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    Summary
    EudraCT Number:2007-003984-33
    Sponsor's Protocol Code Number:206OC201
    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:2007-12-10
    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 number2007-003984-33
    A.3Full title of the trial
    A Phase 2, Single-Arm Study of Volociximab Monotherapy in Subjects With Platinum-Resistant Advanced Epithelial Ovarian Cancer or Primary Peritoneal Cancer
    A.4.1Sponsor's protocol code number206OC201
    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 SponsorBiogen Idec Limited
    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 nameVolociximab
    D.3.2Product code M200
    D.3.4Pharmaceutical form Concentrate for solution 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 INNVolociximab
    D.3.9.1CAS number 558480-40-3
    D.3.9.2Current sponsor codeM200
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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) 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) Yes
    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
    Platinum-Resistant Advanced Epithelial Ovarian Cancer or Primary Peritoneal 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 10052171
    E.1.2Term Peritoneal carcinoma
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10061328
    E.1.2Term Ovarian epithelial cancer
    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 efficacy of volociximab when administered at 15 mg/kg per week in subjects with platinum-resistant, advanced epithelial ovarian cancer or primary peritoneal cancer.
    E.2.2Secondary objectives of the trial
    -To evaluate the safety and tolerability of volociximab when administered at 15mg/kg per week.
    -To evaluate the pharmacokinetics (PK) of volociximab when administered at 15mg/kg per week
    -To evaluate the pharmacodynamic activity and mechanism of action of volociximab using multiple biologic assessments including studies of serum and whole blood proteins and cellular biomarkers
    -To investigate the potential relationship between tumour expressions of alpha5beta1 or other relevant markers and clinical response to volociximab.
    -To measure the concentration of volociximab and protein markers in ascitic fluid obtained from subjects in whom paracentesis can be safely performed and to evaluate potential correlations with clinical outcomes.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Must give written informed consent and any authorizations required by local law.
    2. Females aged at least 18 years old at the time of informed consent.
    3. Advanced (Stage III or IV), histologically-documented epithelial ovarian cancer or primary peritoneal cancer (excluding small, round-cell histologies).
    4. Radiologically-documented evidence of progressive disease.
    5. Platinum-resistant disease defined as having a best response of SD or disease progression during or within 6 months of discontinuing a platinum-based chemotherapy (carboplatinum, cisplatinum, or another organoplatinum compound).
    6. Progression during or following treatment with topotecan or liposomal doxorubicin.
    7. 3 or fewer prior chemotherapy regimens (including a platinum-based therapy).
    8. At least 1 measurable target lesion in accordance with RECIST criteria to assess clinical response (tumors within a previously irradiated field are designated as non-target).
    9. ECOG Performance Status < or = 1.
    10. Life expectancy >12 weeks.
    11. Available paraffin block or unstained paraffin sections on glass slides containing representative tumor tissue from the most recent tumor biopsy/resection.
    12. Subjects of child-bearing potential must be willing to practice effective contraception during the study and be willing and able to continue contraception for at least 6 months after their last dose of study treatment (about 5 half lives). Acceptable methods of contraception include any of the following: oral, depot, or injectable contraceptives; intrauterine devices (IUDs); NuvaRing®; birth control patch, or double-barrier contraception. Double-barrier contraception must consist of 2 of the following: condom, female condom, diaphragm, cap, shield, sponge, spermicide. The only exceptions to contraception are: subject is postmenopausal for at least 1 year before Study Day 1, subject abstains from sexual intercourse, subject or partner is surgically sterile (i.e., no uterus or no ovaries. Note: subjects who have their fallopian tubes ligated are not considered surgically sterile.)
    E.4Principal exclusion criteria
    1. Screening clinical laboratory values:
    a) Absolute neutrophil count <1500/uL
    b) Platelet count <75,000/uL
    c) Hemoglobin <8.5 g/dL (hemoglobin may be supported by transfusion, erythropoietin, or other approved hematopoietic growth factors; darbopoeitin [Aranesp®] is permitted)
    d) Serum bilirubin >2.0 x upper limit of normal (ULN)
    e) AST and ALT >2.5 x ULN (AST and ALT >5 x ULN for subjects with liver metastasis)
    f) Serum creatinine >2.0 mg/dL
    g) International normalized ratio (INR) >1.5
    h) Activated partial thromboplastin time (aPTT) >1.5 x ULN
    2. Clinically significant peripheral vascular disease.
    3. Non-epithelial ovarian tumors.
    4. Active infection requiring systemic antibiotics, antivirals, or antifungals including HIV/AIDS, hepatitis B, or hepatitis C infection.
    5. History of abdominal fistula, gastrointestinal (GI) perforation, or intra-abdominal abscess within 6 months prior to Day 1.
    6. Serious, non-healing wound, or bone fracture.
    7. Known central nervous system or brain metastases.
    8. History of uncontrolled psychiatric condition within 6 months prior to Day 1.
    9. History of other malignancies within 3 years of Day 1, except for adequately treated carcinoma in situ of the cervix, ductal carcinoma in situ (DCIS) of breast, or basal or squamous cell skin cancer.
    10. Evidence of autoimmune disease including, but not limited to, ulcerative colitis, Crohn’s disease, rheumatoid arthritis (RA), systemic lupus erythematosus (SLE) sceloderma, or another diseases in which immune function or immune competence is known to be impaired.
    11. Any history of lymphoproliferative disorder.
    12. Known human anti-murine antibody (HAMA) and/or human anti-chimeric antibody (HACA).
    13. Any medical condition that may be exacerbated by bleeding, including a known bleeding disorder such as a coagulation defect, thrombocytopenia, active gastric or duodenal ulcer, or history of GI bleeding.
    14. Significant hemoptysis within one year prior to Study Day 1.
    15. Any investigational, anti-cancer therapy within 6 weeks prior to Day 1.
    16. Any non-investigational, anti-cancer therapy within 4 weeks prior to Day 1.
    17. Prior treatment with anti-angiogenic agents.
    18. Subjects who require treatment with an anti-coagulant with the exception of low-dose warfarin (< or = 1 mg/day) or heparin for IV catheter patency. (Note: Acetylsalicylic acid and non-steroidal anti-inflammatory drugs are permitted).
    19. Subjects who are taking concomitant immunomodulatory agents including, but not limited to, interferons, interleukins, systemic steroids, cyclosporine, tacrolimus, calcineurin inhibitors, chronic low-dose methotrexate, or azathioprine. (The use of inhaled or intranasal steroids or oral steroids at a dose of < or = 10 mg/day prednisone or its equivalent are permitted.)
    20. Active, unstable severe cardiovascular disease, including poorly controlled angina, congestive heart failure (CHF), arrhythmias, myocardial infarction (MI), cardiomyopathy, atrioventricular (AV) block, electrocardiogram (ECG) evidence of acute ischemia, or significant conduction abnormality.
    21. History of thromboembolic or cerebrovascular events, such as stroke, or transient ischemic attack (TIA). (Note: Prior history of deep vein thrombosis will not exclude subjects from participating in this study.)
    22. Pregnant (positive pregnancy test) or lactating.
    23. Inability to comply with study and follow-up procedures.
    24. Any condition that, in the opinion of the Investigator, makes the subject unsuitable for study participation.
    25. Known hypersensitivity to murine or chimeric antibodies.
    26. Major surgery within 4 weeks prior to Day 1.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is ORR, defined as the proportion of subjects who have achieved a CR or PR.
    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 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 No
    E.8.1.1Randomised No
    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 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 No
    E.8.5.1Number of sites anticipated in the EEA1
    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 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
    When the last subject has completed their end of treatment visit or the last subject has completed 3 months of treatment, whichever occurs first.
    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
    E.8.9.2In all countries concerned by the trial years2
    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 No
    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 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 state
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 56
    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)
    After the end of treatment visit, subjects will be followed at 3-month intervals for the first year and every 6 months thereafter.
    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 Decision2008-01-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-01-21
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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