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    Summary
    EudraCT Number:2012-002841-39
    Sponsor's Protocol Code Number:GINECO-OV-222
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-06-28
    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 ConcernedGermany - PEI
    A.2EudraCT number2012-002841-39
    A.3Full title of the trial
    A randomized, open label, phase II trial of bevacizumab plus weekly paclitaxel followed by bevacizumab monotherapy maintenance versus weekly paclitaxel followed by observation in patients with relapsed ovarian sex-cord stromal tumours
    Eine randomisierte, offene klinische Prüfung der Phase II mit Bevacizumab und wöchentlich verabreichtem Paclitaxel gefolgt von einer Bevacizumab-Monotherapie als Erhaltungstherapie im Vergleich zu wöchentlich verabreichtem Paclitaxel gefolgt von einer Nachbeobachtung bei Patientinnen mit rezidiviertem Keimstrangstroma-Tumor der Ovarien.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluation of efficacy and safety of bevacizumab (Avastin®) combined to weekly paclitaxel followed by bevacizumab (Avastin®) alone versus weekly paclitaxel followed by observation in patients with relapsed ovarian sex-cord stromal tumours
    Beurteilung der Wirksamkeit und Sicherheit von Bevacizumab (Avastin®) kombiniert mit wöchentlich verabreichtem Paclitaxel gefolgt von Bevacizumab (Avastin®) allein im Vergleich zu wöchentlich verabreichtem Paclitaxel gefolgt von einer Nachbeobachtung bei Patientinnen mit mit rezidiviertem Keimstrangstroma-Tumor der Ovarien.
    A.3.2Name or abbreviated title of the trial where available
    ALIENOR
    A.4.1Sponsor's protocol code numberGINECO-OV-222
    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 SponsorARCAGY GINECO
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportROCHE Pharma AG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAGO Research GmbH
    B.5.2Functional name of contact pointAndrea Zanuzzi
    B.5.3 Address:
    B.5.3.1Street AddressMoltkeplatz 63
    B.5.3.2Town/ cityEssen
    B.5.3.3Post code45138
    B.5.3.4CountryGermany
    B.5.4Telephone number004920195981216
    B.5.5Fax number004920195981221
    B.5.6E-mailazanuzzi@ago-ovar.de
    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 Avastin®
    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.3.1Product nameBevacizumab
    D.3.2Product code Ro 487-6646
    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 codeRo 487-6646
    D.3.9.3Other descriptive namerhuMab, VEGF, anti-VEGF
    D.3.9.4EV Substance CodeSUB16402MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400
    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 Yes
    D.3.11.13.1Other medicinal product typeRecombinant humanized monoclonal antibody
    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 an histologically confirmed diagnosis of ovarian sex-cord stromal tumor in relapse after a platinum-based chemotherapy.
    Patientinnen mit einer histologisch gesicherten Diagnose des Keimstrangstroma-Tumors der Ovarien mit Progress nach einer platin-haltigen Chemotherapie.
    E.1.1.1Medical condition in easily understood language
    Patients diagnosed with a rare tumor (ovarian sex-cord stromal tumor) in relapse after a platinum-based chemotherapy.
    Patientinnen, bei denen ein seltener Tumor (Keimstrangstroma-Tumor der Ovarien) diagnositiziert wurde, mit einem Progress nach einer platin-haltigen Chemotherapie.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10033128
    E.1.2Term Ovarian cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the clinical benefit of combining bevacizumab long-term treatment to weekly paclitaxel measured by the non-progression rate after 6 months of treatment
    E.2.2Secondary objectives of the trial
    •The Progression-Free survival
    •The Overall Survival
    •The Objective Response Rate measured with the number of radiological responses defined as PR or CR
    •The duration of response
    •To describe the safety profile of the association paclitaxel + bevacizumab and of bevacizumab long-term maintenance monotherapy. The safety profiles will be defined by the number of patients with adverse events (AE) any type and any grade using the NCI-CTC AE scale version 4.0
    •In arm A, to evaluate progression-free survival after introduction of bevacizumab at progression during the surveillance period.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    I1.Female aged >= 18 years at inclusion
    I2.Histologically confirmed diagnosis of ovarian SCST including the following cell types: granulosa cell tumors (adults and juveniles types), granulosa cell theca cell tumor, Sertoli-Leydig cell tumors, malignant steroïd cell tumors, gynandroblastoma, unclassified SCST and mixed tumors
    I3.Documented relapse of SCST defined by progression of disease (radiologic, clinic or biological progression)
    I4.At least one measurable site of disease as defined by RECIST 1.1
    -Tumors within a previously irradiated field will be designated as “non-target” lesions unless progression is documented or a biopsy is obtained to confirm persistence > 90 days following completion of radiotherapy.
    I5.Patients must have been pre-treated with at least 1 prior line of platinum based chemotherapy
    I6.Adequate bone marrow, liver and renal functions including the following:
    •Absolute neutrophil count ≥ 1.5 G/L, platelet count ≥ 100 G/L, and hemoglobin ≥ 9 g/dL. Prior transfusion is authorized to keep haemoglobin level to ≥9g/dL
    •AST/ALT ≤ 3 x upper limit of normal (ULN) (or ≤ 5.0 ULN if liver metastasis) and total bilirubin ≤ 1.5 ULN
    •Serum creatinine ≤ 1.5 ULN or calculated creatinine clearance ≥ 50 mL/min according to Cockcroft formula (or to MDRD formula for patients older than 65 years-old).
    I7.Adequate coagulation panel:
    •PT ≤ 1.2 ULN
    •aPTT ≤ 1.5 ULN
    •INR ≤ 1.5 ULN
    I8.Adequate neurologic function: only neuropathy (sensory and motor) grade ≤ 1 (CTCAE v4.0) are allowed
    I9.ECOG Performance status of 0, 1, or 2
    I10.Life expectancy ≥ 4 months
    I11.Satisfactory cardiac function defined as no history of cardiac insufficiency.
    I12.Ability to understand and sign informed consent and willingness to comply with the study procedures before study entry
    I13.Women of childbearing potential* are required to have a negative serum pregnancy test within 7 days prior to study treatment initiation (i.e. Cycle 1 Day 1)
    *: Female patients who meet at least one of the following criteria are defined as women of non-childbearing potential:
    •≥ 50 years old and naturally amenorrheic for ≥ 1 year
    •Permanent premature ovarian failure confirmed by a specialist gynaecologist
    •Previous bilateral salpingo- oopherectomy or hysterectomyoophrectomy
    •XY genotype, Turner’s syndrome, or uterine agenesis
    •Female patient who do not meet at least of the above criteria are defined as women of childbearing potential
    I14.Willingness to use adequate contraceptive method during the whole study period and for up to 6 months after the last treatment intake
    I15.Covered by a medical insurance (in country where applicable)
    E.4Principal exclusion criteria
    E1.Prior systemic therapy with bevacizumab
    E2.Active peripheral neuropathy ≥ grade 2 (NCI-CTCAE v4.0)
    E3.Prior history of other malignancies other than ovarian SCST (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix) unless the subjects has been free of the disease for at least 3 years or 5 years for breast cancer
    E4.No resolution of specific toxicities related to any prior anti-cancer therapy to grade ≤1, excluding alopecia, according to the NCI-CTCAE v.4.0
    E5.History or evidence of thrombotic or hemorrhagic disorders, including cerebro-vascular accident/stroke or transient ischemic attack or sub-arachnoids’ haemorrhage within 6 months prior to first dose of study drugs.
    E6.Uncontrolled arterial hypertension (systolic ≥ 150 mmHg or diastolic ≥ 100 mmHg) despite optimal antihypertensive therapy or clinically significant cardiovascular disease including one of the following:
    •Myocardial infarction or instable angina within 6 months prior to first dose of study drugs
    •NYHA grade ≥ II congestive heart failure
    •Serious cardiac arrhythmia requiring medication
    •Peripheral vascular disease ≥ grade 3
    E7.History of bowel obstruction, including sub-occlusive syndrome and history of abdominal fistula, gastro-intestinal perforation or intra-abdominal abscess during the year prior to inclusion
    E8.Prior treatments:
    •Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study inclusion
    •Current or recent treatment with another investigational drug within 30 days of first study treatment dosing or within 6 weeks in case of prior nitrozo-urea and or mitomycin C treatment. In case of hormonotherapy , patients will be eligible if hormonotherapy is discontinued within at least 1 week before treatment initiation
    •Current or recent (within 10 days prior to randomization) chronic use of aspirin
    •> 325 mg/day for use of any other inhibitor of platelet aggregation
    •Chronic treatment (i.e. > 15 days) with non steroids anti-inflammatory agents unless a washout period of 15 days was observed before the inclusion.
    • Intake of granulocyte growth factor within 3 weeks before study entry
    E9. Treatment during the study:
    • Debulking surgery prior to disease progression is not foreseen
    • Concurrent radiotherapy during the study treatment
    E10.Presence of hematuria and proteinuria ≥ 2+ (urine dipstick). Patients with ≥ 2+ proteinuria on dipstick at screening should undergo a 24-hour urine collection and will be eligible only if 24-h proteinuria ≤ 1 g
    E11.Untreated evolutive brain metastases
    E12.Active bacteria or fungal infection (grade ≥2, CTC AE V4.0)
    E13.Known HIV1, HIV2 or chronic hepatitis B or C infection
    E14.Hypersensitivity to Chinese hamster ovary (CHO) cell products or other recombinant human or humanized antibodies
    E15.Any contraindications to paclitaxel treatment: for example severe hypersensitivity reactions to paclitaxel, macrogolglycerol ricinoleate (polyoxyl castor oil) or to any of the excipients (Ethanol Citric acid) (refer to Taxol® SPC for further details)
    E.5 End points
    E.5.1Primary end point(s)
    The 6-month non progression rate will be summarized by treatment arm by a proportion together with its 95% confidence interval. It will be compared between the two arms using a Fisher exact test.
    E.5.1.1Timepoint(s) of evaluation of this end point
    After 6 months of chemotherapy +/- bavacizumab
    E.5.2Secondary end point(s)
    Progression-free survival (PFS) will be measured from the date of randomization to the date of event defined as the first documented progression or death due to any cause. Patients with no event at the time of the analysis will be censored at the date of the last adequate tumour assessment. PFS will be estimated using the Kaplan-Meier method. patients with adverse events (AE) any type and any grade using the NCI-CTC AE scale version 4.0

    Overall survival (OS) will be measured from the date of randomization to the date of death or the date of last contact (censored data) and will be estimated using the Kaplan-Meier method.
    Median OS will be presented in each treatment arm with its 95% confidence interval. Survival curves will be compared using the log-rank test.

    The objective response rate (complete or partial response) will be presented in each treatment arm by a proportion together with its 95% confidence interval and will be compared between the two arms using a Fisher exact test.

    Duration of response will apply only to patients with an objective tumour response. It will be measured from the date of documented objective response to the date of event defined as the first documented progression or death due to underlying disease. Patients with no event at the time of the analysis will be censored at the date of last adequate tumour assessment. Duration of response will be described in each treatment arm and compared between the two arms using a non parametric Wilcoxon test.

    Safety analyses will be based mainly on the frequency of adverse events based on the common toxicity criteria (CTC-V3) grade. Descriptive statistics will be provided for characterizing and assessing patient tolerance to bevacizumab. Adverse events will be coded according to the MedDRA®.
    .
    E.5.2.1Timepoint(s) of evaluation of this end point
    In each treatment arm, PFS rate will be evaluated at 6 months,
    OS evaluation after 54 months
    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 No
    E.6.7Pharmacodynamic No
    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 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
    Paclitaxel as standard of care given in the 2 arms
    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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA50
    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
    Belgium
    Denmark
    Finland
    France
    Germany
    Italy
    Japan
    Netherlands
    Norway
    Spain
    Sweden
    United Kingdom
    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 study period will include a first treatment period of chemotherapy for 6 months followed by a second period of surveillance (Arm A) or bevacizumab maintenance therapy (Arm B) for a maximum of 1 year. Follow-up will be performed for a maximum of 36 months after maintenance treatment.

    The end of the trial is the last visit of the last subject undergoing the trial
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    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 years4
    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: 60
    F.1.3Elderly (>=65 years) No
    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 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 45
    F.4.2.2In the whole clinical trial 60
    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)
    The standard of care in prectice at the investigator site
    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 Decision2013-10-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-10-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-04-28
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