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Evaluation of the Safety and Efficacy of Albumin-bound Docetaxel

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ClinicalTrials.gov Identifier: NCT04471675
Recruitment Status : Recruiting
First Posted : July 15, 2020
Last Update Posted : January 5, 2021
Sponsor:
Information provided by (Responsible Party):
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumors Drug: Albumin-bound docetaxel Phase 1

Detailed Description:
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
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 208 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : December 2, 2020
Estimated Primary Completion Date : March 15, 2022
Estimated Study Completion Date : July 15, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Docetaxel

Arms and Interventions
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Arm Intervention/treatment
Experimental: Experimental: solid tumors
Albumin-bound docetaxel by intravenous infusion.Patients receive albumin-bound docetaxel once every three weeks (a Cycle), starting at a dose of 50mg/m2.
 Drug: Albumin-bound docetaxel
Albumin-bound docetaxel by intravenous infusion.


Outcome Measures
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Primary Outcome Measures :
  1. Number of participants who experienced AE during cycle1. [ Time Frame: 21 days. ]
    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.

  2. Number of participants who experienced DLT during cycle1. [ Time Frame: 21 days. ]
    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).

  3. 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. ]
    The maximum tolerated dose (MTD) (if available) and recommended Phase 2 dose (RP2D) of Albumin-bound Docetaxel.


Secondary Outcome Measures :
  1. Area under the concentration-time curve of Albumin-bound Docetaxel from time 0 to last (AUC 0-∞) [ Time Frame: 21 days. ]
    The pharmacokinetic parameters AUC0-last of Albumin-bound Docetaxel.

  2. Area under the concentration-time curve of Albumin-bound Docetaxel from time 0 to infinity (AUC 0-∞) [ Time Frame: 21 days. ]
    The pharmacokinetic parameters AUC0-∞ of Albumin-bound Docetaxel.

  3. Observed maximum concentration (Cmax )of Albumin-bound Docetaxel [ Time Frame: 21 days. ]
    The pharmacokinetic parameters Cmax of Albumin-bound Docetaxel.

  4. Time to maximum concentration (Tmax) of Albumin-bound Docetaxel [ Time Frame: 21 days. ]
    The pharmacokinetic parameters Tmax of Albumin-bound Docetaxel.

  5. Apparent terminal Half-Life (t1/2) of Albumin-bound Docetaxel [ Time Frame: 21 days. ]
    The pharmacokinetic parameters t½ of Albumin-bound Docetaxel.

  6. Apparent total body clearance (CL/F) of Albumin-bound Docetaxel [ Time Frame: 21 days. ]
    The pharmacokinetic parameters CL/F of Albumin-bound Docetaxel.

  7. Objective response rate (ORR) [ Time Frame: Through study completion, an average of 1 year. ]
    Efficacy measures overall response rate (ORR) of Albumin-bound Docetaxel.

  8. Progression free survival (PFS) [ Time Frame: Through study completion, an average of 1 year. ]
    Efficacy measures progression-free survival (PFS) of Albumin-bound Docetaxel.

  9. Disease control rate (DCR) [ Time Frame: Through study completion, an average of 1 year. ]
    Efficacy measures disease control rate (DCR) of Albumin-bound Docetaxel.

  10. Duration of response (DOR) [ Time Frame: Through study completion, an average of 1 year. ]
    Efficacy measures duration of response (DOR) of Albumin-bound Docetaxel.


Other Outcome Measures:
  1. Biomarkers of Albumin-bound Docetaxel. [ Time Frame: 21 days. ]
    The correlation between the AAG level(in plasma) and albumin-bound docetaxel.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age ≥18, ≤75 years, no gender limitation；
  2. Histologically or cytologically confirmed diagnosis of advanced or metastatic solid tumors, for which standard therapy either does not exist or has proven to be ineffective, intolerable or unacceptable for the patient；
  3. At least one measurable lesion as per RECIST version 1.1；
  4. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1；
  5. Life expectancy ≥3 months；
  6. Adequate bone marrow, cardiac, liver and renal function；

Exclusion Criteria:

  1. Chemotherapy, radiotherapy, biotherapy, endocrine therapy, targeted therapy, immunotherapy and other anti-tumor treatment within 4 weeks of the first dose of the study drug, 6 weeks for mitomycin C or nitrosoureas, 2 weeks (or 5 half-lives whichever is longer) for using fluorouracil or small molecule targeted drugs, 2 weeks for using traditional Chinese medicine with anti-tumor indications；
  2. Currently enrolled in any other clinical study, or administration of other investigational agents w
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04471675


Contacts
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Contact: Bi Feng, Chief doctor 028-85423203 bifenggcp@163.com

Locations
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China, Sichuan
West China Hospital of Sichuan University Recruiting
Chengdu, Sichuan, China
Contact: Bi Feng         
Sponsors and Collaborators
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
More Information
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Responsible Party: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
ClinicalTrials.gov Identifier: NCT04471675    
Other Study ID Numbers: HB1801-CSP-001
First Posted: July 15, 2020    Key Record Dates
Last Update Posted: January 5, 2021
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Docetaxel
Antineoplastic Agents
Tubulin Modulators
 Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action