Colorectal CancerPhase 2NCT06134765
Bemalenograstim Alfa for the Prevention in Patients With Colorectal Cancer/Pancreatic Cancer
A Phase 2 study testing Bemalenograstim alfa in people with Colorectal Cancer and Pancreatic Cancer, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Pancreatic Cancer
- What is being tested?
- Bemalenograstim alfa
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 1 siteChina
- Study dates
- 30 Nov 2023to 30 Mar 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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;
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- 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;
- Received recombinant human granulocyte stimulating factor treatment within 6 weeks before inclusion;
- 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;
Trial locations and contacts
1 site in 1 country.
China1 site
the Second Affiliated Hospital of Medical College of Zhejiang University
Hangzhou
Ying Yuan, +86 13858193601, yuanying1999@zju.edu.cn
About this study
Official title: A Multi-cohort, Open-label, Multicenter Exploratory Clinical Study of Bemalenograstim Alfa for the Prevention of Reduced ANC in Patients With Colorectal Cancer/Pancreatic Cancer Following a Bi-weekly Chemotherapy
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.
Read the detailed description
This multi-cohort, open-label, multicenter exploratory clinical study enrolled 89 patients with colorectal cancer and pancreatic cancer who were scheduled to receive at least 2 courses of a two-week chemotherapy regimen. The study was divided into two cohorts: Cohort 1 was colorectal cancer or pancreatic cancer patients receiving FOLFOXIRI or mFOLFIRINOX in combination with or without targeted drugs, and cohort 2 was colorectal cancer patients receiving FOLFIRI in combination with or without targeted drugs. Patients meeting the inclusion criteria received Bemalenograstim alfa injection (20mg/ time, subcutaneous injection) 24-48h after each course of chemotherapy, and Bemalenograstim alfa injection was used until the change of chemotherapy regimen or the fourth course of chemotherapy, whichever occurred first. After the subjects completed 2 courses of treatment, the follow-up treatment was carried out according to the diagnosis and treatment routine. Investigators need to ensure that the first course of chemotherapy is at the recommended dose; For the second to fourth course of treatment, delayed dosing or dose adjustment due to toxicity is allowed, and the chemotherapy dose is allowed to be adjusted by ±10%.
- Conditions
- Colorectal Cancer, Pancreatic Cancer
- Being tested
- Bemalenograstim alfa
- Medical subject headings
- Colorectal Neoplasms, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bemalenograstim alfaDrug
Also called F-627
Bemalenograstim alfa,20mg, once every treatment
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Bemalenograstim alfa |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From Baseline to primary completion date, about 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start30 Nov 2023 (estimated)
- Primary completion30 Oct 2024 (estimated)
- Study completion30 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 89 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06134765
- Sponsor's protocol ID
- 2023-0302
- Status last verified
- Oct 2023
- First submitted
- 30 Oct 2023
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-cohort, Open-label, Multicenter Exploratory Clinical Study of Bemalenograstim Alfa for the Prevention of Reduced ANC in Patients With Colorectal Cancer/Pancreatic Cancer Following a Bi-weekly Chemotherapy
- ClinicalTrials.gov ID
- NCT06134765
- Acronym / sponsor ID
- 2023-0302
- Conditions
- Colorectal Cancer, Pancreatic Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 89 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 30 Nov 2023 (estimated)
- Primary completion
- 30 Oct 2024 (estimated)
- Study completion
- 30 Mar 2025 (estimated)
- First posted
- 18 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This multi-cohort, open-label, multicenter exploratory clinical study enrolled 89 patients with colorectal cancer and pancreatic cancer who were scheduled to receive at least 2 courses of a two-week chemotherapy regimen. The study was divided into two cohorts: Cohort 1 was colorectal cancer or pancreatic cancer patients receiving FOLFOXIRI or mFOLFIRINOX in combination with or without targeted drugs, and cohort 2 was colorectal cancer patients receiving FOLFIRI in combination with or without targeted drugs. Patients meeting the inclusion criteria received Bemalenograstim alfa injection (20mg/ time, subcutaneous injection) 24-48h after each course of chemotherapy, and Bemalenograstim alfa injection was used until the change of chemotherapy regimen or the fourth course of chemotherapy, whichever occurred first. After the subjects completed 2 courses of treatment, the follow-up treatment was carried out according to the diagnosis and treatment routine. Investigators need to ensure that the first course of chemotherapy is at the recommended dose; For the second to fourth course of treatment, delayed dosing or dose adjustment due to toxicity is allowed, and the chemotherapy dose is allowed to be adjusted by ±10%.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bemalenograstim alfa for the prevention of reduced ANC in patients with colorectal/pancreatic cancer | Experimental | Drug: Bemalenograstim alfaPatients 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. |
| Bemalenograstim alfa for the prevention of reduced ANC in patients with colorectal cancer | Experimental | Drug: Bemalenograstim alfaPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
Key exclusion criteria (13 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bemalenograstim alfaAlso: F-627Bemalenograstim alfa,20mg, once every treatment | Drug | 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 |
Primary outcome
The incidence of reduced absolute neutrophil count(ANC) of grade ≥3 in the first cycle of chemotherapy
Time frame: From Baseline to primary completion date, about 18 months
The incidence of reduced absolute neutrophil count(ANC) of grade ≥3 in the first cycle of chemotherapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bemalenograstim alfa in people with Colorectal Cancer and Pancreatic Cancer, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site 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 10 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Caixia Dong (+86-15068882349, dcx_1982@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of reduced absolute neutrophil count(ANC) of grade ≥3 in the first cycle of chemotherapy (time frame: From Baseline to primary completion date, about 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Nov 2023.