Chemotherapy-induced NeutropeniaPhase 1NCT02725606
Study to Assess the Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of GW003 in Patients With Breast Cancer
A Phase 1 study testing Pegylated Recombinant Human G-CSF and GW003 in people with Chemotherapy-induced Neutropenia, run by Jiangsu T-Mab Biopharma Co.,Ltd at 1 site in China.
Trial summary
The purpose of the present trial is to evaluate the safety, tolerability and pharmacokinetics(PK)/pharmacodynamics(PD) of single subcutaneous injection of GW003 in breast cancer patients. Moreover, the efficacy will be assessed preliminary. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Chemotherapy-induced Neutropenia
- What is being tested?
- Pegylated Recombinant Human G-CSF and GW003
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- Mar 2016to Sep 2017
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 years to 70 years, female
- Patients with histologically-confirmed breast cancer and plan to accept adjuvant chemotherapy(epirubicin plus cyclophosphamide)
- Have an Eastern Cooperative Oncology Group(ECOG) performance status≤2
- Have no clinically significant impairment in cardiac, liver and kidney
- Adequate hematologic, hepatic and renal function which should meet the following requirements:
- Absolute neutrophil count(ANC)≥1.5 x 10^9/L
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- Blood platelet(PLT)≥100 x 10^9/L
- Serum creatinine(sCr)≤1.5 times the upper limit of normal(ULN)
- Total bilirubin(TBIL)≤1.5×ULN
- Aspartate aminotransferase(AST) /serum glutamic-oxaloacetic transaminase(SGOT) and/or alanine aminotransferase(ALT)/serum glutamic pyruvic transaminase(SGPT) ≤ 2.5 x ULN
- Hemoglobin(Hb)>9 g/dL
- Alkaline phosphatase(ALP)≤1.5×ULN
- Expected to comply with protocol
- With urine human chorionic gonadotropin (hCG) negative
- Signed informed consent
Who cannot join
- With acute infection
- With history of bone marrow transplant and/or stem cell transplant
- With primary hematological diseases, such as myelodysplastic syndromes, aplastic anemia, sickle cell anemia
- Received surgery within 3 weeks before chemotherapy
- Received G-CSF within 4 weeks before involved in this study
- Females who are pregnant or lactating
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- Participated in other clinical trials at the same time or within 4 weeks before screening
- Known allergy to chemotherapy drugs,recombinant human granulocyte-colony stimulating factor rh(rhG-CSF) or any other biological products
- With cacoethic addiction such as drug abuse or alcoholism
- With other cases which is not suitable for this study judged by investigator
Trial locations and contacts
1 site in 1 country.
Xichun Hu contact
Guangfu Li contact
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Xichun Hu, xchu2009@hotmail.com
About this study
Official title: A Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of Human Serum Albumin/Human Granulocyte-Colony Stimulating Factor(I) Fusion Protein for Injection (GW003) in Patients With Breast Cancer
The purpose of the present trial is to evaluate the safety, tolerability and pharmacokinetics(PK)/pharmacodynamics(PD) of single subcutaneous injection of GW003 in breast cancer patients. Moreover, the efficacy will be assessed preliminary.
Read the detailed description
This is an single-center, open-label, randomized, active-controlled phase I study evaluating tolerability and pharmacokinetics/pharmacodynamics of single subcutaneous injections of GW003 in the breast cancer patients.GW003 is recombinant human serum albumin/human granulocyte-colony stimulating factor(I)fusion protein .It is a long-acting G-CSF(Granulocyte-Colony Stimulating Factor). In this study, participants will be administered a single dose of GW003. Every subject will only accept one dose. In addition to tolerability and safety, pharmacokinetics/pharmacodynamics, preliminary efficacy and immunogenicity of GW003 will be evaluated as well.
- Conditions
- Chemotherapy-induced Neutropenia
- Being tested
- Pegylated Recombinant Human G-CSF, GW003
- Keywords
- Neutropenia, Breast Cancer, GW003
- Medical subject headings
- Neutropenia, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pegylated Recombinant Human G-CSFBiological
subcutaneous
GW003Biological
subcutaneous
| Study group | Role | What they receive |
|---|---|---|
| Pegylated Recombinant Human G-CSF | Active comparator | 100ug/kg 6 subjects (2 subjects per GW003 cohort) Receives: Biological: Pegylated Recombinant Human G-CSF |
| GW003 300ug/kg | Experimental | 6-8 subjects Receives: Biological: GW003 |
| GW003 650ug/kg | Experimental | 6-8 subjects Receives: Biological: GW003 |
| GW003 850ug/kg | Experimental | 6-8 subjects Receives: Biological: GW003 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of adverse events (AEs) and serious adverse events (SAEs) which are related to GW003 as assessed by CTCAE v4.03
Measured: 21days
Secondary outcomes (12)
Maximum observed maximum plasma concentration [Cmax]
Measured: 21days
Time to reach the maximum observed plasma concentration [Tmax]
Measured: 21days
Area under the plasma concentration-time curve from time zero to infinity[AUC0-inf]
Measured: 21days
Area under the plasma concentration-time curve from time zero to time 't' where t is a defined time point after administration [AUC0-t]
Measured: 21days
Terminal elimination half-life[T1/2]
Measured: 21days
Absolute neutrophil count[ANC]
ANC will be detected pre-dose and 12h,24h,48h,72h,96h,120h,144h,168h,192h,216h,240h,264h,360h,408h,480h post-dose.
Measured: 21days
CD34+ count
CD34+ count will be detected pre-dose and 12h,24h,48h,72h,96h,120h,144h,168h,192h,216h,240h,264h,360h,408h,480h post-dose.
Measured: 21days
Time to absolute neutrophil count(ANC) recovery
The time of ANC of patients who experienced neutropenia after chemotherapy recover to normal levels.
Measured: 21days
Incidence of severe neutropenia
The proportion of patients with grade 3 and 4 neutropenia as assessed by CTCAE v4.03.
Measured: 21days
Duration of severe neutropenia(DSN)
Duration of grade 3 and 4 neutropenia as assessed by CTCAE v4.03.
Measured: 21days
ANC nadir
The minimum value of ANC throughout the study period.
Measured: 21days
Frequency of subjects with anti-GW003 antibody
Anti-GW003 antibody will be detected pre-dose and 21d.
Measured: 21days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2016 (estimated)
- Study startMar 2016
- Primary completionSep 2017 (estimated)
- Study completionSep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy-induced 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu T-Mab Biopharma Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xichun Hu, Principal investigator, Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02725606
- Sponsor's protocol ID
- Tmab-GW003-NP-04
- Status last verified
- Jan 2017
- First submitted
- 24 Mar 2016
- Last updated
- 18 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of Human Serum Albumin/Human Granulocyte-Colony Stimulating Factor(I) Fusion Protein for Injection (GW003) in Patients With Breast Cancer
- ClinicalTrials.gov ID
- NCT02725606
- Acronym / sponsor ID
- Tmab-GW003-NP-04
- Conditions
- Chemotherapy-induced Neutropenia
- Keywords
- Neutropenia, Breast Cancer, GW003
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Jiangsu T-Mab Biopharma Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- Mar 2016
- Primary completion
- Sep 2017 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 1 Apr 2016 (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.
The purpose of the present trial is to evaluate the safety, tolerability and pharmacokinetics(PK)/pharmacodynamics(PD) of single subcutaneous injection of GW003 in breast cancer patients. Moreover, the efficacy will be assessed preliminary.
Detailed description
This is an single-center, open-label, randomized, active-controlled phase I study evaluating tolerability and pharmacokinetics/pharmacodynamics of single subcutaneous injections of GW003 in the breast cancer patients.GW003 is recombinant human serum albumin/human granulocyte-colony stimulating factor(I)fusion protein .It is a long-acting G-CSF(Granulocyte-Colony Stimulating Factor). In this study, participants will be administered a single dose of GW003. Every subject will only accept one dose. In addition to tolerability and safety, pharmacokinetics/pharmacodynamics, preliminary efficacy and immunogenicity of GW003 will be evaluated as well.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Pegylated Recombinant Human G-CSF | Active comparator | Biological: Pegylated Recombinant Human G-CSF100ug/kg 6 subjects (2 subjects per GW003 cohort) |
| GW003 300ug/kg | Experimental | Biological: GW0036-8 subjects |
| GW003 650ug/kg | Experimental | Biological: GW0036-8 subjects |
| GW003 850ug/kg | Experimental | Biological: GW0036-8 subjects |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Aged 18 years to 70 years, female
- Patients with histologically-confirmed breast cancer and plan to accept adjuvant chemotherapy(epirubicin plus cyclophosphamide)
- Have an Eastern Cooperative Oncology Group(ECOG) performance status≤2
- Have no clinically significant impairment in cardiac, liver and kidney
- Adequate hematologic, hepatic and renal function which should meet the following requirements:
Key exclusion criteria (10 listed)
- With acute infection
- With history of bone marrow transplant and/or stem cell transplant
- With primary hematological diseases, such as myelodysplastic syndromes, aplastic anemia, sickle cell anemia
- Received surgery within 3 weeks before chemotherapy
- Received G-CSF within 4 weeks before involved in 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 |
|---|---|---|
| Pegylated Recombinant Human G-CSFsubcutaneous | Biological | Pegylated Recombinant Human G-CSF |
| GW003subcutaneous | Biological | GW003 300ug/kg, GW003 650ug/kg, GW003 850ug/kg |
Primary outcome
Frequency of adverse events (AEs) and serious adverse events (SAEs) which are related to GW003 as assessed by CTCAE v4.03
Time frame: 21days
12 secondary outcomes
Maximum observed maximum plasma concentration [Cmax]
Time frame: 21days
Time to reach the maximum observed plasma concentration [Tmax]
Time frame: 21days
Area under the plasma concentration-time curve from time zero to infinity[AUC0-inf]
Time frame: 21days
Area under the plasma concentration-time curve from time zero to time 't' where t is a defined time point after administration [AUC0-t]
Time frame: 21days
Terminal elimination half-life[T1/2]
Time frame: 21days
Absolute neutrophil count[ANC]
Time frame: 21days
CD34+ count
Time frame: 21days
Time to absolute neutrophil count(ANC) recovery
Time frame: 21days
Incidence of severe neutropenia
Time frame: 21days
Duration of severe neutropenia(DSN)
Time frame: 21days
ANC nadir
Time frame: 21days
Frequency of subjects with anti-GW003 antibody
Time frame: 21days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2017.
- Individual participant dataSharing planned: Undecided
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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.
Xichun Hu contact
Guangfu Li contact
Xichun Hu principal investigator
Principal Investigator
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 Pegylated Recombinant Human G-CSF and GW003 in people with Chemotherapy-induced Neutropenia, run by Jiangsu T-Mab Biopharma 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 15 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: status not confirmed, as of the sponsor's last update on 18 Aug 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xichun Hu (xchu2009@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of adverse events (AEs) and serious adverse events (SAEs) which are related to GW003 as assessed by CTCAE v4.03 (time frame: 21days). 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 Aug 2017.