Advanced Breast CancerPhase 1NCT05274893
A Pharmacokinetic Comparison Study of SYHX2011 and Abraxane® in Patients With Advanced Breast Cancer
A Phase 1 study testing SYHX2011 and Abraxane® in people with Advanced Breast Cancer, run by CSPC Ouyi Pharmaceutical Co., Ltd..
Trial summary
This is a multi-center, open-label, pharmacokinetic comparison study of SYHX2011 and Abraxane® in patients with advanced breast cancers after single IV infusion. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Advanced Breast Cancer
- What is being tested?
- SYHX2011 and Abraxane®
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- 31 Mar 2022to 30 Oct 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily sign the written informed consent.
- Female patients aged 18 to 75 years (inclusive).
- Histologically and/or cytologically diagnosed advanced breast cancer.
- 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.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
- Expected survival time ≥3 months.
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- 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.
- Patients have no pregnancy plan within 6 months after entering the study, voluntarily take effective contraceptive measures, and have no egg donation plan.
- Fully understand the purpose and requirements of this trial, and can complete the whole trial process according to the test requirements.
Who cannot join
- Have severe allergy to paclitaxel drugs or human serum albumin, or history of significant hypersensitivity or idiosyncratic reaction.
- Patients with serious medical conditions are considered unsuitable for inclusion by the investigator.
- Patients who have undergone major surgery within 3 months prior to screening or planned to have major surgery during the study period.
- Have a history of alcohol, drug abuse or drug addiction.
- Patients who are pregnant or breasting.
- 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.
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- 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.
- Obvious abnormality in ECG examination, QTc interval > 470 ms at baseline.
- Peripheral neuropathy ≥ grade 2.
- Blood donation or massive blood loss (> 400 mL) within 90 days before screening.
- Use of drugs with high protein binding rate, or CYP2C8 inhibitors, or CYP3A4 inhibitors, within 1 week before enrollment.
- 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.
- Toxicity due to antitumor drug use before enrollment did not recover to ≤ grade 1 or baseline, except for alopecia.
- Not suitable for this study as judged by the investigator for any other reason.
- -
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
- Conditions
- Advanced Breast Cancer
- Being tested
- SYHX2011 and Abraxane®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SYHX2011 and Abraxane®Drug
IV infusion, 260 mg/m^2
| Study group | Role | What they receive |
|---|---|---|
| SYHX2011(T)-Abraxane®(R) | Experimental | Patients will be administrated with SYHX2011 followed by Abraxane® Receives: Drug: SYHX2011 and Abraxane® |
| Abraxane®(R)-SYHX2011(T) | Experimental | Patients will be administrated with Abraxane® followed by SYHX2011 Receives: Drug: SYHX2011 and Abraxane® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Maximum plasma concentration
Measured: 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
Measured: From time zero up to 72 hours post-dose
AUC0-∞
Area under the plasma concentration-time curve from time zero to infinity
Measured: From time zero up to 72 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2022
- Study start31 Mar 2022 (estimated)
- Primary completion30 Sep 2022 (estimated)
- Study completion30 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Breast CancerStudies of the same condition, open and under way.
- More trials run by CSPC Ouyi Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CSPC Ouyi Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mingxia Wang, Principal investigator, Hebei Medical University Fourth Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05274893
- Sponsor's protocol ID
- SYHX2011-001
- Status last verified
- Mar 2022
- First submitted
- 2 Mar 2022
- Last updated
- 11 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Two-cycle Crossover Pharmacokinetic Comparison Study of SYHX2011 and Abraxane® in Patients With Advanced Breast Cancer
- ClinicalTrials.gov ID
- NCT05274893
- Acronym / sponsor ID
- SYHX2011-001
- Conditions
- Advanced Breast Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- CSPC Ouyi Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 31 Mar 2022 (estimated)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 30 Oct 2022 (estimated)
- First posted
- 11 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SYHX2011(T)-Abraxane®(R) | Experimental | Drug: SYHX2011 and Abraxane®Patients will be administrated with SYHX2011 followed by Abraxane® |
| Abraxane®(R)-SYHX2011(T) | Experimental | Drug: SYHX2011 and Abraxane®Patients will be administrated with Abraxane® followed by SYHX2011 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Voluntarily sign the written informed consent.
- Female patients aged 18 to 75 years (inclusive).
- Histologically and/or cytologically diagnosed advanced breast cancer.
- 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.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
Key exclusion criteria (15 listed)
- Have severe allergy to paclitaxel drugs or human serum albumin, or history of significant hypersensitivity or idiosyncratic reaction.
- Patients with serious medical conditions are considered unsuitable for inclusion by the investigator.
- Patients who have undergone major surgery within 3 months prior to screening or planned to have major surgery during the study period.
- Have a history of alcohol, drug abuse or drug addiction.
- Patients who are pregnant or breasting.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SYHX2011 and Abraxane®IV infusion, 260 mg/m^2 | Drug | Abraxane®(R)-SYHX2011(T), SYHX2011(T)-Abraxane®(R) |
Primary outcome
Cmax
Time frame: From time zero up to 72 hours post-dose
Maximum plasma concentration
AUC0-t
Time frame: From time zero up to 72 hours post-dose
Area under the plasma concentration time curve from time zero to the last measurable concentration
AUC0-∞
Time frame: From time zero up to 72 hours post-dose
Area under the plasma concentration-time curve from time zero to infinity
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mingxia Wang principal investigator
Hebei Medical University Fourth Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SYHX2011 and Abraxane® in people with Advanced Breast Cancer, run by CSPC Ouyi Pharmaceutical Co., Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mingxia Wang (86-0311-66696233, mxia_wang@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax (time frame: From time zero up to 72 hours post-dose). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2022.