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Safety and Pharmacokinetic(PK) Study of GW003 to Metastatic Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02156388
Recruitment Status : Completed
First Posted : June 5, 2014
Last Update Posted : February 24, 2016
Sponsor:
Information provided by (Responsible Party):
Jiangsu T-Mab Biopharma Co.,Ltd

Brief 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.

Condition or disease Intervention/treatment Phase
Chemotherapy-induced Neutropenia Metastatic Tumors Biological: GW003 Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : August 2013
Actual Primary Completion Date : February 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Ia-GW003 50μg/kg
2-3 subjects
Biological: GW003
freeze-dried powder;single SC injection

Experimental: Ia-GW003 150μg/kg
2-3 subjects
Biological: GW003
freeze-dried powder;single SC injection

Experimental: Ia-GW003 300μg/kg
3-6 subjects
Biological: GW003
freeze-dried powder;single SC injection

Experimental: Ia-GW003 400μg/kg
3-6 subjects
Biological: GW003
freeze-dried powder;single SC injection

Experimental: Ia-GW003 500μg/kg
3-6 subjects
Biological: GW003
freeze-dried powder;single SC injection

Experimental: Ia-GW003 600μg/kg
3-6 subjects
Biological: GW003
freeze-dried powder;single SC injection

Experimental: Ib-GW003 150μg/kg
6-8 subjects
Biological: GW003
freeze-dried powder;single SC injection

Experimental: Ib-GW003 300μg/kg
6-8 subjects
Biological: GW003
freeze-dried powder;single SC injection




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Duration of severe neutropenia(DSN) [ Time Frame: Ia: up to 3weeks;Ib: up to 6weeks. ]
  2. Anti-GW003 antibody [ Time Frame: Ia: up to 28weeks;Ib: up to 34weeks. ]

    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.


  3. 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 ]
  4. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with pathologically and/or cytologically-confirmed malignant tumor (phase Ia)
  2. Breast-cancer or NSCLC patients are suitable for chemotherapy regimen of receiving docetaxel plus adriamycin and could finish two-cycles adjuvant chemotherapy on schedule
  3. 18 years to 65years
  4. Patients with Eastern Cooperative Oncology Group(ECOG) performance status 0 or 1 and living at least 6 months
  5. No main organ dysfunction, adequate cardiac,hepatic,renal and bone marrow function
  6. 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.
  7. Adequate hepatic and renal function(value in center laboratory as the standard):
  8. Women of childbearing age need to pregnancy test Prior to receive therapy and agree to use effective contraception throughout the study
  9. 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

Exclusion Criteria:

  1. History of cardiopathy or with signs and symptoms
  2. History of bone marrow transplant and/or stem cell transplant
  3. Patients with acute infection, systemic anti-infection treatment within 72 hours of study
  4. Prior participated in drug therapy, radiotherapy or surgery and other clinical trials within 4 weeks
  5. Prior use of recombinant human G-CSF(rhG-CSF)、PEG-rhG-CSF or erythropoietin within 4 weeks of study
  6. Patients with history of primary myeloid malignancy or myelodysplasia
  7. Known hypersensitivity to test drugs, rhG-CSF or any other biologicals
  8. Pregnant female or nursing mother
  9. Known HIV positive or active hepatitis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02156388


Locations
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China, Tianjin
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin, China, 300060
Sponsors and Collaborators
Jiangsu T-Mab Biopharma Co.,Ltd
Investigators
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Principal Investigator: zhongsheng Tong Tianjin Medical University Cancer Institute and Hospital
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Responsible Party: Jiangsu T-Mab Biopharma Co.,Ltd
ClinicalTrials.gov Identifier: NCT02156388    
Other Study ID Numbers: Tmab-GW003-NP-01
First Posted: June 5, 2014    Key Record Dates
Last Update Posted: February 24, 2016
Last Verified: February 2016
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neutropenia
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases
Neoplastic Processes
Neoplasms
Pathologic Processes