Phase II Study of NGR-hTNF in Combination With Doxorubicin in Platinum-resistant Ovarian Cancer (NGR018)
25 september 2018 bijgewerkt door: AGC Biologics S.p.A.
NGR018: Randomized Phase II Study of NGR-hTNF Plus an Anthracycline Versus an Anthracycline Alone in Platinum-resistant Ovarian Cancer
The primary objective of this randomized phase II trial is to compare progression-free survival (PFS) in patients randomized to NGR-hTNF plus an anthracycline versus patients randomized to an anthracycline alone
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
Considering the safety/toxicity profile of NGR-hTNF characterized by mild-to-moderate constitutional symptoms, the reversibility of these adverse events generally occurring only during the infusion time; the absence of overlapping toxicities with chemotherapeutic agents; the safety and preliminary antitumor activity observed in previous trial with doxorubicin; and the objective response rate (RR) registered in a phase II trial in previously treated ovarian cancer patients seems justified to evaluate in a randomized phase II trial the efficacy of NGR-hTNF against a doxorubicin-based option in advanced ovarian cancer patients progressing or recurrent after a standard platinum/taxane-based chemotherapy.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
119
Fase
- Fase 2
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Milan, Italië, 20132
- Ospedale San Raffaele
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Milan, Italië, 20133
- Fondazione IRCCS Istituto Nazionale dei Tumori
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Milan, Italië, 20141
- Istituto Europeo di Oncologia
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Naples, Italië, 80131
- Istituto Nazionale Tumori IRCCS Fondazione "Giovanni Pascale"
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Perugia, Italië, 06156
- Ospedale S. Maria Della Misericordia
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Rome, Italië, 00168
- Policlinico Universitario "Agostino Gemelli"
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Scotland
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Glasgow, Scotland, Verenigd Koninkrijk, G12 0YN
- Beatson Oncology Centre, Gartnavel Hospital
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Wirral
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Bebington, Wirral, Verenigd Koninkrijk, CH63 4JY
- Clatterbridge Centre for Oncology
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Vrouw
Beschrijving
Inclusion Criteria:
- Age ≥ 18 years
- Histologically-proven ovarian cancer, fallopian tube and primary peritoneal cancer in advanced or metastatic stage
- Patients previously treated with a maximum of two platinum-based regimen plus paclitaxel and with documented progressive disease on treatment (refractory patient population) or within 6 months from last chemotherapy cycle (resistant patient population)
- ECOG Performance status 0 - 2
- Life expectancy of 12 weeks or more
- Normal cardiac function
Adequate baseline bone marrow, hepatic and renal function defined as follows:
- Neutrophils ≥ 1.5 x 109/L; platelets ≥ 100 x 109/L; hemoglobin ≥ 9 g/dL
- Bilirubin ≤ 1.5 x ULN
- AST and/or ALT ≤ 2.5 x ULN in absence of liver metastasis or ≤ 5 x ULN in presence of liver metastasis
- Serum creatinine < 1.5 x ULN
- At least one (not previously irradiated) target lesion or non-measurable disease only, according to RECIST criteria
Patients may have had prior therapy providing the following conditions are met:
- Surgery and radiation therapy: wash-out period of 14 days
- Systemic anti-tumor therapy: wash-out period of 21 days
- Patients must give written informed consent to participate in the study
Exclusion Criteria:
- Patients must not receive any other investigational agents while on study
- More than two previous chemotherapy lines and previous treatment with anthracycline
- Patients with myocardial infarction within the last six months, unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure, or serious cardiac arrhythmia requiring medication
- Prolonged QTc interval (congenital or acquired) > 450 ms
- History or evidence upon physical examination of CNS disease unless adequately treated
- 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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: Arm A: NGR-hTNF+ antracycline
NGR-hTNF+gepegyleerde liposomale doxorubicine of doxorubicine
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NGR-hTNF: 0.8 mcg/m² as 60 minutes intravenous infusion weekly or every 3 or 4 weeks until confirmed evidence of disease progression or unacceptable toxicity occurs
50 mg/m² iv elke 4 weken tot bevestigd bewijs van ziekteprogressie
60 mg/m² iv elke 3 weken gedurende maximaal 8 cycli
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Actieve vergelijker: Arm B: antracycline
Gepegyleerd liposomaal doxorubicine of doxorubicine
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50 mg/m² iv elke 4 weken tot bevestigd bewijs van ziekteprogressie
60 mg/m² iv elke 3 weken gedurende maximaal 8 cycli
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Progression-Free Survival (PFS)
Tijdsspanne: from the date of randomization, every 6 and 8 weeks based on type of chemotherapy during treatment and every 12 weeks during the follow-up until PD or death
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Defined as the time from the date of randomization until disease progression, or death
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from the date of randomization, every 6 and 8 weeks based on type of chemotherapy during treatment and every 12 weeks during the follow-up until PD or death
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Overall survival (OS)
Tijdsspanne: from the date of randomization, every 6 and 8 weeks based on type of chemotherapy during treatment and every 12 weeks during follow-up until death
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defined as the time from the date of randomization until death due to any cause.
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from the date of randomization, every 6 and 8 weeks based on type of chemotherapy during treatment and every 12 weeks during follow-up until death
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Response Rate (RR)
Tijdsspanne: from the date of randomization, every 6 and 8 weeks based on type of chemotherapy during treatment and every 12 weeks during the follow-up until PD or death
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defined as the percentage of patients who have a best-response rating of complete or partial response, according to standard RECIST criteria.
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from the date of randomization, every 6 and 8 weeks based on type of chemotherapy during treatment and every 12 weeks during the follow-up until PD or death
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Disease Control Rate (DCR)
Tijdsspanne: from the date of randomization, every 6 and 8 weeks based on type of chemotherapy during treatment and every 12 weeks during the follow-up until PD or death
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defined as the percentage of patients who have a best-response rating of complete response, partial response, or stable disease, according to standard RECIST criteria.
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from the date of randomization, every 6 and 8 weeks based on type of chemotherapy during treatment and every 12 weeks during the follow-up until PD or death
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Duration of Disease Control
Tijdsspanne: from the date of randomization, every 6 and 8 weeks based on type of chemotherapy during treatment and every 12 weeks during the follow-up until PD or death
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measured from the date of randomization until disease progression, or death due to any cause.
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from the date of randomization, every 6 and 8 weeks based on type of chemotherapy during treatment and every 12 weeks during the follow-up until PD or death
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Safety and Toxicity according to NCI-CTCAE criteria (version 4.03)
Tijdsspanne: from the start of treatment until 28 days after last treatment
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To evaluate safety and toxicity profile related to NGR-hTNF
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from the start of treatment until 28 days after last treatment
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
1 juni 2011
Primaire voltooiing (Werkelijk)
1 december 2016
Studie voltooiing (Werkelijk)
1 december 2016
Studieregistratiedata
Eerst ingediend
19 mei 2011
Eerst ingediend dat voldeed aan de QC-criteria
20 mei 2011
Eerst geplaatst (Schatting)
23 mei 2011
Updates van studierecords
Laatste update geplaatst (Werkelijk)
27 september 2018
Laatste update ingediend die voldeed aan QC-criteria
25 september 2018
Laatst geverifieerd
1 september 2018
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Neoplasmata per histologisch type
- Neoplasmata
- Urogenitale neoplasmata
- Neoplasmata per site
- Carcinoom
- Neoplasmata, glandulair en epitheel
- Genitale neoplasmata, vrouwelijk
- Endocriene systeemziekten
- Ovariële ziekten
- Adnexale ziekten
- Gonadale aandoeningen
- Endocriene klierneoplasmata
- Ovariumneoplasmata
- Carcinoom, ovariumepitheel
- Moleculaire mechanismen van farmacologische werking
- Enzymremmers
- Antineoplastische middelen
- Topoisomerase II-remmers
- Topoisomeraseremmers
- Antibiotica, antineoplastiek
- Doxorubicine
- Liposomale doxorubicine
Andere studie-ID-nummers
- NGR018
- 2010-023613-61 (EudraCT-nummer)
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
product vervaardigd in en geëxporteerd uit de V.S.
Nee
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