Chemotherapy-induced NeutropeniaPhase 1NCT03246009
Fusion Protein rHSA/GCSFclinical Study on Breast Cancer Patients
A Phase 1 study testing rHSA/GCSF in people with Chemotherapy-induced Neutropenia and Cancer, Breast, run by Tianjin SinoBiotech Ltd. at 1 site in China.
Trial summary
The purpose of this study is to evaluate the tolerance and safety of the rHSA/GCSF in breast cancer patients with different doses and multiple injections. To observe the pharmacokinetic characteristics of recombinant human serum albumin /granulocyte colony-stimulating factor fusion protein after single and multiple… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chemotherapy-induced Neutropenia, Cancer, Breast
- What is being tested?
- rHSA/GCSF
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 21 Jan 2016to 10 Apr 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-65.
- Diagnosed breast cancer，received chemotherapy.
- ECOG performance status 0 or 1.
- ANC≥1.5×10 9/L, PLT≥100×10 9/L. No bone marrow metastasis,blood coagulation function normally, no Hemorrhagic tendency.
- Leukocyte reduction occurred after chemotherapy,WBC≤3.0x109/L or ANC≤1.5x109/L.
- No obvious abnormal ecg examination.
- Cr，TBIL, AST, ALT≤1.5×ULN，no serious underlying disease.
- Signed informed consent.
Who cannot join
- Chemotherapy within past 4 weeks.
- Uncontrolled inflammatory disease,axillary temperature≥38℃.
- Merging other malignant tumor.
- Pregnancy or nursing status.
- Participation in another clinical trial with and investigational product within 3 months prior to study entry.
- Severe diabetes mellitus, or poor blood sugar controller.
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- Allergic disease or allergic constitution. History of protein allergy.
- History of drug addiction and alcoholism.
- Hematopoietic stem cell transplantation or organ transplantation.
- Received antibiotic treatment within 72 hours before chemotherapy.
- Long-term use of hormones or immunosuppressive agents.
- Severe mental or neurological disorders.
- Chronic disease of severe cardiac, kidney and liver.
- Other conditions that would be excluded from this study according to doctors'judgment.
Trial locations and contacts
1 site in 1 country.
China1 site
Chinese Academy of Medical Sciences Cancer Hospital
Beijing, Beijing Municipality, 100021
About this study
Official title: Efficacy and Safety Phase Ib Study of Recombinant Human Serum Albumin/ Granulocyte Colony-Stimulating Factor Fusion Protein for Injection to Prevent Neutrophilic Granulocytopenia Among Chemotherapy Patients
The purpose of this study is to evaluate the tolerance and safety of the rHSA/GCSF in breast cancer patients with different doses and multiple injections.
To observe the pharmacokinetic characteristics of recombinant human serum albumin /granulocyte colony-stimulating factor fusion protein after single and multiple administration
Read the detailed description
This experiment adopts the method of multicenter, open, dose escalation study injection with recombinant human blood clean protein/granulocyte stimulating factor fusion protein after single and multiple doses of tolerance, security, and pharmacokinetic characteristics.
Breast cancer patients with reduced white blood cells after chemotherapy were selected as subjects of this study.
The three research doses that were to be incremented were 1.8 mg, 2.1mg and 2.4mg respectively, each of which was studied by single and multiple doses.
Single dose of medicine, dose-climbing study.Two doses of the drug, dose-climbing study
- Conditions
- Chemotherapy-induced Neutropenia, Cancer, Breast
- Being tested
- rHSA/GCSF
- Keywords
- Neutropenia, Chemotherapy, rHSA/GCSF
- Medical subject headings
- Breast Neoplasms, Neutropenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rHSA/GCSFDrug
single injection-1.8mg
rHSA/GCSFDrug
single injection-2.1mg
rHSA/GCSFDrug
single injection-2.4mg
rHSA/GCSFDrug
multiple injection-1.8mg
rHSA/GCSFDrug
multiple injection-2.1mg
rHSA/GCSFDrug
multiple injection-2.4mg
| Study group | Role | What they receive |
|---|---|---|
| single injection-1.8mg | Experimental | rHSA/GCSF,injection,1.8mg,Single subcutaneous injection,Duration 1 day Receives: Drug: rHSA/GCSF |
| single injection-2.1mg | Experimental | rHSA/GCSF,injection,2.1mg,Single subcutaneous injection,Duration 1 day Receives: Drug: rHSA/GCSF |
| single injection-2.4mg | Experimental | rHSA/GCSF,injection,2.4mg,Single subcutaneous injection,Duration 1 day Receives: Drug: rHSA/GCSF |
| multiple injection-1.8mg | Experimental | rHSA/GCSF,injection,1.8mg, subcutaneous injection,Duration 4 day,A total of 2 injections, each interval of 3 days. Receives: Drug: rHSA/GCSF |
| multiple injection-2.1mg | Experimental | rHSA/GCSF,injection,2.1mg, subcutaneous injection,Duration 4 day,A total of 2 injections, each interval of 3 days. Receives: Drug: rHSA/GCSF |
| multiple injection-2.4mg | Experimental | rHSA/GCSF,injection,2.4mg, subcutaneous injection,Duration 4 day,A total of 2 injections, each interval of 3 days. Receives: Drug: rHSA/GCSF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of adverse events
Number of participants with AE as a measure for safety and tolerability after single and multiple dose of rHSA/GCSF
Measured: 14 days
Secondary outcomes (1)
AUC
AUC after single and multiple dose of rHSA/GCSF
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2017
- Study start21 Jan 2016
- Primary completion10 Apr 2017
- Study completion10 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tianjin SinoBiotech Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Binghe XU, MD, Principal investigator, chinese academy of medical sciences tumor hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03246009
- Sponsor's protocol ID
- RG01N-1399
- Status last verified
- Aug 2017
- First submitted
- 8 Aug 2017
- Last updated
- 11 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chen S, Han Y, Ouyang Q, Lu J, Zhang Q, Yang S, Wang J, Huang H, Liu H, Shao Z, Li H, Chen Z, Sun S, Geng C, Lu J, Sun J, Wang J, Xu B. Randomized and dose-escalation trials of recombinant human serum albumin /granulocyte colony-stimulating factor in patients with breast cancer receiving anthracycline-containing chemotherapy. BMC Cancer. 2021 Mar 31;21(1):341. doi: 10.1186/s12885-021-08093-z.
PubMed 33789616
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety Phase Ib Study of Recombinant Human Serum Albumin/ Granulocyte Colony-Stimulating Factor Fusion Protein for Injection to Prevent Neutrophilic Granulocytopenia Among Chemotherapy Patients
- ClinicalTrials.gov ID
- NCT03246009
- Acronym / sponsor ID
- RG01N-1399
- Conditions
- Chemotherapy-induced Neutropenia, Cancer, Breast
- Keywords
- Neutropenia, Chemotherapy, rHSA/GCSF
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Tianjin SinoBiotech Ltd.Industry (pharma, biotech, devices)
- Study start
- 21 Jan 2016 (actual)
- Primary completion
- 10 Apr 2017 (actual)
- Study completion
- 10 Apr 2017 (actual)
- First posted
- 10 Aug 2017 (actual)
- 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 this study is to evaluate the tolerance and safety of the rHSA/GCSF in breast cancer patients with different doses and multiple injections.
To observe the pharmacokinetic characteristics of recombinant human serum albumin /granulocyte colony-stimulating factor fusion protein after single and multiple administration
Detailed description
This experiment adopts the method of multicenter, open, dose escalation study injection with recombinant human blood clean protein/granulocyte stimulating factor fusion protein after single and multiple doses of tolerance, security, and pharmacokinetic characteristics.
Breast cancer patients with reduced white blood cells after chemotherapy were selected as subjects of this study.
The three research doses that were to be incremented were 1.8 mg, 2.1mg and 2.4mg respectively, each of which was studied by single and multiple doses.
Single dose of medicine, dose-climbing study.Two doses of the drug, dose-climbing study
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| single injection-1.8mg | Experimental | Drug: rHSA/GCSFrHSA/GCSF,injection,1.8mg,Single subcutaneous injection,Duration 1 day |
| single injection-2.1mg | Experimental | Drug: rHSA/GCSFrHSA/GCSF,injection,2.1mg,Single subcutaneous injection,Duration 1 day |
| single injection-2.4mg | Experimental | Drug: rHSA/GCSFrHSA/GCSF,injection,2.4mg,Single subcutaneous injection,Duration 1 day |
| multiple injection-1.8mg | Experimental | Drug: rHSA/GCSFrHSA/GCSF,injection,1.8mg, subcutaneous injection,Duration 4 day,A total of 2 injections, each interval of 3 days. |
| multiple injection-2.1mg | Experimental | Drug: rHSA/GCSFrHSA/GCSF,injection,2.1mg, subcutaneous injection,Duration 4 day,A total of 2 injections, each interval of 3 days. |
| multiple injection-2.4mg | Experimental | Drug: rHSA/GCSFrHSA/GCSF,injection,2.4mg, subcutaneous injection,Duration 4 day,A total of 2 injections, each interval of 3 days. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 18-65.
- Diagnosed breast cancer，received chemotherapy.
- ECOG performance status 0 or 1.
- ANC≥1.5×10 9/L, PLT≥100×10 9/L. No bone marrow metastasis,blood coagulation function normally, no Hemorrhagic tendency.
- Leukocyte reduction occurred after chemotherapy,WBC≤3.0x109/L or ANC≤1.5x109/L.
Key exclusion criteria (14 listed)
- Chemotherapy within past 4 weeks.
- Uncontrolled inflammatory disease,axillary temperature≥38℃.
- Merging other malignant tumor.
- Pregnancy or nursing status.
- Participation in another clinical trial with and investigational product within 3 months prior to study entry.
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 |
|---|---|---|
| rHSA/GCSFsingle injection-1.8mg | Drug | single injection-1.8mg |
| rHSA/GCSFsingle injection-2.1mg | Drug | single injection-2.1mg |
| rHSA/GCSFsingle injection-2.4mg | Drug | single injection-2.4mg |
| rHSA/GCSFmultiple injection-1.8mg | Drug | multiple injection-1.8mg |
| rHSA/GCSFmultiple injection-2.1mg | Drug | multiple injection-2.1mg |
| rHSA/GCSFmultiple injection-2.4mg | Drug | multiple injection-2.4mg |
Primary outcome
Number of adverse events
Time frame: 14 days
Number of participants with AE as a measure for safety and tolerability after single and multiple dose of rHSA/GCSF
1 secondary outcome
AUC
Time frame: 14 days
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 11 Aug 2017.
- Derived from this study: PubMed 33789616Chen S, Han Y, Ouyang Q, Lu J, Zhang Q, Yang S, Wang J, Huang H, Liu H, Shao Z, Li H, Chen Z, Sun S, Geng C, Lu J, Sun J, Wang J, Xu B. Randomized and dose-escalation trials of recombinant human serum albumin /granulocyte colony-stimulating factor in patients with breast cancer receiving anthracycline-containing chemotherapy. BMC Cancer. 2021 Mar 31;21(1):341. doi: 10.1186/s12885-021-08093-z.
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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.
Binghe XU, MD principal investigator
chinese academy of medical sciences tumor 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 rHSA/GCSF in people with Chemotherapy-induced Neutropenia and Cancer, Breast, run by Tianjin SinoBiotech 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 14 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 11 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?
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 adverse events (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03246009, which also lists 1 linked publication.
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 11 Aug 2017.