<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/NCT04471675</url>
  </required_header>
  <id_info>
    <org_study_id>HB1801-CSP-001</org_study_id>
    <nct_id>NCT04471675</nct_id>
  </id_info>
  <brief_title>Evaluation of the Safety and Efficacy of Albumin-bound Docetaxel</brief_title>
  <official_title>Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of Albumin-bound Formulation of Docetaxel for Intravenous Infusion in Patients With Advanced Solid Tumors: A Phase 1, Single-center, Open-label, Dose-escalation Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>CSPC ZhongQi Pharmaceutical Technology Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>CSPC ZhongQi Pharmaceutical Technology Co., Ltd.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This trial is an open-label, single-center, dose-escalation and cohort-expansion Phase I&#xD;
      clinical study in patients with advanced solid tumors. The aim of this study is designed to&#xD;
      evaluate the safety, tolerability, pharmacokinetics and preliminary antitumor activity of&#xD;
      albumin-bound formulation of docetaxel for intravenous infusion in patients with advanced&#xD;
      solid tumors.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study was conducted in two stages. The first stage (Stage I) is a dose-escalation study.&#xD;
      A classic 3+3 design will be used to determine the maximum tolerated dose (MTD) and the&#xD;
      recommended Phase 2 dose (RP2D). Patients with advanced solid tumors will be assigned to&#xD;
      receive sequentially higher doses of albumin-bound formulation of docetaxel once every three&#xD;
      weeks (a Cycle) by intravenous infusion, starting at a dose of 50mg/m2. Patients will receive&#xD;
      the albumin-bound formulation of docetaxel&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 2, 2020</start_date>
  <completion_date type="Anticipated">December 15, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 15, 2022</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>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of participants who experienced AE during cycle1.</measure>
    <time_frame>21 days.</time_frame>
    <description>AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product/protocol specified procedure, whether or not considered related to the medicinal product/protocol specified procedure. Any worsening of a preexisting condition temporally associated with the use of the product was also an AE.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants who experienced DLT during cycle1.</measure>
    <time_frame>21 days.</time_frame>
    <description>A DLT was graded using the National Cancer Institute-Common Toxicity Criteria for Adverse Events (NCI-CTCAE) version 4.02 and defined as any of the following: grade 3 or 4 non-hematologic adverse events unless they were not optimally treated with supportive care; grade 3 or 4 asymptomatic laboratory abnormal values lasting &gt;7 days; prolonged grade 2 toxicity (lasting more than 2 weeks) leading to treatment interruption and/or dose reduction; pancytopenia with a hypocellular bone marrow and no marrow blasts lasting ≥6 weeks (AL participants); grade 3 neutropenia with fever or infection (OHM participants); grade 3 thrombocytopenia with bleeding (OHM participants); or grade 4 neutropenia or thrombocytopenia, regardless of symptoms and lasting ≥3 days (OHM participants).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Classic 3+3 design to determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D)</measure>
    <time_frame>Through study completion, an average of 1 year.</time_frame>
    <description>The maximum tolerated dose (MTD) (if available) and recommended Phase 2 dose (RP2D) of Albumin-bound Docetaxel.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Area under the concentration-time curve of Albumin-bound Docetaxel from time 0 to last (AUC 0-∞)</measure>
    <time_frame>21 days.</time_frame>
    <description>The pharmacokinetic parameters AUC0-last of Albumin-bound Docetaxel.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the concentration-time curve of Albumin-bound Docetaxel from time 0 to infinity (AUC 0-∞)</measure>
    <time_frame>21 days.</time_frame>
    <description>The pharmacokinetic parameters AUC0-∞ of Albumin-bound Docetaxel.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Observed maximum concentration (Cmax )of Albumin-bound Docetaxel</measure>
    <time_frame>21 days.</time_frame>
    <description>The pharmacokinetic parameters Cmax of Albumin-bound Docetaxel.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to maximum concentration (Tmax) of Albumin-bound Docetaxel</measure>
    <time_frame>21 days.</time_frame>
    <description>The pharmacokinetic parameters Tmax of Albumin-bound Docetaxel.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apparent terminal Half-Life (t1/2) of Albumin-bound Docetaxel</measure>
    <time_frame>21 days.</time_frame>
    <description>The pharmacokinetic parameters t½ of Albumin-bound Docetaxel.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apparent total body clearance (CL/F) of Albumin-bound Docetaxel</measure>
    <time_frame>21 days.</time_frame>
    <description>The pharmacokinetic parameters CL/F of Albumin-bound Docetaxel.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Objective response rate (ORR)</measure>
    <time_frame>Through study completion, an average of 1 year.</time_frame>
    <description>Efficacy measures overall response rate (ORR) of Albumin-bound Docetaxel.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression free survival (PFS)</measure>
    <time_frame>Through study completion, an average of 1 year.</time_frame>
    <description>Efficacy measures progression-free survival (PFS) of Albumin-bound Docetaxel.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease control rate (DCR)</measure>
    <time_frame>Through study completion, an average of 1 year.</time_frame>
    <description>Efficacy measures disease control rate (DCR) of Albumin-bound Docetaxel.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of response (DOR)</measure>
    <time_frame>Through study completion, an average of 1 year.</time_frame>
    <description>Efficacy measures duration of response (DOR) of Albumin-bound Docetaxel.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Biomarkers of Albumin-bound Docetaxel.</measure>
    <time_frame>21 days.</time_frame>
    <description>The correlation between the AAG level(in plasma) and albumin-bound docetaxel.</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">208</enrollment>
  <condition>Advanced Solid Tumors</condition>
  <arm_group>
    <arm_group_label>Experimental: solid tumors</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Albumin-bound docetaxel by intravenous infusion.Patients receive albumin-bound docetaxel once every three weeks (a Cycle), starting at a dose of 50mg/m2.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Albumin-bound docetaxel</intervention_name>
    <description>Albumin-bound docetaxel by intravenous infusion.</description>
    <arm_group_label>Experimental: solid tumors</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age ≥18, ≤75 years, no gender limitation；&#xD;
&#xD;
          2. Histologically or cytologically confirmed diagnosis of advanced or metastatic solid&#xD;
             tumors, for which standard therapy either does not exist or has proven to be&#xD;
             ineffective, intolerable or unacceptable for the patient；&#xD;
&#xD;
          3. At least one measurable lesion as per RECIST version 1.1；&#xD;
&#xD;
          4. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1；&#xD;
&#xD;
          5. Life expectancy ≥3 months；&#xD;
&#xD;
          6. Adequate bone marrow, cardiac, liver and renal function；&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Chemotherapy, radiotherapy, biotherapy, endocrine therapy, targeted therapy,&#xD;
             immunotherapy and other anti-tumor treatment within 4 weeks of the first dose of the&#xD;
             study drug, 6 weeks for mitomycin C or nitrosoureas, 2 weeks (or 5 half-lives&#xD;
             whichever is longer) for using fluorouracil or small molecule targeted drugs, 2 weeks&#xD;
             for using traditional Chinese medicine with anti-tumor indications；&#xD;
&#xD;
          2. Currently enrolled in any other clinical study, or administration of other&#xD;
             investigational agents w&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Bi Feng, Chief doctor</last_name>
    <phone>028-85423203</phone>
    <email>bifenggcp@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>West China Hospital of Sichuan University</name>
      <address>
        <city>Chengdu</city>
        <state>Sichuan</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Bi Feng</last_name>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>July 7, 2020</study_first_submitted>
  <study_first_submitted_qc>July 14, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 15, 2020</study_first_posted>
  <last_update_submitted>January 27, 2022</last_update_submitted>
  <last_update_submitted_qc>January 27, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 31, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Docetaxel</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04471675
org study id: HB1801-CSP-001
nct id: NCT04471675
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This trial is an open-label, single-center, dose-escalation and cohort-expansion Phase I
      clinical study in patients with advanced solid tumors. The aim of this study is designed to
      evaluate the safety, tolerability, pharmacokinetics and preliminary antitumor activity of
      albumin-bound formulation of docetaxel for intravenous infusion in patients with advanced
      solid tumors.
This study was conducted in two stages. The first stage (Stage I) is a dose-escalation study.
      A classic 3+3 design will be used to determine the maximum tolerated dose (MTD) and the
      recommended Phase 2 dose (RP2D). Patients with advanced solid tumors will be assigned to
      receive sequentially higher doses of albumin-bound formulation of docetaxel once every three
      weeks (a Cycle) by intravenous infusion, starting at a dose of 50mg/m2. Patients will receive
      the albumin-bound formulation of docetaxel
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of participants who experienced AE during cycle1.
time frame: 21 days.
description: AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product/protocol specified procedure, whether or not considered related to the medicinal product/protocol specified procedure. Any worsening of a preexisting condition temporally associated with the use of the product was also an AE.
measure: Number of participants who experienced DLT during cycle1.
time frame: 21 days.
description: A DLT was graded using the National Cancer Institute-Common Toxicity Criteria for Adverse Events (NCI-CTCAE) version 4.02 and defined as any of the following: grade 3 or 4 non-hematologic adverse events unless they were not optimally treated with supportive care; grade 3 or 4 asymptomatic laboratory abnormal values lasting >7 days; prolonged grade 2 toxicity (lasting more than 2 weeks) leading to treatment interruption and/or dose reduction; pancytopenia with a hypocellular bone marrow and no marrow blasts lasting ≥6 weeks (AL participants); grade 3 neutropenia with fever or infection (OHM participants); grade 3 thrombocytopenia with bleeding (OHM participants); or grade 4 neutropenia or thrombocytopenia, regardless of symptoms and lasting ≥3 days (OHM participants).
measure: Classic 3+3 design to determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D)
time frame: Through study completion, an average of 1 year.
description: The maximum tolerated dose (MTD) (if available) and recommended Phase 2 dose (RP2D) of Albumin-bound Docetaxel.
measure: Area under the concentration-time curve of Albumin-bound Docetaxel from time 0 to last (AUC 0-∞)
time frame: 21 days.
description: The pharmacokinetic parameters AUC0-last of Albumin-bound Docetaxel.
measure: Area under the concentration-time curve of Albumin-bound Docetaxel from time 0 to infinity (AUC 0-∞)
time frame: 21 days.
description: The pharmacokinetic parameters AUC0-∞ of Albumin-bound Docetaxel.
measure: Observed maximum concentration (Cmax )of Albumin-bound Docetaxel
time frame: 21 days.
description: The pharmacokinetic parameters Cmax of Albumin-bound Docetaxel.
measure: Time to maximum concentration (Tmax) of Albumin-bound Docetaxel
time frame: 21 days.
description: The pharmacokinetic parameters Tmax of Albumin-bound Docetaxel.
measure: Apparent terminal Half-Life (t1/2) of Albumin-bound Docetaxel
time frame: 21 days.
description: The pharmacokinetic parameters t½ of Albumin-bound Docetaxel.
measure: Apparent total body clearance (CL/F) of Albumin-bound Docetaxel
time frame: 21 days.
description: The pharmacokinetic parameters CL/F of Albumin-bound Docetaxel.
measure: Objective response rate (ORR)
time frame: Through study completion, an average of 1 year.
description: Efficacy measures overall response rate (ORR) of Albumin-bound Docetaxel.
measure: Progression free survival (PFS)
time frame: Through study completion, an average of 1 year.
description: Efficacy measures progression-free survival (PFS) of Albumin-bound Docetaxel.
measure: Disease control rate (DCR)
time frame: Through study completion, an average of 1 year.
description: Efficacy measures disease control rate (DCR) of Albumin-bound Docetaxel.
measure: Duration of response (DOR)
time frame: Through study completion, an average of 1 year.
description: Efficacy measures duration of response (DOR) of Albumin-bound Docetaxel.
measure: Biomarkers of Albumin-bound Docetaxel.
time frame: 21 days.
description: The correlation between the AAG level(in plasma) and albumin-bound docetaxel.
arm group label: Experimental: solid tumors
arm group type: Experimental
description: Albumin-bound docetaxel by intravenous infusion.Patients receive albumin-bound docetaxel once every three weeks (a Cycle), starting at a dose of 50mg/m2.
intervention type: Drug
intervention name: Albumin-bound docetaxel
description: Albumin-bound docetaxel by intravenous infusion.
arm group label: Experimental: solid tumors
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Bi Feng, Chief doctor
phone: 028-85423203
email: bifenggcp@163.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Docetaxel
sharing ipd: Undecided