xml: <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/NCT05984147</url>
    </required_header>
    <id_info>
      <org_study_id>AUR108-101</org_study_id>
      <nct_id>NCT05984147</nct_id>
    </id_info>
    <brief_title>A Study Evaluating the Safety and Efficacy of AUR108 in Patients With Relapsed Advanced Lymphomas (ASHA-1)</brief_title>
    <acronym>ASHA-1</acronym>
    <official_title>A Phase 1, Open Label, Dose Escalation, Dose Expansion, Multicenter Study Evaluating the Safety, Pharmacokinetics and Pharmacodynamics of Oral AUR108 in Patients With Relapsed Advanced Lymphomas(ASHA-1)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Aurigene Discovery Technologies Limited</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Aurigene Discovery Technologies Limited</source>
    <oversight_info>
      <has_dmc>Yes</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>
        An open-label, first-in-human, Phase 1 study in adult patients with relapsed advanced&#xD;
        lymphomas will be done to assess AUR108 safety, tolerability, pharmacokinetics,&#xD;
        pharmacodynamics, and optimal biological dose.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a Phase I, Open Label, Dose-Escalation, First-in-Human study in adult patients with&#xD;
        select relapsed advanced lymphomas. The safety and tolerability of oral AUR108 will be&#xD;
        evaluated in patients with Non-Hodgkin lymphoma and Hodgkin lymphoma who do not have any&#xD;
        available curative or life-prolonging treatment options and have exhausted all effective&#xD;
        locally available therapies. The traditional 3+3 design for dose escalation will be used to&#xD;
        evaluate the safety, pharmacokinetics/pharmacodynamics, and determine the Optimal Biological&#xD;
        Dose of AUR108 as a single agent. The Optimal Biological Dose will be selected using a&#xD;
        totality of safety, PK, and PD data.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 14, 2023</start_date>
    <completion_date type="Anticipated">August 30, 2027</completion_date>
    <primary_completion_date type="Anticipated">August 30, 2025</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>Sequential Assignment</intervention_model>
      <intervention_model_description>Sequential Assignment Dose Escalation &quot;3+3&quot; Design</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>1. First cycle Dose Limiting Toxicities (DLT)</measure>
      <time_frame>28 Days</time_frame>
      <description>Assess dose limiliting toxicities of AUR108</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Safety of AUR108 as measured by the number of participants with treatment-related adverse events (AE) graded according to NCI CTCAE version 5.0</measure>
      <time_frame>Through study completion, an average of 1 year</time_frame>
      <description>Number of participants with TEAEs</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Pharmacokinetics Maximum Concentration (Cmax)</measure>
      <time_frame>Day 1 and Day 17</time_frame>
      <description>Maximum Concentration of AUR108</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Pharmacokinetics: Time to Maximum concentration (Tmax)</measure>
      <time_frame>Day 1 and Day 17</time_frame>
      <description>Tmax in hours</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Pharmacokinetics: Area under the curve (AUC)</measure>
      <time_frame>Day 1 and Day 17</time_frame>
      <description>Area under the curve (AUC) of AUR108 in h* ng/mL</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Pharmacokinetics: Terminal elimination half-life</measure>
      <time_frame>Day 17</time_frame>
      <description>Terminal elimination half-life of AUR 108 in hours</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Maximum concentration (Cmax) administered under fasting/fed condition</measure>
      <time_frame>Day 8</time_frame>
      <description>Compare in fast and fed conditions</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Time to Maximum concentration (Tmax) administered under fasting/fed condition</measure>
      <time_frame>Day 8</time_frame>
      <description>Compare Tmax in fast and fed conditions</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Area under curve (AUC) administered under fasting/fed condition</measure>
      <time_frame>Day 8</time_frame>
      <description>Compare AUC in fast and fed conditions</description>
    </primary_outcome>
    <other_outcome>
      <measure>PD biomarker assessment</measure>
      <time_frame>Day 1, Day 2, Day 17 and Day 18</time_frame>
      <description>Change from baseline in biomarker (DHO) levels</description>
    </other_outcome>
    <other_outcome>
      <measure>Overall Response Rate</measure>
      <time_frame>Through study completion, an average of 1 year</time_frame>
      <description>Efficacy assessments by Overall Response Rate</description>
    </other_outcome>
    <other_outcome>
      <measure>Duration of Response</measure>
      <time_frame>Through study completion, an average of 1 year</time_frame>
      <description>Efficacy assessments by Duration of Response</description>
    </other_outcome>
    <other_outcome>
      <measure>Progression Free Survival</measure>
      <time_frame>Through study completion, an average of 1 year</time_frame>
      <description>Efficacy assessments by Progression Free Survival (PFS)</description>
    </other_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Relapsed Advanced Lymphomas</condition>
    <arm_group>
      <arm_group_label>AUR108, 50mg to 300mg</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Currently, planned dose levels are 50,90,150,220,300 mg will be administered in 3+/4- regimen.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>AUR108</intervention_name>
      <description>3 Days dosing, and 4 days no dose in a week</description>
      <arm_group_label>AUR108, 50mg to 300mg</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Males or females ≥ 18 years of age&#xD;
  &#xD;
            2. Eastern Cooperative Oncology Group (ECOG) Performance status of 0 or 1&#xD;
  &#xD;
            3. Acceptable bone marrow and organ function at screening as described below:&#xD;
  &#xD;
                 1. ANC ≥ 1000/μL (without WBC growth factor support)&#xD;
  &#xD;
                 2. Platelet count ≥ 75,000/μL without transfusion support&#xD;
  &#xD;
                 3. Hemoglobin ≥ 9 g/dL (Transfusion is allowed to achieve this Hb)&#xD;
  &#xD;
                 4. Total Bilirubin ≤ 1.5 x ULN; (Patients with known Gilbert's syndrome are allowed&#xD;
                    with a Total Bilirubin ≤ 2.5 x ULN)&#xD;
  &#xD;
                 5. AST (SGOT) ≤ 3 x ULN (≤ 5 × ULN if known liver metastases)&#xD;
  &#xD;
                 6. ALT (SGPT) ≤ 3 x ULN (≤ 5 × ULN if known liver metastases)&#xD;
  &#xD;
                 7. Creatinine clearance (CrCl) ≥ 30 mL/min (either measured or estimated by the&#xD;
                    Cockcroft-Gault formula). (Cockcroft-Gault formula for estimated creatinine&#xD;
                    clearance [eCrCl]: eCrCl = [140- Age] × Weight [kg] × [0.85 if Female] / [72 ×&#xD;
                    serum creatinine (mg/dL)]).&#xD;
  &#xD;
            4. Ability to swallow and retain oral medications&#xD;
  &#xD;
            5. Histo-pathological diagnosis of a Non-Hodgkin lymphoma orHodgkin Lymphoma. Note: The&#xD;
               lymphoma should be either in Stage III or IV according to Lugano classification&#xD;
               (Cheson BD et al, 2014) at screening.&#xD;
  &#xD;
            6. In the case of subjects who have lymphoma for which high-dose chemotherapy and&#xD;
               autologous stem cell transplantation (HDASCT) is considered a standard curative&#xD;
               therapy, eligibility for this study requires that the subject's disease has relapsed&#xD;
               after HDASCT, that the subject is not eligible for HD-ASCT, or that the subject has&#xD;
               refused HD-ASCT.&#xD;
  &#xD;
            7. In the case of subjects who have lymphoma for which CAR-T therapy is considered a&#xD;
               standard therapy, eligibility for this study requires that the subjects disease has&#xD;
               relapsed after CAR-T, or that the subject has refused CAR-T, or that the CAR-T therapy&#xD;
               is not accessible to the patient.&#xD;
  &#xD;
            8. Evidence of measurable disease as per Lugano Criteria for Lymphoma (Cheson BD et al,&#xD;
               2014).&#xD;
  &#xD;
            9. Standard curative measures do not exist, and patient must have exhausted all effective&#xD;
               therapies, available locally.&#xD;
  &#xD;
                 1. At a minimum, the patients must have received at least 2 prior lines of systemic&#xD;
                    therapies. These systemic therapies could be either in the stage II, III or IV.&#xD;
  &#xD;
                 2. Any cancer patient with access to any effective therapy must not be enrolled.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Systemic anti-cancer therapy, such as chemotherapy, or biological therapy,&#xD;
               immunomodulatory drug therapy, received within the past 28 days or 5 half-lives,&#xD;
               whichever is longer, from the Cycle 1 Day 1 of the study.&#xD;
  &#xD;
               Note: Concomitant use of low dose prednisone (up to 10 mg/day) is allowed.&#xD;
  &#xD;
            2. Presence of an acute or chronic toxicity resulting from prior anticancer treatment,&#xD;
               with the exception of alopecia or nail changes, that has not resolved to Grade ≤ 1, as&#xD;
               determined by NCI CTCAE v 5.0.&#xD;
  &#xD;
            3. Definitive Radiotherapy within the last 21 days of Cycle 1 Day 1 (limited field&#xD;
               palliative radiation is allowed and no restrictions during the screening period or&#xD;
               during the trial).&#xD;
  &#xD;
            4. Use of any investigational agent within 28 days or 5 half-lives (whichever is longer)&#xD;
               prior to Cycle 1 Day 1.&#xD;
  &#xD;
            5. Patients with cutaneous lymphomas, mycosis fungoides (MF) or Sézary syndrome (SS).&#xD;
  &#xD;
            6. Primary CNS lymphoma&#xD;
  &#xD;
            7. Known symptomatic or untreated or recently treated (≤ 6 months of screening) central&#xD;
               nervous system (CNS) lymphoma. Patients with previously treated (&gt; 6 months of&#xD;
               screening) CNS lymphoma and are now stable and asymptomatic, from CNS perspective, are&#xD;
               allowed&#xD;
  &#xD;
            8. Patients with lymphoma that requires immediate cytoreductive therapy&#xD;
  &#xD;
            9. Patients with lymphoma that requires immediate cytoreductive therapy&#xD;
  &#xD;
           10. Patients on the drugs which are sensitive substrates of CYP2C8 and cannot be&#xD;
               discontinued at least one week prior to Cycle 1 Day 1&#xD;
  &#xD;
           11. Patients on the drugs which are sensitive substrates of either Poglycoprotein (P-gp)&#xD;
               or breast cancer resistance protein (BCRP) and cannot be discontinued at least one&#xD;
               week prior to Cycle 1 Day 1&#xD;
  &#xD;
           12. Major surgery ≤ 28 days from Cycle 1 Day 1 (major surgery is defined as a procedure&#xD;
               requiring general anesthesia)&#xD;
  &#xD;
           13. Active infection requiring systemic therapy. Note: Prophylactic use of antibiotics is&#xD;
               allowed. Any infection detected during screening period which is resolved adequately&#xD;
               according to investigator before the Cycle 1 Day 1, is allowed.&#xD;
  &#xD;
           14. Known to be human immunodeficiency virus (HIV) positive or have an acquired&#xD;
               immunodeficiency syndrome-related illness&#xD;
  &#xD;
           15. Known active or chronic hepatitis B (HbsAg +ve) or hepatitis C infection (HCV antibody&#xD;
               +ve)&#xD;
  &#xD;
           16. The patient who is expected to require any other form of antineoplastic therapy or&#xD;
               targeted therapy while on study.&#xD;
  &#xD;
           17. Uncontrolled congestive heart failure (New York Heart Association (NYHA) Class 2-4),&#xD;
               angina, myocardial infarction, cerebrovascular accident, coronary/peripheral artery&#xD;
               bypass graft surgery, or transient ischemic attack, or pulmonary embolism within 3&#xD;
               months prior to Cycle 1 Day 1&#xD;
  &#xD;
           18. Ongoing cardiac dysrhythmias requiring treatment of any grade or treatment of cardiac&#xD;
               dysrhythmias in past 3 months, before Cycle 1 Day 1.&#xD;
  &#xD;
           19. QTc (Bazzett) interval &gt;460 ms on ECG at screening and/or at Cycle 1 Day 1 pre-dose.&#xD;
  &#xD;
           20. Uncontrolled intercurrent illness including, but not limited to, symptomatic&#xD;
               congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac&#xD;
               arrhythmia, active peptic ulcer disease or significant gastritis, active bleeding&#xD;
               diatheses, presence of any major medical illness (e.g. renal, hepatic, hematologic,&#xD;
               gastrointestinal, endocrine, pulmonary, or psychiatric illness/social situations or&#xD;
               clinically significant laboratory / ECG abnormalities at screening, any or a&#xD;
               combination of illnesses, which, in the opinion of the PI, may either put the patient&#xD;
               at risk because of participation in the study, or influence the results or the&#xD;
               patient's ability to participate in the study&#xD;
  &#xD;
           21. Current swab-positive or suspected (under investigation) Covid-19 infection or fever&#xD;
               and other signs or symptoms suggestive of Covid-19 infection with recent contact of&#xD;
               person(s) with confirmed Covid-19 infection, at screening or Cycle 1 Day 1.&#xD;
  &#xD;
           22. History of another primary malignancy within 5 years prior to starting study drug,&#xD;
               except for adequately treated basal or squamous cell carcinoma of the skin or cancer&#xD;
               of the cervix in situ and the disease under study.&#xD;
  &#xD;
           23. Positive pregnancy test for women of child-bearing potential (WOCBP) at the screening&#xD;
               or enrolment visit&#xD;
  &#xD;
           24. Lactating women or WOCBP who are neither surgically sterilized nor willing to use&#xD;
               reliable contraceptive methods (hormonal contraceptive, IUD, or any double combination&#xD;
               of male or female condom, spermicidal gel, diaphragm, sponge, cervical cap).&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>99 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Akhil Kumar</last_name>
      <role>Principal Investigator</role>
      <affiliation>Chief Medical Officer</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Divyesh Mandavia</last_name>
      <phone>9427181182</phone>
      <email>divyesh_m@aurigene.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Suresh Oduru</last_name>
      <phone>9866225593</phone>
      <email>suresh_o@aurigene.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Omega Cancer Hospitals</name>
        <address>
          <city>Visakhapatnam</city>
          <state>Andhra Pradesh</state>
          <zip>530040</zip>
          <country>India</country>
        </address>
      </facility>
      <contact>
        <last_name>Dr Bellala Ravishankar</last_name>
        <phone>9849123256</phone>
        <email>dr.bellalaravishankar@gmail.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Unique Hospital</name>
        <address>
          <city>Surat</city>
          <state>Gujarat</state>
          <zip>395002</zip>
          <country>India</country>
        </address>
      </facility>
      <contact>
        <last_name>Dr. Ankit Patel</last_name>
        <phone>9825404202</phone>
        <email>drankitoncologist@gmail.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Kiran Multi Speciality Hospital</name>
        <address>
          <city>Surat</city>
          <state>Gujarat</state>
          <zip>395004</zip>
          <country>India</country>
        </address>
      </facility>
      <contact>
        <last_name>Dr. Anshul Agarwal</last_name>
        <phone>8657068668</phone>
        <email>drankitoncologist@gmail.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>KLES Dr Prabhakar Kore Hospital and MRC</name>
        <address>
          <city>Belagam</city>
          <state>Karnataka</state>
          <zip>590010</zip>
          <country>India</country>
        </address>
      </facility>
      <contact>
        <last_name>Dr. Rohan Bhise</last_name>
        <phone>9448866712</phone>
        <email>rohanbhise30@gmail.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Sujan Surgical Cancer Hospital and Amravati Cancer Foundation</name>
        <address>
          <city>Amaravati</city>
          <state>Maharashtra</state>
          <zip>444606</zip>
          <country>India</country>
        </address>
      </facility>
      <contact>
        <last_name>Dr. Rajendrasingh Arora</last_name>
        <phone>9823097573</phone>
        <email>rsaroradr@gmail.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>HCG Manavata Cancer Centre</name>
        <address>
          <city>Nashik</city>
          <state>Maharashtra</state>
          <zip>422002</zip>
          <country>India</country>
        </address>
      </facility>
      <contact>
        <last_name>Dr. Rajesh Nagarkar</last_name>
        <phone>9823061929</phone>
        <email>drraj@manavatacancercentre.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>All India Institute of Medical Sciences</name>
        <address>
          <city>Delhi</city>
          <state>New Delhi</state>
          <zip>10029</zip>
          <country>India</country>
        </address>
      </facility>
      <contact>
        <last_name>Dr Deepam Pushpam</last_name>
        <phone>9650629370</phone>
        <email>deepampushpam@gmail.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Sparsh Hospital and Critical Care (P) Ltd.</name>
        <address>
          <city>Bhubaneswar</city>
          <state>Odisha</state>
          <zip>751007</zip>
          <country>India</country>
        </address>
      </facility>
      <contact>
        <last_name>Dr. Ghanashyam Biswas</last_name>
        <phone>9937500878</phone>
        <email>drgbiswas@gmail.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>MNJ Institute of Oncology and Regional Cancer Centre</name>
        <address>
          <city>Hyderabad</city>
          <state>Telangana</state>
          <zip>500004</zip>
          <country>India</country>
        </address>
      </facility>
      <contact>
        <last_name>Dr. P.K. Chaithanya</last_name>
        <phone>8897199994</phone>
        <email>mnjiorccchaithanya@gmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>India</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 20, 2023</study_first_submitted>
    <study_first_submitted_qc>July 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 9, 2023</study_first_posted>
    <last_update_submitted>August 9, 2023</last_update_submitted>
    <last_update_submitted_qc>August 9, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Relapse Advanced Lymphomas</keyword>
    <keyword>Diffuse large B-cell lymphoma</keyword>
    <keyword>Follicular lymphoma</keyword>
    <keyword>Mature T/NK-cell lymphomas</keyword>
    <keyword>Other Hodgkin lymphoma</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Lymphoma</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05984147
  org study id: AUR108-101
  nct id: NCT05984147
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  An open-label, first-in-human, Phase 1 study in adult patients with relapsed advanced
        lymphomas will be done to assess AUR108 safety, tolerability, pharmacokinetics,
        pharmacodynamics, and optimal biological dose.
  This is a Phase I, Open Label, Dose-Escalation, First-in-Human study in adult patients with
        select relapsed advanced lymphomas. The safety and tolerability of oral AUR108 will be
        evaluated in patients with Non-Hodgkin lymphoma and Hodgkin lymphoma who do not have any
        available curative or life-prolonging treatment options and have exhausted all effective
        locally available therapies. The traditional 3+3 design for dose escalation will be used to
        evaluate the safety, pharmacokinetics/pharmacodynamics, and determine the Optimal Biological
        Dose of AUR108 as a single agent. The Optimal Biological Dose will be selected using a
        totality of safety, PK, and PD data.
  allocation: N/A
  intervention model: Sequential Assignment
  intervention model description: Sequential Assignment Dose Escalation "3+3" Design
  primary purpose: Treatment
  masking: None (Open Label)
  measure: 1. First cycle Dose Limiting Toxicities (DLT)
  time frame: 28 Days
  description: Assess dose limiliting toxicities of AUR108
  measure: Safety of AUR108 as measured by the number of participants with treatment-related adverse events (AE) graded according to NCI CTCAE version 5.0
  time frame: Through study completion, an average of 1 year
  description: Number of participants with TEAEs
  measure: Pharmacokinetics Maximum Concentration (Cmax)
  time frame: Day 1 and Day 17
  description: Maximum Concentration of AUR108
  measure: Pharmacokinetics: Time to Maximum concentration (Tmax)
  time frame: Day 1 and Day 17
  description: Tmax in hours
  measure: Pharmacokinetics: Area under the curve (AUC)
  time frame: Day 1 and Day 17
  description: Area under the curve (AUC) of AUR108 in h* ng/mL
  measure: Pharmacokinetics: Terminal elimination half-life
  time frame: Day 17
  description: Terminal elimination half-life of AUR 108 in hours
  measure: Maximum concentration (Cmax) administered under fasting/fed condition
  time frame: Day 8
  description: Compare in fast and fed conditions
  measure: Time to Maximum concentration (Tmax) administered under fasting/fed condition
  time frame: Day 8
  description: Compare Tmax in fast and fed conditions
  measure: Area under curve (AUC) administered under fasting/fed condition
  time frame: Day 8
  description: Compare AUC in fast and fed conditions
  measure: PD biomarker assessment
  time frame: Day 1, Day 2, Day 17 and Day 18
  description: Change from baseline in biomarker (DHO) levels
  measure: Overall Response Rate
  time frame: Through study completion, an average of 1 year
  description: Efficacy assessments by Overall Response Rate
  measure: Duration of Response
  time frame: Through study completion, an average of 1 year
  description: Efficacy assessments by Duration of Response
  measure: Progression Free Survival
  time frame: Through study completion, an average of 1 year
  description: Efficacy assessments by Progression Free Survival (PFS)
  arm group label: AUR108, 50mg to 300mg
  arm group type: Experimental
  description: Currently, planned dose levels are 50,90,150,220,300 mg will be administered in 3+/4- regimen.
  intervention type: Drug
  intervention name: AUR108
  description: 3 Days dosing, and 4 days no dose in a week
  arm group label: AUR108, 50mg to 300mg
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 99 Years
  healthy volunteers: No
  last name: Akhil Kumar
  role: Principal Investigator
  affiliation: Chief Medical Officer
  last name: Divyesh Mandavia
  phone: 9427181182
  email: divyesh_m@aurigene.com
  last name: Suresh Oduru
  phone: 9866225593
  email: suresh_o@aurigene.com
  facility: 
  contact: 
  facility: 
  contact: 
  facility: 
  contact: 
  facility: 
  contact: 
  facility: 
  contact: 
  facility: 
  contact: 
  facility: 
  contact: 
  facility: 
  contact: 
  facility: 
  contact: 
  country: India
  responsible party type: Sponsor
  mesh term: Lymphoma
  sharing ipd: No