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

NCT03906565 | Suspended Phase 2

• 1 other identifier: BG01-1811
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 5

Brief Summary

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

Conditions

Advanced or Metastatic CRC

Outcome Measures

Primary Outcomes (1)

• Tumor response to utidelone 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.

  6 months from first study treatment

Secondary Outcomes (3)

• Progression free survival (PFS)

  1 year from first study treatment

• Overall survival (OS)

  2 year from first study treatment

• Safety profile associated with utidelone injection

  1 year from first study treatment

Study Arms (1)

utidelone

EXPERIMENTAL

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

Drug: utidelone injection

Interventions

utidelone injection DRUG

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

Also known as: UTD1 injection

utidelone

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntarily signed informed consent form; good compliance during the whole study;
• Histologically or cytologically confirmed diagnosis of unresectable advanced or metastatic CRC, not including appendix and anal canal cancer;
• patients failed or intolerable to previous standard second-line treatment for locally advanced or metastatic CRC;
• Patients who have not received previous bevacizumab therapy can be treated in combination with bevacizumab;
• Patients who did not receive chemotherapy, radiotherapy, surgical therapy, molecularly targeted drug therapy 4 weeks prior to enrollment, with no plan for concurrent other chemotherapy and surgery;
• Age 18 -70 years old, ECOG performance status of 0-2; Life expectancy≥ 3 months;
• Patients must have at least one measurable target lesion with long axis ≥10 mm on CT or MRI, with short axis ≥15mm for lymph node based on RECIST 1.1, within 4 weeks before enrolment;
• Seven days prior to treatment, haematology test should meet the following requirements (no treatment with G-CSF or TPO 14 days before test): HGB ≥90 g/L, ANC ≥1.5×109/L, PLT ≥100×109/L, WBC ≥3.0×109/L bilirubin ≤1.5×ULN, aspartate transaminase (AST)/ alanine transaminase (ALT) ≤2.5 ×ULN (patients with liver metastasis ≤5xULN), and creatinine clearance ≥50 mL/min;
• Peripheral neuropathy (PN) ≤grade 1 on the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 within 4 weeks before enrolment; patients with any grade of alopecia are eligible for enrolment;
• Patients with no major organ dysfunctions and heart disease;
• 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 treatmment (postmenopausal women must have no menstruation for at least 12 months before they are considered unable to conceive);
• Patients must agree to provide blood samples for specific biomarkers study;
• No other concurrent investigational agents during the study.

You may not qualify if:

• Patients having history of other malignancies except CRC within the last five years, but patients with fully recovered in situ cervix carcinoma or non-melanoma skin cancer are eligible;
• No other anticancer therapies, such as chemotherapy, hormonal therapy, immunotherapy, antibody therapy and radiotherapy, or concurrent other chemotherapy during treatment;
• Patients with uncontrollable brain metastasis, uncontrollable bone metastasis or recent risk of fracture;
• Arterial or venous thrombosis or embolic events such as cerebrovascular accident (including TIA), deep venous thrombosis or pulmonary embolism occurred within one year;
• history of symptomatic heart disease (including unstable angina, myocardial infarction and heart failure);
• history of interstitial lung disease (ILD), such as interstitial pneumonia, pulmonary fibrosis, or evidence of ILD on baseline chest CT or MRI;
• Patients with gastrointestinal bleeding, active gastrointestinal ulcer or gastrointestinal obstruction (including paralytic intestinal obstruction). Patients with gastrointestinal perforation or gastrointestinal fistula and abdominal abscess within 6 month;
• Previous partial or total gastrectomy, or major operations (such as laparotomy, thoracotomy and intestinal resection) within 4 weeks；
• Patients with AEs caused by any previous treatment (including systemic and local treatment) that have not yet restored to GRADE 1 (excluding hair loss);
• Patients who are pregnanct (positive pregnancy test), breastfeeding or unwilling to take contraceptive measures during the trial;
• active or uncontrollable infections requiring systemic treatment (except simple urinary or upper respiratory infections) within 2 weeks;
• Severely allergic to Cremophor or having severe adverse events associated with paclitaxel in the past;
• Patients with active pulmonary tuberculosis.Patients having obvious cough blood or hemoptysis of half a teaspoon (2.5 ml) or more during the last one month;
• Existence of uncontrolled diabetes, hypertension, active or uncontrollable infections;
• Patients with serous effusion (such as pleural effusion, pericardial effusion and ascites) with clinical symptoms requiring intervention or stabilization for less than 4 weeks;

Sponsors & Collaborators

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

Study Sites (5)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

The Sixth Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510655, China

Location

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, 150081, China

Location

National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, 100021, China

Location

Tianjin People's Hospital

Tianjin, 300000, China

Location

Study Officials

• RUIHUA XU, MD

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2019
• First Posted: April 8, 2019
• Study Start: April 12, 2019
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2024
• Last Updated: January 10, 2023

Record last verified: 2023-01

Locations

CN (5)