safety, tolerability, Pharmacokinetic&#xD;
      (PK) and preliminary clinical activity and to estimate the Maximum Tolerated Doses (MTD(s))/&#xD;
      Recommended Phase 2 Doses (RP2D(s)) of S65487 as single agent administered intravenously&#xD;
      (i.v.) in adult patients with refractory or relapsed Acute Myeloid Leukemia (AML),&#xD;
      Non-Hodgkin Lymphoma (NHL), Multiple Myeloma (MM) or Chronic Lymphocytic Leukemia (CLL).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is designed in two parts: one part for dose escalation, one part for dose&#xD;
      expansion.The dose escalation part will be followed by expansion part at the MTD(s)/RP2D(s)&#xD;
&#xD;
      This study will utilize an adaptative Bayesian Logistic Regression model to guide dose&#xD;
      escalation and estimate the MTD(s) based on the Dose Limiting Toxicity (DLT) relationship(s)&#xD;
      for S65487 in the indications.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">July 17, 2019</start_date>
  <completion_date type="Anticipated">July 10, 2023</completion_date>
  <primary_completion_date type="Anticipated">July 10, 2023</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 Toxicity (DLT)</measure>
    <time_frame>until the end of the first cycle (each cycle is 21days)</time_frame>
    <description>Safety criterion</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence and severity of Adverse Events</measure>
    <time_frame>through study completion an average of 6 months</time_frame>
    <description>Safety and tolerability criteria</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence and severity of Serious Adverse Events</measure>
    <time_frame>through study completion an average of 6 months</time_frame>
    <description>Safety and tolerability criteria</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants with dose reductions</measure>
    <time_frame>through study completion an average of 6 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants with dose interruptions</measure>
    <time_frame>through study completion an average of 6 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Dose intensity</measure>
    <time_frame>through study completion an average of 6 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>The pharmacokinetic (PK) profile of S65487: Area Under the Curve (AUC)</measure>
    <time_frame>Cycle 1 Day 1, Cycle 1 Day 2, Cycle 1 Day 3 (alternative schedule only), Cyle 1 Day 5 (alternative schedule only), Cycle 1 Day 8, Cycle 1 Day 9, Day 1 of next cycles (one cycle is 21 days)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PK profile of S65487: Volume of distribution at steady-state (Vss)</measure>
    <time_frame>Cycle 1 Day 1, Cycle 1 Day 2, Cycle 1 Day 3 (alternative schedule only), Cyle 1 Day 5 (alternative schedule only), Cycle 1 Day 8, Cycle 1 Day 9, Day 1 of next cycles (one cycle is 21 days)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PK profile of S65487: total CLearance (CL)</measure>
    <time_frame>Cycle 1 Day 1, Cycle 1 Day 2, Cycle 1 Day 3 (alternative schedule only), Cyle 1 Day 5 (alternative schedule only), Cycle 1 Day 8, Cycle 1 Day 9, Day 1 of next cycles (one cycle is 21 days)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PK profile of S65487: terminal half-life (t½z)</measure>
    <time_frame>Cycle 1 Day 1, Cycle 1 Day 2, Cycle 1 Day 3 (alternative schedule only), Cyle 1 Day 5 (alternative schedule only), Cycle 1 Day 8, Cycle 1 Day 9, Day 1 of next cycles (one cycle is 21 days)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Best Overall Response (BOR)</measure>
    <time_frame>Through study completion, an average of 6 months</time_frame>
    <description>Best Response observed during the treatment period</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Response Rate (ORR)</measure>
    <time_frame>Through study completion, an average of 6 months</time_frame>
    <description>Proportion of patients in whom a complete response (CR) or a partial response (PR)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Relapsed or Refractory Acute Myeloid Leukemia</condition>
  <condition>Relapsed or Refractory Non-Hodgkin Lymphoma</condition>
  <condition>Relapsed or Refractory Multiple Myeloma</condition>
  <condition>Relapsed or Refractory Chronic Lymphocytic Leukemia</condition>
  <arm_group>
    <arm_group_label>S65487 - initial scheme</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>S65487 - alternative scheme</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>S65487- initial scheme</intervention_name>
    <description>S65487 is administered as single agent via i.v. infusion once a week on a 3-week cycle.</description>
    <arm_group_label>S65487 - initial scheme</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>S65487 - alternative scheme</intervention_name>
    <description>S65487 is administered in 3 to 5 i.v. infusions the first week of each cycle then once a week on the rest of the 3-week cycle.</description>
    <arm_group_label>S65487 - alternative scheme</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with cytologically confirmed and documented de novo, secondary or&#xD;
             therapy-related AML, excluding acute promyelocytic leukaemia with relapsed or&#xD;
             refractory disease without established alternative therapy. Or patients with&#xD;
             measurable confirmed Multiple Myeloma (IMWG) with relapsed or refractory disease who&#xD;
             have previously received at least three lines of treatment and without established&#xD;
             alternative therapy. Or patients with histologically and measurable confirmed Non&#xD;
             Hodgkin Lymphoma defined as Diffuse Large B cell Lymphoma (DLBCL), Follicular Lymphoma&#xD;
             (FL), Mantle Cell Lymphoma (MCL), Marginal Zone Lymphoma (MZL), High-Grade B cell&#xD;
             Lymphoma with relapsed or refractory disease who have received at least two lines of&#xD;
             therapy (including rituximab) and without established alternative therapy. Or patients&#xD;
             with Chronic Lymphocytic Leukemia (CLL) who have relapsed or are refractory (except&#xD;
             treatment failure), as defined per iwCLL, from venetoclax treatment and without&#xD;
             established alternative therapy.&#xD;
&#xD;
          -  ECOG (Eastern Cooperative Oncology Group) performance status ≤ 2.&#xD;
&#xD;
          -  For NHL, MM patients and CLL patients: haematological function (independent of any&#xD;
             growth factor support) based on the last assessment performed before inclusion,&#xD;
             defined as: absolute neutrophil count (ANC) ≥ 1 x 109/L, haemoglobin ≥ 8 g/dL,&#xD;
             platelet count ≥ 50 x 109/L for NHL and MM patients, platelet count ≥ 30 x 109/L for&#xD;
             CLL patients.&#xD;
&#xD;
          -  For AML patients: circulating Blood White Cell count (WBC count) &lt; 25 x 109/L (with or&#xD;
             without use of hydroxycarbamide/leukapheresis) based on the last assessment performed&#xD;
             before inclusion.&#xD;
&#xD;
          -  Adequate renal function based on the last assessment performed before inclusion,&#xD;
             assessed as Glomerular Filtration Rate (GFR) using Modification of Diet in Renal&#xD;
             Disease (MDRD) Formula.&#xD;
&#xD;
          -  Adequate hepatic function based on the last assessment performed before inclusion.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy, breastfeeding or possibility of becoming pregnant during the study.&#xD;
&#xD;
          -  Participation in another interventional study at the same time or another&#xD;
             interventional study requiring investigational treatment intake within 3 weeks or at&#xD;
             least 5 half-lives (whichever is longer) prior to the first S65487 administration.&#xD;
&#xD;
          -  Participant already enrolled in the study (informed consent signed) and has received&#xD;
             at least one dose of S65487.&#xD;
&#xD;
          -  Patients who have not recovered from toxicity of previous anticancer therapy,&#xD;
             including grade ≥ 2 non-hematologic toxicity, prior to the first IMP administration&#xD;
             (including peripheral neurotoxicity). Certain toxicities will not be considered in&#xD;
             this category (e.g. alopecia).&#xD;
&#xD;
          -  Patients refractory to a previous treatment with a Bcl-2 inhibitor.&#xD;
&#xD;
          -  For AML patients : Allogenic stem cell transplant within 3 months before the first IMP&#xD;
             administration and/or patients who still receive immunosuppressive treatment within 3&#xD;
             months before the first IMP administration and/or patients with active&#xD;
             Graft-versus-host disease within 3 months before the first IMP administration and/or&#xD;
             patient who receive donor lymphocyte infusion (DLI) within 3 months before the first&#xD;
             IMP administration.&#xD;
&#xD;
          -  For NHL, MM and CLL patients : Prior allogenic stem cell transplant before the first&#xD;
             IMP administration and/or Autologous stem cell transplant within 3 months before the&#xD;
             first IMP administration.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>The Alfred Hospital Malignant Haematology &amp; Stem Cell Transplantation Services</name>
      <address>
        <city>Melbourne</city>
        <state>Victoria</state>
        <zip>3004</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire Régionale de Lille Hôpital Huriez</name>
      <address>
        <city>Lille</city>
        <zip>59037</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Nantes Hôtel Dieu</name>
      <address>
        <city>Nantes</city>
        <zip>44093</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Nice - Hôpital l'Archet 1 Hématologie clinique</name>
      <address>
        <city>Nice</city>
        <zip>06200</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinica Universidad de Navarra</name>
      <address>
        <city>Madrid</city>
        <zip>28027</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clínica Universidad Navarra- Servicio de Hematología</name>
      <address>
        <city>Pamplona</city>
        <zip>31008</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clínico Universitario de Salamanca- Servicio de Hematología (4a planta)</name>
      <address>
        <city>Salamanca</city>
        <zip>37007</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario La Fe - Servicio de Hematología - Torre F - Planta 7</name>
      <address>
        <city>Valencia</city>
        <zip>46026</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>King's College Hospital NHS Foundation Trust</name>
      <address>
        <city>London</city>
        <zip>SE5 9RS</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Christie NHS foundation Trust</name>
      <address>
        <city>Manchester</city>
        <zip>M20 4BX</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Freeman Hospital</name>
      <address>
        <city>Newcastle</city>
        <zip>NE7 7DN</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>France</country>
    <country>Spain</country>
    <country>United Kingdom</country>
  </location_countries>
  <link>
    <url>https://clinicaltrials.servier.com/</url>
    <description>Find Results on Servier Clinical Trial Data website</description>
  </link>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>November 13, 2018</study_first_submitted>
  <study_first_submitted_qc>November 26, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 27, 2018</study_first_posted>
  <last_update_submitted>April 11, 2023</last_update_submitted>
  <last_update_submitted_qc>April 11, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 12, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Leukemia</keyword>
  <keyword>Lymphoma</keyword>
  <keyword>Myeloma</keyword>
  <keyword>Dose-escalation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lymphoma</mesh_term>
    <mesh_term>Leukemia</mesh_term>
    <mesh_term>Leukemia, Myeloid</mesh_term>
    <mesh_term>Multiple Myeloma</mesh_term>
    <mesh_term>Neoplasms, Plasma Cell</mesh_term>
    <mesh_term>Leukemia, Myeloid, Acute</mesh_term>
    <mesh_term>Lymphoma, Non-Hodgkin</mesh_term>
    <mesh_term>Leukemia, Lymphoid</mesh_term>
    <mesh_term>Leukemia, Lymphocytic, Chronic, B-Cell</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Qualified scientific and medical researchers can request access to anonymized patient-level and study-level clinical trial data.&#xD;
Access can be requested for all interventional clinical studies:&#xD;
used for Marketing Authorization (MA) of medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US).&#xD;
where Servier is the Marketing Authorization Holder (MAH). The date of the first MA of the new medicine (or the new indication) in one of the EEA Member States will be considered for this scope.&#xD;
In addition, access can be requested for all interventional clinical studies in patients:&#xD;
sponsored by Servier&#xD;
with a first patient enrolled as of 1 January 2004 onwards&#xD;
for New Chemical Entity or New Biological Entity (new pharmaceutical form excluded) for which development has been terminated before any Marketing authorization (MA) approval.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>After Marketing Authorisation in EEA or US if the study is used for the approval.</ipd_time_frame>
    <ipd_access_criteria>Researchers should register on Servier Data Portal and fill in the research proposal form. This form in four parts should be fully documented. The Research Proposal Form will not be reviewed until all mandatory fields are completed.</ipd_access_criteria>
    <ipd_url>https://clinicaltrials.servier.com/</ipd_url>
  </patient_data>
  <study_docs>
    <study_doc>
      <doc_type>Individual Participant Data Set</doc_type>
      <doc_url>https://clinicaltrials.servier.com/</doc_url>
    </study_doc>
    <study_doc>
      <doc_type>Study Protocol</doc_type>
      <doc_url>https://clinicaltrials.servier.com/</doc_url>
    </study_doc>
    <study_doc>
      <doc_type>Statistical Analysis Plan</doc_type>
      <doc_url>https://clinicaltrials.servier.com/</doc_url>
    </study_doc>
    <study_doc>
      <doc_type>Informed Consent Form</doc_type>
      <doc_url>https://clinicaltrials.servier.com/</doc_url>
    </study_doc>
    <study_doc>
      <doc_type>Clinical Study Report</doc_type>
      <doc_url>https://clinicaltrials.servier.com/</doc_url>
    </study_doc>
    <study_doc>
      <doc_type>Study-level clinical trial data</doc_type>
      <doc_url>https://clinicaltrials.servier.com/</doc_url>
    </study_doc>
  </study_docs>
  <!-- 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/NCT03755154
org study id: CL1-65487-002
secondary id: 2018-004170-97
nct id: NCT03755154
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this first in human study is to assess safety, tolerability, Pharmacokinetic
      (PK) and preliminary clinical activity and to estimate the Maximum Tolerated Doses (MTD(s))/
      Recommended Phase 2 Doses (RP2D(s)) of S65487 as single agent administered intravenously
      (i.v.) in adult patients with refractory or relapsed Acute Myeloid Leukemia (AML),
      Non-Hodgkin Lymphoma (NHL), Multiple Myeloma (MM) or Chronic Lymphocytic Leukemia (CLL).
This study is designed in two parts: one part for dose escalation, one part for dose
      expansion.The dose escalation part will be followed by expansion part at the MTD(s)/RP2D(s)

      This study will utilize an adaptative Bayesian Logistic Regression model to guide dose
      escalation and estimate the MTD(s) based on the Dose Limiting Toxicity (DLT) relationship(s)
      for S65487 in the indications.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Incidence of Dose Limiting Toxicity (DLT)
time frame: until the end of the first cycle (each cycle is 21days)
description: Safety criterion
measure: Incidence and severity of Adverse Events
time frame: through study completion an average of 6 months
description: Safety and tolerability criteria
measure: Incidence and severity of Serious Adverse Events
time frame: through study completion an average of 6 months
description: Safety and tolerability criteria
measure: Number of participants with dose reductions
time frame: through study completion an average of 6 months
measure: Number of participants with dose interruptions
time frame: through study completion an average of 6 months
measure: Dose intensity
time frame: through study completion an average of 6 months
measure: The pharmacokinetic (PK) profile of S65487: Area Under the Curve (AUC)
time frame: Cycle 1 Day 1, Cycle 1 Day 2, Cycle 1 Day 3 (alternative schedule only), Cyle 1 Day 5 (alternative schedule only), Cycle 1 Day 8, Cycle 1 Day 9, Day 1 of next cycles (one cycle is 21 days)
measure: PK profile of S65487: Volume of distribution at steady-state (Vss)
time frame: Cycle 1 Day 1, Cycle 1 Day 2, Cycle 1 Day 3 (alternative schedule only), Cyle 1 Day 5 (alternative schedule only), Cycle 1 Day 8, Cycle 1 Day 9, Day 1 of next cycles (one cycle is 21 days)
measure: PK profile of S65487: total CLearance (CL)
time frame: Cycle 1 Day 1, Cycle 1 Day 2, Cycle 1 Day 3 (alternative schedule only), Cyle 1 Day 5 (alternative schedule only), Cycle 1 Day 8, Cycle 1 Day 9, Day 1 of next cycles (one cycle is 21 days)
measure: PK profile of S65487: terminal half-life (t½z)
time frame: Cycle 1 Day 1, Cycle 1 Day 2, Cycle 1 Day 3 (alternative schedule only), Cyle 1 Day 5 (alternative schedule only), Cycle 1 Day 8, Cycle 1 Day 9, Day 1 of next cycles (one cycle is 21 days)
measure: Best Overall Response (BOR)
time frame: Through study completion, an average of 6 months
description: Best Response observed during the treatment period
measure: Overall Response Rate (ORR)
time frame: Through study completion, an average of 6 months
description: Proportion of patients in whom a complete response (CR) or a partial response (PR)
arm group label: S65487 - initial scheme
arm group type: Experimental
arm group label: S65487 - alternative scheme
arm group type: Experimental
intervention type: Drug
intervention name: S65487- initial scheme
description: S65487 is administered as single agent via i.v. infusion once a week on a 3-week cycle.
arm group label: S65487 - initial scheme
intervention type: Drug
intervention name: S65487 - alternative scheme
description: S65487 is administered in 3 to 5 i.v. infusions the first week of each cycle then once a week on the rest of the 3-week cycle.
arm group label: S65487 - alternative scheme
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Australia
country: France
country: Spain
country: United Kingdom
url: https://clinicaltrials.servier.com/
description: Find Results on Servier Clinical Trial Data website
responsible party type: Sponsor
mesh term: Lymphoma
mesh term: Leukemia
mesh term: Leukemia, Myeloid
mesh term: Multiple Myeloma
mesh term: Neoplasms, Plasma Cell
mesh term: Leukemia, Myeloid, Acute
mesh term: Lymphoma, Non-Hodgkin
mesh term: Leukemia, Lymphoid
mesh term: Leukemia, Lymphocytic, Chronic, B-Cell
sharing ipd: Yes
ipd description: Qualified scientific and medical researchers can request access to anonymized patient-level and study-level clinical trial data.
Access can be requested for all interventional clinical studies:
used for Marketing Authorization (MA) of medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US).
where Servier is the Marketing Authorization Holder (MAH). The date of the first MA of the new medicine (or the new indication) in one of the EEA Member States will be considered for this scope.
In addition, access can be requested for all interventional clinical studies in patients:
sponsored by Servier
with a first patient enrolled as of 1 January 2004 onwards
for New Chemical Entity or New Biological Entity (new pharmaceutical form excluded) for which development has been terminated before any Marketing authorization (MA) approval.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd time frame: After Marketing Authorisation in EEA or US if the study is used for the approval.
ipd access criteria: Researchers should register on Servier Data Portal and fill in the research proposal form. This form in four parts should be fully documented. The Research Proposal Form will not be reviewed until all mandatory fields are completed.
ipd url: https://clinicaltrials.servier.com/
study doc: 
study doc: 
study doc: 
study doc: 
study doc: 
study doc: 