Clinical trial NCT04471675: Evaluation of the Safety and Efficacy of Albumin-bound Docetaxel
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Advanced Solid Tumors
Lead sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-07-15
Enrollment: 208
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Eligibility 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

Primary outcomes:
measure: Number of participants who experienced AE during cycle1.
timeFrame: 21 days.
measure: Number of participants who experienced DLT during cycle1.
timeFrame: 21 days.
measure: Classic 3+3 design to determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D)
timeFrame: Through study completion, an average of 1 year.
Secondary outcomes:
measure: Area under the concentration-time curve of Albumin-bound Docetaxel from time 0 to last (AUC 0-∞)
timeFrame: 21 days.
measure: Area under the concentration-time curve of Albumin-bound Docetaxel from time 0 to infinity (AUC 0-∞)
timeFrame: 21 days.
measure: Observed maximum concentration (Cmax )of Albumin-bound Docetaxel
timeFrame: 21 days.
measure: Time to maximum concentration (Tmax) of Albumin-bound Docetaxel
timeFrame: 21 days.
measure: Apparent terminal Half-Life (t1/2) of Albumin-bound Docetaxel
timeFrame: 21 days.
measure: Apparent total body clearance (CL/F) of Albumin-bound Docetaxel
timeFrame: 21 days.
measure: Objective response rate (ORR)
timeFrame: Through study completion, an average of 1 year.
measure: Progression free survival (PFS)
timeFrame: Through study completion, an average of 1 year.
measure: Disease control rate (DCR)
timeFrame: Through study completion, an average of 1 year.
measure: Duration of response (DOR)
timeFrame: Through study completion, an average of 1 year.
Other outcomes:
measure: Biomarkers of Albumin-bound Docetaxel.
timeFrame: 21 days.
Locations:
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
state: Sichuan
Study officials:
References: