Non Small Cell Lung CancerPhase 2NCT02005458
Safety and Efficacy of YPEG-rhG-CSF in Cancer Patients Receiving Chemotherapy
A Phase 2 study testing YPEG-rhG-CSF, 20μg/kg, single s.c. at 48hrs after chemotherapy for each experimental cycle, YPEG-rhG-CSF, 30μg/kg, single s.c. at 48hrs after chemotherapy for each experimental cycle and YPEG-rhG-CSF, 45μg/kg, single s.c. at 48hrs after chemotherapy for each experimental cycle in people with Non Small Cell Lung Cancer and Breast Cancer, run by Xiamen Amoytop Biotech Co., Ltd. at 12 sites in China.
Trial summary
This study is to examine which dose of YPEG-rhG-CSF, once-per-cycle, has similar efficacy and safety, comparing to PEG-rhG-CSF, once-per-cycle, in chemotherapy-induced neutropenia Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Non Small Cell Lung Cancer, Breast Cancer
- What is being tested?
- YPEG-rhG-CSF, 20μg/kg, single s.c. at 48hrs after chemotherapy for each experimental cycle, YPEG-rhG-CSF, 30μg/kg, single s.c. at 48hrs after chemotherapy for each experimental cycle and YPEG-rhG-CSF, 45μg/kg, single s.c. at 48hrs after chemotherapy for each experimental cycle
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 12 sitesChina
- Study dates
- Dec 2013to Feb 2018
- 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
- Diagnosis of non-small cell lung cancer or Breast cancer, and adequate for carboplatin combined with taxol or cyclophosphamide combined with pharmorubicin chemotherapy
- Karnofsky Score ≥ 70
- Life Expectancy > 3 months
- Age: 18～70yrs.
- Peripheral blood test: WBC≥3.5×106/mm3, PLT≥100×106/mm3, ANC≥1.5×106/mm3; Normal bone marrow function; Bone marrow biopsy shows active hematopoietic without cancer cells.
- Normal coagulation function, no evidences of hemorrhage tendency.
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- No exiting diseases or condition that may influence drug absorption, distribution, metabolism, and excretion.
- Adequate liver, cardiac, kidney function. Indicators of liver function test ≤ 2.5ULN, Indicators of kidney function test ≤ 1ULN
- Understand and voluntarily sign an informed consent form.
Who cannot join
- Pregnant or lactating females
- Evidence of tumor metastasis in bone marrow
- Lack insight due to tumor metastasis in the central nervous system
- Prior bone marrow transplant or stem cell transplant
- Infective symptom before enrollment into this study
- Other malignancy history
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- Known hypersensitivity to any component of the drug(e.g. rh-G-CSF) that to be administered
- Subject enrolled in any other investigational drug or device trial within 3 months of informed consent date
- Drug abuser or alcoholist
- Prior radiotherapy or expected to received radiotherapy
- Unstable or uncontrolled cardiac or hypertension
- Other conditions which in the opinion of the investigator preclude enrollment into the study
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
China12 sites
Cancer Institute and Hospital, CAMS
Beijing
Fujian cancer hospital
Fuzhou
Fujian Medical University Union Hospital
Fuzhou
Fuzhou General Hospital of Nanjing Military Command
Fuzhou
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou
Shanghai Changzheng Hospital
Shanghai
Shanghai Chest Hospital
Shanghai
Tongji Hospital, Tongji Medical College Huazhou University of Science & Technology
Wuhan
Shaaxi Provincial Tumor Hospital
Xi'an, Shaanxi, 710061
The First Affiliated Hospital of Xiamen University
Xiamen
Zhangzhou Municipal Hospital of Fujian Province
Zhangzhou, Fujian, 363000
Zhejiang cancer hospital
Zhejiang
About this study
Official title: Multi-center, Randomized, Open-labeled, Positive-controlled, Phase Ⅱ Study to Evaluate Efficacy and Safety of YPEG-rhG-CSF, Once-per-cycle, Comparing to PEG-rhG-CSF, Once-per-cycle, in Chemotherapy-induced Neutropenia of Patients With Malignancies Receiving Myelosuppressive Chemotherapy.
This study is to examine which dose of YPEG-rhG-CSF, once-per-cycle, has similar efficacy and safety, comparing to PEG-rhG-CSF, once-per-cycle, in chemotherapy-induced neutropenia
- Conditions
- Non Small Cell Lung Cancer, Breast Cancer
- Being tested
- YPEG-rhG-CSF, 20μg/kg, single s.c. at 48hrs after chemotherapy for each experimental cycle, YPEG-rhG-CSF, 30μg/kg, single s.c. at 48hrs after chemotherapy for each experimental cycle, YPEG-rhG-CSF, 45μg/kg, single s.c. at 48hrs after chemotherapy for each experimental cycle, PEG-rhG-CSF, 100μg/kg, single s.c. at 48hrs after chemotherapy for each experimental cycle
- Keywords
- Neutropenia, Febrile neutropenia, PEG-rhG-CSF, Myelosuppressive chemotherapy
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Breast Neoplasms, Neutropenia, Febrile Neutropenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YPEG-rhG-CSF, 20μg/kg, single s.c. at 48hrs after chemotherapy for each experimental cycleDrug
YPEG-rhG-CSF, 30μg/kg, single s.c. at 48hrs after chemotherapy for each experimental cycleDrug
YPEG-rhG-CSF, 45μg/kg, single s.c. at 48hrs after chemotherapy for each experimental cycleDrug
PEG-rhG-CSF, 100μg/kg, single s.c. at 48hrs after chemotherapy for each experimental cycleDrug
| Study group | Role | What they receive |
|---|---|---|
| YPEG-rhG-CSF 20μg/kg | Experimental | 20μg/kg,single s.c. at 48hrs after chemotherapy for each experimental cycle Receives: Drug: YPEG-rhG-CSF, 20μg/kg, single s.c. at 48hrs after chemotherapy for each experimental cycle |
| YPEG-rhG-CSF 30μg/kg | Experimental | 30μg/kg,single s.c. at 48hrs after chemotherapy for each experimental cycle Receives: Drug: YPEG-rhG-CSF, 30μg/kg, single s.c. at 48hrs after chemotherapy for each experimental cycle |
| YPEG-rhG-CSF 45μg/kg | Experimental | 45μg/kg,single s.c. at 48hrs after chemotherapy for each experimental cycle Receives: Drug: YPEG-rhG-CSF, 45μg/kg, single s.c. at 48hrs after chemotherapy for each experimental cycle |
| PEG-rhG-CSF 100μg/kg | Active comparator | 100μg/kg,single s.c. at 48hrs after chemotherapy for each experimental cycle Receives: Drug: PEG-rhG-CSF, 100μg/kg, single s.c. at 48hrs after chemotherapy for each experimental cycle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Grade 3 &4 neutropenia, and median duration of neutropenia in the two experimental cycles
Grade 3 and 4 neutropenia means absolute neutrophil count is less than 1000/mm3 and 500/mm3 , respectively
Measured: 21 day
Secondary outcomes (2)
Incidence of febrile neutropenia in the two experimental cycles
Febrile neutropenia means absolute neutrophil count is less than 500/mm3 or absolute neutrophil count between 500/mm3 and 1000mm3 but probably to decline to less than 500mm3 within 48hrs, and body temperature is higher than 38.5 degrees celsius or higher than 38.0 degrees celsius and lasting for more than 1hr
Measured: 21 day
Diversification of neutrophil in the two experimental cycles
Measured: 21 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2013 (estimated)
- Study startDec 2013
- Primary completionMar 2017
- Study completionFeb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Xiamen Amoytop Biotech Co., Ltd.The 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xiamen Amoytop Biotech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yuankai Shi, Ph.D, Principal investigator, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02005458
- Sponsor's protocol ID
- TB1309CSF
- Status last verified
- Feb 2018
- First submitted
- 3 Dec 2013
- Last updated
- 17 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center, Randomized, Open-labeled, Positive-controlled, Phase Ⅱ Study to Evaluate Efficacy and Safety of YPEG-rhG-CSF, Once-per-cycle, Comparing to PEG-rhG-CSF, Once-per-cycle, in Chemotherapy-induced Neutropenia of Patients With Malignancies Receiving Myelosuppressive Chemotherapy.
- ClinicalTrials.gov ID
- NCT02005458
- Acronym / sponsor ID
- TB1309CSF
- Conditions
- Non Small Cell Lung Cancer, Breast Cancer
- Keywords
- Neutropenia, Febrile neutropenia, PEG-rhG-CSF, Myelosuppressive chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Xiamen Amoytop Biotech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Dec 2013 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 9 Dec 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 is to examine which dose of YPEG-rhG-CSF, once-per-cycle, has similar efficacy and safety, comparing to PEG-rhG-CSF, once-per-cycle, in chemotherapy-induced neutropenia
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| YPEG-rhG-CSF 20μg/kg | Experimental | Drug: YPEG-rhG-CSF, 20μg/kg, single s.c. at 48hrs after chemotherapy for each experimental cycle20μg/kg,single s.c. at 48hrs after chemotherapy for each experimental cycle |
| YPEG-rhG-CSF 30μg/kg | Experimental | Drug: YPEG-rhG-CSF, 30μg/kg, single s.c. at 48hrs after chemotherapy for each experimental cycle30μg/kg,single s.c. at 48hrs after chemotherapy for each experimental cycle |
| YPEG-rhG-CSF 45μg/kg | Experimental | Drug: YPEG-rhG-CSF, 45μg/kg, single s.c. at 48hrs after chemotherapy for each experimental cycle45μg/kg,single s.c. at 48hrs after chemotherapy for each experimental cycle |
| PEG-rhG-CSF 100μg/kg | Active comparator | Drug: PEG-rhG-CSF, 100μg/kg, single s.c. at 48hrs after chemotherapy for each experimental cycle100μg/kg,single s.c. at 48hrs after chemotherapy for each experimental cycle |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Diagnosis of non-small cell lung cancer or Breast cancer, and adequate for carboplatin combined with taxol or cyclophosphamide combined with pharmorubicin chemotherapy
- Karnofsky Score ≥ 70
- Life Expectancy > 3 months
- Age: 18～70yrs.
- Peripheral blood test: WBC≥3.5×106/mm3, PLT≥100×106/mm3, ANC≥1.5×106/mm3; Normal bone marrow function; Bone marrow biopsy shows active hematopoietic without cancer cells.
Key exclusion criteria (12 listed)
- Pregnant or lactating females
- Evidence of tumor metastasis in bone marrow
- Lack insight due to tumor metastasis in the central nervous system
- Prior bone marrow transplant or stem cell transplant
- Infective symptom before enrollment into this study
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 |
|---|---|---|
| YPEG-rhG-CSF, 20μg/kg, single s.c. at 48hrs after chemotherapy for each experimental cycle | Drug | YPEG-rhG-CSF 20μg/kg |
| YPEG-rhG-CSF, 30μg/kg, single s.c. at 48hrs after chemotherapy for each experimental cycle | Drug | YPEG-rhG-CSF 30μg/kg |
| YPEG-rhG-CSF, 45μg/kg, single s.c. at 48hrs after chemotherapy for each experimental cycle | Drug | YPEG-rhG-CSF 45μg/kg |
| PEG-rhG-CSF, 100μg/kg, single s.c. at 48hrs after chemotherapy for each experimental cycle | Drug | PEG-rhG-CSF 100μg/kg |
Primary outcome
Incidence of Grade 3 &4 neutropenia, and median duration of neutropenia in the two experimental cycles
Time frame: 21 day
Grade 3 and 4 neutropenia means absolute neutrophil count is less than 1000/mm3 and 500/mm3 , respectively
2 secondary outcomes
Incidence of febrile neutropenia in the two experimental cycles
Time frame: 21 day
Diversification of neutrophil in the two experimental cycles
Time frame: 21 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2018.
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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.
Yuankai Shi, Ph.D principal investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing YPEG-rhG-CSF, 20μg/kg, single s.c. at 48hrs after chemotherapy for each experimental cycle, YPEG-rhG-CSF, 30μg/kg, single s.c. at 48hrs after chemotherapy for each experimental cycle and YPEG-rhG-CSF, 45μg/kg, single s.c. at 48hrs after chemotherapy for each experimental cycle in people with Non Small Cell Lung Cancer and Breast Cancer, run by Xiamen Amoytop Biotech Co., Ltd. at 12 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 9 inclusion and 12 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: finished, as of the sponsor's last update on 17 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Grade 3 &4 neutropenia, and median duration of neutropenia in the two experimental cycles (time frame: 21 day). 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 17 Jul 2018.