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    The EU Clinical Trials Register currently displays   35522   clinical trials with a EudraCT protocol, of which   5839   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2004-000725-30
    Sponsor's Protocol Code Number:BAY 43-9006/11538
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2005-02-23
    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 ConcernedUK - MHRA
    A.2EudraCT number2004-000725-30
    A.3Full title of the trial
    A phase II, multi-centre, open-label, uncontrolled study to evaluate the efficacy and safety of BAY 43-9006 given daily in combination with repeated 21-day cycles of dacarbazine (DTIC) chemotherapy in subjects with advanced metastatic melanoma.
    A.3.2Name or abbreviated title of the trial where available
    N/A
    A.4.1Sponsor's protocol code numberBAY 43-9006/11538
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberN/A
    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 SponsorBayer HealthCare AG
    B.1.3.4CountryUnited Kingdom
    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.3.1Product nameSorafenib
    D.3.2Product code BAY 43-9006
    D.3.4Pharmaceutical form Film-coated 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 INNSorafenib
    D.3.9.1CAS number Not avail.
    D.3.9.2Current sponsor codeBAY 43-9006 tosylate (BAY 54-9085)
    D.3.9.3Other descriptive name4-{4-[3-(4-chloro-3-trifluoromethyl-phenyl)-ureido-phenoxy}-pyridine-2-carboxylic acid methylamide-4
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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 Information not present in EudraCT
    D.IMP: 2
    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 Yes
    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 nameDacarbazine
    D.3.4Pharmaceutical form Powder for infusion*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDacarbazine
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100, 200 to plus others
    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 Information not present in EudraCT
    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
    Subjects with advanced, metastatic, histologically confirmed melanoma, for whom treatment with dacarbazine is considered medically acceptable. Subjects should have measurable and evaluable disease (as per the RECIST criteria), and not have received prior cytotoxic chemotherapy.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Classification code 10027481
    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 overall tumour response rate (including complete responses (CR) and partial responses (PR)) of oral BAY 43-9006 given continuously in combination with repeated 21-day cycles of dacarbazine, in subjects with advanced, metastatic melanoma. The response rate will be determined using the RECIST criteria
    E.2.2Secondary objectives of the trial
    To evaluate:
    Progression-free survival;
    Overall survival;
    Duration of response for those subjects who exhibit an objective response (PR or CR);
    Disease control rate (PR+CR+SD);
    Duration of stable disease for those subjects who exhibit SD as their best response;
    Time to response for those subjects who exhibit an objective response (PR or CR);
    Evaluate the safety and toxicity profile of the combination study treatment;
    Explore possible BRAF and RAS mutations in melanoma biopsy samples that may correspond with a better response rate to the combination therapy of BAY 43-9006 and dacarbazine;
    Analyse pERK and pVEGFR2 levels in melanoma biopsy samples to determine whether increased phosphorylation corresponds with a better response rate to the combination therapy of BAY 43-9006 and dacarbazine, and whether levels are modulated by the combination therapy. Other markers associated with these pathways may also be analysed.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subjects with advanced, metastatic, histologically confirmed melanoma, for whom treatment with dacarbazine is considered medically acceptable.
    2. Age >/=18 years.
    3. Subject has measurable and evaluable disease defined as at least one metastatic lesion that can be accurately and serially measured by CT or MRI scan as per the RECIST criteria (see Section 10.5, Appendix 5). Cutaneous lesions measuring at least 20mm in longest diameter can be considered measurable (and therefore target lesions) via color photography including a ruler.
    4. Subject has biopsiable disease at baseline and is willing to provide biopsy samples, or does not have biopsiable disease at baseline.
    5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
    6. Life expectancy of at least 12 weeks.
    7. Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements. These should be conducted at screening, within 7 days prior to the first dose of study drug:
    * Haemoglobin > 9.0 g/dl.
    * Absolute neutrophil count (ANC) >1,500/mm3.
    * Platelet count ≥ 100,000/mm3.
    * Total bilirubin < 1.5 x ULN.
    * Alanine transaminase (ALT) and aspartate transaminase (AST) </= 2.5 x ULN (5.0 x ULN for subjects with hepatic metastases).
    * Serum creatinine < 1.5 x ULN.
    8. Prothrombin time (PT) or the International Normalized Ratio of PT (PT-INR), and partial thromboplastin time (PTT) < 1.5 x ULN. Subjects who are being therapeutically anticoagulated with an agent such as coumadin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in these parameters exists. For subjects on warfarin, close monitoring of at least weekly evaluations will be performed until INR is stable based on a measurement at pre-dose, as defined by the local standard of care.
    9. Serum amylase and lipase must not be above the ULN at screening.
    10. Signed informed consent must be obtained prior to any study specific procedures being performed, including per protocol biopsies.
    E.4Principal exclusion criteria
    1. Primary ocular or mucosal melanoma (cutaneous vulval melanoma is permitted).
    2. Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors [Ta, Tis & T1] or any cancer curatively treated > 3 years prior to study entry.
    3. Presence of:
    * Clinically evident congestive heart failure, NYHA > class 2. NYHA class II states; Patients have cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnoea or anginal pain.
    * Cardiac arrhythmias requiring antiarrythmics, other than beta blockers or digoxin.
    * Active coronary artery disease or ischaemia (myocardial infarction more than 6 months prior to study entry is allowed).
    * Uncontrolled hypertension (> grade 2 NCI-CTCAE v3).
    * Active clinically serious infections (> grade 2 NCI-CTCAE v3).
    * Subjects with seizure disorder requiring medication are excluded.
    * History of or suspected HIV infection, or chronic hepatitis B or C.
    * Symptomatic metastatic brain or meningeal tumours unless the subject is > 6 months from definitive therapy, has a negative imaging study within 4 weeks prior to study entry and is clinically stable with respect to the tumor at the time of study entry. Also the subject must not be undergoing acute steroid therapy or taper (chronic steroid therapy is acceptable provided that the dose is stable for one month prior to and following screening radiographic studies).
    * History of organ allograft.
    * Pregnant or breast-feeding subjects. Women of childbearing potential must have a negative serum pregnancy test result within 7 days prior to the first study drug administration. Both men and women enrolled in this trial must use adequate barrier birth control measures from screening until the end of the active follow-up period of the trial. For the purposes of this study, post-menopausal will be considered to be 1 year without menses.
    4. Excluded prior and concomitant therapies and medications, such as:
    * Subjects who have received prior anticancer chemotherapy, or prior treatment with a Ras pathway inhibitor (including trastuzumab, EGFR inhibitors, farnesyl transferase inhibitors or MEK inhibitors), or treatment with a drug which targets VEGF (such as bevacizumab) will be excluded. Anticancer chemotherapy is defined as any agent or combination of agents with clinically proven anticancer activity administered by any route with the purpose of affecting the cancer, either directly or indirectly, including palliative and therapeutic endpoints. This includes anticancer chemotherapy given by isolated limb perfusion.Prior immunotherapy, cytokine or biological therapy is permitted, as long as there is at least 4 weeks’ recovery following the last dose of therapy prior to study entry. Prior vaccine therapy is also permitted, as long as there is at least 3 months’ recovery following the last administration of therapy prior to study entry.
    * Radiotherapy during the study or within 3 weeks prior to first dose of study drug. Palliative radiotherapy will be allowed as described in Prior and concomitant therapy.
    * Major surgery within 4 weeks prior to study entry.
    * Bone marrow transplant or stem cell rescue within 4 months prior to the first dose of study drug.
    * Biological response modifiers, such as G-CSF, within 3 weeks prior to study entry. G-CSF and other hematopoietic growth factors may be used in the management of acute toxicity such as febrile neutropaenia when clinically indicated or at the discretion of the investigator, however they may not be substituted for a required dose reduction. Erythropoietin given as secondary prophylaxis when clinically indicated is permitted, although use as primary prophylaxis is excluded. Again, this should not be substituted for a required dose reduction.
    * Use of cyclo-oxygenase-2 inhibitors during the study or within 2-weeks prior to the first dose of study drug.
    * Investigational drug therapy outside of this trial during or within 4 weeks prior to study entry.
    5. Substance abuse, medical, psychological or social conditions that may interfere with the subject’s participation in the study or evaluation of the study results.
    6. Known or suspected allergy to the investigational agent or any agent given in association with this trial, including subjects who are known to be hypersensitive to dacarbazine.
    7. Any condition that is unstable or could jeopardize the safety of the subject and their compliance in the study.
    E.5 End points
    E.5.1Primary end point(s)
    Overall tumour response rate. This will be calculated by dividing the total number of complete and partial responses seen by the total number of subjects enrolled.
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    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) No
    E.7.1.1First administration to humans No
    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 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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned11
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA17
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.7Trial has a data monitoring committee Yes
    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
    The end of the study for regulatory purposes will be when the last subject finishes active study follow-up and moves into post-study follow-up. The justification for this is that only survival information will be collected in the post-study follow-up, and the contacts can either be to the subject or to their GP if more appropriate. The subject is not required to attend the clinic or to undergo any physical assessments during this period.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    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 No
    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 state65
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 85
    F.4.2.2In the whole clinical trial 85
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Subjects can continue on combination treatment, if well tolerated and having clear palliative benefit, until PD or death is recorded. Subjects for whom it is appropriate to stop dacarbazine may continue on BAY43-9006 alone until PD occurs. Subjects can receive other anti-cancer therapies once they move into the active follow-up period (after stopping dacarbazine and sorafenib) if necessary. Treatment or care after the subject stops study treatment will therefore be as per local standard of care.
    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 Decision2004-11-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-11-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-06-13
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