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New treatment option for Bioequivalence
Official title Bioequivalence Study of Paclitaxel Protein-bound Particles for Injectable Suspension (Albumin-bound) in Breast Cancer Patients
ClinicalTrials.gov ID: NCT07096869
What this study is testing
What is Paclitaxel protein-bound particles for injectable suspension (albumin-bound)?
Paclitaxel protein-bound particles for injectable suspension (albumin-bound) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for bioequivalence.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The main purpose of this study is to evaluate the bioequivalence of paclitaxel protein-bound particles for injectable suspension (albumin-bound) (100 mg, test product) and Abraxane® (100 mg, reference product) in breast cancer patients.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 1) people fully understand the purpose, nature, method and possible adverse reactions of the study, volunteer as people, and sign informed consent...
- 2) Male and female, ages 18-75 years both inclusive;
- 3) people with breast cancer confirmed by histopathology and/or cytology who meet one of the following conditions: ①Metastatic breast cancer, after...
- 4) ECOG Score ≤ 2 points;
- 5) The expecting life span ≥ 3months;
You likely can't join if
- 1) A severe allergy or hypersensitivity to paclitaxel or human albumin;
- 2) In addition to cancer, have any other serious liver, kidney/genitourinary, gastrointestinal (e.g., abdominal inflammation), cardiovascular (e.g...
- 3) Those who had undergone major surgery within 4 weeks prior to screening, or planned to undergo major surgery during the study period;
- 4) Pregnant or lactating female people;
- 5) Hepatitis B surface antigen positive and HBV DNA positive; HCV core antibody positive and HCV RNA positive; HIV antigen/antibody positive...
- 6) Those who used chemical small molecule anti-tumor drugs (including endocrine therapy), biological macromolecular anti-tumor drugs, biological...
See the full eligibility criteria
- 1) people fully understand the purpose, nature, method and possible adverse reactions of the study, volunteer as people, and sign informed consent prior to the commencement of any study procedure;
- 2) Male and female, ages 18-75 years both inclusive;
- 3) people with breast cancer confirmed by histopathology and/or cytology who meet one of the following conditions: ①Metastatic breast cancer, after failure of combination chemotherapy for metastatic disease or relapse...
- 4) ECOG Score ≤ 2 points;
- 5) The expecting life span ≥ 3months;
- 6) The results of blood, liver and kidney function tests are within the following ranges: Absolute neutrophil counts (ANC) ≥ 1.5×10\^9/L Platelets (PLT) ≥ 100×10\^9/L Hemoglobin (Hb) ≥ 90 g/L Total bilirubin (TBIL) ≤...
- 7) The subject has no fertility plan (including sperm donation and egg donation) for at least 6 months from the signing of informed consent to the last dose and voluntarily takes non-drug effective contraceptive...
- 8) people can communicate well with the investigators, understand and comply with the requirements of the study.
- 1) A severe allergy or hypersensitivity to paclitaxel or human albumin;
- 2) In addition to cancer, have any other serious liver, kidney/genitourinary, gastrointestinal (e.g., abdominal inflammation), cardiovascular (e.g., congestive heart failure, ventricular arrhythmia, myocardial...
- 3) Those who had undergone major surgery within 4 weeks prior to screening, or planned to undergo major surgery during the study period;
- 4) Pregnant or lactating female people;
- 5) Hepatitis B surface antigen positive and HBV DNA positive; HCV core antibody positive and HCV RNA positive; HIV antigen/antibody positive; treponema pallidum antibody positive and rapid plasma reaction hormone (RPR)...
- 6) Those who used chemical small molecule anti-tumor drugs (including endocrine therapy), biological macromolecular anti-tumor drugs, biological therapy, radiotherapy or needed to combine other anti-tumor drugs for...
- 7) Electrocardiogram shows significant abnormality, and/or baseline QTcF interval is \> 470 ms;
- 8) Pre-screening sensory neuropathy/peripheral neuropathy are ≥ grade 2;
- 9) Blood donation or significant blood loss (\> 400 mL) within 90 days before - screening;
- 10) Ingestion of an inhibitor or inducer of CYP2C8 or CYP3A4 within 28 days prior to dosing (acceptable drug use is stable in homeostasis, that is, the dosing regimen remains unchanged; However, the use of...
- 11) Those who consumed more than 14 units of alcohol per week in the 3 months before screening (1 unit ≈ 360 mL for beer, or 45 mL for spirits, or 150 mL for wine) or who could not stop drinking during the study period...
- 12) Smoking \> 5 cigarettes per day within 3 months prior to screening or smoking cannot be stopped during the study period;
- 13) Any clinically significant abnormal results in the people' vital signs, physical examination, clinical laboratory examination (unless otherwise specified in the protocol), 12-lead electrocardiogram (ECG) and other...
- 14) Within 6 months prior to screening, there is a history of drug abuse (except regular use of pain medications due to cancer pain) or positive drug abuse screening;
- 15) Toxicity caused by using of anti-tumor drugs prior to enrolment do not return to ≤ grade 1 or baseline levels, except for alopecia;
- 16) people receiving granulocyte-stimulating growth factor treatment within 2 weeks before dosing;
- 17) people who have participated in any clinical trial within 1 month before screening (start from the time of the last dose);
- 18) Any other circumstances determined by the investigator to be inappropriate are not suitable for participation in this study
The study team makes the final eligibility decision.
Where it's taking place
- Changchun, Jilin, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Changchun, Jilin, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.