EUCTR2011-003754-61-ES进行中（未招募）不适用
A Phase 2 Randomized, Double-Blind, Placebo-ControlledStudy to Evaluate the Efficacy and Safety of GS-6624Combined with FOLFIRI as Second Line Treatment forMetastatic KRAS Mutant Colorectal Adenocarcinomathat Has Progressed Following a First Line Oxaliplatin- andFluoropyrimidine-Containing Regimen.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 265
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. KRAS mutated, histologically confirmed adenocarcinoma of the colon or rectum.
- •2. The subject must have received first-line combination therapy containing oxaliplatin and a fluoropyrimidine with or without bevacizumab for metastatic disease and o Experienced radiographic disease progression during first-line therapy, or Experienced radiographic disease progression within 6 months after the last dose of first-line therapy, or Discontinued part or all of first-line therapy due to toxicity and experienced radiographic disease progression within 6 months after the last dose of first-line therapy; or Not be a candidate for therapy with additional oxaliplatin.
- •3. Stage IV disease.
- •4. ECOG 0-2.
- •5. Age ? 18 years.
- •6. Estimated life expectancy > 3 months.
- •7. Measurable disease per RECIST version 1.1, defined with all of following criteria: 1. Lesions accurately measured in at least 1 dimension 2. The longest diameter in the plane of measurement is to be recorded 3. A minimum size of 10 mm if CT slice thickness ? 5 mm; if thickness is > 5 mm then the minimum size of measurable lesions should be twice slice thickness.
- •8. Women of childbearing potential must agree to use one medically approved (ie, mechanical or pharmacological) contraceptive measure and have their partners agree to an additional barrier method of contraception for the duration of the study and for 90 days after the last administration of study drug.
- •9. Male subjects must agree to use condoms during heterosexual intercourse and avoid sperm donation for the duration of this study and for 90 days after the last administration of study drug.
- •10. Adequate hematologic function: neutrophils ? 1.5 x 109/L, platelets ? 100 x 109/L, hemoglobin ? 9 g/dL.
- •11. Coagulation: International Normalized Ratio (INR) ? 1.6 (unless receiving anticoagulation therapy). Patients on fulldose anticoagulation must be on a stable dose (minimum duration 14 days) of oral anticoagulant or low molecular weight heparin. If receiving warfarin, the patient must have
- •an INR ? 3.0 and no active bleeding (ie, no bleeding within 14 days prior to first dose of study therapy).
- •12. Adequate hepatic function: Direct or total bilirubin ? 1.5 x upper limit of normal (ULN). ALT and AST ? 2.5 x ULN, in case of liver metastases <= 5 x ULN.
- •13. Serum creatinine ? 1.5 x ULN.
- •14. No major operations within 4 weeks prior to treatment start.
- •15. No relevant toxicities due to prior medical treatment at time
- •of study entry.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 255
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •1. More than 1 prior chemotherapy regimen for stage 4
- •colorectal cancer.
- •2. Experimental medical treatment within 30 days prior to
- •study entry.
- •3. Pregnant or breast feeding women (pregnancy needs to be
- •excluded by testing of beta-HCG).
- •4. Known or suspected cerebral metastases.
- •5. Acute or subacute ileus, chronic inflammatory bowel
- •disease, or chronic diarrhea.
- •6. Known dihydropyrimidine dehydrogenase-deficiency
- •(special screening not required).
- •7. Known glucuronidation-deficiency (special screening not
- •8. Known alcohol or drug abuse or any other medical or
- •psychiatric condition which contraindicates participation in
- •9. History or presence of any form of cancer, other than
- •colorectal cancer, within the 3 years prior to enrollment,
- •with the exception of excised basal cell or squamous cell
- •carcinoma of the skin, or cervical carcinoma in situ or breast
- •carcinoma in situ that has been excised or resected
- •completely and is without evidence of local recurrence or
- •metastasis.
- •10. Myocardial infarction within the last 6 months of study
- •Day 1, symptomatic congestive heart failure (New York
- •Heart Association Classification > Class II), unstable angina,
- •or unstable cardiac arrhythmia requiring medication.
- •11. Clinically active liver disease, including active hepatitis (any
- •etiology) or cirrhosis.
- •12. Systemic fungal, bacterial, viral, or other infection that is not
- •controlled (defined as exhibiting ongoing signs/symptoms
- •related to the infection and without improvement) despite
- •appropriate antibiotics use.
- •13. Anti-tumor therapy (chemotherapy, antibody therapy,
- •molecular targeted therapy, retinoid therapy, hormonal
- •therapy) within 21 days prior to randomization.
- •14. Prior irinotecan therapy.
- •15. Known hypersensitivity to the study investigational
- •medicinal products, formulation excipients, irinotecan, 5 FU,
- •or leucovorin.
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