Bemalenograstim Alfa for the Prevention in Patients With Colorectal Cancer/Pancreatic Cancer

NCT06134765 | Unknown Phase 2 DMC

• 1 other identifier: 2023-0302
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

Brief Summary

A multi-cohort, open-label, multicenter exploratory clinical study of Bemalenograstim alfa for the prevention of reduced absolute neutrophil count(ANC) in patients with colorectal cancer/pancreatic cancer following a bi-weekly chemotherapy regimen.A total of 89 patients are planned to be enrolled.

Conditions

Colorectal Cancer; Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• The incidence of reduced absolute neutrophil count(ANC) of grade ≥3 in the first cycle of chemotherapy

  The incidence of reduced absolute neutrophil count(ANC) of grade ≥3 in the first cycle of chemotherapy

  From Baseline to primary completion date, about 18 months

Study Arms (2)

Bemalenograstim alfa for the prevention of reduced ANC in patients with colorectal/pancreatic cancer

EXPERIMENTAL

Patients with colorectal cancer and pancreatic cancer（N=32）receive FOLFOXIRI or mFOLFIRINOX with or without targeted therapy. Subcutaneous injection of Bemalenograstim alfa 20mg/ time 24-48h after each cycle of chemotherapy.

Drug: Bemalenograstim alfa

Bemalenograstim alfa for the prevention of reduced ANC in patients with colorectal cancer

EXPERIMENTAL

Patients with colorectal cancer(N=57)receiving FOLFIRI with or without targeted therapy.Subcutaneous injection of Bemalenograstim alfa, 20mg/ time, 24-48h after each cycle of chemotherapy.

Drug: Bemalenograstim alfa

Interventions

Bemalenograstim alfa DRUG

Bemalenograstim alfa,20mg, once every treatment

Also known as: F-627

Bemalenograstim alfa for the prevention of reduced ANC in patients with colorectal cancer; Bemalenograstim alfa for the prevention of reduced ANC in patients with colorectal/pancreatic cancer

Eligibility Criteria

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

You may qualify if:

• The patients voluntarily joined the study, signed informed consent, had good compliance, and cooperated with follow-up;
• Age 18 and above, male or female;
• Patients with locally advanced or advanced colorectal or pancreatic cancer confirmed by histology or cytology are scheduled to receive at least 2 courses of FOLFIRI, FOLFOXIRI, or mFOLFIRINOX with or without targeted therapy as part of first-line therapy (excluding those who relapse within 6 months after the end of adjuvant therapy) ;
• Eastern Cancer Collaboration Group (ECOG) physical status (PS) score: 0-1;
• Adequate organ and bone marrow function meets the following criteria:
• Blood routine examination standards should be met (no blood transfusion or blood products within 14 days, no G-CSF and other hematopoietic stimulating factors are used to correct): hemoglobin content (HB) ≥80g/L; Neutrophil count (ANC) ≥1.5×109/L; Platelet count (PLT) ≥100×109/L.
• Biochemical examination shall meet the following criteria: Serum total bilirubin (TBIL) ≤1.5 times the upper limit of normal value (ULN); ALT and AST ≤ 2.5 ULN; If with liver metastasis, ALT and AST ≤ 5× ULN; Serum creatinine ≤ 1.5× ULN.
• Left ejection fraction \>50%.
• Infertile women, i.e. those who have been through menopause for at least one year or who have undergone sterilization (bilateral tubal ligation, double ovaries removal, or hysterectomy); Fertile patients agreed to use appropriate contraceptive methods: condoms, foam, gel, diaphragm, intrauterine device (IUD), birth control pills (given orally or by injection) for 1 month before the start of the trial and 30 days after the end of the study.
• The investigators determined that the patient could tolerate the treatment of Bemalenograstim Alfa.

You may not qualify if:

• Acute congestive heart failure, cardiomyopathy, or myocardial infarction as diagnosed by clinical, electrocardiogram or other means;
• Rubber allergic people;
• Patients who had received radiotherapy for bone lesions (patients who had received radiotherapy for lesions other than bone lesions could be enrolled 4 weeks later) ;
• Have received a bone marrow or stem cell transplant;
• Pregnant or lactating women;
• Known to be seropositive for human immunodeficiency virus (HIV) or have AIDS;
• Active tuberculosis disease; Or a recent history of contact with a person with TB, unless the tuberculin test is negative, Or tuberculosis patients undergoing treatment; Or a chest radiograph to check suspected cases;
• Patients with alcohol or substance abuse, which affected their adherence to the study;以上
• Known allergy to granulocyte colony-stimulating factors or excipients of drugs;
• Patients with a diagnosis of primary malignancy other than colorectal or pancreatic cancer were accompanied by the following, except: 1) malignancy in complete remission for at least 2 years prior to enrollment and without additional treatment during the study period; 2) non-melanoma skin cancer or malignant lentigo with adequate treatment and no evidence of disease recurrence; 3) Carcinoma in situ with adequate treatment and no evidence of disease recurrence;
• Use of other investigational drugs within 1 month prior to study enrollment;
• The investigators believe that the patients have diseases or symptoms that are not suitable for participation in the study and that the study drugs may harm the patient's health or affect the judgment of adverse events;

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

the Second Affiliated Hospital of Medical College of Zhejiang University

Hangzhou, China

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases

Central Study Contacts

Caixia Dong

CONTACT

+86-15068882349; dcx_1982@163.com

Ying Yuan

CONTACT

+86-13858193601; yuanying1999@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2023
• First Posted: November 18, 2023
• Study Start: November 30, 2023
• Primary Completion: October 30, 2024
• Study Completion: March 30, 2025
• Last Updated: November 18, 2023

Record last verified: 2023-10

Locations

CN (1)