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

NCT05052437 | Completed Phase 1

• 1 other identifier: BG01-2001
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 2

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. 1.To evaluate the pharmacokinetic characteristics of continuous intravenous administration of utidelone.
2. 2.To evaluate the drug interaction of utidelone and capecitabine.

Conditions

Advanced and Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (3)

• 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 \[Cmax\]

  12 weeks

• C-T curve

  To evaluate the pharmacokinetic interaction of utidelone and capecitabine in patients when administered in combination.

  12 weeks

• Area under the plasma concentration versus time curve (AUC)

  To get area under the plasma concentration versus time curve

  12 weeks

Secondary Outcomes (2)

• Measure and plot r-t curve

  12 weeks

• Incidence of treatment-related adverse events as assessed by CTCAE v4.0

  6 months

Study Arms (2)

Utidelone

EXPERIMENTAL

Drug: Utidelone

Utidelone plus capecitabine

EXPERIMENTAL

Drug: Utidelone Injection; capecitabine

Interventions

Utidelone Injection; capecitabine DRUG

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

Utidelone plus capecitabine

Utidelone DRUG

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.

Utidelone

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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):
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Beijing Biostar Pharmaceuticals Co., Ltd.: lead
• Chengdu Biostar Pharmaceuticals: collaborator

Study Sites (2)

Hunan Cancer Hospital

Changsha, Hunan, China

Location

The Third Xiangya Hospital of Central South University

Changsha, Hunan, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Capecitabine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Quchang Ouyang, MD

  Hunan Cancer Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2021
• First Posted: September 22, 2021
• Study Start: October 15, 2020
• Primary Completion: January 13, 2021
• Study Completion: February 19, 2021
• Last Updated: January 10, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)