Chemotherapy PatientsPhase 1FilgrastimNCT01238562
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of YPEG-Filgrastim in Chemotherapy Patients
A Phase 1 study testing YPEG-Filgrastim in people with Chemotherapy Patients, run by Xiamen Amoytop Biotech Co., Ltd. at 1 site in China.
Trial summary
This study will assess the safety, tolerability, pharmacokinetics, pharmacodynamics of a single-dose of YPEG-Filgrastim in cancer patients receiving chemotherapy, and will establish dose-response relationships between YPEG-Filgrastim and Filgrastim(rhG-CSF, TOPNEUTER). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chemotherapy Patients
- What is being tested?
- YPEG-Filgrastim
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- Apr 2010to Nov 2011
- Phase
- Phase 1
- 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: 18～70yrs
- Signed informed consent
- Confirmed malignant tumor patients by histopathological or cytological diagnosis, suitable for chemotherapy with carboplatin combined with taxol or cyclophosphamide combined with pharmorubicin
- Karnofsky score ≥70
- Life expectancy >3 months
- WBC≥3,500 per cubic milliliter, ANC≥1,500 per cubic milliliter, PLT≥100,000 per cubic milliliter
- Normal coagulation function, no evidences of hemorrhage
- Normal liver, heart, kidney function
Who cannot join
- Pregnant or lactating females
- Proven active infectious diseases (e.g. viral hepatitis, TB)
- Not adequately controlled infections
- Known hypersensitivity to filgrastim or any other components of the study drug
- Unstable or uncontrolled cardiac disease or hypertension
- Currently participated in any other clinical trials
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- Patients with previous or expected to receive systemic radiotherapy
- Evidence of metastatic disease in bone marrow, brain, et al
- Alcoholic or drug abusers
- Other conditions which in the opinion of the investigator preclude enrollment into the study
Trial locations and contacts
1 site in 1 country.
China1 site
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, 100021
About this study
Official title: A Randomized, Open-label, Single-dose, Dose-escalation, Self-controlled Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of YPEG-Filgrastim in Cancer Patients Receiving Chemotherapy
This study will assess the safety, tolerability, pharmacokinetics, pharmacodynamics of a single-dose of YPEG-Filgrastim in cancer patients receiving chemotherapy, and will establish dose-response relationships between YPEG-Filgrastim and Filgrastim(rhG-CSF, TOPNEUTER).
- Conditions
- Chemotherapy Patients
- Being tested
- YPEG-Filgrastim
- Keywords
- cancer patient, chemotherapy, carboplatin, taxol, cyclophosphamide, pharmorubicin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YPEG-FilgrastimDrug
s.c, single dose of 10mcg/kg of YPEG-Filgrastim at 48hr of cycle 2, followed by daily s.c either 2.5 mcg/kg or 5 mcg/kg of filgrastim(TOPNEUTER) starting from 48hr of cycle 3 until WBC≥10,000 per cubic milliliter or ANC≥5,000 per cubic milliliter in two continuous daily tests after ANC nadir.
YPEG-FilgrastimDrug
s.c, single dose of 20mcg/kg of YPEG-Filgrastim at 48hr of cycle 2, followed by daily s.c either 2.5 mcg/kg or 5 mcg/kg of filgrastim(TOPNEUTER) starting from 48hr of cycle 3 until WBC≥10,000 per cubic milliliter or ANC≥5,000 per cubic milliliter in two continuous daily tests after ANC nadir.
YPEG-FilgrastimDrug
s.c, single dose of 30mcg/kg of YPEG-Filgrastim at 48hr of cycle 2, followed by daily s.c either 2.5 mcg/kg or 5 mcg/kg of filgrastim(TOPNEUTER) starting from 48hr of cycle 3 until WBC≥10,000 per cubic milliliter or ANC≥5,000 per cubic milliliter in two continuous daily tests after ANC nadir.
YPEG-FilgrastimDrug
s.c, single dose of 45mcg/kg of YPEG-Filgrastim at 48hr of cycle 2, followed by daily s.c either 2.5 mcg/kg or 5 mcg/kg of filgrastim(TOPNEUTER) starting from 48hr of cycle 3 until WBC≥10,000 per cubic milliliter or ANC≥5,000 per cubic milliliter in two continuous daily tests after ANC nadir
YPEG-FilgrastimDrug
s.c, single dose of 60mcg/kg of YPEG-Filgrastim at 48hr of cycle 2, followed by daily s.c either 2.5 mcg/kg or 5 mcg/kg of filgrastim(TOPNEUTER) starting from 48hr of cycle 3 until WBC≥10,000 per cubic milliliter or ANC≥5,000 per cubic milliliter in two continuous daily tests after ANC nadir.
| Study group | Role | What they receive |
|---|---|---|
| YPEG-Filgrastim, 10mcg/kg | Experimental | Not described Receives: Drug: YPEG-Filgrastim |
| YPEG-Filgrastim, 20mcg/kg | Experimental | Not described Receives: Drug: YPEG-Filgrastim |
| YPEG-Filgrastim, 30mcg/kg | Experimental | Not described Receives: Drug: YPEG-Filgrastim |
| YPEG-Filgrastim, 45mcg/kg | Experimental | Not described Receives: Drug: YPEG-Filgrastim |
| YPEG-Filgrastim, 60mcg/kg | Experimental | Not described Receives: Drug: YPEG-Filgrastim |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of absolute neutrophil counts in the 3 cycles for pharmacodynamic study.
Measured: each cycle
Secondary outcomes (1)
Measurement of serum concentration of drugs for Pharmacokinetic study.
Measured: each cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2010 (estimated)
- Study startApr 2010
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy PatientsStudies 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 1
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xiamen Amoytop Biotech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shi Yuankai, Ph.D, Principal investigator, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01238562
- Sponsor's protocol ID
- TB1004CSF
- Acronym
- Filgrastim
- Status last verified
- Mar 2010
- First submitted
- 5 Nov 2010
- Last updated
- 4 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Single-dose, Dose-escalation, Self-controlled Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of YPEG-Filgrastim in Cancer Patients Receiving Chemotherapy
- ClinicalTrials.gov ID
- NCT01238562
- Acronym / sponsor ID
- Filgrastim / TB1004CSF
- Conditions
- Chemotherapy Patients
- Keywords
- cancer patient, chemotherapy, carboplatin, taxol, cyclophosphamide, pharmorubicin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Xiamen Amoytop Biotech Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Study start
- Apr 2010
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 10 Nov 2010 (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 safety, tolerability, pharmacokinetics, pharmacodynamics of a single-dose of YPEG-Filgrastim in cancer patients receiving chemotherapy, and will establish dose-response relationships between YPEG-Filgrastim and Filgrastim(rhG-CSF, TOPNEUTER).
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| YPEG-Filgrastim, 10mcg/kg | Experimental | Drug: YPEG-Filgrastim |
| YPEG-Filgrastim, 20mcg/kg | Experimental | Drug: YPEG-Filgrastim |
| YPEG-Filgrastim, 30mcg/kg | Experimental | Drug: YPEG-Filgrastim |
| YPEG-Filgrastim, 45mcg/kg | Experimental | Drug: YPEG-Filgrastim |
| YPEG-Filgrastim, 60mcg/kg | Experimental | Drug: YPEG-Filgrastim |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age: 18～70yrs
- Signed informed consent
- Confirmed malignant tumor patients by histopathological or cytological diagnosis, suitable for chemotherapy with carboplatin combined with taxol or cyclophosphamide combined with pharmorubicin
- Karnofsky score ≥70
- Life expectancy >3 months
Key exclusion criteria (10 listed)
- Pregnant or lactating females
- Proven active infectious diseases (e.g. viral hepatitis, TB)
- Not adequately controlled infections
- Known hypersensitivity to filgrastim or any other components of the study drug
- Unstable or uncontrolled cardiac disease or hypertension
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-Filgrastims.c, single dose of 10mcg/kg of YPEG-Filgrastim at 48hr of cycle 2, followed by daily s.c either 2.5 mcg/kg or 5 mcg/kg of filgrastim(TOPNEUTER) starting from 48hr of cycle 3 until WBC≥10,000 per cubic milliliter or ANC≥5,000 per cubic milliliter in two continuous daily tests after ANC nadir. | Drug | YPEG-Filgrastim, 10mcg/kg |
| YPEG-Filgrastims.c, single dose of 20mcg/kg of YPEG-Filgrastim at 48hr of cycle 2, followed by daily s.c either 2.5 mcg/kg or 5 mcg/kg of filgrastim(TOPNEUTER) starting from 48hr of cycle 3 until WBC≥10,000 per cubic milliliter or ANC≥5,000 per cubic milliliter in two continuous daily tests after ANC nadir. | Drug | YPEG-Filgrastim, 20mcg/kg |
| YPEG-Filgrastims.c, single dose of 30mcg/kg of YPEG-Filgrastim at 48hr of cycle 2, followed by daily s.c either 2.5 mcg/kg or 5 mcg/kg of filgrastim(TOPNEUTER) starting from 48hr of cycle 3 until WBC≥10,000 per cubic milliliter or ANC≥5,000 per cubic milliliter in two continuous daily tests after ANC nadir. | Drug | YPEG-Filgrastim, 30mcg/kg |
| YPEG-Filgrastims.c, single dose of 45mcg/kg of YPEG-Filgrastim at 48hr of cycle 2, followed by daily s.c either 2.5 mcg/kg or 5 mcg/kg of filgrastim(TOPNEUTER) starting from 48hr of cycle 3 until WBC≥10,000 per cubic milliliter or ANC≥5,000 per cubic milliliter in two continuous daily tests after ANC nadir | Drug | YPEG-Filgrastim, 45mcg/kg |
| YPEG-Filgrastims.c, single dose of 60mcg/kg of YPEG-Filgrastim at 48hr of cycle 2, followed by daily s.c either 2.5 mcg/kg or 5 mcg/kg of filgrastim(TOPNEUTER) starting from 48hr of cycle 3 until WBC≥10,000 per cubic milliliter or ANC≥5,000 per cubic milliliter in two continuous daily tests after ANC nadir. | Drug | YPEG-Filgrastim, 60mcg/kg |
Primary outcome
Measurement of absolute neutrophil counts in the 3 cycles for pharmacodynamic study.
Time frame: each cycle
1 secondary outcome
Measurement of serum concentration of drugs for Pharmacokinetic study.
Time frame: each cycle
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 4 Feb 2013.
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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.
Shi Yuankai, Ph.D 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 1 study testing YPEG-Filgrastim in people with Chemotherapy Patients, run by Xiamen Amoytop Biotech 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 8 inclusion and 10 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 4 Feb 2013. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Measurement of absolute neutrophil counts in the 3 cycles for pharmacodynamic study. (time frame: each cycle). 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 4 Feb 2013; AzTrials last refreshed its copy on 8 Nov 2026.