Efbemalenograstim Alfa Injection for Ovarian or Cervical Cancer Receiving Chemotherapy Regimen

A Study of Efbemalenograstim Alfa Injection for Ovarian or Cervical Cancer Receiving Chemotherapy Regimen With Risk Factors:A Single-Arm, Multicenter Clinical Trial

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).

Study Overview

• Status: Recruiting
• Conditions: Cervical Cancer; Ovarian Cancer
• Intervention / Treatment: Drug: Efbemalenograstim Alfa

Detailed Description

This study is a single-arm, multicenter clinical trial. A total of 83 patients will be enrolled, including 55 patients with primary epithelial ovarian cancer (including fallopian tube cancer and primary peritoneal cancer) and 28 patients with primary or recurrent/metastatic cervical cancer in the first-line setting.

1) Ovarian Cancer

Chemotherapy regimen (Paclitaxel + Carboplatin ± Bevacizumab):

Paclitaxel 175mg/m2, intravenous infusion over 3 hours, on day 1; followed by Carboplatin Area under the curve 5(AUC5), intravenous infusion over 1 hour, on day 1; Bevacizumab 7.5-15 mg/kg, on day 1, administered as intravenous infusion; repeated every 3 weeks.

(2) Cervical Cancer

Chemotherapy regimen (Paclitaxel + Carboplatin/Cisplatin ± Bevacizumab):

Paclitaxel 175mg/m2, intravenous infusion over 3 hours, on day 1; followed by Carboplatin AUC5, intravenous infusion over 1 hour, on day 1, or Cisplatin 50-80mg/m2, intravenous infusion over 1-3 hours, on day 1; Bevacizumab 7.5-15 mg/kg, on day 1, administered as intravenous infusion; repeated every 3 weeks.

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

• Study Type: Interventional
• Enrollment (Estimated): 83
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Limei Wang; Phone Number: 18560081708; Email: 18560081708@163.com

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China
      • Not yet recruiting
      • Xiangya Hospital, Central South University,
      • Contact: Yu Zhang
  • Jiangsu
    • Nanjing, Jiangsu, China
      • Not yet recruiting
      • Zhongda Hospital, School of Medicine, Southeast University
      • Contact: Yang Shen
  • Shandong
    • Jinan, Shandong, China, 250012
      • Recruiting
      • Qilu Hospital of Shandong University
      • Contact: Jie Jiang
    • Qingdao, Shandong, China
      • Not yet recruiting
      • Qingdao Central Hospital, The Second Affiliated Hospital of Medical College of Qingdao University,
      • Contact: Li Sun
  • Shanxi
    • Taiyuan, Shanxi, China
      • Not yet recruiting
      • Shanxi Provincial Cancer Hospital
      • Contact: Lixin Sun
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Not yet recruiting
      • Zhejiang Cancer Hospital
      • Contact: Tao Zhu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. ≥ 18 years old and ≤ 70 years old.
2. First-line epithelial ovarian cancer (including fallopian tube cancer and primary peritoneal cancer) and first-line treatment or recurrent/metastatic cervical cancer.
3. Planned to receive 3-6 cycles of paclitaxel + carboplatin/cisplatin ± bevacizumab therapy.
4. Eastern Cooperative Oncology Group (ECOG) score < 2.
5. Expected survival time > 3 months.
6. Before enrollment, neutrophil count (ANC) ≥ 2.0 × 10^9/L, hemoglobin (Hb) ≥ 90.0 g/L, and platelet (PLT) ≥ 80 × 10^9/L.
7. 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.
8. Left ventricular ejection fraction (LVEF) > 50%.
9. 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.
10. Willing to provide written informed consent and to compliant study procedure.
11. The investigator determines that the patient can tolerate treatment with Efgbemalenograstim alfa.

Exclusion Criteria:

1. Uncontrolled infection or systemic antibiotic therapy within 72 hours prior to chemotherapy.
2. Pregnant or lactating women.
3. History of bone marrow or stem cell transplantation.
4. Concurrent malignancies other than primary ovarian or cervical cancer.
5. Treatment with recombinant human granulocyte colony-stimulating factor within 6 weeks prior to enrollment.
6. Psychiatric illness or brain metastases.
7. Clinical, electrocardiographic, or other diagnostic evidence of acute congestive heart failure, cardiomyopathy, or myocardial infarction.
8. Diseases associated with splenomegaly.
9. 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.
10. Allergy to recombinant human granulocyte colony-stimulating factor or excipients of the study drug, or allergy to rubber.
11. Known positive serum reaction for human immunodeficiency virus (HIV) or AIDS.
12. 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.
13. Sickle cell anemia patients.
14. Use of other investigational drugs within 1 month prior to enrollment.
15. Patients who abuse alcohol or drugs, affecting their compliance with the study.
16. The investigator believes that the patient has a disease or symptom that makes them unsuitable for participation in this study, or that the study drug may harm the patient's health or affect the assessment of adverse events.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: experimental group; Efbemalenograstim Alfa should be administered subcutaneously, 20mg per injection, within 24-48 hours after the completion of each chemotherapy cycle.	Drug: Efbemalenograstim Alfa; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence rate of Grade 3/4 ANC reduction for each cycle	The incidence rate of Grade 3/4 ANC reduction in every treatment cycle	in every treatment cycle( each cycle is 21 days)
The incidence rate of Grade ≥2 ANC reduction for each cycle	The incidence rate of Grade ≥2 ANC reduction in every treatment cycle	in every treatment cycle( each cycle is 21 days)
The incidence rate of FN	The incidence rate of febrile neutropenia (FN) for each cycle	in every treatment cycle( each cycle is 21 days)
Adverse Events	Including adverse events/serious adverse events and their incidence rates	in every treatment cycle( each cycle is 21 days)

Collaborators and Investigators

• Sponsor: Shandong University
• Collaborators: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: January 22, 2024
• First Submitted That Met QC Criteria: February 1, 2024
• First Posted (Actual): February 9, 2024

Study Record Updates

• Last Update Posted (Actual): May 7, 2024
• Last Update Submitted That Met QC Criteria: May 5, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Uterine Cervical Neoplasms
• Other Study ID Numbers: Guard-05 (Other Identifier: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data for all primary and secondary outcome measures will be made available.
• IPD Sharing Time Frame: Date will be available within 6 months of study completion
• IPD Sharing Access Criteria: Date access requests will be reviewed by an external independent Review Panel.Requestors will be required to sign a Data Access Agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No