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Ovarian CancerPhase 2NCT06251947

Efbemalenograstim Alfa Injection for Ovarian or Cervical Cancer Receiving Chemotherapy Regimen

A Phase 2 study testing Efbemalenograstim Alfa in people with Ovarian Cancer and Cervical Cancer, run by Shandong University at 6 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 70 years, women only
Conditions the study is for
Ovarian Cancer, Cervical Cancer
What is being tested?
Efbemalenograstim Alfa
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
83 participants
Where
6 sitesChina
Study dates
15 Apr 2024to Dec 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ≥ 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.
  • 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.

Trial locations and contacts

6 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Limei Wang contact

18560081708

18560081708@163.com

6 sites in 1 country

China6 sites, 6 recruiting

  • Xiangya Hospital, Central South University,

    Changsha, Hunan

    Yu Zhang

    Not yet recruiting

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang

    Tao Zhu

    Not yet recruiting

  • Qilu Hospital of Shandong University

    Jinan, Shandong, 250012

    Jie Jiang

    Recruiting

  • Zhongda Hospital, School of Medicine, Southeast University

    Nanjing, Jiangsu

    Yang Shen

    Not yet recruiting

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

    Qingdao, Shandong

    Li Sun

    Not yet recruiting

  • Shanxi Provincial Cancer Hospital

    Taiyuan, Shanxi

    Lixin Sun

    Not yet recruiting

Other trials in China

About this study

Official title: 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).

Read the 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.

Being tested
Efbemalenograstim Alfa
Medical subject headings
Ovarian Neoplasms, Uterine Cervical Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Efbemalenograstim AlfaDrug

    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.

Study groups in NCT06251947
Study groupRoleWhat they receive
experimental groupExperimentalEfbemalenograstim Alfa should be administered subcutaneously, 20mg per injection, within 24-48 hours after the completion of each chemotherapy cycle.
Receives: Drug: Efbemalenograstim Alfa

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

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

Secondary outcomes (4)

  1. 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

    Measured: in every treatment cycle( each cycle is 21 days)

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

    The incidence rate of Grade ≥2 ANC reduction in every treatment cycle

    Measured: in every treatment cycle( each cycle is 21 days)

  3. The incidence rate of FN

    The incidence rate of febrile neutropenia (FN) for each cycle

    Measured: in every treatment cycle( each cycle is 21 days)

  4. Adverse Events

    Including adverse events/serious adverse events and their incidence rates

    Measured: in every treatment cycle( each cycle is 21 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Feb 2024
  2. Study start15 Apr 2024
  3. Primary completionJun 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
83 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06251947
Sponsor's protocol ID
Guard-05
Other IDs
Guard-05
Status last verified
May 2024
First submitted
22 Jan 2024
Last updated
7 May 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data for all primary and secondary outcome measures will be made available.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Efbemalenograstim Alfa in people with Ovarian Cancer and Cervical Cancer, run by Shandong University at 6 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 7 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Limei Wang (18560081708, 18560081708@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of grade 3/4 neutropenia (time frame: At the first of cycle 1 (each cycle is 21 days)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06251947.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2024.

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