NeutropeniaPhase 2PEG-rhG-CSFNCT01918241
Saftey and Efficacy of Pegfilgrastim in Preventing Chrmotherapy-induced Neutropenia
A Phase 2 study testing pegfilgrastim,30mcg/kg, pegfilgrastim, 60mcg/kg and pegfilgrastim, 100mcg/kg in people with Neutropenia, run by Hangzhou Jiuyuan Gene Engineering Co. Ltd., at 1 site in China.
Trial summary
This study will assess the Efficacy and Safety of different doses of PEG-rhG-CSF and a single-dose of G-CSF in Preventing Chemotherapy-induced Neutropenia. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Neutropenia
- What is being tested?
- pegfilgrastim,30mcg/kg, pegfilgrastim, 60mcg/kg and pegfilgrastim, 100mcg/kg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Jul 2013to Jan 2016
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age:18-70 years；
- Comfirmed advanced tumor patients by histopathological with regarding initialtreatment or adjuvant, or neoadjuvant chemotherapy,suitable for chemotherapy with canboplatin combined with taxol or cyclophosphamide combined with pharmorubicin in the opinion of the investigator；
- Performance status（EOCG）≤1；
- Normal human peripheral blood are eligible for the chemotherapy, WBC≥3,500 per cubic millilit, ANC ≥ 1,500 per cubic milliliter, PLT ≥ 100,000 per cubic milliliter；
- Normal ECG examination；
- Without liver metastasis patients: the level of ALT、TBIL、AST were in the 2.5 times of upper normal limit; Liver metastasis patients: the level of ALT、TBIL、AST were in the 5 times of upper normal limit;
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- Renal function indices：the level of Cr、BUN were bothe in the 1.25 times of upper normal limit;
- Life expectancy >3 months;
- Signed informed consent.
Who cannot join
- Be treated with radiotherapy in nearly 4 weeks(not included local radiotherapy for the bone metastasis);
- Be treated with hemopoietic stem cell transplantation or bone marrow transplant；
- Not adequately controlled infections(e.g. ANC ≥ 12,000 per cubic milliliter,temperature > 38.2℃)
- Evidence of metastatic disease in bone marrow,or with other malignant tumors （not included cured basal cell carcinoma and endometrial carcinoma）；
- Subjects with unconscious or symptomatic brain metastases；
- Subjects with serious heart、liver and renal disease;
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- Subjects with serious diabetes or poor control in glycemia;
- Pregnant or breast-feeding period females;
- Be treated with antibiotics in 72 hours or currently being treated with antibiotics;
- Treated with PEG-rhG-CSF in past;
- Participated 3 or more than 3 clinical trials in nearly a year(as subjects) or any clinical trials in nearly 3 months;
- Allergic disorders or allergies subjects or known hypersensitivity to filgrastim or any of the products to be administered during dosing;
- Suspected or comfirmed evidences of drug、treatment of drugs or alcohol abused;
- Serious Neurological disorders that would affect the consent or observation;
- Other conditions which in the opinion of the investigator preclude enrollment into the study.
Trial locations and contacts
1 site in 1 country.
Yan Qin, M.D. contact
About this study
Official title: Saftey and Efficacy Phase II Study of Pegfilgrastim in Preventing Chrmotherapy-induced Neutropenia
This study will assess the Efficacy and Safety of different doses of PEG-rhG-CSF and a single-dose of G-CSF in Preventing Chemotherapy-induced Neutropenia.
Read the detailed description
The study consist of a screening period and a 21-day chemotherapy period of the same chemotherapy treatment cycle(s).Screening the subjects according to the inclusion criteria and exclusion criteria before 2 weeks of chemotherapy, and the screening successfully patients will be eligible for this study. The 1st chemotherapy treatment cycle defined as subjects screening period, subjects will be treated with the TC or EC regimen on the 1st day, aiming to screen out Chemotherapy-induced Neutropenia of ≥grade 3 (ANC<1.0×10^9/L) who can have the eligible to enter the 2nd chemotherapy treatment cycle, otherwise to quit the study. On the 1st day in cycle 2, subjects will be treated with the same regimen as the 1st chemotherapy treatment cycle, and be received the test drugs or controlled from the 3rd day to observe the efficacy and safety.
【Primary Outcome Measures】:
- Duration of ≥grade 3 neutropenia in cycle 2
【Secondary Outcome Measures】:
- Incidence of ≥grade 3 neutropenia induce;
- Incidence of febrile neutropenia;
- Duration for ANC from chemotherapy finished to ANC nadir and the minimum ANC ;
- Duration for ANC recovery from nadir to 2.0×10^9/L.
- Conditions
- Neutropenia
- Being tested
- pegfilgrastim,30mcg/kg, pegfilgrastim, 60mcg/kg, pegfilgrastim, 100mcg/kg, filgrastim, 5mcg/kg
- Keywords
- Pegylation, G-CSF, Efficacy, Satety
- Medical subject headings
- Neutropenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pegfilgrastim,30mcg/kgDrug
Also called PEG-rhG-CSF,30mcg/kg
Two doses SC injection of 30 mcg/kg at postchemotherapy 48hr and 120hr in cycle 2.
pegfilgrastim, 60mcg/kgDrug
Also called PEG-rhG-CSF,60mcg/kg
Single SC injection of the appropriate dose of drug ranging from 60 mcg/kg to 100 mcg/kg at postchemotherapy 48hr in cycle 2.
pegfilgrastim, 100mcg/kgDrug
Also called PEG-rhG-CSF,100mcg/kg
Single SC injection of the appropriate dose of drug ranging from 60 mcg/kg to 100 mcg/kg at postchemotherapy 48hr in cycle 2.
filgrastim, 5mcg/kgDrug
Also called rhG-CSF,5mcg/kg
At least 7 days SC injection of 5 mcg/kg at postchemotherapy 48hr in cycle 2.
| Study group | Role | What they receive |
|---|---|---|
| pegfilgrastim,30mcg/kg | Experimental | On the 3rd day and 6th day in Cycle 2, mean after 48h and 120h of chemotherapy, subjects will be received PEG-rhG-CSF(sc) in a fixed time(9:00±30 min), and the dosage is 30 mcg/kg. Receives: Drug: pegfilgrastim,30mcg/kg |
| pegfilgrastim, 60mcg/kg | Experimental | On the 3rd day in Cycle 2, mean after 48h of chemotherapy, subjects will be assigned to PEG-rhG-CSF(sc, single) in a fixed time(9:00±30 min), and the dosage is 60 mcg/kg. Receives: Drug: pegfilgrastim, 60mcg/kg |
| pegfilgrastim,100mcg/kg | Experimental | On the 3rd day in Cycle 2, mean after 48h of chemotherapy, subjects will be assigned to PEG-rhG-CSF(sc, single) in a fixed time(9:00±30 min), and the dosage is 100 mcg/kg. Receives: Drug: pegfilgrastim, 100mcg/kg |
| filgrastim,5mcg/kg | Experimental | On the 3rd day in Cycle 2, mean after 48h of chemotherapy, subjects will be assigned to controlled group with rhG-CSF(sc, once a day) in a fixed time(9:00±30 min), and the dosage is 5mcg/kg, rhG-CSF must be injected for a continous 14 days, or twice observed the results for ANC from the nadir to counts≥5.0×10^9/L, but at least 7 days. Receives: Drug: filgrastim, 5mcg/kg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of ≥grade 3 neutropenia in cycle 2
Measured: 21 days
Secondary outcomes (1)
change of Neutropenia and ANC in cycle 2
- Incidence of ≥grade 3 neutropenia;
- Incidence of febrile neutropenia;
- Measurement the duration from chemotherapy finished to the ANC reached the nadir and the value of ANC's nadir;
- Time to ANC recovery,the time from chemotherapy administration until the patient's ANC increasd to 2.0*109/L after the expected nadir
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2013 (estimated)
- Study startJul 2013
- Primary completionJan 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeutropeniaStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hangzhou Jiuyuan Gene Engineering Co. Ltd.,
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Peking University Cancer Hospital & Institute, Second Affiliated Hospital, Zhejiang University, School of Medicine, Jiangsu Cancer Institute & Hospital, The First Affiliated Hospital with Nanjing Medical University, Wuhan TongJi Hospital, The Affiliated Hospital of Inner Mongolia Medical University, Shandong Cancer Hospital and Institute, Changsha Central Hospital, Yangzhou No.1 People's Hospital, Subei People's Hospital of Jiangsu Province
- Responsible party
- Sponsor
- Investigators
- Yuankai Shi, Principal investigator, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01918241
- Sponsor's protocol ID
- JY062013B
- Acronym
- PEG-rhG-CSF
- Status last verified
- Nov 2015
- First submitted
- 6 Aug 2013
- Last updated
- 10 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Saftey and Efficacy Phase II Study of Pegfilgrastim in Preventing Chrmotherapy-induced Neutropenia
- ClinicalTrials.gov ID
- NCT01918241
- Acronym / sponsor ID
- PEG-rhG-CSF / JY062013B
- Conditions
- Neutropenia
- Keywords
- Pegylation, G-CSF, Efficacy, Satety
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Hangzhou Jiuyuan Gene Engineering Co. Ltd.,Industry (pharma, biotech, devices)
- Collaborators
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Peking University Cancer Hospital & Institute, Second Affiliated Hospital, Zhejiang University, School of Medicine, Jiangsu Cancer Institute & Hospital, The First Affiliated Hospital with Nanjing Medical University, Wuhan TongJi Hospital, The Affiliated Hospital of Inner Mongolia Medical University, Shandong Cancer Hospital and Institute, Changsha Central Hospital, Yangzhou No.1 People's Hospital, Subei People's Hospital of Jiangsu Province
- Study start
- Jul 2013
- Primary completion
- Jan 2016 (estimated)
- First posted
- 7 Aug 2013 (estimated)
- 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.
This study will assess the Efficacy and Safety of different doses of PEG-rhG-CSF and a single-dose of G-CSF in Preventing Chemotherapy-induced Neutropenia.
Detailed description
The study consist of a screening period and a 21-day chemotherapy period of the same chemotherapy treatment cycle(s).Screening the subjects according to the inclusion criteria and exclusion criteria before 2 weeks of chemotherapy, and the screening successfully patients will be eligible for this study. The 1st chemotherapy treatment cycle defined as subjects screening period, subjects will be treated with the TC or EC regimen on the 1st day, aiming to screen out Chemotherapy-induced Neutropenia of ≥grade 3 (ANC<1.0×10^9/L) who can have the eligible to enter the 2nd chemotherapy treatment cycle, otherwise to quit the study. On the 1st day in cycle 2, subjects will be treated with the same regimen as the 1st chemotherapy treatment cycle, and be received the test drugs or controlled from the 3rd day to observe the efficacy and safety.
【Primary Outcome Measures】:
- Duration of ≥grade 3 neutropenia in cycle 2
【Secondary Outcome Measures】:
- Incidence of ≥grade 3 neutropenia induce;
- Incidence of febrile neutropenia;
- Duration for ANC from chemotherapy finished to ANC nadir and the minimum ANC ;
- Duration for ANC recovery from nadir to 2.0×10^9/L.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| pegfilgrastim,30mcg/kg | Experimental | Drug: pegfilgrastim,30mcg/kgOn the 3rd day and 6th day in Cycle 2, mean after 48h and 120h of chemotherapy, subjects will be received PEG-rhG-CSF(sc) in a fixed time(9:00±30 min), and the dosage is 30 mcg/kg. |
| pegfilgrastim, 60mcg/kg | Experimental | Drug: pegfilgrastim, 60mcg/kgOn the 3rd day in Cycle 2, mean after 48h of chemotherapy, subjects will be assigned to PEG-rhG-CSF(sc, single) in a fixed time(9:00±30 min), and the dosage is 60 mcg/kg. |
| pegfilgrastim,100mcg/kg | Experimental | Drug: pegfilgrastim, 100mcg/kgOn the 3rd day in Cycle 2, mean after 48h of chemotherapy, subjects will be assigned to PEG-rhG-CSF(sc, single) in a fixed time(9:00±30 min), and the dosage is 100 mcg/kg. |
| filgrastim,5mcg/kg | Experimental | Drug: filgrastim, 5mcg/kgOn the 3rd day in Cycle 2, mean after 48h of chemotherapy, subjects will be assigned to controlled group with rhG-CSF(sc, once a day) in a fixed time(9:00±30 min), and the dosage is 5mcg/kg, rhG-CSF must be injected for a continous 14 days, or twice observed the results for ANC from the nadir to counts≥5.0×10^9/L, but at least 7 days. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age:18-70 years；
- Comfirmed advanced tumor patients by histopathological with regarding initialtreatment or adjuvant, or neoadjuvant chemotherapy,suitable for chemotherapy with canboplatin combined with taxol or cyclophosphamide combined with pharmorubicin in the opinion of the investigator；
- Performance status（EOCG）≤1；
- Normal human peripheral blood are eligible for the chemotherapy, WBC≥3,500 per cubic millilit, ANC ≥ 1,500 per cubic milliliter, PLT ≥ 100,000 per cubic milliliter；
- Normal ECG examination；
Key exclusion criteria (15 listed)
- Be treated with radiotherapy in nearly 4 weeks(not included local radiotherapy for the bone metastasis);
- Be treated with hemopoietic stem cell transplantation or bone marrow transplant；
- Not adequately controlled infections(e.g. ANC ≥ 12,000 per cubic milliliter,temperature > 38.2℃)
- Evidence of metastatic disease in bone marrow,or with other malignant tumors （not included cured basal cell carcinoma and endometrial carcinoma）；
- Subjects with unconscious or symptomatic brain metastases；
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 |
|---|---|---|
| pegfilgrastim,30mcg/kgAlso: PEG-rhG-CSF,30mcg/kgTwo doses SC injection of 30 mcg/kg at postchemotherapy 48hr and 120hr in cycle 2. | Drug | pegfilgrastim,30mcg/kg |
| pegfilgrastim, 60mcg/kgAlso: PEG-rhG-CSF,60mcg/kgSingle SC injection of the appropriate dose of drug ranging from 60 mcg/kg to 100 mcg/kg at postchemotherapy 48hr in cycle 2. | Drug | pegfilgrastim, 60mcg/kg |
| pegfilgrastim, 100mcg/kgAlso: PEG-rhG-CSF,100mcg/kgSingle SC injection of the appropriate dose of drug ranging from 60 mcg/kg to 100 mcg/kg at postchemotherapy 48hr in cycle 2. | Drug | pegfilgrastim,100mcg/kg |
| filgrastim, 5mcg/kgAlso: rhG-CSF,5mcg/kgAt least 7 days SC injection of 5 mcg/kg at postchemotherapy 48hr in cycle 2. | Drug | filgrastim,5mcg/kg |
Primary outcome
Duration of ≥grade 3 neutropenia in cycle 2
Time frame: 21 days
1 secondary outcome
change of Neutropenia and ANC in cycle 2
Time frame: 21 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2015.
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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.
Yan Qin, M.D. contact
Yuankai Shi principal investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
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 pegfilgrastim,30mcg/kg, pegfilgrastim, 60mcg/kg and pegfilgrastim, 100mcg/kg in people with Neutropenia, run by Hangzhou Jiuyuan Gene Engineering Co. Ltd., 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 9 inclusion and 15 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 10 Nov 2015. 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 Yan Qin, M.D. (010-8778-8507), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of ≥grade 3 neutropenia in cycle 2 (time frame: 21 days). 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 10 Nov 2015.