Efbemalenograstim Alfa Injection for Ovarian or Cervical Cancer Receiving Chemotherapy Regimen

NCT06251947 | Recruiting Phase 2

• 1 other identifier: Guard-05
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 6

Brief Summary

The aim of this study was to observe the efficacy and safety of Efbemalenograstim Alfa in the prevention of absolute neutrophil count (ANC) reduction after chemotherapy in Ovarian and Cervical cancer patients at risk of platinum-containing chemotherapy with risk factors in febrile neutropenia (FN).

Conditions

Ovarian Cancer; Cervical Cancer

Outcome Measures

Primary Outcomes (1)

• Incidence of grade 3/4 neutropenia

  Incidence of grade 3/4 neutropenia during the first chemotherapy cycle for participants receiving primary prophylaxis with Efgbemalenograstim alfa in the first treatment cycle

  At the first of cycle 1 (each cycle is 21 days)

Secondary Outcomes (4)

• The incidence rate of Grade 3/4 ANC reduction for each cycle

  in every treatment cycle( each cycle is 21 days)

• The incidence rate of Grade ≥2 ANC reduction for each cycle

  in every treatment cycle( each cycle is 21 days)

• The incidence rate of FN

  in every treatment cycle( each cycle is 21 days)

• Adverse Events

  in every treatment cycle( each cycle is 21 days)

Study Arms (1)

experimental group

EXPERIMENTAL

Efbemalenograstim Alfa should be administered subcutaneously, 20mg per injection, within 24-48 hours after the completion of each chemotherapy cycle.

Drug: Efbemalenograstim Alfa

Interventions

Efbemalenograstim Alfa DRUG

Efbemalenograstim Alfa is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in adult patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.

experimental group

Eligibility Criteria

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

You may qualify if:

• ≥ 18 years old and ≤ 70 years old.
• First-line epithelial ovarian cancer (including fallopian tube cancer and primary peritoneal cancer) and first-line treatment or recurrent/metastatic cervical cancer.
• Planned to receive 3-6 cycles of paclitaxel + carboplatin/cisplatin ± bevacizumab therapy.
• Eastern Cooperative Oncology Group (ECOG) score \< 2.
• Expected survival time \> 3 months.
• Before enrollment, neutrophil count (ANC) ≥ 2.0 × 10\^9/L, hemoglobin (Hb) ≥ 90.0 g/L, and platelet (PLT) ≥ 80 × 10\^9/L.
• Associated with ≥ 1 self-factors increasing the risk of febrile neutropenia (FN): ① age \> 65 years, receiving full-dose intensity chemotherapy; ② history of previous chemotherapy or radiotherapy; ③ persistent neutropenia; ④ tumor involvement of the bone marrow; ⑤ recent surgery and/or open wounds; ⑥ hepatic dysfunction (bilirubin \> 2.0 mg•dL-1); ⑦ renal dysfunction (creatinine clearance rate \< 50 mL•min-1); ⑧ history of previous FN occurrence; ⑨ concomitant malignant hematological or lymphatic system diseases; ⑩ chronic immunosuppression; ⑪ poor nutritional/physical status. Individualized judgment and decision-making based on the patient's specific condition are required in clinical practice.
• Left ventricular ejection fraction (LVEF) \> 50%.
• Women who are not capable of reproduction, i.e., postmenopausal for at least 1 year or have undergone sterilization procedures (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy). Fertile patients agree to use appropriate contraceptive measures within 1 month before the start of the trial and up to 30 days after the end of the study, such as condoms, spermicidal condoms, foam, gel, diaphragm, intrauterine device (IUD), contraceptive pills (oral or injectable), etc.
• Willing to provide written informed consent and to compliant study procedure.
• The investigator determines that the patient can tolerate treatment with Efgbemalenograstim alfa.

You may not qualify if:

• Uncontrolled infection or systemic antibiotic therapy within 72 hours prior to chemotherapy.
• Pregnant or lactating women.
• History of bone marrow or stem cell transplantation.
• Concurrent malignancies other than primary ovarian or cervical cancer.
• Treatment with recombinant human granulocyte colony-stimulating factor within 6 weeks prior to enrollment.
• Psychiatric illness or brain metastases.
• Clinical, electrocardiographic, or other diagnostic evidence of acute congestive heart failure, cardiomyopathy, or myocardial infarction.
• Diseases associated with splenomegaly.
• Diagnosis of acute infection, chronic active hepatitis B within 1 year (unless known negative for hepatitis B virus antigen prior to enrollment), or hepatitis C.
• Allergy to recombinant human granulocyte colony-stimulating factor or excipients of the study drug, or allergy to rubber.
• Known positive serum reaction for human immunodeficiency virus (HIV) or AIDS.
• Active tuberculosis or recent history of contact with a tuberculosis patient unless negative on tuberculin skin test, or receiving treatment for tuberculosis, or suspected case on chest X-ray examination.
• Sickle cell anemia patients.
• Use of other investigational drugs within 1 month prior to enrollment.
• Patients who abuse alcohol or drugs, affecting their compliance with the study.

Sponsors & Collaborators

• Shandong University: lead
• Chia Tai Tianqing Pharmaceutical Group Co., Ltd.: collaborator

Study Sites (6)

Xiangya Hospital, Central South University,

Changsha, Hunan, China

NOT YET RECRUITING

Zhongda Hospital, School of Medicine, Southeast University

Nanjing, Jiangsu, China

NOT YET RECRUITING

Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

RECRUITING

Qingdao Central Hospital, The Second Affiliated Hospital of Medical College of Qingdao University,

Qingdao, Shandong, China

NOT YET RECRUITING

Shanxi Provincial Cancer Hospital

Taiyuan, Shanxi, China

NOT YET RECRUITING

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

NOT YET RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms; Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Uterine Neoplasms; Uterine Cervical Diseases; Uterine Diseases

Central Study Contacts

Limei Wang

CONTACT

18560081708; 18560081708@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: January 22, 2024
• First Posted: February 9, 2024
• Study Start: April 15, 2024
• Primary Completion: June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 7, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Date will be available within 6 months of study completion
• Access Criteria: Date access requests will be reviewed by an external independent Review Panel.Requestors will be required to sign a Data Access Agreement.

Locations

CN (6)