Phase II Study of Single Agent RAD001 in Patients with Colon Cancer and Activating Mutations in the PI3KCA gene.
- Conditions
- Colon Cancer
- Registration Number
- EUCTR2005-005738-11-ES
- Lead Sponsor
- nidad integral de investigación en oncologia
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 37
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the response, time to progression and survival in patients with colorectal cancer and mutation in the Pl3KCA treated with RAD001.<br><br>;Secondary Objective: To fix the toxicity profile of this medicament in this kind of patients.<br>To analyze the signalization pathways activated in this kind of patients.<br>To fix the pharmadinamic effects of RAD001 on tumour biopsies and healthy tissue (skin) obtained from this kind of patients.;Primary end point(s): free disease progression survival<br>global survival<br>clinical response
- Secondary Outcome Measures
Name Time Method