Chemotherapy-induced NeutropeniaPhase 1NCT02156388
Safety and Pharmacokinetic(PK) Study of GW003 to Metastatic Tumors
A Phase 1 study testing GW003 in people with Chemotherapy-induced Neutropenia and Metastatic Tumors, run by Jiangsu T-Mab Biopharma Co.,Ltd at 1 site in China.
Trial summary
This study is designed to access the safety, tolerance and Pharmacokinetic/Pharmacodynamic(PK/PD) of single subcutaneous(SC) injection of GW003 in patients with metastatic tumors. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chemotherapy-induced Neutropenia, Metastatic Tumors
- What is being tested?
- GW003
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteChina
- Study dates
- Aug 2013to Dec 2015
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with pathologically and/or cytologically-confirmed malignant tumor (phase Ia)
- Breast-cancer or NSCLC patients are suitable for chemotherapy regimen of receiving docetaxel plus adriamycin and could finish two-cycles adjuvant chemotherapy on schedule
- 18 years to 65years
- Patients with Eastern Cooperative Oncology Group(ECOG) performance status 0 or 1 and living at least 6 months
- No main organ dysfunction, adequate cardiac,hepatic,renal and bone marrow function
- Adequate hematologic function (value in center laboratory as the standard); white blood cell count (WBC)≥4.0×109/L neutrophil count (ANC)≥1.5×109/L; platelet count (PLT)≥100×109/L; hemoglobin (HGB)≥lOO g/L.
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- Adequate hepatic and renal function(value in center laboratory as the standard):
- Women of childbearing age need to pregnancy test Prior to receive therapy and agree to use effective contraception throughout the study
- Subjects, who are willing to follow the study protocol and provide written informed consent voluntarily, have understood the purpose and procedures and could follow requirements of the study
Who cannot join
- History of cardiopathy or with signs and symptoms
- History of bone marrow transplant and/or stem cell transplant
- Patients with acute infection, systemic anti-infection treatment within 72 hours of study
- Prior participated in drug therapy, radiotherapy or surgery and other clinical trials within 4 weeks
- Prior use of recombinant human G-CSF(rhG-CSF)、PEG-rhG-CSF or erythropoietin within 4 weeks of study
- Patients with history of primary myeloid malignancy or myelodysplasia
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- Known hypersensitivity to test drugs, rhG-CSF or any other biologicals
- Pregnant female or nursing mother
- Known HIV positive or active hepatitis
Trial locations and contacts
1 site in 1 country.
China1 site
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300060
About this study
Official title: A Single-center, Uncontrolled, Open, Phase 1 Study of Recombinant(Expressed by Pichia Pastoris) Human Serum Albumin/Human Granulocyte-Colony Stimulating Factor(I)Fusion Protein For Injection(GW003)to Metastatic Tumors
This study is designed to access the safety, tolerance and Pharmacokinetic/Pharmacodynamic(PK/PD) of single subcutaneous(SC) injection of GW003 in patients with metastatic tumors.
Read the detailed description
So far, granulocyte colony stimulating factor (G-CSF) is still currently the only effective and security therapy drug for neutropenia caused by cancer chemotherapy. At present, the widely used G-CSF products are of such short-acting G-CSF product in China. However, there existed some shortcoming about short-acting G-CSF, such as shorter half-life, continuous monitoring of the patient's blood neutrophil count and so on.
Nowadays,long-acting G-CSF product,such as Neulasta®, has become the mainstream of the foreign G-CSF market for its superiority of long half-life and absence of monitoring of the patient's blood neutrophil count. The new drug Recombinant(Expressed by Pichia pastoris) Human Serum Albumin/Human Granulocyte-Colony Stimulating Factor(I)Fusion Protein(GW003) is a long-acting G-CSF.Preclinical studies have shown that GW003 has accelerated neutrophil recovery and can shorten the duration of neutropenia symptoms, also reduce its extent, therefore minimize the likelihood of serious infections, reflecting a better efficacy and more long half-life.
Phase I was performed as two parts, Ia and Ib. Ia was a sequential dose escalation to observe the dose-limiting toxicity(DLT) and Maximum Tolerated Dose of GW003 given subcutaneously to patients without receiving chemotherapy,6 dose cohorts(50、150、300、400、500 and 600μg/kg) with 2-3 subjects in the 50、150μg/kg cohorts and 3-6 subjects（depend on the Dose-limiting toxicity） in the 300、400、500 and 600μg/kg cohorts, to evaluate safety and pharmacokinetics prior to the Ⅰb.
Ib proposed two arms (150 and 300μg/kg；n=6-8/arm), and to determine whether to continue to increase other dose arm based on the safety and efficacy assessment. Subjects need to receive two cycles treatment of AT chemotherapy. In cycle 1, subjects received AT chemotherapy only; in cycle 2, subjects were administered subcutaneously GW003 24 hours after chemotherapy drugs.
- Being tested
- GW003
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GW003Biological
freeze-dried powder；single SC injection
| Study group | Role | What they receive |
|---|---|---|
| Ia-GW003 50μg/kg | Experimental | 2-3 subjects Receives: Biological: GW003 |
| Ia-GW003 150μg/kg | Experimental | 2-3 subjects Receives: Biological: GW003 |
| Ia-GW003 300μg/kg | Experimental | 3-6 subjects Receives: Biological: GW003 |
| Ia-GW003 400μg/kg | Experimental | 3-6 subjects Receives: Biological: GW003 |
| Ia-GW003 500μg/kg | Experimental | 3-6 subjects Receives: Biological: GW003 |
| Ia-GW003 600μg/kg | Experimental | 3-6 subjects Receives: Biological: GW003 |
| Ib-GW003 150μg/kg | Experimental | 6-8 subjects Receives: Biological: GW003 |
| Ib-GW003 300μg/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.
Number of participants with adverse event
To evaluate the safety and tolerance of single SC injection of GW003 to Metastatic Tumors.
Measured: Ia:up to 4weeks;Ib: up to 10weeks
Secondary outcomes (4)
Duration of severe neutropenia(DSN)
Measured: Ia: up to 3weeks;Ib: up to 6weeks.
Anti-GW003 antibody
Ia:anti-GW003 antibody was detected pre-dose and when visit,if there exist positive anti-GW003 antibody, another detected should be conducted 6 months after the trial.
Ib:anti-GW003 antibody was detected pre-dose ,after cycle 2 chemotherapy and when visit,if there exist positive anti-GW003 antibody, another detected should be conducted 6 months after the trial.
Measured: Ia: up to 28weeks;Ib: up to 34weeks.
half-life(consists of distribution half-life [t1/2α] and elimination half-life [t1/2β])
Measured: Pre-dose、0.5h、1h、2h、3h、6h、9h、12h、24h、48h、72h、96h、120h、144h and 168h post-dose
area under the concentration-time curve (AUC)
Measured: Pre-dose、0.5h、1h、2h、3h、6h、9h、12h、24h、48h、72h、96h、120h、144h and 168h post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2014 (estimated)
- Study startAug 2013
- Primary completionFeb 2015
- Study completionDec 2015
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
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu T-Mab Biopharma Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- zhongsheng Tong, Principal investigator, Tianjin Medical University Cancer Institute and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02156388
- Sponsor's protocol ID
- Tmab-GW003-NP-01
- Status last verified
- Feb 2016
- First submitted
- 28 May 2014
- Last updated
- 24 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Uncontrolled, Open, Phase 1 Study of Recombinant(Expressed by Pichia Pastoris) Human Serum Albumin/Human Granulocyte-Colony Stimulating Factor(I)Fusion Protein For Injection(GW003)to Metastatic Tumors
- ClinicalTrials.gov ID
- NCT02156388
- Acronym / sponsor ID
- Tmab-GW003-NP-01
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Jiangsu T-Mab Biopharma Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- Aug 2013
- Primary completion
- Feb 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 5 Jun 2014 (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 designed to access the safety, tolerance and Pharmacokinetic/Pharmacodynamic(PK/PD) of single subcutaneous(SC) injection of GW003 in patients with metastatic tumors.
Detailed description
So far, granulocyte colony stimulating factor (G-CSF) is still currently the only effective and security therapy drug for neutropenia caused by cancer chemotherapy. At present, the widely used G-CSF products are of such short-acting G-CSF product in China. However, there existed some shortcoming about short-acting G-CSF, such as shorter half-life, continuous monitoring of the patient's blood neutrophil count and so on.
Nowadays,long-acting G-CSF product,such as Neulasta®, has become the mainstream of the foreign G-CSF market for its superiority of long half-life and absence of monitoring of the patient's blood neutrophil count. The new drug Recombinant(Expressed by Pichia pastoris) Human Serum Albumin/Human Granulocyte-Colony Stimulating Factor(I)Fusion Protein(GW003) is a long-acting G-CSF.Preclinical studies have shown that GW003 has accelerated neutrophil recovery and can shorten the duration of neutropenia symptoms, also reduce its extent, therefore minimize the likelihood of serious infections, reflecting a better efficacy and more long half-life.
Phase I was performed as two parts, Ia and Ib. Ia was a sequential dose escalation to observe the dose-limiting toxicity(DLT) and Maximum Tolerated Dose of GW003 given subcutaneously to patients without receiving chemotherapy,6 dose cohorts(50、150、300、400、500 and 600μg/kg) with 2-3 subjects in the 50、150μg/kg cohorts and 3-6 subjects（depend on the Dose-limiting toxicity） in the 300、400、500 and 600μg/kg cohorts, to evaluate safety and pharmacokinetics prior to the Ⅰb.
Ib proposed two arms (150 and 300μg/kg；n=6-8/arm), and to determine whether to continue to increase other dose arm based on the safety and efficacy assessment. Subjects need to receive two cycles treatment of AT chemotherapy. In cycle 1, subjects received AT chemotherapy only; in cycle 2, subjects were administered subcutaneously GW003 24 hours after chemotherapy drugs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Ia-GW003 50μg/kg | Experimental | Biological: GW0032-3 subjects |
| Ia-GW003 150μg/kg | Experimental | Biological: GW0032-3 subjects |
| Ia-GW003 300μg/kg | Experimental | Biological: GW0033-6 subjects |
| Ia-GW003 400μg/kg | Experimental | Biological: GW0033-6 subjects |
| Ia-GW003 500μg/kg | Experimental | Biological: GW0033-6 subjects |
| Ia-GW003 600μg/kg | Experimental | Biological: GW0033-6 subjects |
| Ib-GW003 150μg/kg | Experimental | Biological: GW0036-8 subjects |
| Ib-GW003 300μg/kg | Experimental | Biological: GW0036-8 subjects |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients with pathologically and/or cytologically-confirmed malignant tumor (phase Ia)
- Breast-cancer or NSCLC patients are suitable for chemotherapy regimen of receiving docetaxel plus adriamycin and could finish two-cycles adjuvant chemotherapy on schedule
- 18 years to 65years
- Patients with Eastern Cooperative Oncology Group(ECOG) performance status 0 or 1 and living at least 6 months
- No main organ dysfunction, adequate cardiac,hepatic,renal and bone marrow function
Key exclusion criteria (9 listed)
- History of cardiopathy or with signs and symptoms
- History of bone marrow transplant and/or stem cell transplant
- Patients with acute infection, systemic anti-infection treatment within 72 hours of study
- Prior participated in drug therapy, radiotherapy or surgery and other clinical trials within 4 weeks
- Prior use of recombinant human G-CSF(rhG-CSF)、PEG-rhG-CSF or erythropoietin within 4 weeks of 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 |
|---|---|---|
| GW003freeze-dried powder；single SC injection | Biological | Ia-GW003 150μg/kg, Ia-GW003 300μg/kg, Ia-GW003 400μg/kg, Ia-GW003 500μg/kg, Ia-GW003 50μg/kg, Ia-GW003 600μg/kg, Ib-GW003 150μg/kg, Ib-GW003 300μg/kg |
Primary outcome
Number of participants with adverse event
Time frame: Ia:up to 4weeks;Ib: up to 10weeks
To evaluate the safety and tolerance of single SC injection of GW003 to Metastatic Tumors.
4 secondary outcomes
Duration of severe neutropenia(DSN)
Time frame: Ia: up to 3weeks;Ib: up to 6weeks.
Anti-GW003 antibody
Time frame: Ia: up to 28weeks;Ib: up to 34weeks.
half-life(consists of distribution half-life [t1/2α] and elimination half-life [t1/2β])
Time frame: Pre-dose、0.5h、1h、2h、3h、6h、9h、12h、24h、48h、72h、96h、120h、144h and 168h post-dose
area under the concentration-time curve (AUC)
Time frame: Pre-dose、0.5h、1h、2h、3h、6h、9h、12h、24h、48h、72h、96h、120h、144h and 168h post-dose
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 24 Feb 2016.
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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.
zhongsheng Tong principal investigator
Tianjin Medical University Cancer Institute and Hospital
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 GW003 in people with Chemotherapy-induced Neutropenia and Metastatic Tumors, 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 9 inclusion and 9 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 24 Feb 2016. 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?
Number of participants with adverse event (time frame: Ia:up to 4weeks;Ib: up to 10weeks). 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 24 Feb 2016.