The Comparison of the Pharmacokinetics of Albumin-bound Docetaxel and Taxotere

NCT04811118 | Unknown Phase 1

• 1 other identifier: HB1801-CSP-002
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (2)

• The pharmacokinetic parameters (free docetaxel and total docetaxel) : Cmax

  Peak Plasma Concentration (Cmax)

  At the end of Cycle 2 (each cycle is 21 days)

• The pharmacokinetic parameters (free docetaxel and total docetaxel) : AUC0-t、AUC0-∞

  Area under the plasma concentration versus time curve (AUC)

  At the end of Cycle 2 (each cycle is 21 days)

Secondary Outcomes (5)

• 1.The occurrence and frequency of adverse events and serious adverse events

  through study completion, up to 18 weeks

• 2. 1 Efficacy measures such as overall response rate (ORR)

  through study completion, up to 18 weeks

• 2. 2 Efficacy measures such as progression-free survival (PFS)

  through study completion, up to 18 weeks

• 2.3 Efficacy measures such as disease control rate (DCR)

  through study completion, up to 18 weeks

• 2. 4 Efficacy measures such as duration of response (DOR).

  through study completion, up to 18 weeks

Study Arms (2)

Albumin-bound docetaxel

EXPERIMENTAL

Subjects will receive albumin-bound docetaxel via intravenous infusion (IV) once every three weeks (a cycle), at the dose of 75mg/m2

Drug: Docetaxel for Injection (Albumin-bound)

Taxotere

EXPERIMENTAL

Subjects will receive Taxotere via intravenous infusion once every three weeks (a cycle), at the dose of 75mg/m2.

Drug: Taxotere

Interventions

Docetaxel for Injection (Albumin-bound) DRUG

Docetaxel for Injection (Albumin-bound) by intravenous infusion

Also known as: Docetaxel

Albumin-bound docetaxel

Taxotere DRUG

Taxotere

Also known as: Docetaxel

Taxotere

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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；

Sponsors & Collaborators

• CSPC ZhongQi Pharmaceutical Technology Co., Ltd.: lead

Study Sites (1)

Cangzhou Central Hospital

Cangzhou, China

Location

MeSH Terms

Interventions

Docetaxel; Injections

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Hui Shan, master

  CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2021
• First Posted: March 23, 2021
• Study Start: May 18, 2021
• Primary Completion: October 31, 2022
• Study Completion: December 31, 2022
• Last Updated: January 31, 2022

Record last verified: 2021-06

Locations

CN (1)