<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/NCT01708993</url>
  </required_header>
  <id_info>
    <org_study_id>I211</org_study_id>
    <nct_id>NCT01708993</nct_id>
  </id_info>
  <brief_title>Reolysin in Previously Treated Advanced/Metastatic, Non Small Cell Lung Cancer Receiving Standard Salvage Therapy</brief_title>
  <official_title>A Randomized Phase II Study of Reolysin in Patients With Previously Treated Advanced or Metastatic, Non Small Cell Lung Cancer Receiving Standard Salvage Therapy.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Canadian Cancer Trials Group</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Oncolytics Biotech</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Canadian Cancer Trials Group</source>
  <oversight_info>
    <has_dmc>Yes</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 study is to find out if giving reolysin in combination with docetaxel or&#xD;
      pemetrexed can offer better results than standard therapy with docetaxel or pemetrexed alone.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Reolysin is a virus which has been shown to target and destroy cancer cells in laboratory&#xD;
      tests. Reolysin has been studied in over 360 cancer patients to find safe doses that can be&#xD;
      given and has also undergone testing in combination with docetaxel.&#xD;
&#xD;
      Docetaxel and pemetrexed have anticancer activity in certain cancers including lung and they&#xD;
      have been approved by Health Canada for the treatment of patients with advanced or metastatic&#xD;
      non-small cell lung cancer.&#xD;
&#xD;
      Researchers doing this study also want to evaluate the side effects of reolysin when given&#xD;
      together with docetaxel or pemetrexed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 10, 2012</start_date>
  <completion_date type="Actual">September 26, 2018</completion_date>
  <primary_completion_date type="Actual">January 26, 2016</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Progression free survival</measure>
    <time_frame>30 months</time_frame>
    <description>Evaluation of the effect of reolysin in combination with standard salvage chemotherapy on the progression free survival of patients with advanced or metastatic NSCLC. Response and progression will be evaluated in this study using the revised international criteria (1.1) proposed by the RECIST (Response Evaluation Criteria in Solid Tumours) committee</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of patients with adverse events</measure>
    <time_frame>30 months</time_frame>
    <description>To determine the tolerability and toxicity of reolysin and standard salvage chemotherapy when given in combination.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Response rates</measure>
    <time_frame>30 months</time_frame>
    <description>To investigate additional potential measures of efficacy including:&#xD;
Progression rates at 3 months&#xD;
Objective response rate&#xD;
Overall survival (OS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Explore potential molecular factors predictive of response</measure>
    <time_frame>30 months</time_frame>
    <description>Exploration of potential molecular factors predictive of response by assessment of archival tumour tissue and serial blood samples.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">166</enrollment>
  <condition>Non Small Cell Lung Cancer</condition>
  <arm_group>
    <arm_group_label>Arm A: Pemetrexed and Reolysin (and safety run-in)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm B: Pemetrexed</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm C: Docetaxel and Reolysin (and safety run-in)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm D: Docetaxel</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pemetrexed and Reolysin (and safety run-in)</intervention_name>
    <description>Pemetrexed: 500 mg/m², IV (10 min) - Day 1 every 3 weeks Reolysin: 4.5 x 10^10 TCID50 IV (1 hour) - Days 1-3, every 3 weeks</description>
    <arm_group_label>Arm A: Pemetrexed and Reolysin (and safety run-in)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pemetrexed</intervention_name>
    <description>Pemetrexed: 500 mg/m² IV (10 min) - Day 1 every 3 weeks</description>
    <arm_group_label>Arm B: Pemetrexed</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Docetaxel and Reolysin</intervention_name>
    <description>Docetaxel: 75 mg/m² IV (1 hour) - Day 1 every 3 weeks Reolysin: 4.5x10^10 TCID50 IV (1 hour) - Days 1-3, every 3 weeks</description>
    <arm_group_label>Arm C: Docetaxel and Reolysin (and safety run-in)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Docetaxel</intervention_name>
    <description>Docetaxel: 75 mg/m² IV (1 hour) - Day 1 every 3 weeks</description>
    <arm_group_label>Arm D: Docetaxel</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients must have histologically or cytologically confirmed diagnosis of non-small&#xD;
             cell lung cancer (NSCLC). As treatment arm is assigned based on histology subtype, it&#xD;
             must be feasible to subtype into squamous or other.&#xD;
&#xD;
          -  All patients must have a formalin fixed paraffin embedded tissue block (from primary&#xD;
             or metastatic tumour) available for translational studies and must have provided&#xD;
             informed consent for the release of the block as well as for blood samples for&#xD;
             correlative studies.&#xD;
&#xD;
          -  Presence of clinically and/or radiologically documented disease. At least one site of&#xD;
             disease must be unidimensionally measurable as follows:&#xD;
&#xD;
               -  Chest X-ray ≥ 20 mm&#xD;
&#xD;
               -  CT/MRI scan (with slice thickness of &lt; 5 mm) ≥ 10 mm --&gt; longest diameter&#xD;
&#xD;
               -  Physical exam (using calipers) ≥ 10 mm&#xD;
&#xD;
               -  Lymph nodes by CT scan ≥ 15 mm --&gt; measured in short axis All radiology studies&#xD;
                  must be performed within 28 days prior to randomization (within 35 days if&#xD;
                  negative).&#xD;
&#xD;
          -  Patients must have advanced and or metastatic disease, for which no curative therapy&#xD;
             exists and for which systemic therapy is indicated.&#xD;
&#xD;
          -  ECOG performance of 0 or 1.&#xD;
&#xD;
          -  Age ≥ 18 years.&#xD;
&#xD;
        Surgery: Previous major surgery is permitted provided that it has been at least 14 days&#xD;
        prior to patient randomization and that wound healing has occurred.&#xD;
&#xD;
        Chemotherapy: Patients must have received one regimen of palliative first line chemotherapy&#xD;
        (must be platinum containing combination unless patient's age &gt; 70 years) which may not&#xD;
        have contained docetaxel. Patients who have had concurrent platinum based chemoradiotherapy&#xD;
        for stage three disease and have relapsed within one year of treatment, or patients who&#xD;
        have had platinum based adjuvant chemotherapy after complete surgical resection and have&#xD;
        relapsed within one year of treatment, may be considered to have had one prior platinum&#xD;
        containing regimen.&#xD;
&#xD;
        Prior paclitaxel is permissible. Patients who have had prior pemetrexed for first line&#xD;
        therapy will be randomized to Treatment Arm C or D (docetaxel ± reolysin). Prior&#xD;
        maintenance therapy with pemetrexed is not permitted. Prior adjuvant chemotherapy is&#xD;
        permissible providing completed at least 1 year prior to relapse/recurrence of disease and&#xD;
        the patient has received one regimen of palliative first line chemotherapy as described&#xD;
        above.&#xD;
&#xD;
        Other Therapy: Patients may have received other therapies including immunotherapy, or with&#xD;
        signal transduction inhibitors, including EGFR inhibitors.&#xD;
&#xD;
        Radiation: Prior external beam radiation is permitted provided a minimum of 4 weeks has&#xD;
        elapsed between the last dose and enrollment to the trial. Exceptions may be made for low&#xD;
        dose, non-myelosuppressive radiotherapy.&#xD;
&#xD;
          -  Laboratory Requirements (must be done within 7 days prior to randomization)&#xD;
&#xD;
               -  Hematology:&#xD;
&#xD;
               -  Neutrophils ≥ 1.5 x 10^9/L&#xD;
&#xD;
               -  Platelets ≥ 100 x 10^9/L&#xD;
&#xD;
               -  Biochemistry:&#xD;
&#xD;
               -  Serum creatinine ≤ 1.5 x ULN (For patients enrolled to a pemetrexed arm, the&#xD;
                  creatinine clearance must also be &gt;45 ml/min)&#xD;
&#xD;
               -  Total bilirubin ≤ 1.0 x ULN (unless elevated secondary to conditions such as&#xD;
                  Gilbert's disease)&#xD;
&#xD;
               -  ALT and AST ≤ 1.5 x ULN (≤ 3x ULN is permitted in the presence of known liver&#xD;
                  metastases)&#xD;
&#xD;
               -  Proteinuria &lt;2g/24hrs (screen using spot testing; if ≥ grade 2 repeat with&#xD;
                  mid-stream urine; if still ≥ grade 2 then uring collection for 24 hours to&#xD;
                  confirm &lt;2g/24hrs).&#xD;
&#xD;
          -  Patient consent must be appropriately obtained in accordance with applicable local and&#xD;
             regulatory requirements. Each patient must sign a consent form prior to enrollment in&#xD;
             the trial to document their willingness to participate.&#xD;
&#xD;
        Patients who cannot give informed consent (i.e. mentally incompetent patients, or those&#xD;
        physically incapacitated such as comatose patients) are not to be recruited into the study.&#xD;
        Patients competent but physically unable to sign the consent form may have the document&#xD;
        signed by their nearest relative or legal guardian. Each patient will be provided with a&#xD;
        full explanation of the study before consent is requested.&#xD;
&#xD;
          -  Patients must be accessible for treatment and follow-up. Patients registered on this&#xD;
             trial must be treated and followed at the participating centre. This implies there&#xD;
             must be reasonable geographical limits (for example: 2 hour's driving distance) placed&#xD;
             on patients being considered for this trial. Investigators must assure themselves that&#xD;
             the patients registered on this trial will be available for complete documentation of&#xD;
             the treatment, adverse events, response assessment and follow-up.&#xD;
&#xD;
          -  In accordance with NCIC CTG policy, protocol treatment is to begin within 5 working&#xD;
             days of patient randomization.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with a history of other malignancies, except for adequately treated&#xD;
             non-melanoma skin cancer or solid tumours curatively treated with no evidence of&#xD;
             disease for &gt; 3 years.&#xD;
&#xD;
          -  Patients who are on immunosuppressive therapy or have known HIV infection or active&#xD;
             hepatitis B or C.&#xD;
&#xD;
          -  Patients with active or uncontrolled infections or with serious illnesses or medical&#xD;
             conditions which would not permit the patient to be managed according to the protocol.&#xD;
&#xD;
          -  Patients with significant cardiac (including uncontrolled hypertension) or pulmonary&#xD;
             disease, or active CNS disease or infection.&#xD;
&#xD;
          -  Patients with a known hypersensitivity to the study drug(s) or their components.&#xD;
&#xD;
          -  Patients with untreated brain metastases, untreated spinal cord compression or&#xD;
             meningeal metastases are not eligible (CT scans are not required to rule this out&#xD;
             unless there is a clinical suspicion of CNS disease). Patients with treated brain&#xD;
             metastases who have radiologic evidence of stable brain metastases, with no evidence&#xD;
             of cavitation or hemorrhage in the brain lesion, are eligible providing that they are&#xD;
             asymptomatic and do not require corticosteroids (must have discontinued steroids at&#xD;
             least 1 week prior to randomization).&#xD;
&#xD;
          -  Patients who have neuropathy ≥ grade 2 (patients planned for docetaxel Arms C and D&#xD;
             only).&#xD;
&#xD;
          -  Women must be post-menopausal, surgically sterile or use two reliable forms of&#xD;
             contraception while on study and for 6 months after discontinuing therapy. Women of&#xD;
             childbearing potential must have a pregnancy test taken and proven negative within 7&#xD;
             days prior to registration/randomization and must not be lactating. Men must be&#xD;
             surgically sterile or use a barrier method of contraception.&#xD;
&#xD;
          -  Concurrent treatment with other investigational drugs or anti-cancer therapy.&#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>Donald G Morris</last_name>
    <role>Study Chair</role>
    <affiliation>Tom Baker Cancer Centre, Calgary Alberta Canada</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Tom Baker Cancer Centre</name>
      <address>
        <city>Calgary</city>
        <state>Alberta</state>
        <zip>T2N 4N2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>BCCA - Abbotsford Centre</name>
      <address>
        <city>Abbotsford</city>
        <state>British Columbia</state>
        <zip>V2S 0C2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>BCCA - Fraser Valley Cancer Centre</name>
      <address>
        <city>Surrey</city>
        <state>British Columbia</state>
        <zip>V3V 1Z2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>BCCA - Vancouver Cancer Centre</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V5Z 4E6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Juravinski Cancer Centre at Hamilton Health Sciences</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <zip>L8V 5C2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cancer Centre of Southeastern Ontario at Kingston</name>
      <address>
        <city>Kingston</city>
        <state>Ontario</state>
        <zip>K7L 5P9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>London Regional Cancer Program</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <zip>N6A 4L6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lakeridge Health Oshawa</name>
      <address>
        <city>Oshawa</city>
        <state>Ontario</state>
        <zip>L1G 2B9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ottawa Hospital Research Institute</name>
      <address>
        <city>Ottawa</city>
        <state>Ontario</state>
        <zip>K1H 8L6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Univ. Health Network-Princess Margaret Hospital</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 2M9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHUM - Hopital Notre-Dame</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H2L 4M1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Allan Blair Cancer Centre</name>
      <address>
        <city>Regina</city>
        <state>Saskatchewan</state>
        <zip>S4T 7T1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <results_reference>
    <citation>Bradbury PA, Morris DG, Nicholas G, Tu D, Tehfe M, Goffin JR, Shepherd FA, Gregg RW, Rothenstein J, Lee C, Kuruvilla S, Keith BD, Torri V, Blais N, Hao D, Korpanty GJ, Goss G, Melosky BL, Mates M, Leighl N, Ayoub JP, Sederias J, Feilotter H, Seymour L, Laurie SA. Canadian Cancer Trials Group (CCTG) IND211: A randomized trial of pelareorep (Reolysin) in patients with previously treated advanced or metastatic non-small cell lung cancer receiving standard salvage therapy. Lung Cancer. 2018 Jun;120:142-148. doi: 10.1016/j.lungcan.2018.03.005. Epub 2018 Mar 9.</citation>
    <PMID>29748010</PMID>
  </results_reference>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>October 15, 2012</study_first_submitted>
  <study_first_submitted_qc>October 16, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 17, 2012</study_first_posted>
  <last_update_submitted>August 3, 2023</last_update_submitted>
  <last_update_submitted_qc>August 3, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 4, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Neoplasms</mesh_term>
    <mesh_term>Carcinoma, Non-Small-Cell Lung</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Docetaxel</mesh_term>
    <mesh_term>Pemetrexed</mesh_term>
  </intervention_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/NCT01708993
org study id: I211
nct id: NCT01708993
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to find out if giving reolysin in combination with docetaxel or
      pemetrexed can offer better results than standard therapy with docetaxel or pemetrexed alone.
Reolysin is a virus which has been shown to target and destroy cancer cells in laboratory
      tests. Reolysin has been studied in over 360 cancer patients to find safe doses that can be
      given and has also undergone testing in combination with docetaxel.

      Docetaxel and pemetrexed have anticancer activity in certain cancers including lung and they
      have been approved by Health Canada for the treatment of patients with advanced or metastatic
      non-small cell lung cancer.

      Researchers doing this study also want to evaluate the side effects of reolysin when given
      together with docetaxel or pemetrexed.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Progression free survival
time frame: 30 months
description: Evaluation of the effect of reolysin in combination with standard salvage chemotherapy on the progression free survival of patients with advanced or metastatic NSCLC. Response and progression will be evaluated in this study using the revised international criteria (1.1) proposed by the RECIST (Response Evaluation Criteria in Solid Tumours) committee
measure: Number of patients with adverse events
time frame: 30 months
description: To determine the tolerability and toxicity of reolysin and standard salvage chemotherapy when given in combination.
measure: Response rates
time frame: 30 months
description: To investigate additional potential measures of efficacy including:
Progression rates at 3 months
Objective response rate
Overall survival (OS)
measure: Explore potential molecular factors predictive of response
time frame: 30 months
description: Exploration of potential molecular factors predictive of response by assessment of archival tumour tissue and serial blood samples.
arm group label: Arm A: Pemetrexed and Reolysin (and safety run-in)
arm group type: Active Comparator
arm group label: Arm B: Pemetrexed
arm group type: Active Comparator
arm group label: Arm C: Docetaxel and Reolysin (and safety run-in)
arm group type: Active Comparator
arm group label: Arm D: Docetaxel
arm group type: Active Comparator
intervention type: Drug
intervention name: Pemetrexed and Reolysin (and safety run-in)
description: Pemetrexed: 500 mg/m², IV (10 min) - Day 1 every 3 weeks Reolysin: 4.5 x 10^10 TCID50 IV (1 hour) - Days 1-3, every 3 weeks
arm group label: Arm A: Pemetrexed and Reolysin (and safety run-in)
intervention type: Drug
intervention name: Pemetrexed
description: Pemetrexed: 500 mg/m² IV (10 min) - Day 1 every 3 weeks
arm group label: Arm B: Pemetrexed
intervention type: Drug
intervention name: Docetaxel and Reolysin
description: Docetaxel: 75 mg/m² IV (1 hour) - Day 1 every 3 weeks Reolysin: 4.5x10^10 TCID50 IV (1 hour) - Days 1-3, every 3 weeks
arm group label: Arm C: Docetaxel and Reolysin (and safety run-in)
intervention type: Drug
intervention name: Docetaxel
description: Docetaxel: 75 mg/m² IV (1 hour) - Day 1 every 3 weeks
arm group label: Arm D: Docetaxel
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Donald G Morris
role: Study Chair
affiliation: Tom Baker Cancer Centre, Calgary Alberta Canada
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Canada
citation: Bradbury PA, Morris DG, Nicholas G, Tu D, Tehfe M, Goffin JR, Shepherd FA, Gregg RW, Rothenstein J, Lee C, Kuruvilla S, Keith BD, Torri V, Blais N, Hao D, Korpanty GJ, Goss G, Melosky BL, Mates M, Leighl N, Ayoub JP, Sederias J, Feilotter H, Seymour L, Laurie SA. Canadian Cancer Trials Group (CCTG) IND211: A randomized trial of pelareorep (Reolysin) in patients with previously treated advanced or metastatic non-small cell lung cancer receiving standard salvage therapy. Lung Cancer. 2018 Jun;120:142-148. doi: 10.1016/j.lungcan.2018.03.005. Epub 2018 Mar 9.
PMID: 29748010
responsible party type: Sponsor
mesh term: Lung Neoplasms
mesh term: Carcinoma, Non-Small-Cell Lung
mesh term: Docetaxel
mesh term: Pemetrexed
sharing ipd: No