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    The EU Clinical Trials Register currently displays   43843   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:2016-001755-45
    Sponsor's Protocol Code Number:OX4325
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2016-08-18
    Trial 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 - BfArM
    A.2EudraCT number2016-001755-45
    A.3Full title of the trial
    FOCUS: A Multicenter, Multinational, Double-blind, 2-Arm, Randomized, Phase 2/3, Study of Physician’s Choice Chemotherapy (PCC) (Weekly Paclitaxel or Pegylated Liposomal Doxorubicin [PLD]) Plus Bevacizumab and CA4P Versus PCC Plus Bevacizumab and Placebo for Subjects with Platinum-Resistant, Recurrent, Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Cancer
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    FOCUS: A multicenter, multinational clinical study in patients who have platinum-based chemotherapy resistant and recurrent epithelial ovarian, primary peritoneal or fallopian tube types of cancer. Patients will receive treatment with study medication C4P or placebo (patients have a 50/50 chance of receiving study medication or placebo). All patients will also receive doctor recommended chemotherapy (either Paclitaxel or pegylated liposomal doxorubicin) and Bevacizimab for their cancer.
    A.3.2Name or abbreviated title of the trial where available
    FOCUS
    A.4.1Sponsor's protocol code numberOX4325
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02641639
    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 SponsorMateon Therapeutics, Inc.
    B.1.3.4CountryUnited States
    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 supportMateon Therapeutics, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMateon Therapeutics, Inc.
    B.5.2Functional name of contact pointCharles Cram
    B.5.3 Address:
    B.5.3.1Street Address701 Gateway Blvd., Suite 210
    B.5.3.2Town/ citySouth San Francisco
    B.5.3.3Post codeCA 94080
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1650635-7000
    B.5.5Fax number+1650635-7001
    B.5.6E-mailccram@mateon.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 nameFosbretabulin tromethamine
    D.3.2Product code CA4P
    D.3.4Pharmaceutical form Lyophilisate 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 INNFosbretabulin
    D.3.9.1CAS number 404886-32-4
    D.3.9.2Current sponsor codeCA4P
    D.3.9.3Other descriptive nameCOMBRETASTATIN A4 PHOSPHATE
    D.3.9.4EV Substance CodeSUB26303
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number90
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Platinum-resistant, recurrent, epithelial ovarian, primary peritoneal or fallopian tube cancer
    E.1.1.1Medical condition in easily understood language
    Ovarian cancers resistant to platinum based chemotherapy
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    E.1.2Level PT
    E.1.2Classification code 10016180
    E.1.2Term Fallopian tube cancer
    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 19.1
    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.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    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 No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate an improvement in Progression Free Survival
    E.2.2Secondary objectives of the trial
    - Improvement in objective response rate (by RECIST and GCIG CA-125 criteria).
    - Overall survival.
    - Assessment of proportion of subjects who remain progression-free at 6, 9 and 12 months on the regimen of PCC plus bevacizumab and CA4P compared with PCC plus bevacizumab and placebo.
    - To evaluate the safety and tolerability of PCC plus bevacizumab and CA4P compared with PCC plus bevacizumab and placebo, as measured by physical exams, vital signs, laboratory measures, ECG, ECOG performance status and incidence of AEs (using NCI CTCAE version 4.03).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Signed informed consent form (ICF).
    2. Age ≥ 18 years (age ≥ 19 years if required by local regulatory authorities).
    3. ECOG performance status of 0-1.
    4. Histologically or cytologically-confirmed epithelial ovarian, fallopian tube or primary peritoneal cancer in recurrent stage.
    5. Platinum-resistant ovarian cancers defined as progression within 6 months of receiving last platinum-based therapy.
    6. Received ≥ 1 prior platinum-based regimen.
    7. Measurable disease according to RECIST 1.1.
    8. LVEF greater than or equal to at least 45% at baseline assessment if subject is receiving pegylated liposomal doxorubicin and/or anthracycline as a concomitant medication.
    9. No evidence of active (progressing) brain metastasis (treated brain metastasis allowed with a post-treatment MRI or CT of brain showing no active (progressing) brain metastasis). Treatment of brain metastasis may include surgery, radiosurgery (LINAC, gamma knife) or whole brain irradiation. Surgery for brain metastasis must be > 8 weeks from study entry.
    10. Hemoglobin > 9 g/dL without transfusions or growth factors.
    11. Adequate bone marrow function in the investigator’s opinion.
    12. Adequate hepatic function defined by the following:
    − Total bilirubin < 2 x ULN;
    − Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2.5 X ULN for the referenced lab (< 5 X ULN for subjects with liver metastases).
    13. Adequate renal function defined by the following:
    − Serum creatinine < 2 X ULN for the referenced lab.
    14. Subjects of childbearing potential must have a negative serum pregnancy test prior to study entry and must be practicing a highly effective form of contraception.
    15. At least 2 weeks since prior radiotherapy and has recovered from any Grade 3 toxicities.
    16. Life expectancy ≥ 12 weeks.
    E.4Principal exclusion criteria
    1. Subjects who have received prior CA4P therapy.
    2. Previously having failed treatment with bevacizumab combined with the intended physician's choice chemotherapy (PCC). Investigators should not select a bevacizumab + PCC combination for the FOCUS trial if the patient has previously failed that same regimen, however they may select a new PCC regimen to combine with bevacizumab.
    3. Previous treatment with greater than two chemotherapy treatment regimens.
    4. Untreated brain metastasis or leptomeningeal brain metastasis.
    5. Solid organ or bone marrow transplant.
    6. Primary platinum-refractory disease (defined as progression during or within 1 month of completing patients first platinum-containing regimen).
    7. > Grade 2 peripheral neuropathy.
    8. Current thrombotic or hemorrhagic disorder/event or history of prior event within 6 months of start of screening.
    9. History of prior cerebrovascular event (including transient ischemic attack) within 6 months of start of screening.
    10. Recent history (within 6 months of start of screening) of angina pectoris, myocardial infarction (including non-Q wave MI), or NYHA Class III and IV congestive heart failure.
    11. History of torsade de pointes, ventricular tachycardia or fibrillation, pathologic sinus bradycardia (<60 bpm), heart block (excluding 1st degree block, benign PR interval prolongation only), congenital long QT syndrome or new ST segment elevation or depression or new Q wave on ECG.
    12. Known uncontrolled HIV infection.
    13. Uncontrolled, clinically significant active infection.
    14. Serious non-healing wound, ulcer or bone fracture.
    15. Subjects with known hypersensitivity to any of the components of CA4P, paclitaxel, pegylated liposomal doxorubicin or bevacizumab.
    16. Subjects who are currently or planning on receiving concurrent investigational therapy or who have received investigational therapy for any indication within 30 days of the first scheduled day of dosing.
    17. Subjects with any other intercurrent medical condition, including mental illness or substance abuse, deemed by the Investigator to be likely to interfere with a subjects ability to provide informed consent, cooperate and participate in the study, or interfere with the interpretation of the study results.
    18. Subjects with other invasive malignancies, with the exception of non-melanoma skin cancer, or with previous cancer treatment that contraindicates this protocol therapy within last 5 years.
    19. Prior radiation therapy to the pelvis or abdomen within 4 weeks of entry into the study.
    20. History of fistula, gastrointestinal (GI) perforation or intra-abdominal abscess, or invasive disease/metastases of the bowel which may increase the risk of GI perforation with bevacizumab treatment.
    21. Uncontrolled hypertension:
    − Sustained BP greater than 150 mmHg SBP / 100 mmHg DBP.
    22. Uncontrolled elevated proteinuria levels in the investigator's opinion.
    23. Corrected QT interval ([QTc] Fridericia) > 480 ms.
    24. Significant vascular disease or recent peripheral arterial thrombosis.
    25. Subjects with active bleeding or pathologic conditions that carry high risk of bleeding.
    26. Subjects who are pregnant or lactating.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is PFS, defined as the time from the date of randomization until progressive disease (PD) or death from any cause.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Subjects will be assessed for disease response or progression throughout the study according to RECIST after every 8 weeks using the same imaging method as used during screening (CT scan or MRI). Disease progression will be assessed by the investigator according to RECIST criteria.
    E.5.2Secondary end point(s)
    Objective response rate (ORR), overall survival OS and the proportion of progression-free subjects.
    E.5.2.1Timepoint(s) of evaluation of this end point
    At 6, 9 and 12 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 Yes
    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) Yes
    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) No
    E.8.2.2Placebo Yes
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA15
    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
    Belgium
    Germany
    Netherlands
    United States
    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
    LVLS - last visit of the last subject
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    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 years6
    E.8.9.2In all countries concerned by the trial months8
    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: 300
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 136
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 86
    F.4.2.2In the whole clinical trial 436
    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)
    None
    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 Decision2016-12-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-05-03
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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