Clinical trials: Utidelone
Gastric or Gastroesophageal Junction Adenocarcinoma
Utidelone Capsule Combined With Fluoropyrimidine- and Platinum-containing Therapy in First-line Treatment of Patients With Gastric or Gastroesophageal Junction Adenocarcinoma
This is a multi-national, open-label, randomized, seamless phase II/III clinical study of UTD2 combined with fluoropyrimidine- and platinum-containing therapy to evaluate the efficacy and safety in patients with locally advanced…
- Trial name
- NCT06841679
- Testing
- Utidelone Capsule, Fluoropyrimidine- and Platinum-containing Therapy, Oxaliplatin
- Where
- 10 sites in United States, China
- Volunteers
- 778 people
- Sponsor
- Beijing Biostar Pharmaceuticals Co., Ltd.
Breast Cancer
Utidelone in Combination With AC Versus Docetaxel in Combination With AC for Neoadjuvant Chemotherapy in Patients With HER2-negative Breast Cancer
The purpose of this clinical trial is to evaluate the efficacy and safety of Utidelone plus AC versus Docetaxel plus AC as neoadjuvant chemotherapy in high-risk HER2-negative early-stage or locally advanced breast cancer.
- Trial name
- NCT05673629
- Testing
- Utidelone Injection in combination with AC, Docetaxel Injection in combination with AC
- Where
- China
- Volunteers
- 552 people
- Sponsor
- Beijing Biostar Pharmaceuticals Co., Ltd.
Advanced Solid Tumor
Tolerability of Utidelone Capsule in Patients With Advanced Solid Tumors
The purpose of this trial is to evaluate the safety and tolerability of Utidelone Capsule in patients with advanced solid tumors and determine the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT).
- Trial name
- NCT05681000
- Testing
- Utidelone Capsule
- Where
- United States
- Volunteers
- 28 people
- Sponsor
- Biostar Pharma, Inc.
Advanced Breast Cancer
Efficacy and Safety of Utidelone Capsule and Utidelone Injection in Patients With HER-2 Negative Advanced Breast Cancer
This study is a randomized controlled study.The primary objective is to evaluate the Progression-Free Survival(PFS) of Utidelone Capsule combined with Capecitabine compared with Utidelone Injection combined with Capecitabine in…
- Trial name
- NCT07684456
- Testing
- Utidelone Capsule, Utidelone Injection, Capecitabine
- Where
- China
- Volunteers
- 308 people
- Sponsor
- Beijing Biostar Pharmaceuticals Co., Ltd.
Advanced and Metastatic Breast Cancer
PK and Drug Interaction Study of Utidelone Plus Capecitabine in Patients With Advanced 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.
- Trial name
- NCT05052437
- Testing
- Utidelone Injection; capecitabine, Utidelone
- Where
- 2 sites in China
- Volunteers
- 16 people
- Sponsor
- Beijing Biostar Pharmaceuticals Co., Ltd.
Advanced or Metastatic CRC
Clinical Study of Utidelone Injection in Patients With Advanced or Metastatic Colorectal Cancer
To assess the effectiveness and safety of utidelone injection in patients with advanced or metastatic colorectal cancer (CRC) as a phase II trial
- Trial name
- NCT03906565
- Testing
- utidelone injection
- Where
- 5 sites in China
- Volunteers
- 30 people
- Sponsor
- Beijing Biostar Pharmaceuticals Co., Ltd.
Solid Tumor
Clinical Study of Utidelone Injection in Patients With Advanced or Metastatic Solid Tumors
This trial is an open, two-stage, multi-center, phase II clinical trial to evaluate the efficacy and safety of Utidelone in advanced solid tumors (excluding breast cancer, lung cancer, and colorectal cancer) that have failed…
- Trial name
- NCT04911907
- Testing
- utidelone injection
- Where
- 3 sites in China
- Volunteers
- 126 people
- Sponsor
- Beijing Biostar Pharmaceuticals Co., Ltd.
Ovarian Cancer, Fallopian Tube Cancer
Phase II Clinical Study of Utidelone Capsule (UTD2) in Patients With Advanced Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
This is an open, multicenter, phase II clinical study enrolling patients with platinum-resistant advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer to evaluate the safety and efficacy of Utidelone Capsules.
- Conditions
- Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer
- Trial name
- NCT07044349
- Testing
- Utidelone capsule 75mg/m2/d QD, Utidelone capsule 40mg/m2/d BID, Utidelone capsule 50mg/m2/d BID
- Volunteers
- 72 people
- Sponsor
- Beijing Biostar Pharmaceuticals Co., Ltd.
Soft Tissue Sarcoma (STS), Utidelone
Utidelone Capsules Combined With Doxorubicin for Advanced Soft Tissue Sarcoma
This trial is an open, multicenter, phase II clinical trial evaluating the efficacy and safety of uterostatin capsules (UTD2) combined with doxorubicin and tislelizumab in the treatment of advanced soft tissue sarcoma.
- Conditions
- Soft Tissue Sarcoma (STS), Utidelone, Doxorubicin
- Trial name
- NCT07842276
- Testing
- UTD2 + tislelizumab + doxorubicin
- Where
- China
- Volunteers
- 49 people
- Sponsor
- Beijing Biostar Pharmaceuticals Co., Ltd.
Gastric Cancer Adenocarcinoma Metastatic, Ovarian Cancer
Utidelone Capsule Monotherapy for Patients with Advanced Solid Tumors
This trial is an open, multicenter, phase II clinical trial to evaluate the efficacy and safety of Utidelone capsules in patients with advanced solid tumors.
- Conditions
- Gastric Cancer Adenocarcinoma Metastatic, Ovarian Cancer, Bile Duct Cancer
- Trial name
- NCT06730581
- Testing
- Utidelone Capsule 60mg/m2/d, Utidelone capsule 75mg/m2, Utidelone Capsule
- Volunteers
- 100 people
- Sponsor
- Beijing Biostar Pharmaceuticals Co., Ltd.
Advanced Solid Tumor
Phase I-II Clinical Trial of Utidelone Capsule in Patients With Advanced Solid Tumors
This study has three parts. Part 1 is a dose-escalation trial, Part 2 is a pharmacokinetic comparison and food effect study, and Part 3 is extended trial of combination of utidelone capsule and capecitabine.
- Trial name
- NCT05700084
- Testing
- Utidelone Capsule (Part 1), Drug A Utidelone Capsule (Part 2: Group A-B), Drug A Utidelone Capsule (Part 2: Group B-A)
- Where
- 10 sites in China
- Volunteers
- 84 people
- Sponsor
- Beijing Biostar Pharmaceuticals Co., Ltd.
Non-small Cell Lung Cancer Patients with Brain Metastases
Utidelone Injection Combined with Bevacizumab Injection for Non-small Cell Lung Cancer Patients with Brain Metastases
This study is a prospective, multicenter, two-stage phase II clinical trial evaluating the efficacy and safety of Utidelone combined with Bevacizumab in patients with non-small cell lung cancer with brain metastases.
- Trial name
- NCT06683703
- Testing
- Utidelone combined with Bevacizumab, Utidelone
- Volunteers
- 118 people
- Sponsor
- Beijing Biostar Pharmaceuticals Co., Ltd.
Advanced Non-small Cell Lung Cancer
Clinical Study of Utidelone Injection in Patients With Advanced Non-small Cell Lung Cancer（NSCLC）
To assess the effectiveness and safety of utidelone injection in patients with advanced or metastatic NSCLC as a phase II trial
- Trial name
- NCT03693547
- Testing
- utidelone injection
- Where
- 4 sites in China
- Volunteers
- 26 people
- Sponsor
- Beijing Biostar Pharmaceuticals Co., Ltd.
HER2-negative Breast Cancer Patients With Brain Metastases
A Pivotal Phase II Clinical Trial of Utidelone Injection Plus Capecitabine in HER2-negative Breast Cancer Patients With Brain Metastases
This study is a multicenter, two-stage clinical trial to evaluate the efficacy and safety of utidelone in combination with capecitabine in patients with HER2-negative breast cancer with brain metastases.
- Trial name
- NCT06764940
- Testing
- Utidelone, Utidelone in combination with capecitabine
- Where
- 12 sites in United States
- Volunteers
- 120 people
- Sponsor
- Biostar Pharma, Inc.
Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Utidelone Versus Docetaxel in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer
The purpose of this clinical trial is to compare Utidelone with Docetaxel in patients with locally advanced or metastatic non-small cell lung cancer previously failed platinum-containing chemotherapy regimens.
- Trial name
- NCT05673590
- Testing
- Utidelone Injection, Docetaxel Injection
- Where
- China
- Volunteers
- 612 people
- Sponsor
- Beijing Biostar Pharmaceuticals Co., Ltd.