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    Summary
    EudraCT Number:2005-005738-11
    Sponsor's Protocol Code Number:CRAD001C2445
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2006-04-24
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2005-005738-11
    A.3Full title of the trial
    Phase II Study of Single Agent RAD001 in Patients with Colon Cancer and Activating Mutations in the PI3KCA gene.
    A.4.1Sponsor's protocol code numberCRAD001C2445
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorUnidad integral de investigación en oncologia
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Information not present in EudraCT
    D.2.1.1.1Trade name EVEROLIMUS
    D.2.1.1.2Name of the Marketing Authorisation holder-
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameEVEROLIMUS
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNEVEROLIMUS
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Colon Cancer
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the response, time to progression and survival in patients with colorectal cancer and mutation in the Pl3KCA treated with RAD001.
    E.2.2Secondary objectives of the trial
    To fix the toxicity profile of this medicament in this kind of patients.
    To analyze the signalization pathways activated in this kind of patients.
    To fix the pharmadinamic effects of RAD001 on tumour biopsies and healthy tissue (skin) obtained from this kind of patients.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    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
    E.4Principal exclusion criteria
    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.
    E.5 End points
    E.5.1Primary end point(s)
    free disease progression survival
    global survival
    clinical response
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Information not present in EudraCT
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) Information not present in EudraCT
    E.7.4Therapeutic use (Phase IV) Information not present in EudraCT
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned Information not present in EudraCT
    E.8.5The trial involves multiple Member States Information not present in EudraCT
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Information not present in EudraCT
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    intololable toxicity
    full response
    disease pregresion
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2006-04-24. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state37
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 37
    F.4.2.2In the whole clinical trial 37
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2006-08-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-04-04
    P. End of Trial
    P.End of Trial StatusOngoing
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