Evaluation of the Safety and Efficacy of Albumin-bound Docetaxel

NCT04471675 | Unknown Phase 1

• 1 other identifier: HB1801-CSP-001
• Study Type: interventional
• Target: 208
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (3)

• Number of participants who experienced AE during cycle1.

  AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product/protocol specified procedure, whether or not considered related to the medicinal product/protocol specified procedure. Any worsening of a preexisting condition temporally associated with the use of the product was also an AE.

  21 days.

• Number of participants who experienced DLT during cycle1.

  A DLT was graded using the National Cancer Institute-Common Toxicity Criteria for Adverse Events (NCI-CTCAE) version 4.02 and defined as any of the following: grade 3 or 4 non-hematologic adverse events unless they were not optimally treated with supportive care; grade 3 or 4 asymptomatic laboratory abnormal values lasting \>7 days; prolonged grade 2 toxicity (lasting more than 2 weeks) leading to treatment interruption and/or dose reduction; pancytopenia with a hypocellular bone marrow and no marrow blasts lasting ≥6 weeks (AL participants); grade 3 neutropenia with fever or infection (OHM participants); grade 3 thrombocytopenia with bleeding (OHM participants); or grade 4 neutropenia or thrombocytopenia, regardless of symptoms and lasting ≥3 days (OHM participants).

  21 days.

• Classic 3+3 design to determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D)

  The maximum tolerated dose (MTD) (if available) and recommended Phase 2 dose (RP2D) of Albumin-bound Docetaxel.

  Through study completion, an average of 1 year.

Secondary Outcomes (10)

• Area under the concentration-time curve of Albumin-bound Docetaxel from time 0 to last (AUC 0-∞)

  21 days.

• Area under the concentration-time curve of Albumin-bound Docetaxel from time 0 to infinity (AUC 0-∞)

  21 days.

• Observed maximum concentration (Cmax )of Albumin-bound Docetaxel

  21 days.

• Time to maximum concentration (Tmax) of Albumin-bound Docetaxel

  21 days.

• Apparent terminal Half-Life (t1/2) of Albumin-bound Docetaxel

  21 days.

Other Outcomes (1)

• Biomarkers of Albumin-bound Docetaxel.

  21 days.

Study Arms (1)

Experimental: solid tumors

EXPERIMENTAL

Albumin-bound docetaxel by intravenous infusion.Patients receive albumin-bound docetaxel once every three weeks (a Cycle), starting at a dose of 50mg/m2.

Drug: Albumin-bound docetaxel

Interventions

Albumin-bound docetaxel DRUG

Albumin-bound docetaxel by intravenous infusion.

Experimental: solid tumors

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18, ≤75 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 or unacceptable 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；
• Adequate bone marrow, cardiac, liver and renal function；

You may not qualify if:

• 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 w

Sponsors & Collaborators

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

Study Sites (1)

West China Hospital of Sichuan University

Chengdu, Sichuan, China

RECRUITING

Central Study Contacts

Bi Feng, Chief doctor

CONTACT

028-85423203; bifenggcp@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2020
• First Posted: July 15, 2020
• Study Start: December 2, 2020
• Primary Completion: December 15, 2022
• Study Completion: December 15, 2023
• Last Updated: January 31, 2022

Record last verified: 2022-01

Locations

CN (1)