<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/NCT02249650</url>
  </required_header>
  <id_info>
    <org_study_id>SUNTSBA20110201</org_study_id>
    <nct_id>NCT02249650</nct_id>
  </id_info>
  <brief_title>To Determine the MTD and to Evaluate the Safety, Efficacy and PK Profiles of TSB-9-W1 in Pre-treated Patients With mCRC.</brief_title>
  <acronym>TSB-9-W1</acronym>
  <official_title>A Phase I Study to Determine the Maximum Tolerated Dose (MTD) and to Evaluate the Safety, Efficacy and Pharmacokinetics Profiles of TSB-9-W1 in Pre-treated Patients With Metastatic Colorectal Cancer (mCRC).</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Taiwan Sunpan Biotechnology Development Co., Ltd.</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Virginia Contract Research Organization Co., Ltd.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Taiwan Sunpan Biotechnology Development Co., Ltd.</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>
      TSB-9-W1, prepared by Taiwan Sunpan Biotechnology Co., Ltd. (TSB) is a botanical drug and&#xD;
      applied patent in the United States (US patent No. 7,138,428 B2), Japan (Patent No.&#xD;
&#xD;
      5441947) and Taiwan (Patent No. I432191 and I282280). The R&amp;D laboratory in TSB is ISO/IEC&#xD;
      17025 certified by Taiwan Accreditation Foundation (TAF) and the laboratory number is&#xD;
      2026.The trade name of TSB-9-W1 is &quot;IDS&quot; in English, the registration number is 01472800 at&#xD;
      2011 by Intellectual Property Office (IPO), Taiwan.&#xD;
&#xD;
      A phase I and pk study to determine the Maximum Tolerated Dose (MTD) and to evaluate the&#xD;
      safety and efficacy profiles of TSB-9-W1 in pre-treated patients with metastatic colorectal&#xD;
      cancer (mCRC).&#xD;
&#xD;
      there are 5 cohorts and a minimal 2 patients and up to 30 patients are required at phase I.&#xD;
&#xD;
      This is a single arm study. All eligible patients with mCRC will receive TSB-9-W1 treatment.&#xD;
&#xD;
      Each treatment cycle is composed by a contiguous 2-day oral administration and a contiguous&#xD;
      3-day rest. Patient should take the study drug once daily before meal with approximately 250&#xD;
      ml or appropriate amount of water.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study Design&#xD;
&#xD;
      This study is to establish the MTD of TSB-9-W1 for mCRC patients with a traditional 3+3 dose&#xD;
      escalation method.&#xD;
&#xD;
      Study Structure&#xD;
&#xD;
      A dose escalation scenario is designed to determine the MTD according to the DLT.&#xD;
&#xD;
      Dose escalation scale:&#xD;
&#xD;
      The dose levels of investigation product are planned to be administered for determining MTD&#xD;
      and DLT.&#xD;
&#xD;
      Dose escalation scenario:&#xD;
&#xD;
      Patients will be enrolled in a cohort of 3 patients for each dose level. Dose escalation will&#xD;
      proceed sequentially from the lowest dose cohort. No intra-subject dose escalation is&#xD;
      allowed. Each patient's first dose will be at least 3-day apart from the very next patient's&#xD;
      first dose.&#xD;
&#xD;
      DLT (except diarrhea) is determined by (NCI-CTCAE) version 4.03 (2010/6/14) defined treatment&#xD;
      related toxicity ≥ grade 3 and is worsen from the baseline. Any grade ≥ 3 toxicity (except&#xD;
      for diarrhea) is considered a DLT unless there is a clear alternative explanation as to the&#xD;
      attribution of the adverse event. Diarrhea event is considered as a DLT if the episode is&#xD;
      with NCI-CTCAE Grade of 3 and this event lasts &gt; 3 days despite appropriate supportive cares&#xD;
      or if it is a Grade 4 event. Diarrhea event reaches Grade 4 will trigger the patient to&#xD;
      withdraw from the study. AEs are evaluated according to the NCI-CTCAE version 4.03 as&#xD;
      determined by the investigator to be at least possibly related in causality to the IP&#xD;
      administration.&#xD;
&#xD;
      DLT is to be observed during the first 6-treatment cycles (1 cycle = 5 days). If none of the&#xD;
      first 3 patients experience DLT, then dose escalation will proceed for the next cohort of&#xD;
      patients unless the present dose level is level 5 (1000 mg/day). If 1 of 3 patients develops&#xD;
      DLT, the cohort will be expanded to 6 patients (another 3 patients to be added subsequently).&#xD;
      If no more than 1 of the 6 patients experiences DLT, then escalation to the next dose level&#xD;
      will proceed unless the present dose level is level 5. If more than 1 patient develops DLT in&#xD;
      any dose cohort, the dose escalation will be withheld and the prior dose level is considered&#xD;
      as the MTD unless present dose level is level 1 (200 mg/day).&#xD;
&#xD;
      Data and Safety Monitoring Board (DSMB) meeting will be held to review safety data prior to&#xD;
      each dose escalation&#xD;
&#xD;
      Cut-off criteria Enrolled patients will be treated until disease progression. This study will&#xD;
      be ended while either condition below is confirmed.&#xD;
&#xD;
        1. All patients are Disease Progression (PD) or death or loss of follow up.&#xD;
&#xD;
        2. Last treated patient receives 9-month treatment.&#xD;
&#xD;
      Duration of Treatment&#xD;
&#xD;
      TSB-9-W1 in a 5-day treatment cycle until disease progression or study cut-off.&#xD;
&#xD;
      Compensation/reward information&#xD;
&#xD;
      There is no Compensation/reward for subject attend the study.&#xD;
&#xD;
      Results&#xD;
&#xD;
      Primary Endpoint:&#xD;
&#xD;
      MTD and DLTs DCR assessed by RECIST 1.1.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 10, 2017</start_date>
  <completion_date type="Actual">August 25, 2020</completion_date>
  <primary_completion_date type="Actual">February 12, 2020</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Maximum Tolerated Dose (MTD)</measure>
    <time_frame>up to 3 years</time_frame>
    <description>DLT is to be observed during the first 6-treatment cycles (1 cycle = 5 days). If none of the first 3 patients experience DLT, then dose escalation will proceed for the next cohort of patients unless the present dose level is level 5 (1000 mg/day). If 1 of 3 patients develops DLT, the cohort will be expanded to 6 patients (another 3 patients to be added subsequently). If no more than 1 of the 6 patients experiences DLT, then escalation to the next dose level will proceed unless the present dose level is level 5. If more than 1 patient develops DLT in any dose cohort, the dose escalation will be withheld and the prior dose level is considered as the MTD unless present dose level is level 1 (200 mg/day).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Dose limiting toxicities (DLTs)</measure>
    <time_frame>30 days</time_frame>
    <description>DLT (except diarrhea) is determined by (NCI-CTCAE) version 4.03 (2010/6/14) defined treatment related toxicity ≥ grade 3 and is worsen from the baseline. Any grade ≥ 3 toxicity (except for diarrhea) is considered a DLT unless there is a clear alternative explanation as to the attribution of the adverse event. Diarrhea event is considered as a DLT if the episode is with NCI-CTCAE Grade of 3 and this event lasts &gt; 3 days despite appropriate supportive cares or if it is a Grade 4 event. Diarrhea event reaches Grade 4 will trigger the patient to withdraw from the study. AEs are evaluated according to the NCI-CTCAE version 4.03 as determined by the investigator to be at least possibly related in causality to the IP administration.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">21</enrollment>
  <condition>Metastatic Colorectal Cancer</condition>
  <arm_group>
    <arm_group_label>TSB-9-W1 cohort</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>TSB-9-W1 200 mg/day (Cohort 1) TSB-9-W1 400 mg/day (Cohort 2) TSB-9-W1 600 mg/day (Cohort 3) TSB-9-W1 800 mg/day (Cohort 4) TSB-9-W1 1000 mg/day (Cohort 5)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>TSB-9-W1</intervention_name>
    <description>Product name: TSB-9-W1 Unit dose: 100 mg per capsule Dosage form: Capsule Treatment cycle: A treatment cycle consists of 2-day on-dose oral administering and followed by a 3-day off-dose.</description>
    <arm_group_label>TSB-9-W1 cohort</arm_group_label>
    <other_name>TSB-9-W1(IDS)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Female or male, age ≥ 20 years old&#xD;
&#xD;
          2. Patient who is eligible and able to participate in the study and accepts to enter the&#xD;
             study by signing written informed consent&#xD;
&#xD;
          3. Patient has histologically or cytologically confirmed colorectal adenocarcinoma in&#xD;
             stage IV under the Tumor-Node-Metastasis (TNM) staging system&#xD;
&#xD;
          4. Patient must have at least one measurable lesion according to Response Evaluation&#xD;
             Criteria in Solid Tumors (RECIST) version 1.1&#xD;
&#xD;
          5. Patient should have received at least two prior therapies for colorectal cancer (CRC)&#xD;
             including oxaliplatin and irinotecan based regimens.&#xD;
&#xD;
          6. Patient should have received at least one of the target therapies for CRC including&#xD;
             Cetuximab, Bevacizumab, Panitumumab, Regorafenib, and Ziv-aflibercept.&#xD;
&#xD;
          7. Patient with primary major surgery needs to have elapsed ≥ 2 weeks prior to the&#xD;
             planned first study treatment day&#xD;
&#xD;
          8. Patient who has ever received chemotherapy, or immunotherapy, or biologic therapy&#xD;
             modalities need to wash-out ≥ 2 weeks prior to the baseline visit&#xD;
&#xD;
          9. Patient who has ever received radiotherapy (including chemoradiation therapy) need to&#xD;
             end the course ≥ 2 weeks before baseline visit (palliative radiotherapy can be&#xD;
             performed on non-study-related local lesions)&#xD;
&#xD;
         10. Patient's life expectancy ≥ 3 months&#xD;
&#xD;
         11. Within 4 weeks of planned first study treatment day, adequate hematopoietic functions&#xD;
             are presented:&#xD;
&#xD;
               -  Total white blood cell (WBC) ≥ 3,000 cells/mm3&#xD;
&#xD;
               -  Absolute neutrophil count (ANC) ≥ 1,500 /mm3&#xD;
&#xD;
               -  Hemoglobin (Hb) ≥ 9.0 g/dL&#xD;
&#xD;
               -  Platelets ≥ 100,000 cells/mm3&#xD;
&#xD;
         12. Within 4 weeks of planned first study treatment day, adequate hepatic and renal&#xD;
             functions (AST: aspartate aminotransferase, ALT: alanine aminotransferase, ALP:&#xD;
             alkaline phosphatase) are presented:&#xD;
&#xD;
               -  Total bilirubin ≤ 2.0 mg/dL&#xD;
&#xD;
               -  AST ≤ 3 x ULN; liver metastasis patients: AST ≤ 5 x ULN&#xD;
&#xD;
               -  ALT ≤ 3 x ULN; liver metastasis patients: ALT ≤ 5 x ULN&#xD;
&#xD;
               -  ALP ≤ 5 x ULN&#xD;
&#xD;
               -  Creatinine ≤ 1.5 mg/dL&#xD;
&#xD;
         13. Eastern Cooperative Oncology Group (ECOG) performance score ≤ 2&#xD;
&#xD;
         14. Patient can take food and drug orally&#xD;
&#xD;
         15. Male and female patients should use appropriate contraception method(s) shown below&#xD;
             during the study and at least 2 weeks after the end of treatment for female patients.&#xD;
&#xD;
               -  Total abstinence (when this is in line with the preferred and usual lifestyle of&#xD;
                  the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal,&#xD;
                  post-ovulation methods) and withdrawal are not acceptable methods of&#xD;
                  contraception).&#xD;
&#xD;
               -  Female sterilization (have had surgical bilateral oophorectomy with or without&#xD;
                  hysterectomy) or tubal ligation at least six weeks before taking study treatment.&#xD;
                  In case of oophorectomy alone, only when the reproductive status of the woman has&#xD;
                  been confirmed by follow up hormone level assessment.&#xD;
&#xD;
               -  Male sterilization (at least 6 months prior to screening). For female subjects on&#xD;
                  the study, the vasectomized male partner should be the sole partner for that&#xD;
                  subject&#xD;
&#xD;
               -  Combination of any two of the following (a+b or a+c, or b+c):&#xD;
&#xD;
                    1. Use of oral, injected or implanted hormonal methods of contraception or&#xD;
                       other forms of hormonal contraception that have comparable efficacy (failure&#xD;
                       rate &lt;1%), for example hormone vaginal ring or transdermal hormone&#xD;
                       contraception.&#xD;
&#xD;
                    2. Placement of an intrauterine device (IUD) or intrauterine system (IUS).&#xD;
&#xD;
                    3. Barrier methods of contraception: Condom or Occlusive cap (diaphragm or&#xD;
                       cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal&#xD;
                       suppository.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patient who has participated in other investigational studies within 4 weeks prior to&#xD;
             the first dose of the study medications&#xD;
&#xD;
          2. Patient has history of another malignancy within 5 years prior to study entry, except&#xD;
             curatively treated non-melanoma skin cancer, or cervical cancer in situ&#xD;
&#xD;
          3. Patient with known or suspected hypersensitivity to TSB-9-W1 or its formulation&#xD;
             excipients&#xD;
&#xD;
          4. Patient has another severe and/or life-threatening medical disease&#xD;
&#xD;
          5. Patient has immuno-compromised condition, with known autoimmune conditions or human&#xD;
             immunodeficiency virus (HIV) seropositivity&#xD;
&#xD;
          6. Patient with active systemic infections, active and clinically significant cardiac&#xD;
             diseases, clinically active gastroduodenal ulcers, or medical conditions that may&#xD;
             significantly affect adequate absorption of investigational product&#xD;
&#xD;
          7. Patient with known brain metastasis&#xD;
&#xD;
          8. Patient with medical, social or psychological factors interfering with compliance&#xD;
&#xD;
          9. Patient having grade ≥ 3 adverse event (AE) based on National Cancer Institute -&#xD;
             Common Terminology Criteria for Adverse Event (NCI-CTCAE) 4.03 except blood total&#xD;
             bilirubin, AST, ALT, ALP and creatinine at baseline visit&#xD;
&#xD;
         10. Patient having grade ≥ 1 diarrhea based on NCI-CTCAE 4.03.&#xD;
&#xD;
         11. Patient with a medical history of myocardial infraction in the last 6 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tsai-Sheng Yang, Bachelor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chang Gung Memorial Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Chang Gung Medical Foundation</name>
      <address>
        <city>Taoyuan</city>
        <zip>33305</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <reference>
    <citation>Le Tourneau C, Lee JJ, Siu LL. Dose escalation methods in phase I cancer clinical trials. J Natl Cancer Inst. 2009 May 20;101(10):708-20. doi: 10.1093/jnci/djp079. Epub 2009 May 12.</citation>
    <PMID>19436029</PMID>
  </reference>
  <reference>
    <citation>Sanoff HK, Sargent DJ, Campbell ME, Morton RF, Fuchs CS, Ramanathan RK, Williamson SK, Findlay BP, Pitot HC, Goldberg RM. Five-year data and prognostic factor analysis of oxaliplatin and irinotecan combinations for advanced colorectal cancer: N9741. J Clin Oncol. 2008 Dec 10;26(35):5721-7. doi: 10.1200/JCO.2008.17.7147. Epub 2008 Nov 10.</citation>
    <PMID>19001325</PMID>
  </reference>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>September 4, 2014</study_first_submitted>
  <study_first_submitted_qc>September 22, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2014</study_first_posted>
  <last_update_submitted>March 21, 2022</last_update_submitted>
  <last_update_submitted_qc>March 21, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 1, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>metastatic colorectal cancer</keyword>
  <keyword>TSB-9-W1</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colorectal Neoplasms</mesh_term>
  </condition_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/NCT02249650
org study id: SUNTSBA20110201
nct id: NCT02249650
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
TSB-9-W1, prepared by Taiwan Sunpan Biotechnology Co., Ltd. (TSB) is a botanical drug and
      applied patent in the United States (US patent No. 7,138,428 B2), Japan (Patent No.

      5441947) and Taiwan (Patent No. I432191 and I282280). The R&D laboratory in TSB is ISO/IEC
      17025 certified by Taiwan Accreditation Foundation (TAF) and the laboratory number is
      2026.The trade name of TSB-9-W1 is "IDS" in English, the registration number is 01472800 at
      2011 by Intellectual Property Office (IPO), Taiwan.

      A phase I and pk study to determine the Maximum Tolerated Dose (MTD) and to evaluate the
      safety and efficacy profiles of TSB-9-W1 in pre-treated patients with metastatic colorectal
      cancer (mCRC).

      there are 5 cohorts and a minimal 2 patients and up to 30 patients are required at phase I.

      This is a single arm study. All eligible patients with mCRC will receive TSB-9-W1 treatment.

      Each treatment cycle is composed by a contiguous 2-day oral administration and a contiguous
      3-day rest. Patient should take the study drug once daily before meal with approximately 250
      ml or appropriate amount of water.
Study Design

      This study is to establish the MTD of TSB-9-W1 for mCRC patients with a traditional 3+3 dose
      escalation method.

      Study Structure

      A dose escalation scenario is designed to determine the MTD according to the DLT.

      Dose escalation scale:

      The dose levels of investigation product are planned to be administered for determining MTD
      and DLT.

      Dose escalation scenario:

      Patients will be enrolled in a cohort of 3 patients for each dose level. Dose escalation will
      proceed sequentially from the lowest dose cohort. No intra-subject dose escalation is
      allowed. Each patient's first dose will be at least 3-day apart from the very next patient's
      first dose.

      DLT (except diarrhea) is determined by (NCI-CTCAE) version 4.03 (2010/6/14) defined treatment
      related toxicity ≥ grade 3 and is worsen from the baseline. Any grade ≥ 3 toxicity (except
      for diarrhea) is considered a DLT unless there is a clear alternative explanation as to the
      attribution of the adverse event. Diarrhea event is considered as a DLT if the episode is
      with NCI-CTCAE Grade of 3 and this event lasts > 3 days despite appropriate supportive cares
      or if it is a Grade 4 event. Diarrhea event reaches Grade 4 will trigger the patient to
      withdraw from the study. AEs are evaluated according to the NCI-CTCAE version 4.03 as
      determined by the investigator to be at least possibly related in causality to the IP
      administration.

      DLT is to be observed during the first 6-treatment cycles (1 cycle = 5 days). If none of the
      first 3 patients experience DLT, then dose escalation will proceed for the next cohort of
      patients unless the present dose level is level 5 (1000 mg/day). If 1 of 3 patients develops
      DLT, the cohort will be expanded to 6 patients (another 3 patients to be added subsequently).
      If no more than 1 of the 6 patients experiences DLT, then escalation to the next dose level
      will proceed unless the present dose level is level 5. If more than 1 patient develops DLT in
      any dose cohort, the dose escalation will be withheld and the prior dose level is considered
      as the MTD unless present dose level is level 1 (200 mg/day).

      Data and Safety Monitoring Board (DSMB) meeting will be held to review safety data prior to
      each dose escalation

      Cut-off criteria Enrolled patients will be treated until disease progression. This study will
      be ended while either condition below is confirmed.

        1. All patients are Disease Progression (PD) or death or loss of follow up.

        2. Last treated patient receives 9-month treatment.

      Duration of Treatment

      TSB-9-W1 in a 5-day treatment cycle until disease progression or study cut-off.

      Compensation/reward information

      There is no Compensation/reward for subject attend the study.

      Results

      Primary Endpoint:

      MTD and DLTs DCR assessed by RECIST 1.1.
allocation: N/A
intervention model: Sequential Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Maximum Tolerated Dose (MTD)
time frame: up to 3 years
description: DLT is to be observed during the first 6-treatment cycles (1 cycle = 5 days). If none of the first 3 patients experience DLT, then dose escalation will proceed for the next cohort of patients unless the present dose level is level 5 (1000 mg/day). If 1 of 3 patients develops DLT, the cohort will be expanded to 6 patients (another 3 patients to be added subsequently). If no more than 1 of the 6 patients experiences DLT, then escalation to the next dose level will proceed unless the present dose level is level 5. If more than 1 patient develops DLT in any dose cohort, the dose escalation will be withheld and the prior dose level is considered as the MTD unless present dose level is level 1 (200 mg/day).
measure: Dose limiting toxicities (DLTs)
time frame: 30 days
description: DLT (except diarrhea) is determined by (NCI-CTCAE) version 4.03 (2010/6/14) defined treatment related toxicity ≥ grade 3 and is worsen from the baseline. Any grade ≥ 3 toxicity (except for diarrhea) is considered a DLT unless there is a clear alternative explanation as to the attribution of the adverse event. Diarrhea event is considered as a DLT if the episode is with NCI-CTCAE Grade of 3 and this event lasts > 3 days despite appropriate supportive cares or if it is a Grade 4 event. Diarrhea event reaches Grade 4 will trigger the patient to withdraw from the study. AEs are evaluated according to the NCI-CTCAE version 4.03 as determined by the investigator to be at least possibly related in causality to the IP administration.
arm group label: TSB-9-W1 cohort
arm group type: Experimental
description: TSB-9-W1 200 mg/day (Cohort 1) TSB-9-W1 400 mg/day (Cohort 2) TSB-9-W1 600 mg/day (Cohort 3) TSB-9-W1 800 mg/day (Cohort 4) TSB-9-W1 1000 mg/day (Cohort 5)
intervention type: Drug
intervention name: TSB-9-W1
description: Product name: TSB-9-W1 Unit dose: 100 mg per capsule Dosage form: Capsule Treatment cycle: A treatment cycle consists of 2-day on-dose oral administering and followed by a 3-day off-dose.
arm group label: TSB-9-W1 cohort
other name: TSB-9-W1(IDS)
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Tsai-Sheng Yang, Bachelor
role: Principal Investigator
affiliation: Chang Gung Memorial Hospital
facility: 
country: Taiwan
citation: Le Tourneau C, Lee JJ, Siu LL. Dose escalation methods in phase I cancer clinical trials. J Natl Cancer Inst. 2009 May 20;101(10):708-20. doi: 10.1093/jnci/djp079. Epub 2009 May 12.
PMID: 19436029
citation: Sanoff HK, Sargent DJ, Campbell ME, Morton RF, Fuchs CS, Ramanathan RK, Williamson SK, Findlay BP, Pitot HC, Goldberg RM. Five-year data and prognostic factor analysis of oxaliplatin and irinotecan combinations for advanced colorectal cancer: N9741. J Clin Oncol. 2008 Dec 10;26(35):5721-7. doi: 10.1200/JCO.2008.17.7147. Epub 2008 Nov 10.
PMID: 19001325
responsible party type: Sponsor
mesh term: Colorectal Neoplasms
sharing ipd: No