EUCTR2011-003754-61-PL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.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 266
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. Subject has signed the written informed consent
- •2. KRAS mutated, histologically confirmed adenocarcinoma of
- •the colon or rectum that is not amenable to complete surgical
- •3. The subject must have received first-line combination
- •therapy containing oxaliplatin and a fluoropyrimidine with
- •or without bevacizumab for metastatic disease and must not
- •be a candidate for further oxaliplatin, meeting one of the
- •following criteria:
- •o Experienced radiographic disease progression during
- •first-line therapy, or
- •o Experienced radiographic disease progression within
- •6 months after the last dose of first-line therapy, or
- •o 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
- •o Experienced radiographic disease progression
- •following first line therapy and not be a candidate for
- •therapy with additional oxaliplatin.
- •4. Stage IV disease.
- •5. ECOG 0-2.
- •6. Age = 18 years.
- •7. Estimated life expectancy > 3 months.
- •8. 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
- •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.
- •9. 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.
- •10. Male subjects must agree to use protocol-recommended methods of contraception during heterosexual intercourse and avoid sperm donation for the duration of this study and for 90 days after the last administration of study drug.
- •11. Adequate hematologic function:
- •o neutrophils = 1.5 x 109/L
- •o platelets = 100 x 109/L
- •o hemoglobin = 9 g/dL.
- •12. Coagulation: International Normalized Ratio (INR) = 1.6
- •(unless receiving anticoagulation therapy). Patients on
- •full-dose anticoagulation must be on a CstableCTT 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).
- •13. Adequate hepatic function:
- •o Direct or total bilirubin = 1.5 x upper limit of normal
- 另有 12 项未显示
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 homozygosity for the UGT1A1*28 allele (UGT1A1 7/7 genotype) (special screening not required). 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, stage 0 or 1 melanoma, 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. Subjects with angina pectoris, poorly controlled ventricular
- •arrhythmias (does not include asymptomatic, occasional
- •premature ventricular contractions), history of clinically significant coronary heart disease or cardiomyopathy, or ECG abnormalities
- •consistent with ischemia.
- •11. Uncontrolled hypertension (seated systolic blood pressure
- •> 180 mmHg or diastolic blood pressure > 110 mmHg) at
- •12. Clinically active liver disease, including active hepatitis (any
- •etiology) or cirrhosis.
- •13. 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.
- •14. Anti-tumor therapy (chemotherapy, antibody therapy,
- •molecular targeted therapy, retinoid therapy, hormonal
- •therapy) within 21 days prior to randomization.
- •15. Prior irinotecan therapy for metastatic disease is not
- •permitted. However, prior adjuvant therapy with irinotecan
- •is permitted. The use of prior fluoropyrimidine and/or
- •oxaliplatin as adjuvant therapy is permitted but the subject
- •must also have received fluoropyrimidine and oxaliplatin as
- •first line therapy for metastatic disease.
- •16. Known hypersensitivity to the study investigational
- •medicinal products, formulation excipients, irinotecan, 5 FU,
- •or leucovorin.
研究者
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This is a clinical research study involving an experimental drug named GS-6624 for the treatment of metastatic colorectal adenocarcinoma, a sub-type of cancer of the colon and/or rectum. The purpose of this study is to test the effectiveness and safety of GS-6624 at different dose levels when it is given with FOLFIRI. We want to find out what effects, good and/or bad, GS-6624 has on you and your metastatic colorectal adenocarcinoma when it is given with FOLFIRI.EUCTR2011-003754-61-ESGilead Sciences, Inc.265