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    The EU Clinical Trials Register currently displays   43846   clinical trials with a EudraCT protocol, of which   7282   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2010-024077-39
    Sponsor's Protocol Code Number:55092
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-09-30
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2010-024077-39
    A.3Full title of the trial
    Phase IB-II, open label, multicentre feasibility study of pazopanib in combination with Paclitaxel and Carboplatin in patients with platinumrefractory/ resistant ovarian, fallopian tube or peritoneal carcinoma.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase IB-II, open label, multicentre feasibility study of pazopanib in combination with Paclitaxel and Carboplatin in patients with platinumrefractory/ resistant ovarian, fallopian tube or peritoneal carcinoma.
    A.4.1Sponsor's protocol code number55092
    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 SponsorEuropean Organisation for Research and Treatment of Cancer
    B.1.3.4CountryBelgium
    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 supportNovartis
    B.4.2CountryUnited Kingdom
    B.4.1Name of organisation providing supportEORTC
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEuropean Organisation for Research and Treatment of Cancer
    B.5.2Functional name of contact pointHead Clinical Operations Dpt
    B.5.3 Address:
    B.5.3.1Street AddressAvenue E. Mounier, 83/11
    B.5.3.2Town/ cityBrussels
    B.5.3.3Post code1200
    B.5.3.4CountryBelgium
    B.5.4Telephone number3227741015
    B.5.5Fax number3227723545
    B.5.6E-maileortc@eortc.be
    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 Votrient
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis
    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 namePazopanib
    D.3.2Product code GW786034
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    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 INNPAZOPANIB
    D.3.9.1CAS number 444731-52-6
    D.3.9.4EV Substance CodeSUB29175
    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) 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 No
    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 platinum resistant ovarian, fallopian tube or peritoneal carcinoma.
    E.1.1.1Medical condition in easily understood language
    Patients with platinum resistant ovarian, fallopian tube or peritoneal carcinoma.
    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 10066697
    E.1.2Term Ovarian cancer recurrent
    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
    Phase Ib:
    -establish the optimum dose for Pazopanib in combination with paclitaxel and carboplatin given weekly in a group of patients with platinum-refractory or -resistant ovarian, fallopian tube or peritoneal carcinoma. In order to achieve this, the study will
    determine the maximum tolerated dose (MTD) based on the documentation of the dose limiting toxicity (DLT).
    Phase II:
    - determine the progression free survival (PFS) according to the RECIST 1.1 of the combination of Pazopanib with weekly paclitaxel and carboplatin in platinum resistant ovarian, fallopian tube or peritoneal carcinoma.
    E.2.2Secondary objectives of the trial
    Phase Ib:
    - evaluate safety and adverse event profiles.
    - characterize the Pharmacokinetics (PK) of Pazopanib and chemotherapies using intensive sampling.
    - determine if there is PK interaction (and if so, what kind of PK interaction) between Carboplatin
    and Paclitaxel as well as Pazopanib.
    - evaluate the response rate (RR)
    - determine and evaluate predictive biomarkers
    Phase II:
    - evaluate the response rate (RR), overall survival (OS) and progression free survival (PFS).
    - determine and evaluate predictive biomarkers.
    - evaluate safety and adverse event profiles.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Female subjects of age 18 years or older
    - Histologically confirmed diagnosis of ovarian, fallopian tube, or
    peritoneal carcinoma with recurrent disease
    - All patients with at least one earlier platinum treatment can be
    included but should be resistant. There is no restriction on the number of prior lines. Non-platinum treatment after proven
    platinum-resistance disease is allowed.
    Platinum-resistant cancer is defined as disease that responded to platinum-based chemotherapy but with documented recurrence between 28 days and 6 months after completing this therapy
    - Evaluable (measurable or non-measurable) disease by RECIST version 1.1 (CT or MRI from thorax, abdomen and pelvis: within 3 weeks before randomization)
    - Patient must be able to receive the infusions (paclitaxel, carboplatin, bevacizumab) and swallow the tablets (pazopanib)
    -WHO Performance status must be ≤ 2
    -LVEF assessed by ECHO or MUGA scan of the heart > 50%, if clinically indicated
    -Adequate organ function as defined in the table in the protocol on the page 19
    -Patients with childbearing potential should have a negative serum
    pregnancy test, within 1 week before first day of treatment and use
    effective contraceptive methods for the whole duration of the study and for 6 months after discontinuing treatment.
    -Patients who are lactating should discontinue nursing prior to the first dose
    -Patients must be able and willing to discontinue use of prohibited
    medications for at least 14 days (28 days for drugs with a longer half-life) prior to the first dose of study drug and for the duration of the study
    -Before patient registration/randomization, written informed consent must be given according to ICH/GCP, and national/local regulations
    E.4Principal exclusion criteria
    -Patients with prior treatment for recurrence with weekly paclitaxel (with/without weekly carboplatin).
    -Prior Bevacizumab treatment is allowedKnown metastatic disease to the brain or leptomeninges.
    -Other prior malignancies treated primarily or for recurrence within 2
    years prior to inclusion in this study, except for completely resected non-melanomatous skin carcinoma or successfully treated in situ carcinoma of the skin or cervix of the uterus.
    - Treatment with any of the following anti-cancer therapies:
    •Radiation therapy, surgery or tumor embolization within 14 days prior to the first dose of study drug
    •Prior radiation to the pelvis
    •Chemotherapy, immunotherapy, biologic therapy, investigational therapy or hormonal therapy within 14 days (28 days for drugs with a longer half-life) prior to the first dose of study drug. -Patients with ongoing toxicity from prior anti-cancer therapy that is > Grade 1 and/or that is progressing in severity, except alopecia and ≤ Grade 2 peripheral neuropathy.
    -Patients with known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs similar or related to paclitaxel, carboplatin, bevacizumab and pazopanib. Mild infusion related reaction to carboplatin are allowed (e.g. hot flushing, rash, pruritus without bronchospasm nor shortness of breath nor changes in blood pressure requiring treatment).
    -Patients with unstable or serious condition e.g. uncontrolled infection requiring systemic therapy.
    -Prior major surgery (including open but not core biopsy) or trauma within 28 days prior to the first dose of study drug and/or presence of any non-healing or dehiscing wound, untreated bone, fracture, or ulcer.
    -History of any of the following cardiovascular conditions within 6 months prior to randomization: cardiac angioplasty or stenting, myocardial infarction, unstable angina, coronary artery bypass graft surgery, symptomatic peripheral vascular disease, Class II or greater congestive heart failure, as defined by the NYHA. - Inadequately controlled hypertension (defined as systolic blood pressure > 150 mm Hg and/or diastolic blood pressure > 100 mm Hg despite intensive medical management) or prior history of hypertensive crisis or hypertensive encephalopathy. Anti-hypertensive therapy is allowed. Initiation or adjustment of blood pressure medication is permitted prior to the study entry.
    -Prolonged corrected QT interval (QTc) defined as >480 msecs usingBazett's formula.
    - History of cerebrovascular accident including transient ischemic attack (TIA), pulmonary embolism, untreated deep venous thrombosis (DVT), aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis within 6 months prior to randomization. Note: Subjects with recent DVT who have been treated with therapeutic anti-coagulating agents for at least 6 weeks are eligible.
    -Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation) and no current or recent (within 10 days prior to randomization) use of dipyridamole, ticlopidine, clopidogrel, cilostazol, prasugrel, or ticagrelor; or use of full-dose oral or parenteral anticoagulants or thrombolytic agents for therapeutic (as opposed to prophylactic) purpose
    •Prophylactic anticoagulation for the patency of venous access devices is allowed, provided the activity of the agent results in PT or an INR < 1.5 × ULN and aPTT is within normal limits within 1 week prior to randomization.
    •Prophylactic or therapeutic use of low molecular-weight heparin (e.g., enoxaparin) is allowed. -Obvious signs of, or risks for gastrointestinal fistula formation or perforation, such as
    •History of abdominal or tracheoesophageal fistula or gastrointestinal perforation within 6 months prior to randomization
    •Clinical signs or symptoms of gastrointestinal obstruction or requirement for routine parenteral hydration, parenteral nutrition, or tube feeding
    •History of bowel obstruction (excluding postoperative (i.e. within 4 weeks post-surgery)) during the whole prior history of the patient, or other GI condition with increased risk of perforation such as clear infiltration into the rectosigmoid, colon or small bowel.
    - Clinically significant gastro-intestinal tract abnormalities that may increase the risk for GI bleeding including but not limited to: active peptic ulcer disease, known intraluminal metastatic lesion/s with risk of bleeding, inflammatory bowel disease (e.g. ulcerative colitis, Crohn's disease).
    -Clinically significant gastrointestinal abnormalities that may affect absorption of investigational product including, but not limited to: malabsorption syndrome, major resection of stomach or small bowel.
    -Clinically significant evidence of tumor invading up to the mucosa of the GI tract (esophagus, stomach, small or large bowel, rectum or anus).
    -Known endobronchial lesions and/or lesions infiltrating major pulmonary vessels.
    E.5 End points
    E.5.1Primary end point(s)
    Phase Ib part (dose escalation):
    - document the dose limiting toxicity (DLT) within the first 6 weeks (at the end of week 3 and week 6) to identify the MTD for pazopanib and weekly paclitaxel/carboplatin.

    Phase II part:
    - Progression Free Survival (PFS) defined by RECIST 1.1 at 1 year.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Phase Ib: end of week 3 and end of week 6

    Phase II: 1 year
    E.5.2Secondary end point(s)
    Phase Ib part
    -PK data of paclitaxel, carboplatin and pazopanib
    -Safety and tolerability of the combination, according to CTCAE 4.0
    -Response Rate (RR)
    -Predictive biomarkers

    Phase II
    -Response Rate
    -Overall Survival
    -PFS
    -Safety and tolerability of the combination, according to CTCAE 4.0
    -Predictive biomarkers
    -Age related sub-analysis for toxicity and efficacy (cut-off 65 years)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Phase Ib
    •PK – day 1 and 22
    •Safety … – weekly during trt; 3 monthly during yrs 1-2 and 6 monthly
    during years 3-5.
    •RR within 2 wks before rando; within 2 wks before tmt course 10; every 3 mths until progr during yrs 1-2 and every 6 mths until progr during years 3-5.
    •biomarkers – within 2 weeks before rando, during course 4 and 12

    Phase II
    •RR/OS/PFS – within 2 wks before rando; within 2 wks before tmt
    course 10; within 2-4 weeks after end of tmt; every 3 mths until progr during yrs 1-2 and every 6 mths until progr during years 3-5
    •Safety … – see Ib.
    •biomarkers – see Ib.
    •Age – collected as safety and RR, OS, PFS endpoints.
    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 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) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    dose escalation
    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 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 No
    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 EEA10
    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 No
    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
    End of tiral occurs when all of the following criteria have been satisfied:
    1. Thirty days after all patients have stopped protocol treatment
    2. The trial is mature for the analysis of the primary endpoint as defined in the protocol
    3. The database has been fully cleaned and frozen for this analysis
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years7
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years7
    E.8.9.2In all countries concerned by the trial months3
    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: 80
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 8
    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 88
    F.4.2.2In the whole clinical trial 88
    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)
    At discretion of the treating physician and in the patient's best interest.
    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 Decision2011-10-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-05-18
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-07-13
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