EUCTR2005-005738-11-ES进行中（未招募）不适用
Phase II Study of Single Agent RAD001 in Patients with Colon Cancer and Activating Mutations in the PI3KCA gene.
nidad integral de investigación en oncologia0 个研究点目标入组 37 人开始时间: 2006年4月24日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 37
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.Signed IC
- •2.Cytological o pathological diagnosis of colorectal adenocarcinome, methastasic or refractary at least at one previous chemotheraphy and without effective chirurgical treatment.
- •3.At least for weeks since the last treatment at the beginning of the study.
- •4.Tumoural tissue available for mutation analysis, if not, the patient must permit to undergo to a biopsy.
- •5.Tumoural mutations in Pl3KCA gene. The mutations will be determinate by Kathleen Murphy at the Pathology department, Johns Hopkins Hospital.
- •6.Patients with biopsiable disease or agree to undergo to two biopsies (skin and tumour).
- •7.Age = 18.
- •8.ECOG 0-2 (Karnofski = 60 < 5 annexe 4)
- •9.Hope of life = 12 weeks
- •10.Wright bone marrow function (7 days before starting the trial): leukocyte = 3.0 x 109 /l RAN = 1.5 x 109 /l platelets = 100 x 109 /l
- •11.Wright hepatic function (7 days before starting the trial): seric bilirrubin inside normal limits, AST and ALT = 2.5 x ULN
- •12.Wright renal function (7 days before starting the trial): seric creatinine inside normal limits or CrC = 60 ml/min for those patients who has creatinine higher than normal limits. Total cholesterol triglycerides = 2.5 ULN.
- •13.Scanner measurable disease, available for external revision with, at least one lesion = 2cm (if helicoidal scanner used lesion = 1cm) on a non radiated area.
- •14.RDA001 effects on foetus are unknowns so fertile women must use wright contraceptive methods (hormones, barrier, abstinence…) before and during the trial. If a woman knows or suspect his in pregnancy, she must immediately inform to the doctor
- •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
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Patients whose have received radio or chemotheraphy ( 6 weeks if treatment with nitrosourees or mitomicine C) on the previous 4 weeks before starting the trial. Also if they are not recovered from the adverse effects produced by previous oncologycal treatments.
- •2.Patients whose have had previous medicaments with a m-tor against target.
- •3.Patients with another experimental treatment.
- •4.Patients with cerebral metastasis. The prognostic for these patients is actually bad and the neurological symptomatology associated can make more laborious to evaluate the adverse effects associated to RAD001
- •5.Allergic to any substance similar to RAD001
- •6.Patients having forbidden treatments points 5.4.3 and 5.4.4 from the protocol.
- •7.Not controlled intercurrent diseases as hypertension, infections, cardiac insufficiency, pectoris angina, cardiac arrhythmias or psychiatric psychosocial diseases.
- •8.Antecedents or evidence of hereditary hemorrhagic diathesis or coagulophaty with hemorrhagic risk.
- •9.Patients can not receive anticoagulant treatment. It is allowed to receive prophylactic treatments (for example warfarin at low doses ) in case of venous or arterial reservoirs and only if TTPa, INR and TP requirements are ok.
- •10.Incapacity to take oral treatments or previous chirurgical treatments that affect to absortion or make necessary i.v. nutrition or parenteral lipid nutrition.
- •11.Women in pregnancy or in laitance period. A negative pregnancy test is required (in serum or orine) 7 days before starting the trial in all premenopausal women . RDA001 effects on foetus are unknowns, so women on laitance period must interrupt it before starting the treatment.
- •12.Patients with immune deficiencies have a bigger risk of lethal infections when mielosuppressor treatment is given. Patients with HIV and a retroviral therapy will be excluded from this trial because of possible medicamentous interactions with RAD001 or another medicaments administrated on this trial.
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