NCT00835185已完成2 期
Open Label, Multicenter, Phase II Study Evaluating the Efficacy and Safety of IMC-11F8 in Combination With 5-FU/FA and Oxaliplatin (mFOLFOX-6) in Patients With Treatment-naïve, Locally-advanced or Metastatic Colorectal Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response )
研究概览
简要总结
The purpose of this study is to determine if IMC-11F8 in combination with chemotherapy is effective in treating colorectal cancer (CRC).
详细描述
The purpose of this study is to evaluate the anti-tumor activity (best overall response) of the anti-epidermal growth factor receptor (EGFR) monoclonal antibody IMC-11F8 administered in combination with mFOLFOX-6 chemotherapy regimen in treatment-naive, locally-advanced or metastatic CRC participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically-confirmed, EGFR-detectable or EGFR-undetectable CRC
- •Locally-advanced unresectable or metastatic adenocarcinoma of the colon or rectum
- •At least 1 unidimensional-measurable target lesion by computed tomography (CT) scan or magnetic resonance imaging (MRI); target lesion(s) must not lie within an irradiated area
- •Age ≥18 years
- •Life expectancy of ≥6 months
- •Eastern Cooperative Oncology Group (ECOG) performance status ≤2 at study entry
- •Adequate hematologic function, as evidenced by an absolute neutrophil count (ANC) ≥1.5 x 10^9 liter (L), hemoglobin ≥10 grams per deciliter (g/dL), and platelets ≥100 x 10^9/L
- •Adequate hepatic function as defined by a total bilirubin ≤1.5 milligrams per deciliter (mg/dL), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 x upper limit of normal (ULN) (or 5.0 x ULN in the case of liver metastases), and alkaline phosphatase (AP) ≤2.5 x ULN (or 5.0 x ULN in the case of liver metastases)
- •Adequate renal function as defined by a serum creatinine ≤1.5 x ULN, creatinine clearance ≥ 60 milliliters per minute (mL/min), or serum albumin ≥lower limit of normal (LLN)
- •Participant's relevant toxicities/effects of prior therapy [surgery/radiation therapy (RT)] must have recovered to a stable or chronic level
- •Participant agrees to use adequate contraception during the study period and for 4 weeks after the last dose of study treatment. Participants must notify the principal investigator if they themselves or their partner becomes pregnant.
- •Participant has provided signed Informed Consent
排除标准
- •Has received prior systemic chemotherapy for locally-advanced unresectable or metastatic CRC.
- •Has received prior radiotherapy to >25% of bone marrow
- •Has documented and/or symptomatic brain metastases
- •Has participated in clinical studies of non-approved experimental agents or procedures within 12 weeks of study entry
- •Has received previous therapy with monoclonal antibodies
- •Has received previous therapy with any agent that targets the EGFR
- •Has serious concomitant medical conditions including active uncontrolled infection or cardiac disease, which in the opinion of the investigator, could compromise the participant or study.
- •On chronic non-topical corticosteroid treatment for >6 months at doses >10 milligrams per day (mg/day) of prednisolone or equivalent before study entry, which in the opinion of the investigator could compromise the participant or the study
- •Has a known dihydropyrimidine dehydrogenase deficiency
- •Has a known allergy to any of the treatment components
- •Has an acute or subacute intestinal occlusion
- •Has peripheral neuropathy ≥Grade 2
- •Has a history of other malignancies, with the exception of curatively treated non-melanoma skin cancer or carcinoma in situ of the cervix
- •If female, is pregnant (confirmed by urine or serum beta human chorionic gonadotropin test) or breast-feeding
- •Has received a prior autologous or allogeneic organ or tissue transplantation
- •Has interstitial pneumonia or interstitial fibrosis of the lung
- •Has pleural effusion or ascites that causes ≥Grade 2 dyspnea
- •Has psychological, familial, sociological, or geographical conditions which do not permit adequate study follow-up, compliance with the protocol, or signature of Informed Consent
研究组 & 干预措施
IMC-11F8 (necitumumab) /mFOLFOX-6 regimen
Experimental
Participants will receive IMC-11F8 (necitumumab) once every 2 weeks in combination with the mFOLFOX-6 regimen (oxaliplatin/5-FU/FA)
干预措施: IMC-11F8 (necitumumab) (Biological)
IMC-11F8 (necitumumab) /mFOLFOX-6 regimen
Experimental
Participants will receive IMC-11F8 (necitumumab) once every 2 weeks in combination with the mFOLFOX-6 regimen (oxaliplatin/5-FU/FA)
干预措施: Oxaliplatin (Drug)
IMC-11F8 (necitumumab) /mFOLFOX-6 regimen
Experimental
Participants will receive IMC-11F8 (necitumumab) once every 2 weeks in combination with the mFOLFOX-6 regimen (oxaliplatin/5-FU/FA)
干预措施: Folinic acid (FA) (Drug)
IMC-11F8 (necitumumab) /mFOLFOX-6 regimen
Experimental
Participants will receive IMC-11F8 (necitumumab) once every 2 weeks in combination with the mFOLFOX-6 regimen (oxaliplatin/5-FU/FA)
干预措施: 5-FU (Drug)
结局指标
主要结局
Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response )
时间窗: Up to 30 Months
CR and PR defined using Response Evaluation Criteria In Solid Tumors (RECIST) version (v) 1.0 criteria. CR was defined as the disappearance of all target and non-target lesions and PR defined as a ≥30% decrease in the sum of the longest diameters (LD) of the target lesions, taking as reference the baseline sum of the LD. Percentage of participants was calculated as: (total number of participants with CR or PR from start of the treatment until disease progression or recurrence) / (total number of participants treated) \* 100.
次要结局
- Serum Anti-IMC-11F8 Antibody Assessment (Immunogenicity)(Baseline up to last day of treatment plus 45 days after last treatment (127 weeks))
- Maximum Concentration (Cmax) of IMC-11F8 at Study Day 1 of Cycle 1(Cycle 1 Day 1 predose, immediately after infusion, and 1, 2, 4, 24, 72, 96, 144, 168 and 236 hours postdose)
- Volume of Distribution (Vss) of IMC-11F8 at Study Day 1 of Cycle 1(Cycle 1 Day 1 predose, immediately after infusion, and 1, 2, 4, 24, 72, 96, 144, 168 and 236 hours postdose)
- Overall Survival (OS)(First dose to date of death from any cause up to 30 months)
- Progression-Free Survival (PFS)(First dose to measured PD or death up to 30 months)
- Duration of Response(Time of response to time of measured PD or death up to 30 months)
- Area Under the Concentration-Time Curve From Time 0 to Infinity [AUC(0-∞)] of IMC-11F8 at Study Day 1 of Cycle 1(Cycle 1 Day 1 predose, immediately after infusion, and 1, 2, 4, 24, 72, 96, 144, 168 and 236 hours postdose)
- Clearance (CL) of IMC-11F8 at Study Day 1 of Cycle 1(Cycle 1 Day 1 predose, immediately after infusion, and 1, 2, 4, 24, 72, 96, 144, 168 and 236 hours postdose)
- Cmax at Study Day 1 of Cycles 2 Through 6(Day 1 Cycles 2 through 6 predose and 1 hour postdose)
- CL at Study Day 1 of Cycles 2 Through 6(Day 1 Cycles 2 through 6 predose and 1 hour postdose)
- Number of Participants With Adverse Events (AEs), Serious AEs (SAEs) or Death(First dose to end of treatment and 30-day post treatment follow-up up to 31 months)
- Area Under the Curve (AUC) at Study Day 1 of Cycles 2 Through 6(Day 1 Cycles 2 through 6 predose and 1 hour postdose)
- t1/2 at Study Day 1 of Cycles 2 Through 6(Day 1 Cycles 2 through 6 predose and 1 hour post dose)
- Change From Baseline in Tumor Size(Baseline, 29 Months)
- Kirsten Rat Sarcoma (KRAS) Mutation Status(Baseline)
- Half-Life (t1/2) of IMC-11F8 at Study Day 1 of Cycle 1(Cycle 1 Day 1 predose, immediately after infusion, and 1, 2, 4, 24, 72, 96, 144, 168 and 236 hours postdose)
- Vss at Study Day 1 of Cycles 2 Through 6(Day 1 Cycles 2 through 6 predose and 1 hour postdose)
研究者
研究点 (1)
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