計劃書編號20080763
2010-02-01 - 2013-12-31
Phase III
終止收納5
A Randomized, Multicenter, Open-label, Phase 3 Study to Compare the Efficacy and Safety of Panitumumab and Cetuximab in Subjects with Previously Treated, Wild-type KRAS, Metastatic Colorectal Cancer.一項隨機分配、多中心、開放標記之第三期試驗，比較曾接受治療、原生型 KRAS 之轉移結直腸癌 (mCRC) 患者，使用 Panitumumab 與 Cetuximab 的療效與安全性
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試驗申請者
艾昆緯股份有限公司
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試驗委託 / 贊助單位名稱
Amgen 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
轉移結直腸癌 (mCRC)
試驗目的
主要目標：比較原生型 KRAS 腫瘤、化療復發之 mCRC 受試者，使用 panitumumab 與 cetuximab 治療，對於整體存活期 (overall survival, OS) 的影響。
次要目標：
比較原生型 KRAS 腫瘤、化療效果不彰之 mCRC 受試者，使用 panitumumab 與 cetuximab的治療效果：
�H 療效：腫瘤未惡化存活期 (progression-free survival, PFS)，客觀反應率 (objective response rate, ORR)，出現治療反應時間，治療失敗時間，治療反應持續時間
�H 安全性：受試者不良事件發生率，顯著之實驗室檢驗值變化，與免疫原性
�H 病患者報告結果 (Patient Reported Outcomes, PRO)
探索性目標：
�H 以治療化療復發、原生型 KRAS腫瘤之 mCRC 受試者，來估計關於疾病治療、嚴重不良事件處理及施用試驗藥物 panitumumab 及 cetuximab的資源使用率。
�H 研究腫瘤遺傳變異對於訊號傳遞基因、癌症基因、藥物作用目標基因、與其他已知與實體腫瘤發展與惡化有關之生物標記基因的影響。
�H 研究已知與實體腫瘤發展與惡化有關的基因，其腫瘤 mRNA 表現量與蛋白質濃度之間的關連性
�H 研究藥物代謝基因、癌症基因與藥物作用目標基因的基因體 DNA 多型性，對於療效的影響（選擇性）
藥品名稱
AMG 954
主成份
Panitumumab
劑型
vial
劑量
20 mg
評估指標
Primary
• Overall survival: time from randomization date to date of death.
Secondary
• Progression free survival (PFS): time from randomization date to date of disease
progression per RECIST version 1.1 or death.
• ORR: The incidence of either a complete response (CR) or partial response (PR) per
RECIST version 1.1.
• Duration of response: (calculated only for those subjects with an objective response) time
from first objective response to disease progression per the RECIST version 1.1.
• Time to response: time from randomization date to date of first objective response.
• Time to treatment failure: time from randomization date to date that decision was made to
end the treatment period for any reason.
• Patient-reported outcomes(PRO):
- HRQOL:
EQ-5D Health Index Scale
EQ Visual Analog Scale
- CRC Symptomatology
NCCN FACT Colorectal Symptom Index (FCSI)
• Safety
Incidence of AEs, significant laboratory changes, and
immunogenicity
• Overall survival: time from randomization date to date of death.
Secondary
• Progression free survival (PFS): time from randomization date to date of disease
progression per RECIST version 1.1 or death.
• ORR: The incidence of either a complete response (CR) or partial response (PR) per
RECIST version 1.1.
• Duration of response: (calculated only for those subjects with an objective response) time
from first objective response to disease progression per the RECIST version 1.1.
• Time to response: time from randomization date to date of first objective response.
• Time to treatment failure: time from randomization date to date that decision was made to
end the treatment period for any reason.
• Patient-reported outcomes(PRO):
- HRQOL:
EQ-5D Health Index Scale
EQ Visual Analog Scale
- CRC Symptomatology
NCCN FACT Colorectal Symptom Index (FCSI)
• Safety
Incidence of AEs, significant laboratory changes, and
immunogenicity
主要納入條件
Inclusion Criteria
Disease Related
• Histologically or cytologically confirmed diagnosis of adenocarcinoma of the colon or
rectum
o Metastatic disease
• Wild-type KRAS tumor status by protocol-specified testing (see Section 7.10)
o Formalin-fixed paraffin-embedded tumor tissue from either the primary tumor or a
metastatic lesion must be submitted for biomarker testing (see Section 7.10)
• ECOG performance status of 0, 1 or 2
• Measurable or non-measurable disease per RECIST version 1.1
• Must have failed a prior regimen containing irinotecan for metastatic disease and a prior
regimen containing oxaliplatin for metastatic disease. Oxaliplatin and irinotecan may
have been administered sequentially or in combination.
o Failure is defined as either disease progression (clinical or radiological) or
intolerance to the regimen
o Subjects in whom relapse is diagnosed within 6 months after completing adjuvant
chemotherapy (with either an irinotecan or oxaliplatin containing regimen) will be
considered as having failed a prior regimen for metastatic disease
• Must have previously received a thymidylate synthase inhibitor (e.g. fluorouracil,
capecitabine, raltitrexed, or fluorouracil-uracil) at any point for treatment of CRC
Demographic
• Man or woman ≥ 18 years of age
Laboratory
• Hematologic function, as follows: (≤ 10 days prior to randomization)
o Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
o Platelet count ≥ 75 x 109/L
o Hemoglobin ≥ 8.0 g/dL
• Renal function, as follows: (≤ 10 days prior to randomization)
o Creatinine ≤ 1.5 x ULN
• Hepatic function, as follows: (≤ 10 days prior to randomization)
o Aspartate aminotransferase (AST) ≤ 3 x ULN (if liver metastases ≤ 5 x ULN)
o Alanine aminotransferase (ALT) ≤ 3 x ULN (if liver metastases ≤ 5 x ULN)
o Total Bilirubin ≤ 1.5 x ULN
• Metabolic function, as follows: (≤ 10 days prior to randomization)
o Magnesium ≥ lower limit of normal
• Negative pregnancy test ≤ 72 hours before randomization (for women of childbearing
potential only)
Ethical
• Competent to comprehend, sign, and date a written IEC/IRB approved informed consent
form before any study-specific procedure
Exclusion Criteria
Disease Related
• Symptomatic brain metastases requiring treatment
• History of other malignancy, except:
o Malignancy treated with curative intent and with no known active disease present
for ≥ 5 years prior to randomization and felt to be at low risk for recurrence by the
treating physician
o Adequately treated non-melanomatous skin cancer or lentigo maligna without
evidence of disease
o Adequately treated cervical carcinoma in situ without evidence of disease
o Prostatic intraepithelial neoplasia without evidence of prostate cancer
Medications
• Known hypersensitivity to any of the protocol-specified agents or their excipients
• Prior anti-EGFr antibody therapy (eg, panitumumab or cetuximab) or treatment with small
molecule EGFr inhibitors (eg, gefitinib, erlotinib, lapatinib)
• Antitumor therapy (eg, chemotherapy, hormonal therapy, immunotherapy, antibody
therapy, radiotherapy), or investigational agent or therapy ≤ 30 days before
randomization. Subjects must have recovered from any acute toxicity
General
• Subject previously randomized to this study
• Other investigational procedure ≤ 30 days before randomization
• Subject currently enrolled in or ≤ 30 days from ending other investigational device or drug
study(s)
• Major surgery (eg, requiring general anesthesia) ≤ 28 days before randomization.
Subjects must have recovered from any surgery related toxicities
• Clinically significant cardiovascular disease (as defined by: unstable angina, symptomatic
congestive heart failure, serious uncontrolled cardiac arrhythmia)
• Myocardial infarction within last 6 months before randomization
• History of interstitial lung disease (ILD) eg, interstitial pneumonitis, pulmonary fibrosis or
evidence of ILD on baseline chest CT or MRI
• History of any medical or psychiatric condition or laboratory abnormality that in the
opinion of the investigator may increase the risk associated with the study participation or
investigational product(s) administration or may interfere with the interpretation of the
results
• Subject pregnant or breast feeding, or planning to become pregnant during treatment and
within 6 months after the end of treatment
• Subject (male or female) is not willing to use highly effective methods of contraception
(per institutional standard) during treatment and for an additional 6 months (males and
females) after the end of treatment
• Known positive test(s) for human immunodeficiency virus infection (testing is not required
in the absence of clinical suspicion)
• Active infection requiring systemic treatment or any uncontrolled infection ≤14 days prior
to randomization
• Subject has any kind of disorder that compromises the ability of the subject to give written
informed consent and/or to comply with study procedures or is unwilling or unable to
comply with study requirements
Disease Related
• Histologically or cytologically confirmed diagnosis of adenocarcinoma of the colon or
rectum
o Metastatic disease
• Wild-type KRAS tumor status by protocol-specified testing (see Section 7.10)
o Formalin-fixed paraffin-embedded tumor tissue from either the primary tumor or a
metastatic lesion must be submitted for biomarker testing (see Section 7.10)
• ECOG performance status of 0, 1 or 2
• Measurable or non-measurable disease per RECIST version 1.1
• Must have failed a prior regimen containing irinotecan for metastatic disease and a prior
regimen containing oxaliplatin for metastatic disease. Oxaliplatin and irinotecan may
have been administered sequentially or in combination.
o Failure is defined as either disease progression (clinical or radiological) or
intolerance to the regimen
o Subjects in whom relapse is diagnosed within 6 months after completing adjuvant
chemotherapy (with either an irinotecan or oxaliplatin containing regimen) will be
considered as having failed a prior regimen for metastatic disease
• Must have previously received a thymidylate synthase inhibitor (e.g. fluorouracil,
capecitabine, raltitrexed, or fluorouracil-uracil) at any point for treatment of CRC
Demographic
• Man or woman ≥ 18 years of age
Laboratory
• Hematologic function, as follows: (≤ 10 days prior to randomization)
o Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
o Platelet count ≥ 75 x 109/L
o Hemoglobin ≥ 8.0 g/dL
• Renal function, as follows: (≤ 10 days prior to randomization)
o Creatinine ≤ 1.5 x ULN
• Hepatic function, as follows: (≤ 10 days prior to randomization)
o Aspartate aminotransferase (AST) ≤ 3 x ULN (if liver metastases ≤ 5 x ULN)
o Alanine aminotransferase (ALT) ≤ 3 x ULN (if liver metastases ≤ 5 x ULN)
o Total Bilirubin ≤ 1.5 x ULN
• Metabolic function, as follows: (≤ 10 days prior to randomization)
o Magnesium ≥ lower limit of normal
• Negative pregnancy test ≤ 72 hours before randomization (for women of childbearing
potential only)
Ethical
• Competent to comprehend, sign, and date a written IEC/IRB approved informed consent
form before any study-specific procedure
Exclusion Criteria
Disease Related
• Symptomatic brain metastases requiring treatment
• History of other malignancy, except:
o Malignancy treated with curative intent and with no known active disease present
for ≥ 5 years prior to randomization and felt to be at low risk for recurrence by the
treating physician
o Adequately treated non-melanomatous skin cancer or lentigo maligna without
evidence of disease
o Adequately treated cervical carcinoma in situ without evidence of disease
o Prostatic intraepithelial neoplasia without evidence of prostate cancer
Medications
• Known hypersensitivity to any of the protocol-specified agents or their excipients
• Prior anti-EGFr antibody therapy (eg, panitumumab or cetuximab) or treatment with small
molecule EGFr inhibitors (eg, gefitinib, erlotinib, lapatinib)
• Antitumor therapy (eg, chemotherapy, hormonal therapy, immunotherapy, antibody
therapy, radiotherapy), or investigational agent or therapy ≤ 30 days before
randomization. Subjects must have recovered from any acute toxicity
General
• Subject previously randomized to this study
• Other investigational procedure ≤ 30 days before randomization
• Subject currently enrolled in or ≤ 30 days from ending other investigational device or drug
study(s)
• Major surgery (eg, requiring general anesthesia) ≤ 28 days before randomization.
Subjects must have recovered from any surgery related toxicities
• Clinically significant cardiovascular disease (as defined by: unstable angina, symptomatic
congestive heart failure, serious uncontrolled cardiac arrhythmia)
• Myocardial infarction within last 6 months before randomization
• History of interstitial lung disease (ILD) eg, interstitial pneumonitis, pulmonary fibrosis or
evidence of ILD on baseline chest CT or MRI
• History of any medical or psychiatric condition or laboratory abnormality that in the
opinion of the investigator may increase the risk associated with the study participation or
investigational product(s) administration or may interfere with the interpretation of the
results
• Subject pregnant or breast feeding, or planning to become pregnant during treatment and
within 6 months after the end of treatment
• Subject (male or female) is not willing to use highly effective methods of contraception
(per institutional standard) during treatment and for an additional 6 months (males and
females) after the end of treatment
• Known positive test(s) for human immunodeficiency virus infection (testing is not required
in the absence of clinical suspicion)
• Active infection requiring systemic treatment or any uncontrolled infection ≤14 days prior
to randomization
• Subject has any kind of disorder that compromises the ability of the subject to give written
informed consent and/or to comply with study procedures or is unwilling or unable to
comply with study requirements
試驗計畫預計收納受試者人數
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台灣人數
20 人
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全球人數
1000 人
