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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
27
Docetaxel for Injection (Albumin-bound) by intravenous infusion
Taxotere
Cangzhou Central Hospital
Cangzhou, China
The pharmacokinetic parameters (free docetaxel and total docetaxel) : Cmax
Peak Plasma Concentration (Cmax)
Time frame: 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)
Time frame: At the end of Cycle 2 (each cycle is 21 days)
1.The occurrence and frequency of adverse events and serious adverse events
1\. The occurrence and frequency of adverse events and serious adverse events
Time frame: through study completion, up to 18 weeks
2. 1 Efficacy measures such as overall response rate (ORR)
overall response rate (ORR)
Time frame: through study completion, up to 18 weeks
2. 2 Efficacy measures such as progression-free survival (PFS)
progression-free survival (PFS)
Time frame: through study completion, up to 18 weeks
2.3 Efficacy measures such as disease control rate (DCR)
disease control rate (DCR)
Time frame: through study completion, up to 18 weeks
2. 4 Efficacy measures such as duration of response (DOR).
duration of response (DOR)
Time frame: through study completion, up to 18 weeks
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