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Breast Diseases

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All Drugs and Chemicals

Capecitabine

Antimetabolites

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 Injection; capecitabine

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

Quchang Ouyang, MD

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.

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

Open, Multicenter, Phase Ic Clinical Study on the Pharmacokinetics and Drug Interactions of Utidelone Plus Capecitabine in Patients With Recurrent and Metastatic Breast Cancer

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 \[Cmax\]

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

To get area under the plasma concentration versus time curve

Chengdu Biostar Pharmaceuticals

Beijing Biostar Pharmaceuticals Co., Ltd.

Oral capsules, 30 mg and 100 mg capsule strengths; administered twice daily for 14 days in a 28 day cycle

MKC-1

This phase 2 study will determine the antitumor activity, based on the objective rate, of oral MKC-1, administered twice daily for 14 consecutive days every 4 weeks, in patients with advanced or metastatic breast carcinoma. The study will also evaluate the safety and response duration in patients, time to tumor progression, and overall survival in patients following MKC-1 therapy.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
PK and Drug Interaction Study of Utidelone Plus Capecitabine in Patients With Advanced Breast Cancer	NCT05052437	Advanced and Me...	Utidelone Injec... Utidelone	18 Years - 75 Years	Beijing Biostar Pharmaceuticals Co., Ltd.
A Study to Determine the Antitumor Activity and Evaluate the Safety of MKC-1	NCT00306631	Breast Cancer	MKC-1	18 Years -	CASI Pharmaceuticals, Inc.

Spots Global Cancer Trial Database for advanced and metastatic breast cancer