- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04811118
The Comparison of the Pharmacokinetics of Albumin-bound Docetaxel and Taxotere
January 27, 2022 updated by: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
A Randomized, Open-label, Two-period, Crossover Trial to Compare the Pharmacokinetic Profiles Between Albumin-bound Docetaxel and Taxotere in Patients With Advanced Solid Tumors
This is a randomized, open-label, two-period, crossover trial to evaluate the pharmacokinetic profiles of albumin-bound docetaxel for intravenous infusion and Taxotere in patients with advanced solid tumors.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
The trial will be performed as a randomized, open-label, two-period crossover trial to compare the test drug (T, albumin-bound docetaxel) to the reference drug (R, Taxotere).
Approximately 28 subjects will be randomized to the two treatment sequences (T-R or R-T) at the ratio of 1:1.
Each enrolled subject will receive an intravenous infusion of the reference drug and the test drug in two treatment periods per the randomization schedule.
The treatment periods will be separated by a washout period of 21 to 35 days.
After completing two cycles of treatments, subjects may continue to receive the treatment used in the second cycle according to the responses (up to 1 year).
Study Type
Interventional
Enrollment (Actual)
27
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Cangzhou, China
- Cangzhou Central Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age ≥18, ≤65 years, no gender limitation;
- 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, unacceptable or with other limitations for the patient;
- At least one measurable lesion as per RECIST version 1.1;
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1;
- Life expectancy ≥3 months;
- Major organ function within 7 days prior to treatment meets the following criteria (no blood transfusion, EPO, G-CSF or other medical support within 14 days prior to study drug administration): ANC≥1.5×109/L,PLT≥100×109/L,Hb≥90g/L or≥5.6 mmol/L;Cr≤1.5×ULN and creatinine clearance rate≥50ml/min;TBIL≤1.0×ULN,AAG≥1.0×LLN,except for those with AST/ALT>1.5 × ULN and ALP>2.5× ULN;
- Patients of childbearing potential must agree to use effective contraceptive measures (such as IUD, contraceptive pill or condom) during the period of the trial and for at least 6 months after completion of the study. Female patients must be negative on the serum pregnancy test within 7 days before enrollment, and must be nonlactating. Male patients refrains from donating sperm during the study period and for at least 6 months after completion of the study;
- Signed informed consent form.
Exclusion Criteria:
- Treatment failure of prior docetaxel or paclitaxel treatment (such as: patients who relapse within 6 months after last treatment);
- 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;
- Currently enrolled in any other clinical study, or administration of other investigational agents within 4 weeks of the first dose of the study drug;
- Major surgery (excluding biopsy) or significant trauma within 4 weeks of the first dose of the study drug. Or have a surgical schedule during the study period.
- Administration of glucocorticoids or other immunosuppressants within 14 days prior to the first dose of d the study drug.Local, ocular, intraarticular, intranasal, inhaled glucocorticoids, and a short-term use of glucocorticoids for preventive treatment is allowed;
- Concomitant use of strong CYP3A4 inhibitors or inducers within 14 days of the first dose of the study drug;
- Allergic history to Taxanes or any excipients of the study drug (CTCAE 5.0 grade ≥ 3 grade);
- Adverse reactions from the previous anti-tumor treatment have not yet recovered to ≤ level 1 based on CTCAE 5.0 (except for the toxicity without safety risk judged by the investigator, such as hair loss);
- Central nervous system metastasis or meningeal metastasis with clinical symptoms, or other evidence shows that the patient's central nervous system metastasis or meningeal metastasis has not been controlled and not suitable for the study according to the judgment of the investigator;
- History of autoimmune diseases, immunodeficiency, including HIV positive, or other acquired, congenital immunodeficiency, or organ transplant history;
- Known Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), or other active viral infection;
- History of serious cardiovascular disease;
- Uncontrollable effusion (eg. large amount of pleural effusion, ascites or pericardial effusion);
- Known alcohol or drug abuse;
- Visual impairment such as cystoid macular edema;
- History of neurological or psychiatric disorders;
- Homozygous carriers of ABCB1-1236C>T(rs1128503);
- Not suitable for this study as determined by the investigator due to other reasons.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Albumin-bound docetaxel
Subjects will receive albumin-bound docetaxel via intravenous infusion (IV) once every three weeks (a cycle), at the dose of 75mg/m2
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Docetaxel for Injection (Albumin-bound) by intravenous infusion
Other Names:
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Experimental: Taxotere
Subjects will receive Taxotere via intravenous infusion once every three weeks (a cycle), at the dose of 75mg/m2.
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Taxotere
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The pharmacokinetic parameters (free docetaxel and total docetaxel) : Cmax
Time Frame: At the end of Cycle 2 (each cycle is 21 days)
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Peak Plasma Concentration (Cmax)
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At the end of Cycle 2 (each cycle is 21 days)
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The pharmacokinetic parameters (free docetaxel and total docetaxel) : AUC0-t、AUC0-∞
Time Frame: At the end of Cycle 2 (each cycle is 21 days)
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Area under the plasma concentration versus time curve (AUC)
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At the end of Cycle 2 (each cycle is 21 days)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
1.The occurrence and frequency of adverse events and serious adverse events
Time Frame: through study completion, up to 18 weeks
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1.
The occurrence and frequency of adverse events and serious adverse events
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through study completion, up to 18 weeks
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2. 1 Efficacy measures such as overall response rate (ORR)
Time Frame: through study completion, up to 18 weeks
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overall response rate (ORR)
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through study completion, up to 18 weeks
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2. 2 Efficacy measures such as progression-free survival (PFS)
Time Frame: through study completion, up to 18 weeks
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progression-free survival (PFS)
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through study completion, up to 18 weeks
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2.3 Efficacy measures such as disease control rate (DCR)
Time Frame: through study completion, up to 18 weeks
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disease control rate (DCR)
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through study completion, up to 18 weeks
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2. 4 Efficacy measures such as duration of response (DOR).
Time Frame: through study completion, up to 18 weeks
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duration of response (DOR)
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through study completion, up to 18 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Hui Shan, master, CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 18, 2021
Primary Completion (Anticipated)
October 31, 2022
Study Completion (Anticipated)
December 31, 2022
Study Registration Dates
First Submitted
March 10, 2021
First Submitted That Met QC Criteria
March 19, 2021
First Posted (Actual)
March 23, 2021
Study Record Updates
Last Update Posted (Actual)
January 31, 2022
Last Update Submitted That Met QC Criteria
January 27, 2022
Last Verified
June 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HB1801-CSP-002
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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