- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT02004093
A Study to Evaluate the Effect of the Combination of Pertuzumab With Carboplatin-Based Standard Chemotherapy in Patients With Recurrent Ovarian Cancer
25. November 2014 aktualisiert von: Hoffmann-La Roche
A Randomized, Open-label Study of the Effect of Omnitarg in Combination With Carboplatin-based Chemotherapy Versus Carboplatin-based Therapy Alone on Treatment Response in Patients With Platinum-sensitive Recurrent Ovarian Cancer
This study will evaluate the efficacy and safety of pertuzumab in combination with carboplatin-based standard chemotherapy in patients with platinum-sensitive recurrent ovarian cancer.
The anticipated time on study treatment is 3-12 months.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Studientyp
Interventionell
Einschreibung (Tatsächlich)
149
Phase
- Phase 2
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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Bruxelles, Belgien, 1000
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Leuven, Belgien, 3000
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Wilrijk, Belgien, 2610
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Emilia-Romagna
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Parma, Emilia-Romagna, Italien, 43100
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Lombardia
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Milano, Lombardia, Italien, 20133
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Alberta
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Calgary, Alberta, Kanada, T2N 4N2
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British Columbia
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Kelowna, British Columbia, Kanada, V1Y 5L3
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Vancouver, British Columbia, Kanada, V5Z 4E6
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Amsterdam, Niederlande, 1081 HV
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Amsterdam, Niederlande, 1066 CX
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Poznan, Polen, 60-535
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Warszawa, Polen, 02-781
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Kazan, Russische Föderation, 420029
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Moscow, Russische Föderation, 125284
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Moscow, Russische Föderation, 105203
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Moscow, Russische Föderation, 115478
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Moscow, Russische Föderation, 143423
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Moscow, Russische Föderation, 117837
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Saint-Petersburg, Russische Föderation, 197022
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St Petersburg, Russische Föderation, 197758
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Tomsk, Russische Föderation, 634028
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Barcelona, Spanien, 08036
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Barcelona, Spanien, 08035
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Madrid, Spanien, 28041
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Valencia, Spanien, 46009
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Budapest, Ungarn, 1122
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Debrecen, Ungarn, 4032
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Gyor, Ungarn, 9024
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Birmingham, Vereinigtes Königreich, B18 7QH
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London, Vereinigtes Königreich, W12 OHS
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Manchester, Vereinigtes Königreich, M20 4BX
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Plymouth, Vereinigtes Königreich, PL6 8DH
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Sutton, Vereinigtes Königreich, SM2 5PT
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Yeovil, Vereinigtes Königreich, BA21 4AT
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre und älter (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Weiblich
Beschreibung
Inclusion Criteria:
- histologically confirmed ovarian, primary peritoneal, or fallopian tube cancer;
- only 1 previous regimen, which must be platinum-based;
- platinum-sensitive disease which is defined by a progression-free interval of greater than 6 months after completion of platinum-based chemotherapy.
Exclusion Criteria:
- previous radiotherapy;
- previous treatment with an anti-cancer vaccine or any targeted therapy;
- major surgery or traumatic injury within 4 weeks of study;
- history or evidence of central nervous system metastases.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Aktiver Komparator: Chemotherapie
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175 mg/m2 IV every 3 weeks for 6 cycles
1000 mg/m2 IV Day 1 and 8 of each cycle for 6 cycles
Target AUC of 5 following paclitaxel or AUC of 4 following gemcitabine IV every 3 weeks for 6 cycles
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Experimental: Chemotherapy + Pertuzumab
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Loading dose of 840 mg IV, followed by 420 mg IV every 3 weeks
175 mg/m2 IV every 3 weeks for 6 cycles
1000 mg/m2 IV Day 1 and 8 of each cycle for 6 cycles
Target AUC of 5 following paclitaxel or AUC of 4 following gemcitabine IV every 3 weeks for 6 cycles
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Percentage of Participants With Disease Progression or Death
Zeitfenster: Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until disease progression up to 104 weeks
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Disease progression was assessed according to RECIST (Response Evaluation Criteria In Solid Tumors), for participants with measurable disease, or by changes in CA 125 (Cancer Antigen 125) according to GCIG (Gynecologic Cancer Inter Group) for all participants.
Participants who did not progress or died while being followed were censored at the time of the last valid tumor assessment or valid CA 125 assessment.
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Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until disease progression up to 104 weeks
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Progression-Free Survival
Zeitfenster: Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until disease progression up to 104 weeks
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Progression-free survival was defined as the time from first administration of study drug (Study Day 1) to documented disease progression or death, whichever occurred earlier.
Disease progression was assessed according to RECIST, for participants with measurable disease, or by changes in CA 125 according to GCIG for all participants.
Participants who did not progress or died while being followed were censored at the time of the last valid tumor assessment or valid CA 125 assessment.
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Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until disease progression up to 104 weeks
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Kaplan-Meier Probability of No Disease or Progression at 1 Year
Zeitfenster: 1 year
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The probability of being event free (no disease progression or death events) at 1 year in participants remaining at risk.
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1 year
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Percentage of Participants With a Best Overall Confirmed Response Based on Combined CA 125 and RECIST Measurements
Zeitfenster: Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until disease progression up to 104 weeks
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Response by tumor measurement occurred if there was documented and confirmed complete response (CR) or partial response (PR).
For all participants, response was assessed by both the RECIST and by CA 125 levels, according to whether the participant had measurable or non-measurable disease at baseline.
Response according to CA 125 levels was defined as at least a 50% reduction from baseline.
The decrease had to be confirmed and maintained for at least 28 days.
The confirmatory sample must have been less than or equal to the previous sample (within an assay variability of 10%).
For overall response, the response categories were "response", "stable disease" and "progressive disease".
Stable disease included 1) stable disease as defined by RECIST for solid tumors and 2) CA 125 levels that had not met the definition of "response" or "progressive disease".
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Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until disease progression up to 104 weeks
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Duration of Response
Zeitfenster: Day 15 of Cycles 2, 4, 6, and Day 15 of all Cycles from Cycle 7 to 17 until disease progression up to 104 weeks
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For participants who achieved a response, the duration of response was defined as the interval between initial documentation of response to the first documentation of disease progression or death.
Participants who responded and did not progress or die while on study or while being followed were censored at the last valid tumor or CA 125 measurement.
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Day 15 of Cycles 2, 4, 6, and Day 15 of all Cycles from Cycle 7 to 17 until disease progression up to 104 weeks
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Kaplan-Meier Probability of Maintaining a Response to at Least 1 Year
Zeitfenster: 1 year
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1 year
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Percentage of Participants With Disease Progression
Zeitfenster: Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until disease progression
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Disease progression was assessed according to RECIST, for participants with measurable disease, or by changes in CA 125 according to GCIG for all participants.
Participants who did not progress while being followed were censored at the time of the last valid tumor assessment or valid CA 125 assessment.
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Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until disease progression
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Time to Progressive Disease
Zeitfenster: Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until disease progression
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The time to progressive disease is the interval of time from date of first dose of study medication to date of first documentation of progressive disease by either RECIST or CA 125 criteria.
Participants who never progressed while being followed were censored at the last valid tumor measurement or CA 125 measurement.
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Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until disease progression
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Kaplan-Meier Probability of Being Progression Free at 1 Year
Zeitfenster: 1 year
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1 year
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Time To Response
Zeitfenster: Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until 2 years after last dose of treatment
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Time to response was the date of first dose of study medication to the date of the first documentation of response, according to CA 125 criteria for all participants or response according to RECIST criteria for participants with measurable disease.
If response was evaluable by both criteria, then the date of response was for the earlier of the two events.
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Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until 2 years after last dose of treatment
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Percentage of Participants Who Died
Zeitfenster: Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until 2 years after last dose of treatment
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Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until 2 years after last dose of treatment
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Overall Survival
Zeitfenster: Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until 2 years after last dose of treatment
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Survival was the interval of time from date of first dose of study medication to date of death at any time.
Participants who had not died were censored at the date of last contact when they were known to be alive.
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Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until 2 years after last dose of treatment
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Kaplan-Meier Probability of Being Alive at 1 Year
Zeitfenster: 1 year
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1 year
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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn
1. Dezember 2005
Primärer Abschluss (Tatsächlich)
1. September 2008
Studienabschluss (Tatsächlich)
1. September 2008
Studienanmeldedaten
Zuerst eingereicht
3. Dezember 2013
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
3. Dezember 2013
Zuerst gepostet (Schätzen)
6. Dezember 2013
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
4. Dezember 2014
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
25. November 2014
Zuletzt verifiziert
1. November 2014
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
- Neubildungen nach histologischem Typ
- Neubildungen
- Urogenitale Neoplasmen
- Neubildungen nach Standort
- Karzinom
- Neubildungen, Drüsen und Epithelien
- Genitale Neubildungen, weiblich
- Erkrankungen des endokrinen Systems
- Eierstockerkrankungen
- Adnexerkrankungen
- Gonadenstörungen
- Neoplasmen der endokrinen Drüse
- Eierstocktumoren
- Karzinom, Eierstockepithel
- Physiologische Wirkungen von Arzneimitteln
- Molekulare Mechanismen der pharmakologischen Wirkung
- Antiinfektiva
- Antivirale Mittel
- Enzym-Inhibitoren
- Antimetaboliten, antineoplastisch
- Antimetaboliten
- Antineoplastische Mittel
- Immunsuppressive Mittel
- Immunologische Faktoren
- Tubulin-Modulatoren
- Antimitotische Mittel
- Mitose-Modulatoren
- Antineoplastische Mittel, Phytogen
- Antineoplastische Mittel, immunologische
- Gemcitabin
- Carboplatin
- Paclitaxel
- Pertuzumab
Andere Studien-ID-Nummern
- BO17931
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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