Advanced and Metastatic Breast CancerPhase 1NCT05052437
PK and Drug Interaction Study of Utidelone Plus Capecitabine in Patients With Advanced Breast Cancer
A Phase 1 study testing Utidelone Injection; capecitabine and Utidelone in people with Advanced and Metastatic Breast Cancer, run by Beijing Biostar Pharmaceuticals Co., Ltd. at 2 sites in China.
Trial summary
This trial is an open, multi-center, phase Ic clinical study on the pharmacokinetics and drug interactions of utidelone injection combined with capecitabine in patients with recurrent and metastatic breast cancer. The purpose of this trial is: 1. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Advanced and Metastatic Breast Cancer
- What is being tested?
- Utidelone Injection; capecitabine and Utidelone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 2 sitesChina
- Study dates
- 15 Oct 2020to 19 Feb 2021
- 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 an informed consent form, have good compliance, and cooperate with relevant inspections.
- Histologically and/or cytologically diagnosed patients with advanced, metastatic breast cancer.
- Patients who have previously received at least one anthracycline and taxane drug therapy (neoadjuvant therapy, adjuvant therapy, or recurrence and metastasis therapy), or the investigator believes that they can be included in this study.
- Age ≥18 years; physical condition score ECOG 0~2 points.
- Within 4 weeks before enrollment, Neuropathy should be less than grade 2 (NCI CTCAE 5.0).
- Within 1 week before enrollment, routine blood examinations were basically normal (based on the normal value of each research center laboratory):
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- White blood cell count (WBC) ≥3.0×109/L;
- Neutrophil count (ANC) ≥ 1.5×109/L;
- Platelet count (PLT) ≥100×109/L.
- Hemoglobin ≥9g/dL.
- Within 1 week before enrollment, liver and kidney function tests were basically normal (the normal value of each research center laboratory is standard):
- Total bilirubin (TBIL)≤1.5×upper limit of normal (ULN);
- Alanine aminotransferase (SGPT/ALT)≤2.5×ULN (for liver metastases≤5×ULN);
- Aspartate aminotransferase (SGOT/AST)≤2.5×ULN (for liver metastases≤5×ULN);
- Creatinine clearance rate (Ccr) ≥60 ml/min.
- No major organ dysfunction.
- The patient must agree to provide blood, urine and stool samples for pharmacokinetic studies, and collect them in strict accordance with the required time points and intervals.
- No mental abnormality, able to understand and undertake informed consent.
Who cannot join
- Those who need to receive non-investigative anti-cancer therapy (such as chemotherapy, immunotherapy or biological therapy) during the administration period of this trial.
- People who are severely allergic to castor oil, or who have had serious adverse reactions to anti-microtubule drugs in the past.
- Within 4 weeks before receiving treatment, have had any major surgery or suffered major trauma; or are expected to undergo major surgery during the treatment.
- Pregnancy (positive pregnancy test), breastfeeding patients, or those who are unwilling to use contraception during the test;
- Those with uncontrollable intracranial hypertension syndrome (persistent headache, short-term blurred vision, and/or diplopia)
- Combined serious diseases, including severe heart disease, cerebrovascular disease, uncontrolled diabetes, uncontrolled high blood pressure, severe infection, active peptic ulcer, etc.
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- Known HIV infection, or untreated active hepatitis B or C;
- Known to have alcohol or drug addiction, or have a history of uncontrollable mental illness, lack of legal capacity or limited legal capacity;
- The investigator believes that it is inappropriate to participate in this trial.
- Participate in another clinical trial or use other research treatments at the same time.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Hunan Cancer Hospital
Changsha, Hunan
The Third Xiangya Hospital of Central South University
Changsha, Hunan
About this study
Official title: Open, Multicenter, Phase Ic Clinical Study on the Pharmacokinetics and Drug Interactions of Utidelone Plus Capecitabine in Patients With Recurrent and Metastatic Breast Cancer
This trial is an open, multi-center, phase Ic clinical study on the pharmacokinetics and drug interactions of utidelone injection combined with capecitabine in patients with recurrent and metastatic breast cancer.
The purpose of this trial is:
- To evaluate the pharmacokinetic characteristics of continuous intravenous administration of utidelone.
- To evaluate the drug interaction of utidelone and capecitabine.
- Conditions
- Advanced and Metastatic Breast Cancer
- Being tested
- Utidelone Injection; capecitabine, Utidelone
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Utidelone Injection; capecitabineDrug
8 patients will be assigned to utidelone plus capecitabine arm receiving utidelone plus capecitabine. Utidelone injection 30mg/m2/day, intravenously administered once a day for 5 consecutive days; capecitabine tablets, 1000mg/m2, orally, 2 times a day for 14 consecutive days. 21 days is a cycle
UtideloneDrug
8 patients will be assigned to utidelone arm and receive utidelone injection 30 mg/m2/day intravenously, once a day for 5 consecutive days in a 21-day cycle.
| Study group | Role | What they receive |
|---|---|---|
| Utidelone | Experimental | Not described Receives: Drug: Utidelone |
| Utidelone plus capecitabine | Experimental | Not described Receives: Drug: Utidelone Injection; capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Plasma Concentration (Cmax)
To measure the maximal plasma concentration of the study drugs and evaluate the pharmacokinetic characteristics of continuous intravenous administration of utidelone, measure PK parameters such as Maximum Plasma Concentration [Cmax]
Measured: 12 weeks
C-T curve
To evaluate the pharmacokinetic interaction of utidelone and capecitabine in patients when administered in combination.
Measured: 12 weeks
Area under the plasma concentration versus time curve (AUC)
To get area under the plasma concentration versus time curve
Measured: 12 weeks
Secondary outcomes (2)
Measure and plot r-t curve
To analyse mass balance
Measured: 12 weeks
Incidence of treatment-related adverse events as assessed by CTCAE v4.0
To evaluate the safety of the study
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2021
- Study start15 Oct 2020
- Primary completion13 Jan 2021
- Study completion19 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced and Metastatic Breast CancerStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Biostar Pharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Chengdu Biostar Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Quchang Ouyang, MD, Principal investigator, Hunan Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05052437
- Sponsor's protocol ID
- BG01-2001
- Status last verified
- Jan 2023
- First submitted
- 30 May 2021
- Last updated
- 10 Jan 2023
- 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 10 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open, Multicenter, Phase Ic Clinical Study on the Pharmacokinetics and Drug Interactions of Utidelone Plus Capecitabine in Patients With Recurrent and Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT05052437
- Acronym / sponsor ID
- BG01-2001
- Conditions
- Advanced and Metastatic Breast Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Beijing Biostar Pharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Chengdu Biostar Pharmaceuticals
- Study start
- 15 Oct 2020 (actual)
- Primary completion
- 13 Jan 2021 (actual)
- Study completion
- 19 Feb 2021 (actual)
- First posted
- 22 Sep 2021 (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 trial is an open, multi-center, phase Ic clinical study on the pharmacokinetics and drug interactions of utidelone injection combined with capecitabine in patients with recurrent and metastatic breast cancer.
The purpose of this trial is:
- To evaluate the pharmacokinetic characteristics of continuous intravenous administration of utidelone.
- To evaluate the drug interaction of utidelone and capecitabine.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Utidelone | Experimental | Drug: Utidelone |
| Utidelone plus capecitabine | Experimental | Drug: Utidelone Injection; capecitabine |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Voluntarily sign an informed consent form, have good compliance, and cooperate with relevant inspections.
- Histologically and/or cytologically diagnosed patients with advanced, metastatic breast cancer.
- Patients who have previously received at least one anthracycline and taxane drug therapy (neoadjuvant therapy, adjuvant therapy, or recurrence and metastasis therapy), or the investigator believes that they can be included in this study.
- Age ≥18 years; physical condition score ECOG 0~2 points.
- Within 4 weeks before enrollment, Neuropathy should be less than grade 2 (NCI CTCAE 5.0).
Key exclusion criteria (10 listed)
- Those who need to receive non-investigative anti-cancer therapy (such as chemotherapy, immunotherapy or biological therapy) during the administration period of this trial.
- People who are severely allergic to castor oil, or who have had serious adverse reactions to anti-microtubule drugs in the past.
- Within 4 weeks before receiving treatment, have had any major surgery or suffered major trauma; or are expected to undergo major surgery during the treatment.
- Pregnancy (positive pregnancy test), breastfeeding patients, or those who are unwilling to use contraception during the test;
- Those with uncontrollable intracranial hypertension syndrome (persistent headache, short-term blurred vision, and/or diplopia)
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 |
|---|---|---|
| Utidelone Injection; capecitabine8 patients will be assigned to utidelone plus capecitabine arm receiving utidelone plus capecitabine. Utidelone injection 30mg/m2/day, intravenously administered once a day for 5 consecutive days; capecitabine tablets, 1000mg/m2, orally, 2 times a day for 14 consecutive days. 21 days is a cycle | Drug | Utidelone plus capecitabine |
| Utidelone8 patients will be assigned to utidelone arm and receive utidelone injection 30 mg/m2/day intravenously, once a day for 5 consecutive days in a 21-day cycle. | Drug | Utidelone |
Primary outcome
Peak Plasma Concentration (Cmax)
Time frame: 12 weeks
To measure the maximal plasma concentration of the study drugs and evaluate the pharmacokinetic characteristics of continuous intravenous administration of utidelone, measure PK parameters such as Maximum Plasma Concentration [Cmax]
C-T curve
Time frame: 12 weeks
To evaluate the pharmacokinetic interaction of utidelone and capecitabine in patients when administered in combination.
Area under the plasma concentration versus time curve (AUC)
Time frame: 12 weeks
To get area under the plasma concentration versus time curve
2 secondary outcomes
Measure and plot r-t curve
Time frame: 12 weeks
Incidence of treatment-related adverse events as assessed by CTCAE v4.0
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2023.
- 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.
Quchang Ouyang, MD principal investigator
Hunan Cancer Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Utidelone Injection; capecitabine and Utidelone in people with Advanced and Metastatic Breast Cancer, run by Beijing Biostar Pharmaceuticals Co., Ltd. at 2 sites in China.
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 18 inclusion and 10 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: finished, as of the sponsor's last update on 10 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak Plasma Concentration (Cmax) (time frame: 12 weeks). 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 10 Jan 2023.