PK and Drug Interaction Study of Utidelone Plus Capecitabine in Patients With Advanced Breast Cancer

Phase 1

Completed

• Conditions: Advanced and Metastatic Breast Cancer
• Interventions: Drug: Utidelone Injection; capecitabine; Drug: Utidelone

• Registration Number: NCT05052437
• Lead Sponsor: Beijing Biostar Pharmaceuticals Co., Ltd.

Brief 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. To evaluate the pharmacokinetic characteristics of continuous intravenous administration of utidelone.

2. To evaluate the drug interaction of utidelone and capecitabine.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-15
• Primary Completion: 2021-01-13
• Study Completion: 2021-02-19
• Study First Submitted: 2021-05-30
• Study First Submitted QC: 2021-09-12
• Study First Posted: 2021-09-22
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-08
• Last Update Posted: 2023-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 16

Inclusion Criteria

1. Voluntarily sign an informed consent form, have good compliance, and cooperate with relevant inspections.

2. Histologically and/or cytologically diagnosed patients with advanced, metastatic breast cancer.

3. 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.

4. Age ≥18 years; physical condition score ECOG 0~2 points.

5. Within 4 weeks before enrollment, Neuropathy should be less than grade 2 (NCI CTCAE 5.0).

6. Within 1 week before enrollment, routine blood examinations were basically normal (based on the normal value of each research center laboratory):

   1. White blood cell count (WBC) ≥3.0×109/L;
   2. Neutrophil count (ANC) ≥ 1.5×109/L;
   3. Platelet count (PLT) ≥100×109/L.
   4. Hemoglobin ≥9g/dL.

7. Within 1 week before enrollment, liver and kidney function tests were basically normal (the normal value of each research center laboratory is standard):

   1. Total bilirubin (TBIL)≤1.5×upper limit of normal (ULN);
   2. Alanine aminotransferase (SGPT/ALT)≤2.5×ULN (for liver metastases≤5×ULN);
   3. Aspartate aminotransferase (SGOT/AST)≤2.5×ULN (for liver metastases≤5×ULN);
   4. Creatinine clearance rate (Ccr) ≥60 ml/min.

8. No major organ dysfunction.

9. 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.

10. No mental abnormality, able to understand and undertake informed consent.

Exclusion Criteria

1. Those who need to receive non-investigative anti-cancer therapy (such as chemotherapy, immunotherapy or biological therapy) during the administration period of this trial.
2. People who are severely allergic to castor oil, or who have had serious adverse reactions to anti-microtubule drugs in the past.
3. 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.
4. Pregnancy (positive pregnancy test), breastfeeding patients, or those who are unwilling to use contraception during the test;
5. Those with uncontrollable intracranial hypertension syndrome (persistent headache, short-term blurred vision, and/or diplopia)
6. Combined serious diseases, including severe heart disease, cerebrovascular disease, uncontrolled diabetes, uncontrolled high blood pressure, severe infection, active peptic ulcer, etc.
7. Known HIV infection, or untreated active hepatitis B or C;
8. Known to have alcohol or drug addiction, or have a history of uncontrollable mental illness, lack of legal capacity or limited legal capacity;
9. The investigator believes that it is inappropriate to participate in this trial.
10. Participate in another clinical trial or use other research treatments at the same time.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Utidelone plus capecitabine	Utidelone Injection; capecitabine	-
Utidelone	Utidelone	-

Primary Outcome Measures

Name	Time	Method
Peak Plasma Concentration (Cmax)	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 \[Cmax\]
Area under the plasma concentration versus time curve (AUC)	12 weeks	To get area under the plasma concentration versus time curve
C-T curve	12 weeks	To evaluate the pharmacokinetic interaction of utidelone and capecitabine in patients when administered in combination.

Secondary Outcome Measures

Name	Time	Method
Measure and plot r-t curve	12 weeks	To analyse mass balance
Incidence of treatment-related adverse events as assessed by CTCAE v4.0	6 months	To evaluate the safety of the study

Trial Locations

Locations (2)

Hunan Cancer Hospital; 🇨🇳 Changsha, Hunan, China

The Third Xiangya Hospital of Central South University; 🇨🇳 Changsha, Hunan, China