Clinical Trial Page

Summary
EudraCT Number:2007-000004-33
Sponsor's Protocol Code Number:IPR/18
National Competent Authority:Italy - Italian Medicines Agency
Clinical Trial Type:EEA CTA
Trial Status:Completed
Date on which this record was first entered in the EudraCT database:2007-04-10
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
A. Protocol Information
A.1Member State ConcernedItaly - Italian Medicines Agency
A.2EudraCT number2007-000004-33
A.3Full title of the trial
NGR012: A phase II study of NGR-hTNF administered in combination with doxorubicin every 3 weeks in patients affected by advanced or metastatic ovarian cancer
NGR012: studio di fase II relativo alla somministrazione di NGR-hTNF in combinazione con doxorubicina ogni 3 settimane in pazienti affetti da carcinoma ovarico in stadio avanzato o metastatico
A.3.2Name or abbreviated title of the trial where available
NGR012
NGR012
A.4.1Sponsor's protocol code numberIPR/18
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 SponsorMOLMED
B.1.3.4CountryItaly
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 Yes
D.2.1.2Country which granted the Marketing AuthorisationItaly
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.3.4Pharmaceutical form 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 INNDoxorubicin
D.3.10 Strength
D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
D.3.10.3Concentration number2
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 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 Yes
D.3.11.13.1Other medicinal product typeAntracicilina
D.IMP: 2
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.2.1.2Country which granted the Marketing AuthorisationItaly
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.3.4Pharmaceutical form 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 INNDoxorubicin
D.3.10 Strength
D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
D.3.10.3Concentration number2
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 Yes
D.3.11.13.1Other medicinal product typeAntracicilina
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 affected by advanced or metastatic ovarian cancer previously treated with platinum regimens (cis or carboplatin) plus paclitaxel
Pazienti affetti da carcinoma ovarico in stadio avanzato o metastatico precedentemente trattati con regimi a base di platino (cisplatino o carboplatino) piu' taxolo
E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
MedDRA Classification
E.1.2 Medical condition or disease under investigation
E.1.2Version 14.1
E.1.2Level PT
E.1.2Classification code 10057529
E.1.2Term Ovarian 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
Antitumor activity defined as response rate according to RECIST criteria
Attivita' antitumorale definita come tasso di risposta (response rate) valutata secondo criteri RECIST
E.2.2Secondary objectives of the trial
•Progression Free Survival (PFS) •Overall survival (OS) •CA125 (U/mL) measurement •Safety
• Sopravvivenza libera da progressione di malattia (PFS) •Sopravvivenza globale •Dosaggio CA125 • Tollerabilita`
E.2.3Trial contains a sub-study No
E.3Principal inclusion criteria
•Patients >=18 years old affected by advanced or metastatic ovarian cancer previously treated with platinum regimens (cis or carboplatin) plus paclitaxel and with documented progression disease within 6 months from last chemotherapy administered (refractory/resistant population) or in progression disease after 6 months from last chemotherapy (platinum regimens plus paclitaxel) administered • Rechallenge with platinum regimens • No previous exposure to anthracyclines • Histologically or cytologically confirmed ovarian carcinoma • Life expectancy more than 3 months • ECOG Performance status 0 - 1 • Normal cardiac function (LVEF >=55%) and absence of uncontrolled hypertension • Measurable disease defined as >=1 unidimentionally measurable lesion >= 20 mm by conventional technics or >= 10 mm ( spiral CT scan or PET); ascites is allowed if present with peritoneal carcinosis •Adequate baseline bone marrow, hepatic and renal function, defined as follows: neutrophils > 1.5 x 10^9/L and platelets > 100 x 10^9/L; bilirubin < 1.5 x ULN;AST and/or ALT < 2.5 x ULN in absence of liver metastasis;AST and/or ALT < 5 x ULN in presence of liver metastasis;Serum creatinine < 1.5 x ULN • Absence of any conditions in which hypervolaemia and its consequences or haemodilution could represent a risk for the patient • Patients must give written informed consent to participate in the study
•Pazienti adulti di eta` &gt;=18 anni affetti da carcinoma ovarico in stadio avanzato o metastatico precedentemente trattati con regimi a base di platino (cisplatino o carboplatino) piu` taxolo e con documentata progressione di malattia entro 6 mesi dall'ultimo ciclo di chemioterapia somministrata (popolazione refrattaria/resistente) o in progressione di malattia dopo 6 mesi dall'ultimo ciclo di chemioterapia somministrato ( regimi a base di platino piu` taxolo) •Pazienti ritrattati ('rechallenge') con regimi a base di platino •Assenza di precedenti trattamenti con antracicline •Conferma citologica o istologica di carcinoma ovarico •Aspettativa di vita superiore ai 3 mesi •ECOG Performance status 0 - 1 •Funzionalita` cardiaca nella norma (frazione di eiezione ventricolare sinistra &gt;= 55%) ed assenza di ipertensione non controllata •Malattia misurabile definita come almeno 1 lesione misurabile con diametro &gt;= 20 mm con tecniche convenzionali o &gt;= 10 mm (TC o PET); la presenza di ascite come parametro di valutazione e` consentita se associata a carcinosi peritoneale •Funzionalita` ematica, epatica e renale nei limiti, definite come: Neutrofili &gt; 1.5 x 10^9/L; piastrine &gt; 100 x 10^9/L; bilirubina &lt; 1.5 x ULN;AST e/o ALT &lt; 2.5 x ULN in assenza di metastasi epatiche; AST e/o ALT &lt; 5 x ULN in presenza di metastasi epatiche; creatinina sierica &lt; 1.5 x ULN •Assenza di qualsiasi condizione nella quale l' ipervolemia e le sue complicanze o l'emodiluizione potrebbero rappresentare un rischio per i pazienti •Consenso informato scritto
E.4Principal exclusion criteria
• Concurrent anticancer therapy • Patients must not receive any other investigational agents while on study • New York Heart Association class II-IV cardiac disease • Acute angina • Patients with myocardial infarction within the last six (6) months • Patient with significant peripheral vascular disease • Thrombosis of main portal vein • Clinical signs of CNS involvement • Patients with active or uncontrolled systemic disease/infections or with serious illness or medical conditions, which is incompatible with the protocol • Known hypersensitivity/allergic reaction to human albumin preparations or to any of the excipients • Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol • Pregnancy or lactation.
• Concomitanti terapie anti-tumorali • I pazienti non devono essere arruolati in nessun altro studio clinico che prevede la somministrazione di altri trattamenti ai fini sperimentali • New York Heart Association classe II-IV • Angina acuta • Pazienti con infarto miocardico verificatosi negli ultimi sei (6) mesi • Pazienti con gravi malattie al sistema vascolare • Trombosi alla vena porta • Segni clinici di coinvolgimento del SNC • Pazienti affetti da malattie/infezioni in fase attiva o non controllata o in condizioni cliniche serie o condizioni mediche incompatibili con il protocollo • Reazioni allergiche/ipersensibilita` note ai preparati a base di albumina o a qualsiasi altro eccipiente • Qualsiasi condizione psicologica, familiare, sociale o geografica che ostacolano la 'compliance' del paziente con il protocollo dello studio • Gravidanza ed allattamento.
E.5 End points
E.5.1Primary end point(s)
Antitumor activity defined as response rate according to RECIST criteria
Attivita' antitumorale definita come tasso di risposta (response rate) valutata secondo criteri RECIST
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 No
E.8.1.1Randomised No
E.8.1.2Open No
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) Information not present in EudraCT
E.8.2.2Placebo Information not present in EudraCT
E.8.2.3Other Information not present in EudraCT
E.8.2.4Number of treatment arms in the trial1
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 concerned2
E.8.5The trial involves multiple Member States No
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 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
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 months0
E.8.9.1In the Member State concerned days0
F. Population of Trial Subjects
F.1 Age Range
F.1.1Trial has subjects under 18 No
F.1.1Number of subjects for this age range: 0
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 Yes
F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2007-04-10. Yes
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 state37
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 Decision2008-10-13
N.Ethics Committee Opinion of the trial applicationFavourable
N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
N.Date of Ethics Committee Opinion2007-03-01
P. End of Trial
P.End of Trial StatusCompleted

Sponsors and Collaborators

Medical Conditions

Drug Interventions

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