計劃書編號212HC201
2009-07-01 - 2011-06-30
Phase I
終止收納5
A phase 1b/2, Open-Label, Randomized Study of Sorafenib With or Without BIIB022 in Subjects With Advanced Hepatocellular Carcinoma
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試驗申請者
保瑞爾生技股份有限公司
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試驗委託 / 贊助單位名稱
Biogen Idec Inc.
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臨床試驗規模
多國多中心
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更新日期
2025/08/20
試驗主持人及試驗醫院
實際收案人數
0 停止召募
實際收案人數
0 停止召募
實際收案人數
0 停止召募
適應症
Advanced Hepatocellular Carcinoma
試驗目的
比較Sorafenib併用或不併用BIIB022對於患有晚期肝細胞癌受試者的療效反應
藥品名稱
BIIB022
主成份
Anti IGF-1R Antibody
劑型
Vial
劑量
10mg/mL
評估指標
Phase 1b Objectives
Primary objectives:
• To determine the RP2D of BIIB022 given once every
3 weeks (q3wk) in combination with sorafenib in subjects
with advanced HCC.
• To evaluate the safety and tolerability of BIIB022 in
combination with sorafenib in this study population.
Phase 2 Objectives
Primary objectives:
• To compare the time-to-progression (TTP) of BIIB022 in
combination with sorafenib with sorafenib monotherapy in
subjects with advanced HCC.
• To identify candidate predictive biomarkers that may
potentially be used to identify subjects who will
preferentially benefit from or be resistant to treatment with
BIIB022 in combination with sorafenib.
Primary objectives:
• To determine the RP2D of BIIB022 given once every
3 weeks (q3wk) in combination with sorafenib in subjects
with advanced HCC.
• To evaluate the safety and tolerability of BIIB022 in
combination with sorafenib in this study population.
Phase 2 Objectives
Primary objectives:
• To compare the time-to-progression (TTP) of BIIB022 in
combination with sorafenib with sorafenib monotherapy in
subjects with advanced HCC.
• To identify candidate predictive biomarkers that may
potentially be used to identify subjects who will
preferentially benefit from or be resistant to treatment with
BIIB022 in combination with sorafenib.
主要納入條件
Inclusion Criteria:
1. Ability to understand the purpose and risks of the study and provide signed and dated
informed consent and authorization to use protected health information (PHI) in
accordance with national and local subject privacy regulations.
2. Age >=18 years at the time of informed consent or subjects meet the minimum age of
consent in accordance with national regulations (whichever is higher).
3. Histologically-confirmed advanced HCC with at least 1 target lesion measurable by
modified RECIST(Version 1.1).
4. Child-Pugh score A5 or A6.
5. ECOG Performance Status of <=2.
6. For Part 2 only: Available formalin-fixed, paraffin-embedded (FFPE) tumor tissue from a
previously obtained biopsy/resection that meets specific tissue sample requirements (see
Study Laboratory Manual). Note that fine needle aspirate material will not be an
acceptable tumor tissue sample
7. Expected survival time of >=3 months in the opinion of the Investigator.
8. Screening clinical laboratory values as follows:
a. absolute neutrophil count (ANC) >=1500/μL
b. Platelet count >= 75,000/μL
c. Total hemoglobin >= 8.5 g/dL
d. Blood glucose of <=125 mg/dL after fasting overnight
e. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <= 5 times upper
limit of normal (ULN)
f. Creatinine <1.5 mg/dL or creatinine clearance >= 60 mL/min
9. Negative pregnancy test at screening.
10. All subjects of childbearing potential must practice effective contraception during the
study and be willing and able to continue contraception for 9 months after the last
dose of study treatment.
Exclusion criteria
1. History of another primary cancer within the last 3 years with the exception of
completely resected skin cancer (other than melanoma) or curatively-treated cervical
carcinoma in-situ.
2. Known central nervous system or brain metastases.
3. Acute hepatitis
4. Fibrolamellar HCC
5. Prior anti-IGF-1R therapy.
6. Prior systemic therapy for advanced HCC. Prior local therapies are only permitted if
subjects have documented disease progression according to modified RECIST (Version 1.1).
7. Investigational agents for non-malignant disease within 4 weeks or 5 half-lives of
previous used medication.(whichever is shorter) prior to Day 1.
8. Concurrent anticancer therapy.
9. Concurrent investigational agents for non-malignant disease.
10. Known history of human immunodeficiency virus (HIV).
11. History of myocardial infarction within 12 months prior to Day 1 or chronic heart
failure.
12. New York Heart Association (NYHA) ≥Grade II congestive heart failure.
13. Unstable coronary disease or clinically significant electrocardiogram (12-lead ECG)
abnormalities, as determined by the Investigator.
14. Female subjects who are currently breastfeeding.
15. Inability to comply with study and follow-up procedures.
16. Any other disease, metabolic dysfunction, physical examination finding, or clinical
laboratory finding that leads to reasonable suspicion of a disease or condition that
contraindicates the use of an investigational drug or that may affect the
interpretation of the results or render the subject at high risk from treatment
complications.
17. Other unspecified reasons that, in the opinion of the Investigator or Biogen Idec, make
the subject unsuitable for enrollment
1. Ability to understand the purpose and risks of the study and provide signed and dated
informed consent and authorization to use protected health information (PHI) in
accordance with national and local subject privacy regulations.
2. Age >=18 years at the time of informed consent or subjects meet the minimum age of
consent in accordance with national regulations (whichever is higher).
3. Histologically-confirmed advanced HCC with at least 1 target lesion measurable by
modified RECIST(Version 1.1).
4. Child-Pugh score A5 or A6.
5. ECOG Performance Status of <=2.
6. For Part 2 only: Available formalin-fixed, paraffin-embedded (FFPE) tumor tissue from a
previously obtained biopsy/resection that meets specific tissue sample requirements (see
Study Laboratory Manual). Note that fine needle aspirate material will not be an
acceptable tumor tissue sample
7. Expected survival time of >=3 months in the opinion of the Investigator.
8. Screening clinical laboratory values as follows:
a. absolute neutrophil count (ANC) >=1500/μL
b. Platelet count >= 75,000/μL
c. Total hemoglobin >= 8.5 g/dL
d. Blood glucose of <=125 mg/dL after fasting overnight
e. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <= 5 times upper
limit of normal (ULN)
f. Creatinine <1.5 mg/dL or creatinine clearance >= 60 mL/min
9. Negative pregnancy test at screening.
10. All subjects of childbearing potential must practice effective contraception during the
study and be willing and able to continue contraception for 9 months after the last
dose of study treatment.
Exclusion criteria
1. History of another primary cancer within the last 3 years with the exception of
completely resected skin cancer (other than melanoma) or curatively-treated cervical
carcinoma in-situ.
2. Known central nervous system or brain metastases.
3. Acute hepatitis
4. Fibrolamellar HCC
5. Prior anti-IGF-1R therapy.
6. Prior systemic therapy for advanced HCC. Prior local therapies are only permitted if
subjects have documented disease progression according to modified RECIST (Version 1.1).
7. Investigational agents for non-malignant disease within 4 weeks or 5 half-lives of
previous used medication.(whichever is shorter) prior to Day 1.
8. Concurrent anticancer therapy.
9. Concurrent investigational agents for non-malignant disease.
10. Known history of human immunodeficiency virus (HIV).
11. History of myocardial infarction within 12 months prior to Day 1 or chronic heart
failure.
12. New York Heart Association (NYHA) ≥Grade II congestive heart failure.
13. Unstable coronary disease or clinically significant electrocardiogram (12-lead ECG)
abnormalities, as determined by the Investigator.
14. Female subjects who are currently breastfeeding.
15. Inability to comply with study and follow-up procedures.
16. Any other disease, metabolic dysfunction, physical examination finding, or clinical
laboratory finding that leads to reasonable suspicion of a disease or condition that
contraindicates the use of an investigational drug or that may affect the
interpretation of the results or render the subject at high risk from treatment
complications.
17. Other unspecified reasons that, in the opinion of the Investigator or Biogen Idec, make
the subject unsuitable for enrollment
試驗計畫預計收納受試者人數
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台灣人數
6/6 人
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全球人數
22/22 人
