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    Summary
    EudraCT Number:2007-003751-37
    Sponsor's Protocol Code Number:BO21128
    National Competent Authority:Greece - EOF
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-01-30
    Trial results Removed from public view
    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 ConcernedGreece - EOF
    A.2EudraCT number2007-003751-37
    A.3Full title of the trial
    A Phase II, Dose-Escalation to Rash Trial of Erlotinib (Tarceva®) plus Gemcitabine in Patients With Metastatic Pancreatic Cancer
    A.3.2Name or abbreviated title of the trial where available
    RACHEL
    A.4.1Sponsor's protocol code numberBO21128
    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 SponsorF. Hoffmann- La Roche Ltd
    B.1.3.4CountrySwitzerland
    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 Yes
    D.2.1.1.1Trade name Tarceva
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Ltd
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.4Pharmaceutical 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 INNErlotinib
    D.3.9.1CAS number 183321-74-6
    D.3.9.2Current sponsor codeRo 50-8231
    D.3.9.3Other descriptive nameErlotinib hydrochloride
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNErlotinib
    D.3.9.1CAS number 183321-74-6
    D.3.9.2Current sponsor codeRo 50-8231
    D.3.9.3Other descriptive nameErlotinib hydrochloride
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNErlotinib
    D.3.9.1CAS number 183321-74-6
    D.3.9.2Current sponsor codeRo 50-8231
    D.3.9.3Other descriptive nameErlotinib hydrochloride
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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
    Metastatic Pancreatic Cancer
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10033605
    E.1.2Term Pancreatic cancer metastatic
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine, in patients who do not develop any rash, or develop only grade 1 rash, within 4 weeks of start of treatment with gemcitabine + erlotinib, if overall survival can be improved by increasing the dose of erlotinib compared to patients who continue on 100 mg erlotinib
    E.2.2Secondary objectives of the trial
    • To evaluate the safety and tolerability of increased doses of erlotinib in combination with gemcitabine
    • To evaluate if increasing the dose of erlotinib increases the incidence of grade >= 2 rash vs those who continue on 100 mg erlotinib
    • To compare PFS, response and disease control rates between patients with increased dose of erlotinib vs those who continue on 100 mg erlotinib
    • To make a non randomized comparison of efficacy and safety between patients who do develop vs those who do not develop grade 2 or higher rash during the first 4 weeks of therapy
    • To correlate biomarkers (EGFR expression, EGFR gene copy number, K-ras mutations, EGFR Intron 1 polymorphisms) with outcomes and response to treatment (ORR, PFS, OS)
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Pharmacogenetic substudy as part of the Protocol BO21128 Version A- Final, 26 November 2007
    E.3Principal inclusion criteria
    Disease specific inclusion criteria:
    1. Histologically or cytologically confirmed pancreatic cancer (adenocarcinoma) with measurable or non-measurable metastatic disease (stage IV)
    2. Life expectancy of >= 8 weeks
    General inclusion criteria:
    3. Age >= 18 years
    4. ECOG performance status of 0 - 1 (see section 5.3.2)
    5. Able to comply with the protocol
    6. Written (signed) Informed Consent to participate in the study
    7. Adequate hematological function: ANC >= 1.5 x 10[9]/L, platelet count >= 100 x 10[9]/L and Hb >= 9 g/dL
    8. PT-INR <= 1.5 and PTT <= 1.5 x ULN within 7 days prior to start of study treatment
    9. Adequate liver function: serum (total) bilirubin <=1.5 x ULN, SGOT (AST) and SGPT (ALT) < 2.0 x ULN
    10. Albumin > 3.0 g/dL
    11. Adequate renal function: serum creatinine < 1.5 ULN
    12. For all females of childbearing potential a negative pregnancy test must be obtained within 7 days before start of treatment
    Inclusion criteria for randomization between day 29 and 35 (after 4 weeks run-in period)
    1. Completion of 4 weeks run-in period, without clinical evidence of disease progression, as per investigators opinion
    2. Patients who have not developed rash grade >= 2 during the 4 weeks run-in period
    3. Patients who have not developed any other toxicity leading to dose adjustments /
    discontinuation (for either gemcitabine or erlotinib) during the 4 weeks run-in period
    4. ECOG performance status of 0 - 1 (see section 5.3.2)
    5. Adequate hematological function: ANC >= 1.5 x 10[9]/L, platelet count >= 100 x 10[9]/L and Hb >= 9 g/dL
    6. Adequate liver function: serum (total) bilirubin <= 1.5 x ULN, SGOT (AST) and
    SGPT (ALT) < 2.0 x ULN
    7. Albumin > 3.0 g/dL
    8. Adequate renal function: serum creatinine < 1.5 ULN
    E.4Principal exclusion criteria
    Disease specific exclusion criteria:
    1. Local (Stage Ia to IIb) pancreatic cancer and locally advanced (stage III) pancreatic cancer. (Patients relapsing with metastatic disease, after initial diagnosis with local or locally advanced disease can be enrolled into this study)
    2. Prior chemotherapy or treatment with another systemic anti-cancer agent for metastatic pancreatic cancer
    3. Less than (or equal to) 6 months since last adjuvant chemotherapy. Patient must have recovered from all treatment related toxicities prior to 4 weeks run-in period and must have documented evidence of disease progression (metastatic) following adjuvant chemotherapy
    4. Prior treatment with an investigational or marketed agent which acts on the EGFR axis. EGFR inhibitors include (but are not limited to) erlotinib, gefitinib or other anti-EGFR or EGF monoclonal antibody therapy or dual TKI inhibitors
    5. Prior adjuvant radiotherapy for pancreatic cancer, except for patients with progressive lesions outside the radiation port who completed the radiotherapy at least 6 months prior to study entry
    6. Any other malignancies within the last 5 years before study start, except for adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer
    7. Evidence of spinal cord compression or current evidence of CNS metastases. CT/MRI of the brain is mandatory (within 4 weeks before study start) in case of clinical suspicion or evidence of brain metastases
    General exclusion criteria:
    8. Any disease (including psychotic disorders, drug abuse, active infection, uncontrolled hypertension, clinically significant cardiovascular disease for example CVA (<= 6 months before study start), myocardial infarction (<= 6 months before study start), unstable angina, NYHA >= grade 2 CHF, arrhythmia requiring medication, hepatic, renal or metabolic disease, metabolic dysfunction), physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contra-indicates the use of an investigational drug or puts the patient at high risk for treatment-related complications
    9. Patients who have had any major surgery within 2 weeks prior to study start
    10. Any known significant ophthalmologic abnormalities of the surface of the eye (the use of contact lenses is not recommended)
    11. Patients unable to take oral medication, requiring intravenous alimentation, who have mal-absorption syndrome or any other conditions affecting gastrointestinal absorption, or who have active peptic ulcer disease
    12. Pregnant or lactating females
    13. Men and women of childbearing potential (<2 years after last menstruation) not using effective means of contraception (e.g. oral contraceptives, intrauterine contraceptive device, sexual abstinence, or surgically sterile), effective meaning failure rate < 1%/year
    14. Current or recent (within the 30 days prior to starting study treatment) treatment with another investigational drug or participation in another investigational study
    15. Patients known to be HIV positive. Testing is not required in the absence of clinical signs and symptoms suggestive of HIV infection.
    16. Hypersensitivity to erlotinib or to gemcitabine or to any of the excipients or to compounds with similar chemical or biologic composition
    E.5 End points
    E.5.1Primary end point(s)
    Primary efficacy parameter is Overall Survival (OS)
    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 Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Correlation of outcome with biomarkers
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    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 Yes
    E.8.2.3.1Comparator description
    Different dose
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA58
    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
    The trial will end when the last patient has stopped treatment with both gemcitabine and erlotinib. If very few patients remain in the study for a long time after the cut-off date the study may be closed at that time and patients still benefiting from erlotinib and/or gemcitabine will be provided with commercial drug
    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 months9
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months9
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 260
    F.4.2.2In the whole clinical trial 400
    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)
    Patients will continue to be treated according to their treatment arm until PD, unacceptable toxicities, death or withdrawal of the last patient. If very few patients remain in the study for a long time after the cut-off date the study may be closed at that time and patients still benefiting from erlotinib and/or gemcitabine will be provided with commercial drug
    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 Decision2008-10-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-01-22
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-02-20
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