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

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ClinicalTrials.gov Identifier: NCT04911907
Recruitment Status : Recruiting
First Posted : June 3, 2021
Last Update Posted : September 1, 2021
Sponsor:
Collaborator:
Chengdu Biostar Pharmaceuticals, Ltd
Information provided by (Responsible Party):
Beijing Biostar Technologies, Ltd

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Solid Tumor Drug: utidelone injection Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : January 22, 2021
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : June 2022

Arm Intervention/treatment
Experimental: Squamous cell carcinoma of head and neck: Utidelone Injection
Cohort 1 Squamous cell carcinoma of head and neck. Participants will be treated with utidelone monotherapy
Drug: utidelone injection
Utidelone monotherapy 35 mg/m2/day IV transfusing over 90 min. on day 1-day 5 of each 21 day cycle

Experimental: Esophageal cancer: Utidelone injection
Cohort 2 Esophageal cancer. Participants will be treated with utidelone monotherapy.
Drug: utidelone injection
Utidelone monotherapy 35 mg/m2/day IV transfusing over 90 min. on day 1-day 5 of each 21 day cycle

Experimental: Stomach cancer: Utidelone injection
Cohort 3 Stomach cancer. Participants will be treated with utidelone monotherapy.
Drug: utidelone injection
Utidelone monotherapy 35 mg/m2/day IV transfusing over 90 min. on day 1-day 5 of each 21 day cycle

Experimental: Pancreatic cancer: Utidelone Injection
Cohort4 Pancreatic cancer. Participants will be treated with Utidelone monotherapy.
Drug: utidelone injection
Utidelone monotherapy 35 mg/m2/day IV transfusing over 90 min. on day 1-day 5 of each 21 day cycle

Experimental: Ovarian cancer: Utidelone Injection
Cohort5 Ovarian cancer. Participants will be treated with Utidelone monotherapy.
Drug: utidelone injection
Utidelone monotherapy 35 mg/m2/day IV transfusing over 90 min. on day 1-day 5 of each 21 day cycle

Experimental: Cholangiocarcinoma: Utidelone
Cohort 6 Cholangiocarcinoma. Participants will be treated with Utidelone monotherapy
Drug: utidelone injection
Utidelone monotherapy 35 mg/m2/day IV transfusing over 90 min. on day 1-day 5 of each 21 day cycle

Experimental: Other solid tumors: Utidelone Injection
Cohort 7 Other solid tumors. Participants will be treated with Utidelone monotherapy
Drug: utidelone injection
Utidelone monotherapy 35 mg/m2/day IV transfusing over 90 min. on day 1-day 5 of each 21 day cycle




Primary Outcome Measures :
  1. Tumor response to utidelone treatment [ Time Frame: 12 months from first study 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.


Secondary Outcome Measures :
  1. Clinical benefit rate (CBR) [ Time Frame: 12 months from first study treatment ]
  2. Progression free survival (PFS) [ Time Frame: 18 months from first study treatment ]
    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

  3. Safety profile associated with utidelone injection [ Time Frame: 18 months from first study treatment ]
    Observe and record incidence of Treatment-Emergent Adverse Events and severe adverse effects associated with utidelone injection



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Histologically or cytologically documented locally-advanced and/or metastatic solid malignancy (including Squamous cell carcinoma of head and neck, Esophageal cancer, Stomach cancer, Pancreatic cancer, Cholangiocarcinoma, Ovarian cancer and Other solid tumors) that is incurable, and has failed prior standard therapy or for which standard therapy is not appropriate.
  2. Have measurable disease based on Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
  3. Age 18 -70 years old
  4. ECOG performance status of 0-1
  5. Life expectancy≥ 3 months
  6. Basically normal results from routine blood test within 1 week prior to enrollment

    1. Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
    2. Hemoglobin >= 9 g/dL
    3. Platelets >= 80 x 10^9/L
  7. Basically normal liver and renal functions within 1 week prior to enrollment

    1. total bilirubin =< 1.5 x ULN with direct bilirubin within normal range
    2. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 3 x ULN (ALT and AST =< 5 x ULN is acceptable if liver metastases are present)
    3. Creatinine clearance>=50 ml/min
  8. Women and men of childbearing potential must agree to take effective contraceptive measures during the study and within six months after the last treatment. Female patients must have negative urinary pregnancy test within 7 days before the first treatment (postmenopausal women must have no menstruation for at least 12 months before they are considered unable to conceive)
  9. Patients who give written informed consent with good compliance.

Exclusion Criteria:

  1. Received chemotherapy, radiotherapy, biological therapy, endocrine therapy, immunotherapy and other anti-tumor treatments within 4 weeks prior to enrollment while participating in this trial, except for the following items:

    1. Nitrosourea or mitomycin C is within 6 weeks before the first dosage of the study drug;
    2. Oral fluorouracil and small molecule targeted drugs are 2 weeks before the first use of the study drug or 5 half-life periods of the drug (whichever is longer);
    3. The traditional Chinese medicine with anti-tumor indication is within 2 weeks before the first use of the research medicine.
  2. Received other unlaunched clinical research drugs or treatment within 4 weeks before the first dosage of the research drug.
  3. Have undergone major organ surgery (excluding needle biopsy) or experienced significant trauma within 4 weeks prior to the first dosage of study drug, or require elective surgery during the trial period.
  4. Symptomatic peripheral neuropathy CTCAE 5.0 grade evaluation ≥ grade 2
  5. With severe allergies to castor oil, or have had serious adverse reactions with anti-microtubule drugs in the past
  6. Patients of pregnancy or breast feeding
  7. Patients with AEs caused by any previous treatment (including systemic and local treatment) that have not yet restored to GRADE 1 (excluding hair loss)
  8. Patient with known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
  9. Patients with active infections and currently need systemic anti-infective treatment
  10. Patient with immunodeficiency, including a positive HIV antibody test.
  11. Patients with history of active hepatitis B (hepatitis B virus titer> ULN), allow prophylactic antiviral treatment other than interferon; have a history of hepatitis C virus infection (hepatitis C antibody positive).
  12. Patients with history of serious cardiovascular and cerebrovascular diseases.
  13. Patients with mental disorders or patients with poor compliance.
  14. Patients not fitted for this study determined by the investigators.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04911907


Contacts
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Contact: RONGGUO QIU, PhD 01186-5631-5388 rqiu2001@yahoo.com

Locations
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China
Luhe Hospital, Capital Medical University Recruiting
Beijing, China
Contact: Dong Yan, MD         
Obstetrics and Gynecology Hospital, Capital Medical University Recruiting
Beijing, China
Contact: Yumei Wu, MD         
Shanghai East Hospital of Tongji University Recruiting
Shanghai, China
Contact: Jin Li, MD         
Sponsors and Collaborators
Beijing Biostar Technologies, Ltd
Chengdu Biostar Pharmaceuticals, Ltd
Investigators
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Principal Investigator: JIN LI, MD Shanghai Tongji University Affiliated Oriental Hospital
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Responsible Party: Beijing Biostar Technologies, Ltd
ClinicalTrials.gov Identifier: NCT04911907    
Other Study ID Numbers: BG01-2002
First Posted: June 3, 2021    Key Record Dates
Last Update Posted: September 1, 2021
Last Verified: May 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms