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    The EU Clinical Trials Register currently displays   35896   clinical trials with a EudraCT protocol, of which   5892   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2008-002606-18
    Sponsor's Protocol Code Number:D1600C00001
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2008-07-29
    Trial results View 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 ConcernedFrance - ANSM
    A.2EudraCT number2008-002606-18
    A.3Full title of the trial
    A Phase I/II, Open Label, Multi-centre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of the Tor Kinase Inhibitor AZD8055 Administered Orally to Patients with Advanced Solid Tumours, Lymphomas and Endometrial Carcinoma
    A.4.1Sponsor's protocol code numberD1600C00001
    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 SponsorAstrazeneca AB
    B.1.3.4CountrySweden
    B.3.1 and B.3.2Status of the sponsorCommercial
    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 No
    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.3.2Product code AZD8055
    D.3.4Pharmaceutical form Oral solution
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    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 No
    D.3.11.8Extractive medicinal product No
    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
    Advanced solid tumours, lymphomas and endometrial carcinoma
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10014733
    E.1.2Term Endometrial cancer
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10065143
    E.1.2Term Malignant solid tumour
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10025632
    E.1.2Term Malignant lymphoma
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the safety and tolerability of AZD8055 in patients with advanced solid tumours or lymphomas (including 20 patients with endometrial carcinoma in Part B).
    E.2.2Secondary objectives of the trial
    1. To determine the pharmacokinetics of AZD8055 following both single and multiple oral dosing of AZD8055 in patients with advanced solid tumours or lymphomas (including 20 patients with endometrial carcinoma in Part B).
    2. To obtain a preliminary evaluation of the role of renal excretion in the disposition of AZD8055.
    3. To evaluate phosphorylation levels of biomarkers such as AKT following treatment with AZD8055.
    4. To investigate possible relationships between plasma AZD8055 concentrations/exposure and changes in safety and PD parameters.
    5. To give an early indication of efficacy by evaluation of tumour size.
    6. To determine inhibition of tumour glucose uptake by assessment with FDG-PET.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Provision of signed written informed consent
    2. Male or female, aged 18 years or older
    3. Cancer which is refractory to standard therapies, or for which no standard therapies exist, or for which the investigator feels no other active therapy is required for the duration of the study. Inclusion is irrespective of stage of disease.
    4. Histological or cytological confirmation of an advanced, solid, malignant tumour or lymphoma. Patients with endometrial carcinosarcomas can be included in the study but will be analysed in the non-endometrial sub group in Part B.
    5. WHO performance status 0-2 (those with performance status 2 must have been stable with no deterioration over the previous 2 weeks)
    6. Evidence of post-menopausal status, permanent or surgically sterile, or negative serum or urine pregnancy test for female patients of child-bearing potential. Women will be considered post menopausal if they are over 50 years old and have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments. Permanent sterilisation includes hysterectomy and/or bilateral oopherectomy and/or bilateral salpingectomy but excludes bilateral tubal occlusion. Tubal occlusion is considered a highly effective method of birth control but does not absolutely exclude the possibility of pregnancy. (The term occlusion refers to both occluding and ligating techniques that do not physically remove the oviducts). Women who have undergone tubal occlusion should be managed as if they are of child-bearing potential (eg undergo pregnancy testing as required by the study). Females of reproductive potential are required to use reliable contraception (see Section 3.3.4)
    7. For Parts A and B of the study, patients with measurable and non-measurable disease (according to RECIST criteria) can be recruited.
    E.4Principal exclusion criteria
    1. Laboratory values as listed below: (SI Units)
    - ANC <1.5x109/L
    - Platelets <100x109/L
    - Haemoglobin (Hb) <9.0 g/dL
    - AST (SGOT) or ALT (SGPT) >2.5 x ULN if no demonstrable liver metastases or >5 x ULN in the presence of liver metastases, total bilirubin (TBL) >1.5 x ULN if no demonstrable liver metastases or >3 x ULN in the presence of liver metastases
    - Serum creatinine >1.5 x ULN or creatinine clearance ≤50 mL/min (measured or calculated by Cockcroft-Gault method)
    - Clinically relevant and treatment resistant abnormalities in potassium, sodium, calcium (corrected for plasma albumin) or magnesium
    - Proteinuria +1 on dipstick analysis or >500 mg/24 hours
    2. Endometrial cancer who have isolated recurrences of their disease (vaginal, pelvic or para-aortic) that are amenable to potentially curative treatment with radiation therapy or surgery
    3. Prior chemotherapy, biological therapy, radiation therapy, androgens, thalidomide, corticosteroids or other investigational anti-cancer therapy within 21 days of entering the trial (not including palliative radiotherapy at focal sites). Patients must have also recovered from previous chemo-associated toxicities to Grade 0-1.
    4. Treatment with any haemopoietic growth factors (eg G-CSF, GM-CSF) within 2 weeks prior to receiving study drug
    5. Active spinal cord compression as evidenced by clinical signs and/or oedema or progressive growth demonstrated by imaging unless treated and stable off steroids for at least 1 month prior to study treatment
    6. History of peripheral neuropathy, pre-existing leg weakness or muscle diseases
    7. Family history of myopathy
    8. Past history or current evidence of brain metastases
    9. Evidence of severe or uncontrolled systemic conditions (eg, severe hepatic impairment, interstitial lung disease [bilateral, diffuse, parenchymal lung disease]) or current unstable or uncompensated respiratory or cardiac conditions which makes it undesirable for the patient to participate in the study or which could jeopardise compliance with the protocol
    10. Patients with pre existing renal disease including glomerulonephritis, nephritic syndrome, Fanconi Syndrome or Renal tubular acidosis
    11. Impaired oral glucose tolerance test (OGTT) as defined by fasting glucose >109 mg/dL (6.1 mmol/L) and postprandial glucose 2h level >140mg/dL (>7.8 mmol/L).
    12. Manifest Diabetes Type I and II or Erythrocyte-HbA1c >6.5%
    13. Uncontrolled hypercholesterolaemia or hypertriglyceridaemia (fasting state) despite lipid-lowering therapy
    14. Evidence of active infection or active bleeding diatheses
    15. Experience of any of the following in the preceding 12 months: coronary artery bypass graft, angioplasty, vascular stent, myocardial infarction (MI), angina pectoris, congestive heart failure NYHA Grade 2, uncontrolled hypertension (BP>150/90 mmHg despite maximal medical management), ventricular arrhythmias requiring continuous therapy, supraventricular arrhythmias including AF, which are uncontrolled, haemorrhagic or thrombotic stroke, including transient ischaemic attacks or any other central nervous system bleeding
    16. Abnormal echocardiogram at baseline (LVEF < 55% and shortening fraction SF <15%)
    17. Torsades de Pointes, currently or within 2 weeks of study entry
    18. Patients with mean QTc interval >450ms from 3 ECGs using Fridericia's correction at both screening visit and predose on the first day of dosing
    19. Patients taking concomitant medications known to prolong QT interval or with factors that increase the risk of QT prolongation or arrhythmic events (heart failure, hyperkalaemia, personal or family history of long QT syndrome)
    20. Uncontrolled severe thyroid hyperfunction or hypofunction.
    21. History of neurocardiogenic syncope
    22. Recent major surgery within 4 weeks prior to study entry (excluding the placement of vascular access), or minor surgery within 2 weeks of entry into the study
    23. Patients with documented cases of HIV or hepatitis B or C
    24. Involvement in the planning or conduct of study (AstraZeneca staff and staff at the study site)
    25. Previous enrolment into the present study
    26. Patients receiving potent and moderate inhibitors and inducers of CYP3A4 if they are taken within the stated washout periods (see protocol)
    27. Any other severe, acute or chronic medical or psychiatric condition or laboratory abnormality that could increase the risk associated with study participation or study drug administration or could interfere with the interpretation of the study results and, in the judgment of the investigator, would make a patient inappropriate for entry
    28. Refractory nausea and vomiting, chronic gastrointestinal diseases (eg inflammatory bowel disease) or significant bowel resection that would preclude adequate absorption
    29. See Appendix E/I for exclusion criteria from the optional host genetic research/buccal biopsies
    30. Investigator's clinical judgement that the patient should not participate in the study
    E.5 End points
    E.5.1Primary end point(s)
    Safety and tolerability:
    Assessed by incidence and severity of adverse events (CTCAE Version 3.0), vital signs, general organ function, clinical chemistry (including liver function test), haematology and urinalysis, coagulation, glucose management, ECG and echocardiography, nervous and musculoskeletal system examination.
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans Yes
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA2
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial has a data monitoring committee No
    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
    30 days after the last patient discontinues study treatment
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    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) Yes
    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 Yes
    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 2008-07-29. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 100
    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 Decision2008-09-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-11-03
    P. End of Trial
    P.End of Trial StatusOngoing
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