<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/NCT03782415</url>
  </required_header>
  <id_info>
    <org_study_id>MN-166-GBM-1201</org_study_id>
    <nct_id>NCT03782415</nct_id>
  </id_info>
  <brief_title>Study to Evaluate Ibudilast and TMZ Combo Treatment in Newly Diagnosed and Recurrent Glioblastoma</brief_title>
  <official_title>Phase 1b/2a Single-center, Open-label, Dose Escalation Study to Evaluate the Safety, Tolerability, and Efficacy of MN-166 (Ibudilast) and Temozolomide Combination Treatment in Patients With Newly Diagnosed or Recurrent Glioblastoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>MediciNova</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>MediciNova</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Part 1 is an open-label, single-arm, dose escalation study of MN-166 (ibudilast) and&#xD;
      temozolomide (TMZ) combination treatment. Evaluate safety and tolerability of ibudilast&#xD;
      (MN-166) and TMZ combination treatment for 1 cycle (28 days); determine dosage in&#xD;
      dose-finding study. Part 2 will evaluate efficacy of fixed-dose MN-166 (ibudilast) and TMZ&#xD;
      combination treatment for 6 cycles (~6 months) until disease progression, unacceptable&#xD;
      tolerability and/or toxicity or loss of life.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a single-center open-label, dose-escalation study to evaluate the safety,&#xD;
      tolerability and efficacy of MN-166 (ibudilast) and Temozolomide combination treatment in&#xD;
      patients with newly diagnosed or recurrent glioblastoma. To be eligible, subjects are&#xD;
      histologically confirmed glioblastoma or gliosarcoma, or astrocytomas with molecular features&#xD;
      of glioblastoma, WHO Grade 4. Recurrent glioblastoma patients must have a Karnofsky&#xD;
      Performance Status (KPS) ≥70 or Eastern Cooperative Oncology Group (ECOG) performance status&#xD;
      of 0-2. Patients having newly diagnosed glioblastoma, gliosarcoma, or astrocytomas with&#xD;
      molecular features of glioblastoma must have a KPS ≥60 and ECOG score 0-1. This is divided&#xD;
      into a dose-escalation phase (Part 1) followed by a fixed-dose phase (Part 2).&#xD;
&#xD;
      Part 1 will evaluate the safety and tolerability of MN-166 when given in combination with&#xD;
      temozolomide, and determine the dose of MN-166 to be used in Part 2 of the study. Up to 18&#xD;
      adult subjects are planned to be enrolled in Part 1.&#xD;
&#xD;
      Part 2 will evaluate the efficacy of MN-166 and temozolomide combination treatment as&#xD;
      measured by the proportion of subjects who are progression-free at 6 months. Other outcome&#xD;
      measures include the evaluation of overall survival, response rate, and median six-month&#xD;
      progression-free survival up to 2 years and up to 50 subjects are planned to be enrolled in&#xD;
      Part 2.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">December 29, 2018</start_date>
  <completion_date type="Anticipated">June 30, 2024</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date>
  <phase>Phase 1/Phase 2</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>Phase 1b/2a Single-center, Open-label, Dose-escalation study followed by a fixed-dose study to evaluate the safety, tolerability, and preliminary efficacy of MN-166 plus temozolomide in patients with newly diagnosed or recurrent glioblastoma.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluate safety and tolerability of ibudilast and temozolomide combination treatment</measure>
    <time_frame>1-6 months</time_frame>
    <description>Determine the proportion of patients with&#xD;
Treatment-emergent adverse events (TEAEs) as measured by the CTCAE v4.0 and&#xD;
Treatment discontinuations due to TEAEs and Dose-Limiting Toxicities (DLTs).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Evaluate efficacy of ibudilast and TMZ combination treatment</measure>
    <time_frame>1-6 months</time_frame>
    <description>Proportion of patients who are progression free at 6 months (PFS6) using the RANO criteria.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evaluate Tmax</measure>
    <time_frame>1-6 months</time_frame>
    <description>Time from start of dosing at which the maximum concentration is observed)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cmax</measure>
    <time_frame>1-6 months</time_frame>
    <description>Maximum observed concentration)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUC</measure>
    <time_frame>1-6 months</time_frame>
    <description>Area under the concentration versus time curve from the start of dose administration to the last quantifiable point within the dosing interval.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Terminal rate constant</measure>
    <time_frame>1-6 months</time_frame>
    <description>Calculated from the terminal slope of the log-linear regression of concentration with time.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Terminal half-life</measure>
    <time_frame>1-6 months</time_frame>
    <description>Time required for the plasma concentration of a drug to decrease 50% in the final stage of its elimination</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum tolerated dose determination</measure>
    <time_frame>1-6 months</time_frame>
    <description>Determine maximum tolerable dose of ibudilast taken in combination with TMZ</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the safety of fixed-dose ibudilast in combination with TMZ</measure>
    <time_frame>1-6 months</time_frame>
    <description>Reporting of treatment-emergent adverse events&#xD;
Treatment-emergent adverse events (TEAEs) as measured by the CTCAE v4.0 and&#xD;
Treatment discontinuations due to TEAEs and Dose-Limiting Toxicities (DLTs).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate overall survival, response rate, and median 6-month progression-free survival (PFS6)</measure>
    <time_frame>1-6 months</time_frame>
    <description>Overall survival will be measured for each subject with time origin at the date of Study Day 1 until recorded date or death or last follow-up visit.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Glioblastoma</condition>
  <condition>Recurrent Glioblastoma</condition>
  <condition>GBM</condition>
  <condition>Newly Diagnosed Glioblastoma</condition>
  <arm_group>
    <arm_group_label>MN-166 and temozolomide</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Part 1: Combination treatment of MN-166 60 mg/day (30 mg twice a day) for 28 days and temozolomide 150 mg/m² on Days 1-5 of 28-day cycle. Part 2: Open-label, fixed-dose MN-166 and temozolomide combination treatment for 6 cycles until disease progression, unacceptable tolerability and/or toxicity or loss of life.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>MN-166</intervention_name>
    <description>MN-166 is an anti-inflammatory/neuroprotective agent. MN-166 distributes well to the CNS (Sanftner et al. 2009) and it is a selective inhibitor of certain cyclic nucleotide phosphodiesterases (PDE) and the pro-inflammatory cytokine, macrophage migration inhibitory factor (MIF). At clinically-relevant plasma or CNS concentrations, MN-166 selectively inhibits macrophage migration inhibitory factor (MIF) (Cho et al 2010) and, secondarily, PDE3, 4 and 10 (Gibson et al 2006).</description>
    <arm_group_label>MN-166 and temozolomide</arm_group_label>
    <other_name>ibudilast</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Temozolomide</intervention_name>
    <description>Temozolomide is an oral chemotherapy drug. It is an alkylating agent used as a treatment of some brain cancers; and a first-line treatment for glioblastoma multiforme.</description>
    <arm_group_label>MN-166 and temozolomide</arm_group_label>
    <other_name>TMZ</other_name>
    <other_name>Temodar</other_name>
    <other_name>Temodal</other_name>
    <other_name>Temcad</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Major Inclusion Criteria for Recurrent GBM Patients:&#xD;
&#xD;
          1. Age 18 or older;&#xD;
&#xD;
          2. Histologically confirmed GBM (glioblastoma), WHO Grade 4;&#xD;
&#xD;
          3. Patients must have a Karnofsky Performance Status (KPS) ≥70 or Eastern Cooperative&#xD;
             Oncology Group (ECOG) performance status of 0-2 (see Appendix 7);&#xD;
&#xD;
          4. Previously received standard front-line GBM treatment including maximal surgical&#xD;
             resection followed by external beam radiation therapy and TMZ therapy. Prior use of&#xD;
             NovoTTF (Optune) and Gliadel wafers is allowed;&#xD;
&#xD;
          5. Patients must be in first relapse;&#xD;
&#xD;
               1. Relapse is defined as progression following initial therapy (i.e., radiation&#xD;
                  and/or chemotherapy). The intent therefore is that patients had no more than 1&#xD;
                  prior therapy (i.e., initial treatment). If the patient had a surgical resection&#xD;
                  for relapsed disease and no anti-cancer therapy was instituted for up to 12&#xD;
                  weeks, and the patient undergoes another surgical resection, this is considered&#xD;
                  to constitute one (1) relapse;&#xD;
&#xD;
               2. Documented recurrence or progression by brain MRI imaging ≤14 days before study&#xD;
                  registration;&#xD;
&#xD;
               3. Measurable disease by RANO criteria (≥ 10 mm x 10 mm).&#xD;
&#xD;
        Major Inclusion criteria for newly diagnosed patients:&#xD;
&#xD;
          1. Ages 18 or older;&#xD;
&#xD;
          2. Newly diagnosed glioblastoma or gliosarcoma (WHO Grade 4) confirmed by histology or&#xD;
             astrocytomas with molecular features of gliobastoma;&#xD;
&#xD;
          3. Starting maintenance therapy with temozolomide (150 mg/m^2 on Days 1-5 every 28 days)&#xD;
             within 4 weeks prior to screening phase;&#xD;
&#xD;
          4. If patient is receiving corticosteroid, dose must be stable or decreasing for at least&#xD;
             5 days prior to the scan. If steroids are added or the steroid dose is increased&#xD;
             between the date of the pretreatment MRI and the start of study, a new baseline MRI or&#xD;
             CT scan is required;&#xD;
&#xD;
          5. Karnofsky Performance Status ≥60 at time of screening;&#xD;
&#xD;
          6. ECOG score of 0 or 1 at time of screening;&#xD;
&#xD;
          7. Life expectancy of at least 3 months.&#xD;
&#xD;
        Exclusion Criteria (applied to all patients):&#xD;
&#xD;
          1. History of Grade 2 (CTCAE v4.0) or greater intracranial or intratumoral hemorrhage&#xD;
             confirmed by either MRI or CT scan;&#xD;
&#xD;
          2. Current use of anticoagulant treatment with coumadin (low-molecular-weight heparin and&#xD;
             factor Xa inhibitors are permitted);&#xD;
&#xD;
          3. Any systemic illness or unstable medical condition that might pose additional risk,&#xD;
             including: cardiac, unstable metabolic or endocrine disturbances, renal or liver&#xD;
             disease;&#xD;
&#xD;
          4. Patients with a history of a different malignancy except the following circumstances:&#xD;
&#xD;
               1. They have been disease-free for at least 2 years prior to starting study drug and&#xD;
                  are deemed by the investigator to be at low risk for recurrence of that&#xD;
                  malignancy. Patients with the following cancers are eligible if diagnosed and&#xD;
                  treated within the past 2 years: i. Cervical cancer in situ, and basal cell or&#xD;
                  squamous cell carcinoma of the skin;&#xD;
&#xD;
        7) Patients who have not recovered to ≤ Grade 1 toxicity by NCI CTCAE v4.0 from the toxic&#xD;
        effects of previous therapy with exception of lymphopenia, alopecia and fatigue; 9) For use&#xD;
        of other investigational drug or other anti-tumor treatment, the following time periods&#xD;
        must have elapsed from the projected start of scheduled study treatment:&#xD;
&#xD;
          1. 4 weeks or 5 half-lives (whichever is shorter) from any investigational agent;&#xD;
&#xD;
          2. 4 weeks from cytotoxic therapy (except 23 days for TMZ; 6 weeks from nitrosoureas);&#xD;
&#xD;
          3. 6 weeks from antibodies treatment (i.e., anti-VEGF antibody);&#xD;
&#xD;
          4. 4 weeks or 5 half-lives (whichever is shorter) from other anti-tumor therapies;&#xD;
&#xD;
          5. 2 days from NOVO-TTF (Optune®).&#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>Kazuko Matsuda, MD PhD MPH</last_name>
    <role>Study Director</role>
    <affiliation>MediciNova, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Dana-Farber Cancer Institute</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Cho Y, Crichlow GV, Vermeire JJ, Leng L, Du X, Hodsdon ME, Bucala R, Cappello M, Gross M, Gaeta F, Johnson K, Lolis EJ. Allosteric inhibition of macrophage migration inhibitory factor revealed by ibudilast. Proc Natl Acad Sci U S A. 2010 Jun 22;107(25):11313-8. doi: 10.1073/pnas.1002716107. Epub 2010 Jun 8.</citation>
    <PMID>20534506</PMID>
  </reference>
  <reference>
    <citation>Gibson LC, Hastings SF, McPhee I, Clayton RA, Darroch CE, Mackenzie A, Mackenzie FL, Nagasawa M, Stevens PA, Mackenzie SJ. The inhibitory profile of Ibudilast against the human phosphodiesterase enzyme family. Eur J Pharmacol. 2006 May 24;538(1-3):39-42. doi: 10.1016/j.ejphar.2006.02.053. Epub 2006 Mar 13.</citation>
    <PMID>16674936</PMID>
  </reference>
  <reference>
    <citation>Sanftner LM, Gibbons JA, Gross MI, Suzuki BM, Gaeta FC, Johnson KW. Cross-species comparisons of the pharmacokinetics of ibudilast. Xenobiotica. 2009 Dec;39(12):964-77. doi: 10.3109/00498250903254340.</citation>
    <PMID>19925385</PMID>
  </reference>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>December 17, 2018</study_first_submitted>
  <study_first_submitted_qc>December 19, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 20, 2018</study_first_posted>
  <last_update_submitted>September 8, 2023</last_update_submitted>
  <last_update_submitted_qc>September 8, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 13, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>MN-166</keyword>
  <keyword>GBM</keyword>
  <keyword>glioblastoma</keyword>
  <keyword>recurrent GBM</keyword>
  <keyword>temozolomide</keyword>
  <keyword>newly diagnosed glioblastoma</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Glioblastoma</mesh_term>
    <mesh_term>Recurrence</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Temozolomide</mesh_term>
    <mesh_term>Ibudilast</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/NCT03782415
org study id: MN-166-GBM-1201
nct id: NCT03782415
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
Part 1 is an open-label, single-arm, dose escalation study of MN-166 (ibudilast) and
      temozolomide (TMZ) combination treatment. Evaluate safety and tolerability of ibudilast
      (MN-166) and TMZ combination treatment for 1 cycle (28 days); determine dosage in
      dose-finding study. Part 2 will evaluate efficacy of fixed-dose MN-166 (ibudilast) and TMZ
      combination treatment for 6 cycles (~6 months) until disease progression, unacceptable
      tolerability and/or toxicity or loss of life.
This is a single-center open-label, dose-escalation study to evaluate the safety,
      tolerability and efficacy of MN-166 (ibudilast) and Temozolomide combination treatment in
      patients with newly diagnosed or recurrent glioblastoma. To be eligible, subjects are
      histologically confirmed glioblastoma or gliosarcoma, or astrocytomas with molecular features
      of glioblastoma, WHO Grade 4. Recurrent glioblastoma patients must have a Karnofsky
      Performance Status (KPS) ≥70 or Eastern Cooperative Oncology Group (ECOG) performance status
      of 0-2. Patients having newly diagnosed glioblastoma, gliosarcoma, or astrocytomas with
      molecular features of glioblastoma must have a KPS ≥60 and ECOG score 0-1. This is divided
      into a dose-escalation phase (Part 1) followed by a fixed-dose phase (Part 2).

      Part 1 will evaluate the safety and tolerability of MN-166 when given in combination with
      temozolomide, and determine the dose of MN-166 to be used in Part 2 of the study. Up to 18
      adult subjects are planned to be enrolled in Part 1.

      Part 2 will evaluate the efficacy of MN-166 and temozolomide combination treatment as
      measured by the proportion of subjects who are progression-free at 6 months. Other outcome
      measures include the evaluation of overall survival, response rate, and median six-month
      progression-free survival up to 2 years and up to 50 subjects are planned to be enrolled in
      Part 2.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Phase 1b/2a Single-center, Open-label, Dose-escalation study followed by a fixed-dose study to evaluate the safety, tolerability, and preliminary efficacy of MN-166 plus temozolomide in patients with newly diagnosed or recurrent glioblastoma.
primary purpose: Treatment
masking: None (Open Label)
measure: Evaluate safety and tolerability of ibudilast and temozolomide combination treatment
time frame: 1-6 months
description: Determine the proportion of patients with
Treatment-emergent adverse events (TEAEs) as measured by the CTCAE v4.0 and
Treatment discontinuations due to TEAEs and Dose-Limiting Toxicities (DLTs).
measure: Evaluate efficacy of ibudilast and TMZ combination treatment
time frame: 1-6 months
description: Proportion of patients who are progression free at 6 months (PFS6) using the RANO criteria.
measure: Evaluate Tmax
time frame: 1-6 months
description: Time from start of dosing at which the maximum concentration is observed)
measure: Cmax
time frame: 1-6 months
description: Maximum observed concentration)
measure: AUC
time frame: 1-6 months
description: Area under the concentration versus time curve from the start of dose administration to the last quantifiable point within the dosing interval.
measure: Terminal rate constant
time frame: 1-6 months
description: Calculated from the terminal slope of the log-linear regression of concentration with time.
measure: Terminal half-life
time frame: 1-6 months
description: Time required for the plasma concentration of a drug to decrease 50% in the final stage of its elimination
measure: Maximum tolerated dose determination
time frame: 1-6 months
description: Determine maximum tolerable dose of ibudilast taken in combination with TMZ
measure: Evaluate the safety of fixed-dose ibudilast in combination with TMZ
time frame: 1-6 months
description: Reporting of treatment-emergent adverse events
Treatment-emergent adverse events (TEAEs) as measured by the CTCAE v4.0 and
Treatment discontinuations due to TEAEs and Dose-Limiting Toxicities (DLTs).
measure: Evaluate overall survival, response rate, and median 6-month progression-free survival (PFS6)
time frame: 1-6 months
description: Overall survival will be measured for each subject with time origin at the date of Study Day 1 until recorded date or death or last follow-up visit.
arm group label: MN-166 and temozolomide
arm group type: Experimental
description: Part 1: Combination treatment of MN-166 60 mg/day (30 mg twice a day) for 28 days and temozolomide 150 mg/m² on Days 1-5 of 28-day cycle. Part 2: Open-label, fixed-dose MN-166 and temozolomide combination treatment for 6 cycles until disease progression, unacceptable tolerability and/or toxicity or loss of life.
intervention type: Drug
intervention name: MN-166
description: MN-166 is an anti-inflammatory/neuroprotective agent. MN-166 distributes well to the CNS (Sanftner et al. 2009) and it is a selective inhibitor of certain cyclic nucleotide phosphodiesterases (PDE) and the pro-inflammatory cytokine, macrophage migration inhibitory factor (MIF). At clinically-relevant plasma or CNS concentrations, MN-166 selectively inhibits macrophage migration inhibitory factor (MIF) (Cho et al 2010) and, secondarily, PDE3, 4 and 10 (Gibson et al 2006).
arm group label: MN-166 and temozolomide
other name: ibudilast
intervention type: Drug
intervention name: Temozolomide
description: Temozolomide is an oral chemotherapy drug. It is an alkylating agent used as a treatment of some brain cancers; and a first-line treatment for glioblastoma multiforme.
arm group label: MN-166 and temozolomide
other name: TMZ
other name: Temodar
other name: Temodal
other name: Temcad
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Kazuko Matsuda, MD PhD MPH
role: Study Director
affiliation: MediciNova, Inc.
facility: 
country: United States
citation: Cho Y, Crichlow GV, Vermeire JJ, Leng L, Du X, Hodsdon ME, Bucala R, Cappello M, Gross M, Gaeta F, Johnson K, Lolis EJ. Allosteric inhibition of macrophage migration inhibitory factor revealed by ibudilast. Proc Natl Acad Sci U S A. 2010 Jun 22;107(25):11313-8. doi: 10.1073/pnas.1002716107. Epub 2010 Jun 8.
PMID: 20534506
citation: Gibson LC, Hastings SF, McPhee I, Clayton RA, Darroch CE, Mackenzie A, Mackenzie FL, Nagasawa M, Stevens PA, Mackenzie SJ. The inhibitory profile of Ibudilast against the human phosphodiesterase enzyme family. Eur J Pharmacol. 2006 May 24;538(1-3):39-42. doi: 10.1016/j.ejphar.2006.02.053. Epub 2006 Mar 13.
PMID: 16674936
citation: Sanftner LM, Gibbons JA, Gross MI, Suzuki BM, Gaeta FC, Johnson KW. Cross-species comparisons of the pharmacokinetics of ibudilast. Xenobiotica. 2009 Dec;39(12):964-77. doi: 10.3109/00498250903254340.
PMID: 19925385
responsible party type: Sponsor
mesh term: Glioblastoma
mesh term: Recurrence
mesh term: Temozolomide
mesh term: Ibudilast
sharing ipd: No