Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Utidelone Injection: 30 mg/m2/day, IV on day 1-day 5 of each 21 day cycle, administered to enrolled patients with advanced NSCLC

utidelone monotherapy in patients with advanced NSCLC by utidelone

utidelone injection

YUANKAI SHI, MD, PhD

To assess the effectiveness and safety of utidelone injection in patients with advanced or metastatic NSCLC as a phase II trial

Clinical Study of Utidelone Injection in Patients With Advanced Non-small Cell Lung Cancer（NSCLC）

Open, Multicenter, Monotherapy, Phase II Clinical Study of Utidelone Injection in Patients With Advanced Non-small Cell Lung Cancer After Failure or Intolerability to Second-line Standard Treatment

Reflected by percentage of tumor size reduction or regression, assessed by imaging techniques and expressed as Objective Response Rate (ORR）ORR is defined as the proportion of patients with a best overall response of Complete Response (CR) or Partial Response (PR) according to RECIST. 1.1.

PFS is defined as the duration of time from first study treatment to disease progression or death from any cause as documented by the investigator

OS is defined as the duration of time from first study treatment until death from any cause.

Observe and record incidence of adverse events and severe adverse events associated with utidelone treatment, assessed by investigators according to CTCAE version 4·03

Chengdu Biostar Pharmaceuticals

Beijing Biostar Pharmaceuticals Co., Ltd.

Anti-Inflammatory Agents

Antineoplastic Agents

Antiemetics

Gastrointestinal Agents

All Drugs and Chemicals

Anti-Allergic Agents

Central Nervous System Depressants

Dermatologic Agents

Dexamethasone

Docetaxel

Dexamethasone acetate

Diphenhydramine

Promethazine

Cimetidine

Tubulin Modulators

Antimitotic Agents

Drug: Utidelone Injection Dose: 40 mg/m2/d intravenously Regimen: once daily on days 1-5 in a 21-day cycle

Drug: Docetaxel Injection Dose:75 mg/m2/d, administered intravenously Regimen: once on day 1 in a 21-day cycle

Pretreatment: diphenhydramine 40 mg by intramuscular injection or oral administration, and dexamethasone10 mg and cimetidine 300 mg by intravenous injection 30 minutes prior to Utidelone iv drip at the first day of each cycle. The dose of dexamethasone and diphenhydramine can be halved by the physician based on patient's condition in the following day through the fifth day in each cycle, as detailed in the protocol.

Dexamethasone 8 mg per oral, bid, one day prior to docetaxel iv drip for 3 days.

The treatment group will be treated with Utidelone Injection at 40 mg/m2/d intravenously once daily on days 1-5 in a 21-day cycle until disease progression or an occurrence of intolerable toxicities.

Utidelone Injection

Pretreatment: Dexamethasone should be administered orally for 3 days at 16 mg per day (8 mg twice daily), starting one day before the start of Docetaxel.

The control group will be treated with Docetaxel Injection at 75 mg/m2/d, administered intravenously once on day 1. Patients in this group will be treated in 21-day cycles until disease progression or intolerable toxicities occurs.

Docetaxel Injection

RONGGUO QIU, PhD

Caicun Zhou

Caicun Zhou, MD

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. This phase III, open-label, randomized controlled trial aims to evaluate and compare the efficacy and safety of Utidelone and Docetaxel in the aforementioned lung cancers.

In this study, 612 patients will be screened, enrolled and randomly assigned in a 1:1 ratio to either the Utidelone (40 mg/m2/d intravenously once daily on days 1-5) treatment or the docetaxel (75 mg/m2/d, intravenously once on day 1) control group, stratified by prior immunotherapy status (PD-1/PD-L1 vs. no PD-1/PD-L1). Both groups will be treated in a 21-day cycle until disease progression or an occurrence of intolerable toxicities. Tumor assessments will be performed at baseline and every 6 weeks (±7 days) after randomization and continued until disease progression as assessed by RECIST v1.1 criteria, with or without discontinuation of study treatment; the EORTC QLQ-C30 questionnaire will be used to assess patients' quality of life based on a signed informed consent.

Utidelone Versus Docetaxel in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

A Phase III, Open-label, Randomized, Controlled Clinical Study of Utidelone Versus Docetaxel in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Previously Failed Platinum-containing Chemotherapy Regimens

Comparing the OS of Utidelone and Docetaxel for locally advanced or metastatic non-small cell lung cancer patients who previously failed Platinum-containing chemotherapy regimens

The number of patients with an observed best efficacy rating of CR or PR as a percentage of the total number of evaluable patients according to RECIST 1.1.

The number of patients with best efficacy ratings of CR, PR and SD as a percentage of the total number of evaluable patients according to RECIST 1.1.

Digestive System Diseases

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Utidelone Injection: 40 mg/m2/day, IV transfusing over 90 min. on day 1-day 5 of each 21 day cycle, administered to enrolled patients with advanced or metastatic CRC

utidelone monotherapy in patients with advanced or metastatic CRC by iv transfusing utidelone injection

RUIHUA XU, MD

To assess the effectiveness and safety of utidelone injection in patients with advanced or metastatic colorectal cancer (CRC) as a phase II trial

Clinical Study of Utidelone Injection in Patients With Advanced or Metastatic Colorectal Cancer

Open, Multicenter, Monotherapy, Phase II Clinical Study of Utidelone Injection in Patients With Advanced or Metastatic Colorectal Cancer After Failure or Intolerability to Second-line Standard Treatment

Observe and record adverse effects and severe adverse effects associated with utidelone injection

Cohort 1 Squamous cell carcinoma of head and neck. Participants will be treated with utidelone monotherapy

Cohort 2 Esophageal cancer. Participants will be treated with utidelone monotherapy.

Cohort 3 Stomach cancer. Participants will be treated with utidelone monotherapy.

Cohort4 Pancreatic cancer. Participants will be treated with Utidelone monotherapy.

Cohort5 Ovarian cancer. Participants will be treated with Utidelone monotherapy.

Cohort 6 Cholangiocarcinoma. Participants will be treated with Utidelone monotherapy

Cohort 7 Other solid tumors. Participants will be treated with Utidelone monotherapy

Utidelone monotherapy 35 mg/m2/day IV transfusing over 90 min. on day 1-day 5 of each 21 day cycle

Dong Yan, MD

Yumei Wu, MD

Jin Li, MD

JIN LI, MD

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 standard of treatment or were unable to perform standard treatment.

This trial is divided into 2 stages, screening stage and expansion stage. In the screening stage, 10 patients were enrolled for each tumor type(including Squamous cell carcinoma of head and neck, Esophageal cancer, Stomach cancer, Pancreatic cancer, Cholangiocarcinoma, Ovarian cancer and Other solid tumors). Based on the results of the tumor type screening stage, the sponsor and the main investigator will have a discussion and have the alignment of tumor types to enter the expansion stage. The expansion stage will refine the inclusion / exclusion criteria and may adjust the treatment plan based on the tumor type and the combination drug selection. A total of 30-50 patients (including patients enrolled in the screening stage) were enrolled in each specified tumor type during the expansion stage.

Clinical Study of Utidelone Injection in Patients With Advanced or Metastatic Solid Tumors

Open, Two-stage, Multicenter, Monotherapy, Phase II Clinical Study of Utidelone Injection in Patients With Advanced or Metastatic Solid Tumors After Failure or Intolerability to Standard Treatment

Reflected by percentage of tumor size reduction or regression, assessed by imaging techniques and expressed as Objective Response Rate (ORR) ORR is defined as the proportion of patients with a best overall response of Complete Response (CR) or Partial Response (PR) according to RECIST. 1.1.

Observe and record incidence of Treatment-Emergent Adverse Events and severe adverse effects associated with utidelone injection

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Clinical Study of Utidelone Injection in Patients With Advanced Non-small Cell Lung Cancer（NSCLC）	NCT03693547	Advanced Non-sm...	utidelone injec...	18 Years - 70 Years	Beijing Biostar Pharmaceuticals Co., Ltd.
Utidelone Versus Docetaxel in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer	NCT05673590	Locally Advance...	Utidelone Injec... Docetaxel Injec...	18 Years - 70 Years	Beijing Biostar Pharmaceuticals Co., Ltd.
Clinical Study of Utidelone Injection in Patients With Advanced or Metastatic Colorectal Cancer	NCT03906565	Advanced or Met...	utidelone injec...	18 Years - 70 Years	Beijing Biostar Pharmaceuticals Co., Ltd.
Utidelone Versus Docetaxel in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer	NCT05673590	Locally Advance...	Utidelone Injec... Docetaxel Injec...	18 Years - 70 Years	Beijing Biostar Pharmaceuticals Co., Ltd.
Clinical Study of Utidelone Injection in Patients With Advanced or Metastatic Solid Tumors	NCT04911907	Solid Tumor	utidelone injec...	18 Years - 75 Years	Beijing Biostar Pharmaceuticals Co., Ltd.

Spots Global Cancer Trial Database for utidelone injection