A Pharmacokinetic Comparison Study of SYHX2011 and Abraxane® in Patients With Advanced Breast Cancer

A Randomized, Open-label, Two-cycle Crossover Pharmacokinetic Comparison Study of SYHX2011 and Abraxane® in Patients With Advanced Breast Cancer

This is a multi-center, open-label, pharmacokinetic comparison study of SYHX2011 and Abraxane® in patients with advanced breast cancers after single IV infusion.

Study Overview

• Status: Not yet recruiting
• Conditions: Advanced Breast Cancer
• Intervention / Treatment: Drug: SYHX2011 and Abraxane®

• Study Type: Interventional
• Enrollment (Anticipated): 28
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Mingxia Wang; Phone Number: 86-0311-66696233; Email: mxia_wang@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

1. Voluntarily sign the written informed consent.
2. Female patients aged 18 to 75 years (inclusive).
3. Histologically and/or cytologically diagnosed advanced breast cancer.
4. Patients who are receiving paclitaxel for injection (albumin bound) monotherapy or who, in the judgement of the investigator, may benefit from monotherapy with the trial formulation.
5. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
6. Expected survival time ≥3 months.

7. The results of hematological, renal, and hepatic function are within the following ranges:

   White blood cell count (WBC) ≥3.0 × 10^9/L; Absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L; Platelet count (PLT)≥ 100 × 10^9/L; Hemoglobin (Hb) ≥ 90 g/L; Prothrombin time (PT)/activated partial thrombin time (APTT) ≤1.5 × ULN; Total bilirubin (TBIL) ≤ 1.5 × ULN; AST、ALT ≤ 2.5 × ULN (≤5 × ULN in patients with liver metastasis); Serum creatinine ≤ 1.5 × ULN.

8. Patients have no pregnancy plan within 6 months after entering the study, voluntarily take effective contraceptive measures, and have no egg donation plan.
9. Fully understand the purpose and requirements of this trial, and can complete the whole trial process according to the test requirements.

Exclusion Criteria:

1. Have severe allergy to paclitaxel drugs or human serum albumin, or history of significant hypersensitivity or idiosyncratic reaction.
2. Patients with serious medical conditions are considered unsuitable for inclusion by the investigator.
3. Patients who have undergone major surgery within 3 months prior to screening or planned to have major surgery during the study period.
4. Have a history of alcohol, drug abuse or drug addiction.
5. Patients who are pregnant or breasting.
6. Patients with one or more positive tests for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab), human immunodeficiency virus (HIV) or treponema pallidum antibody.
7. Received anti-tumor therapy such as radiotherapy, biotherapy, endocrine therapy, targeted therapy, immunotherapy, chemotherapy [paclitaxel for injection (albumin bound) monotherapy less than 21 days] within 4 weeks prior to study dosing or participated in other clinical trials within the 5 half-lives of the treated drug, whichever is longer. According to the determination of the investigator, the washout period can be appropriately shortened or extended. If there are interfering monoclonal antibodies that require an appropriate extension of the washout period when necessary, or if other antitumor drugs need to be combined during the study.
8. Obvious abnormality in ECG examination, QTc interval > 470 ms at baseline.
9. Peripheral neuropathy ≥ grade 2.
10. Blood donation or massive blood loss (> 400 mL) within 90 days before screening.
11. Use of drugs with high protein binding rate, or CYP2C8 inhibitors, or CYP3A4 inhibitors, within 1 week before enrollment.
12. Ingestion of a specific diet (e.g., grapefruit) within 48 hours prior to the administration of the study drug, capable of affecting the absorption, distribution, metabolism, and excretion of the drug.
13. Toxicity due to antitumor drug use before enrollment did not recover to ≤ grade 1 or baseline, except for alopecia.

14. Not suitable for this study as judged by the investigator for any other reason.

    -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SYHX2011(T)-Abraxane®(R); Patients will be administrated with SYHX2011 followed by Abraxane®	Drug: SYHX2011 and Abraxane®; IV infusion, 260 mg/m^2
Experimental: Abraxane®(R)-SYHX2011(T); Patients will be administrated with Abraxane® followed by SYHX2011	Drug: SYHX2011 and Abraxane®; IV infusion, 260 mg/m^2

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax	Maximum plasma concentration	From time zero up to 72 hours post-dose
AUC0-t	Area under the plasma concentration time curve from time zero to the last measurable concentration	From time zero up to 72 hours post-dose
AUC0-∞	Area under the plasma concentration-time curve from time zero to infinity	From time zero up to 72 hours post-dose

Collaborators and Investigators

• Sponsor: CSPC Ouyi Pharmaceutical Co., Ltd.
• Investigators: Principal Investigator: Mingxia Wang, The Fourth Hospital of Hebei Medical University

Study record dates

Study Major Dates

• Study Start (Anticipated): March 31, 2022
• Primary Completion (Anticipated): September 30, 2022
• Study Completion (Anticipated): October 30, 2022

Study Registration Dates

• First Submitted: March 2, 2022
• First Submitted That Met QC Criteria: March 2, 2022
• First Posted (Actual): March 11, 2022

Study Record Updates

• Last Update Posted (Actual): March 11, 2022
• Last Update Submitted That Met QC Criteria: March 2, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Antineoplastic Agents; Albumin-Bound Paclitaxel
• Other Study ID Numbers: SYHX2011-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No