The aim of this study is designed to evaluate the safety, tolerability, pharmacokinetics and preliminary antitumor activity of docetaxel for injection (albumin-bound) in different dose regimens in patients with advanced solid tumors.
This study will be 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 will receive the docetaxel for injection (albumin-bound) until disease progression, or intolerable toxicity, or other reasons for termination of the study. All dose-escalation decisions will be based on the safety data generated from the current highest dose group. In the cohort-expansion study (Stage Ⅱ), patients with a potential to have better response to the study drug will be recruited. Patients will receive the docetaxel for injection (albumin-bound) at the recommended phase 2 dose (RP2D) and follow the treatment regimen established in Stage I.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
144
Albumin-bound docetaxel by intravenous infusion
Liu yunjiang
Shijiazhuang, Hebei, China
RECRUITINGThe occurrence and frequency of adverse events and serious adverse events
Incidence of adverse events and serious adverse events
Time frame: Up to approximately 2 years
The maximum tolerated dose (MTD) (if available) and recommended phase 2 dose (RP2D) in stage I
The maximum tolerated dose
Time frame: At the end of Cycle 1 (each cycle is 28 or 21 days)
Overall response rate (ORR) in stage Ⅱ
Objective response rate
Time frame: Up to approximately 2 years
Progression-free survival (PFS) in stage Ⅱ
Progression-free survival
Time frame: Up to approximately 2 years
Disease control rate (DCR) in stage Ⅱ
Disease control rate
Time frame: Up to approximately 2 years
Duration of response (DOR) in stage Ⅱ
Duration of response
Time frame: Up to approximately 2 years
Area under the plasma concentration-time curve from time 0 to time of last quantifiable concentration (AUC0-last)
Area under the plasma concentration-time curve
Time frame: At the end of Cycle 1 (each cycle is 28 or 21 days)
Area under the plasma concentration-time curve from time 0 to infinity (AUC0-inf)
Area under the plasma concentration-time curve
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: At the end of Cycle 1 (each cycle is 28 or 21 days)
Maximum plasma concentration (Cmax)
Maximum plasma concentration
Time frame: At the end of Cycle 1 (each cycle is 28 or 21 days)
Time to maximum plasma concentration (Tmax)
Time to maximum plasma concentration
Time frame: At the end of Cycle 1 (each cycle is 28 or 21 days)
Plasma half-life (t½)
Plasma half-life
Time frame: At the end of Cycle 1 (each cycle is 28 or 21 days)
Volume of distribution (Vd)
Volume of distribution
Time frame: At the end of Cycle 1 (each cycle is 28 or 21 days)
Plasma clearance (CL)
Plasma clearance
Time frame: At the end of Cycle 1 (each cycle is 28 or 21 days)
Cumulative urinary excretion rate of docetaxel prototypes
Cumulative urinary excretion rate of docetaxel prototypes
Time frame: At the end of Cycle 1 (each cycle is 28 or 21 days)
Preliminary identification of major metabolites in plasma and urine samples
Preliminary identification of major metabolites in plasma and urine samples
Time frame: At the end of Cycle 1 (each cycle is 28 or 21 days)