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    Summary
    EudraCT Number:2013-005108-32
    Sponsor's Protocol Code Number:BP29262
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2014-09-02
    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 number2013-005108-32
    A.3Full title of the trial
    A PHASE II, MULTICENTER, RANDOMIZED, DOUBLE-BLIND STUDY TO
    EVALUATE THE EFFICACY AND SAFETY OF RO5520985 (VANUCIZUMAB)
    PLUS FOLFOX VERSUS BEVACIZUMAB PLUS FOLFOX IN PATIENTS WITH
    PREVIOUSLY UNTREATED METASTATIC COLORECTAL CANCER
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A blinded phase II study to evaluate the efficacy and safety of 2 different treatments arms (RO5520985 plus standard chemotherapy FOLFOX versus bevacizumab plus standard chemotherapy FOLFOX) in patients who have not been treated before for their metastatic disease of colorectal cancer.
    A.4.1Sponsor's protocol code numberBP29262
    A.7Trial is part of a Paediatric Investigation Plan No
    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 supportF. Hoffman-La Roche Ltd
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationF. Hoffmann-La Roche Ltd
    B.5.2Functional name of contact pointTrial Information Support Line-TSIL
    B.5.3 Address:
    B.5.3.1Street AddressGrenzacherstrasse 124
    B.5.3.2Town/ cityBasel
    B.5.3.3Post code4070
    B.5.3.4CountrySwitzerland
    B.5.6E-mailglobal.rochegenentechtrials@roche.com
    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 nameCrossMab Ang-2/VEGF
    D.3.2Product code 552-0985/F02-01
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeRO5520985
    D.3.9.3Other descriptive nameRO5520985
    D.3.9.4EV Substance CodeSUB76433
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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 No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 Yes
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Avastin
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Limited
    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.3.1Product nameAvastin
    D.3.2Product code RO487-6646/F02-02
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    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 INNBEVACIZUMAB
    D.3.9.1CAS number 216974-75-3
    D.3.9.2Current sponsor codeRO4876646
    D.3.9.4EV Substance CodeSUB16402MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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 No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 Yes
    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
    Patients with cancer of the colon or rectum where the tumor has already spread to other organs(s),
    E.1.1.1Medical condition in easily understood language
    Patients with cancer of the colon or rectum where the tumor has already spread to other organs(s),
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level PT
    E.1.2Classification code 10052358
    E.1.2Term Colorectal cancer metastatic
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level PT
    E.1.2Classification code 10055097
    E.1.2Term Rectal cancer metastatic
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level PT
    E.1.2Classification code 10055114
    E.1.2Term Colon cancer metastatic
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of Study BP29262 is to estimate the efficacy of RO5520985 in combination with oxaliplatin, folinic acid, and 5 fluorouracil (mFOLFOX-6) vs. bevacizumab in combination with mFOLFOX-6, as measured by progression-free survival (PFS).
    E.2.2Secondary objectives of the trial
    •Evaluate the safety and tolerability of RO5520985 in combination with mFOLFOX-6
    •Estimate the efficacy of RO5520985 in combination with mFOLFOX-6, as measured by overall survival, objective response rate, and duration of objective response
    •Characterize the pharmacokinetics of RO5520985 when combined with mFOLFOX-6
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Histologically or cytologically confirmed mCRC not amenable to
    potentially curative resection with at least one measurable metastatic
    lesion, as defined by RECIST v1.1
    a)Results of local RAS mutational analysis must be available for
    stratified randomization
    b)Representative tumor specimens in FFPE blocks (preferred) or slides
    must be available for central extended RAS mutational analysis testing
    2.Signed written informed consent, obtained prior to any screening
    procedure
    3.Age> 18 years
    4.ECOG (WHO) performance status of 0 or 1
    5.Adequate hematologic, liver, renal, coagulation and cardiovascular
    function
    6.Recovery from all reversible adverse events of previous medical
    therapies to baseline or NCI CTCAE Grade 1, except for alopecia (any
    grade)
    7.Negative serum pregnancy test within 7 days prior to starting study
    treatment in premenopausal women and women < 2 years after the
    onset of menopause
    E.4Principal exclusion criteria
    1.Any prior systemic therapy (including chemotherapy, antibody therapy, tyrosine kinase inhibitors, immunotherapy, hormonal therapy) before Day 1 of Cycle 1 for treatment of mCRC
    Patients who received prior systemic adjuvant therapy or radiotherapy for CRC are not excluded if the time interval from last administration of adjuvant therapy until disease progression is > 12 months
    2.Radiotherapy within 28 days and abdominal/ pelvic radiotherapy
    within 60 days prior to Day 1 of Cycle 1, except palliative radiotherapy to bone lesions within 7 days prior to Day 1 of Cycle 1
    3.Symptomatic CNS metastases or carcinomatous meningitis:
    4.Significant cardiovascular or cerebrovascular disease within 6 months prior to Day 1 of Cycle 1
    5.Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation)
    6.Current use of anticoagulants (e.g., warfarin or any other coumadin-derivate coagulants) at therapeutic doses within 7 days prior to study drug administration. Prophylactic use of unfractioned heparin or low molecular weight heparin (LMWH) is permitted (e.g., enoxaparin 40 mg QD)
    7.Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 1, or anticipation of need for major surgical procedure during the course of the study or nonrecovery from side effects of any such procedure
    8.History of abdominal or tracheo-oesophageal fistula or GI perforation or intra abdominal abscess within 6 months prior to Day 1
    9.Clinical signs or symptoms of GI obstruction or a requirement for routine parenteral hydration, parenteral nutrition, or tube feeding
    10.Evidence of abdominal free air not explained by paracentesis or recent surgical procedure
    11.History of bronchopulmonary hemorrhage NCI CTCAE > Grade 2 within 2 months prior to randomization
    12.Severe, nonhealing or dehiscing wound, active ulcer, or untreated bone fracture
    13.Known dihydropyrimidine dehydrogenase deficiency or thymidylate synthase gene polymorphism predisposing the patient for 5 FU toxicity
    14.History of intra-abdominal inflammatory process within 6 months
    prior to Day 1 of Cycle 1, including but not limited to peptic ulcer
    disease, diverticulitis,or colitis.
    15. Colonic prosthesis (stent) implant in place.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint for Study BP29262 is progression-free survival (PFS), defined as the time from randomization to the date of first documented occurrence of progression based on RECIST v1.1 criteria as determined by the Investigator or death from any cause on study, whichever occurs first.
    E.5.1.1Timepoint(s) of evaluation of this end point
    endpoint Tumor assessments will be performed every 8 (+/-1) weeks acc. RECIST 1.1.
    E.5.2Secondary end point(s)
    Secondary Efficacy End Points •Objective response rate (ORR). Objective response rate is defined as the rate of patients with an objective tumor response, i.e. partial response (PR) or complete response (CR) as determined by the Investigator using RECIST v1.1 criteria on two consecutive occasions at least 4 weeks apart
    •Duration of response, defined as the first occurrence of a documented objective response until the time of progression or death from any cause on study
    •Overall Survival, defined as the time from randomization until death from any cause
    Secondary Safety End Points
    •Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
    •Changes in hematology, biochemistry, coagulation, specifically those associated with vascular and renal function
    •Physical examinations (including ECOG), vital signs and ECG
    •Incidence and titers of human anti-human antibodies (HAHAs)
    •Adverse events leading to RO5520985, bevacizumab, or chemotherapy discontinuation
    •Incidence of the following selected adverse events according to NCI CTCAE, v4.03:
    Arterial hypertension (Grade 3)
    Proteinuria (Grade 3)
    Arterial thromboembolic events (any grade)
    Venous thromboembolic events (Grade 3)
    Vascular disorder - other: Thrombotic microangiopathy (any grade)
    Gastrointestinal perforation (any grade)
    Fistula involving an internal organ (any grade)
    Fistulae (Grade 4)
    Wound dehiscence/complication (Grade 3)
    Bleeding/hemorrhage (Grade 3)
    Pulmonary bleeding (Grade 2)
    CNS bleeding (Grade 2)
    Congestive heart failure (Grade 3)
    Reversible posterior leukoencephalopathy syndrome (any grade)
    Secondary PK End Points :
    •The PK profile of RO5520985 will be characterized with the plasma concentration time data following IV administration of RO5520985, and will include the following parameters: Cmax, Cmin, Tmax, t1/2, AUC, AUC, CL, Vss, accumulation ratio (RA)
    •The PK profiles of oxaliplatin (free and total) and 5-FU will be characterized with the plasma concentration-time data following IV administration of FOLFOX, and will include the following parameters: Cmax, Cmin, Tmax, t1/2, AUC (when applicable)
    •Additional PK parameters may be evaluated as appropriate
    E.5.2.1Timepoint(s) of evaluation of this end point
    Please see Schedule of assessment for the different timepoints of safety, PK and efficacy measurements.
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Folfox
    E.8.2.4Number of treatment arms in the trial2
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA25
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Austria
    Belgium
    Canada
    France
    Italy
    Spain
    United Kingdom
    United States
    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 study will formally end once the survival follow-up is complete or the last patient has completed the EoS Visit or is withdrawn from the study prior to that time (whichever occurs last), but may be prematurely terminated by the Sponsor.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months6
    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 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.1.2.1Number of subjects for this age range: 150
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 110
    F.4.2.2In the whole clinical trial 190
    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)
    All patients, also in case of early discontinuation, will attend a safety visit 21 ( > 7) days after receiving the last administration of RO5520985, which is the End of Study (EoS) Visit. Patients off study will receive standard of care for the stage of their disease.
    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 Decision2014-06-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-11-03
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2017-02-01
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