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A Study of the Addition of Avastin (Bevacizumab) to Carboplatin and Paclitaxel Therapy in Patients With Ovarian Cancer

3 mei 2016 bijgewerkt door: Hoffmann-La Roche

Global Study to Assess the Addition of Bevacizumab to Carboplatin and Paclitaxel as Front-line Treatment of Epithelial Ovarian Cancer, Fallopian Tube Carcinoma or Primary Peritoneal Carcinoma

This open-label, non-comparative, multi-center study will assess the safety profile and efficacy of Avastin (bevacizumab) when added to carboplatin and paclitaxel therapy in participants with epithelial ovarian cancer, fallopian tube carcinoma or primary peritoneal carcinoma. Participants will receive 15 milligrams/kilogram (mg/kg) Avastin intravenously (IV) on Day 1 of every cycle for up to 36 cycles of 3 weeks each, carboplatin (area under the plasma concentration-time curve [AUC] 5-6 mg/ml/min) on Day 1 every 3 weeks for a maximum of 8 cycles and paclitaxel 175 milligram per square meter (mg/m^2) on Day 1 every 3 weeks or 80 mg/m^2 every week for a maximum of 8 cycles. The anticipated time on study drug will be 108 weeks or until disease progression or unacceptable toxicity.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Werkelijk)

1021

Fase

  • Fase 3

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

  • Argentinië
      • Buenos Aires, Argentinië, C1199ACI
      • Buenos Aires, Argentinië, C1280AEB
      • Buenos Aires, Argentinië, C1426ANZ
      • Rosario, Argentinië, S2002KDS
      • Tucuman, Argentinië, T4000IAK
  • Brazilië
    • BA
      • Salvador, BA, Brazilië, 41950-610
    • CE
      • Fortaleza, CE, Brazilië, 60125-120
    • GO
      • Goiania, GO, Brazilië, 74605-070
    • PR
      • Curitiba, PR, Brazilië, 80530-010
    • RJ
      • Rio de Janeiro, RJ, Brazilië, 20230-130
    • RS
      • Porto Alegre, RS, Brazilië, 90430-090
      • Porto Alegre, RS, Brazilië, 90020-090
    • SP
      • Piracicaba, SP, Brazilië, 13419-155
      • Sao Paulo, SP, Brazilië, 01246-000
      • Sao Paulo, SP, Brazilië, 01308-050
      • Sao Paulo, SP, Brazilië, 01317-000
      • Sao Paulo, SP, Brazilië, 01509-010
  • Bulgarije
      • Sofia, Bulgarije, 1756
      • Varna, Bulgarije, 9010
      • Veliko Tarnovo, Bulgarije, 5000
  • Canada
      • Quebec, Canada, G1R 3S1
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N2
    • Ontario
      • Ottawa, Ontario, Canada, K1H 8L6
      • Toronto, Ontario, Canada, M5G 2M9
    • Quebec
      • Montreal, Quebec, Canada, H2L 4M1
  • Denemarken
      • Aalborg, Denemarken, 9000
      • Roskilde, Denemarken, 4000
      • Vejle, Denemarken, 7100
  • Egypte
      • Cairo, Egypte, 11555
      • Tanta, Egypte
  • Estland
      • Tallinn, Estland, 11312
      • Tallinn, Estland, 13419
      • Tartu, Estland, 50406
  • Frankrijk
      • Amiens, Frankrijk, 80090
      • Bordeaux, Frankrijk, 33076
      • Brest, Frankrijk, 29200
      • Caen, Frankrijk, 14076
      • Clermont Ferrand, Frankrijk, 63011
      • Grenoble, Frankrijk, 38028
      • Lille, Frankrijk, 59020
      • Lyon, Frankrijk, 69373
      • Marseille, Frankrijk, 13273
      • Mougins, Frankrijk, 06250
      • Paris, Frankrijk, 75970
      • Paris, Frankrijk, 75908
      • Paris, Frankrijk, 75651
      • Paris, Frankrijk, 75674
      • Paris, Frankrijk, 75231
      • Paris, Frankrijk, 75571
      • Reims CEDEX, Frankrijk, 51056
      • Strasbourg, Frankrijk, 67065
      • Toulouse, Frankrijk, 31059
      • Villejuif, Frankrijk, 94805
  • Griekenland
      • Athens, Griekenland, 11527
      • Athens, Griekenland, 115 28
      • Athens, Griekenland, 145 64
      • Heraklion, Crete, Griekenland, 71110
      • Larissa, Griekenland, 41 110
      • Patras, Griekenland, 265 00
      • Thessaloniki, Griekenland, 56429
  • Hongarije
      • Budapest, Hongarije, 1125
      • Budapest, Hongarije, 1122
      • Debrecen, Hongarije, 4032
      • Pecs, Hongarije, 7624
      • Szeged, Hongarije, 6720
  • Hongkong
      • Hong Kong, Hongkong
      • Hong Kong, Hongkong, 852
  • Ierland
      • Dublin, Ierland, 7
  • Indië
      • Bangalore, Indië, 560017
      • Bangalore, Indië, 560054
      • Hyderabad, Indië, 650034
      • Jaipur, Indië, 302013
      • Kochi, Indië, 682304
      • New Delhi, Indië, 110029
      • Pune, Indië, 411004
  • Israël
      • Afula, Israël, 18101
      • Beer Sheva, Israël, 8410101
      • Haifa, Israël, 34362
      • Haifa, Israël, 31096
      • Holon, Israël, 58100
      • Jerusalem, Israël, 91120-01
      • Jerusalem, Israël, 9372212
      • Kfar Saba, Israël, 44281
      • Petach Tikva, Israël, 49100
      • Ramat Gan, Israël, 52621
      • Rehovot, Israël, 7610001
      • Tel Aviv, Israël, 64239-06
  • Italië
    • Campania
      • Napoli, Campania, Italië, 80131
    • Emilia-Romagna
      • Bologna, Emilia-Romagna, Italië, 40138
      • Meldola, Emilia-Romagna, Italië, 47014
    • Lazio
      • Roma, Lazio, Italië, 00128
      • Roma, Lazio, Italië, 00157
    • Liguria
      • Genova, Liguria, Italië, 16128
    • Lombardia
      • Brescia, Lombardia, Italië, 25123
      • Milano, Lombardia, Italië, 20162
      • Milano, Lombardia, Italië, 20141
      • Monza, Lombardia, Italië, 20052
      • Saronno, Lombardia, Italië, 21047
    • Piemonte
      • Novara, Piemonte, Italië, 28100
      • Torino, Piemonte, Italië, 10126
      • Torino, Piemonte, Italië, 10128
    • Sicilia
      • Palermo, Sicilia, Italië, 90146
    • Toscana
      • Firenze, Toscana, Italië, 50139
      • Pisa, Toscana, Italië, 56126
    • Umbria
      • Perugia, Umbria, Italië, 06123
      • Terni, Umbria, Italië, 05100
  • Kalkoen
      • Ankara, Kalkoen, 06500
      • Ankara, Kalkoen, 06230
      • Diyarbakir, Kalkoen, 10000
      • Istanbul, Kalkoen, 34390
  • Koeweit
      • Shuwaikh, Koeweit, 70653
  • Letland
      • Daugavpils, Letland, 5417
      • Riga, Letland, LV-1002
      • Riga, Letland, LV 1079
  • Litouwen
      • Kaunas, Litouwen, 50009
      • Klaipeda, Litouwen, 92288
      • Vilnius, Litouwen, 08660
  • Macedonië, de Voormalige Joegoslavische Republiek
      • Bitola, Macedonië, de Voormalige Joegoslavische Republiek, 7000
      • Skopje, Macedonië, de Voormalige Joegoslavische Republiek, 1000
  • Mexico
      • Distrito Federal, Mexico, 14080
      • Oaxaca, Mexico, 68000
      • Toluca, Mexico, 50180
  • Nederland
      • Alkmaar, Nederland, 1815 JD
      • Amsterdam, Nederland, 1091 AC
      • Apeldoorn, Nederland, 7334 DZ
      • Blaricum, Nederland, 1261 AN
      • Breda, Nederland, 4819 EV
      • Capelle a/d IJssel, Nederland, NL 2900 AR
      • Den Haag, Nederland, 2545 CH
      • Den Haag, Nederland, 2512 VA
      • Deventer, Nederland, 7416 SE
      • Dordrecht, Nederland, 3318 AT
      • Eindhoven, Nederland, 5623 EJ
      • Leidschendam, Nederland, 2262 BA
      • Rotterdam, Nederland, 3045 PM
      • Sittard-Geleen, Nederland, 6162 BG
      • Utrecht, Nederland, 3582 KE
  • Oostenrijk
      • Graz, Oostenrijk, 8020
      • Graz, Oostenrijk, 8036
      • Innsbruck, Oostenrijk, 6020
      • Ried-innkreis, Oostenrijk, 4910
      • Salzburg, Oostenrijk, 5020
      • Steyr, Oostenrijk, 4400
      • Villach, Oostenrijk, 9500
      • Wien, Oostenrijk, 1130
      • Wien, Oostenrijk, 1090
  • Polen
      • Bydgoszcz, Polen, 85-796
      • Warszawa, Polen, 03-242
  • Portugal
      • Porto, Portugal, 4200-072
  • Roemenië
      • Bucuresti, Roemenië, 022328
      • Cluj Napoca, Roemenië, 400015
      • Iasi, Roemenië, 700106
  • Russische Federatie
      • Barnaul, Russische Federatie, 656049
      • Moscow, Russische Federatie, 115478
      • Obninsk, Kaluzhskaya Region, Russische Federatie, 249034
      • Saint-Petersburg, Russische Federatie, 197022
      • Stavropol, Russische Federatie, 355045
      • UFA, Russische Federatie, 450054
  • Saoedi-Arabië
      • Dammam, Saoedi-Arabië, 31444
  • Servië
      • Belgrade, Servië, 11000
      • Nis, Servië, 18000
  • Slovenië
      • Ljubljana, Slovenië, 1000
      • Maribor, Slovenië, 2000
  • Slowakije
      • Bratislava, Slowakije, 833 10
      • Kosice, Slowakije, 04001
  • Spanje
      • Albacete, Spanje, 02006
      • Alicante, Spanje, 3010
      • Badajoz, Spanje, 06080
      • Barcelona, Spanje, 08036
      • Barcelona, Spanje, 08003
      • Barcelona, Spanje, 08906
      • Barcelona, Spanje, 08017
      • Burgos, Spanje, 09006
      • Caceres, Spanje, 10003
      • Castellon, Spanje, 12002
      • Ciudad Real, Spanje, 13005
      • Cordoba, Spanje, 14004
      • Girona, Spanje, 17007
      • Granada, Spanje, 18014
      • Guadalajara, Spanje, 19002
      • Jaen, Spanje, 23007
      • La Coruña, Spanje, 15006
      • Lugo, Spanje, 27003
      • Madrid, Spanje, 28040
      • Madrid, Spanje, 28041
      • Madrid, Spanje, 28007
      • Madrid, Spanje, 28222
      • Madrid, Spanje, 28033
      • Madrid, Spanje, 28002
      • Madrid, Spanje, 28050
      • Malaga, Spanje, 29010
      • Malaga, Spanje, 29011
      • Navarra, Spanje, 31008
      • Salamanca, Spanje, 37007
      • Segovia, Spanje, 40002
      • Sevilla, Spanje, 41014
      • Sevilla, Spanje, 41009
      • Toledo, Spanje, 45004
      • Valencia, Spanje, 46017
      • Valencia, Spanje, 46026
      • Valencia, Spanje, 46009
      • Valencia, Spanje, 46015
      • Valladolid, Spanje, 47010
      • Zaragoza, Spanje, 50009
    • Alicante
      • Elda, Alicante, Spanje, 03600
    • Asturias
      • Oviedo, Asturias, Spanje, 33011
    • Badajoz
      • Llerena (Badajoz), Badajoz, Spanje, 06900
    • Barcelona
      • Manresa, Barcelona, Spanje, 08243
    • Cadiz
      • Cádiz, Cadiz, Spanje, 11009
      • Jerez de La Frontera, Cadiz, Spanje, 11407
    • Guipuzcoa
      • San Sebastian, Guipuzcoa, Spanje, 20080
      • San Sebastian de Los Reyes, Guipuzcoa, Spanje, 28702
    • Islas Baleares
      • Palma De Mallorca, Islas Baleares, Spanje, 07014
      • Palma de Mallorca, Islas Baleares, Spanje, 07198
    • La Coruña
      • Santiago de Compostela, La Coruña, Spanje, 15706
    • Las Palmas
      • Las Palmas de Gran Canaria, Las Palmas, Spanje, 35020
    • Madrid
      • Leganes, Madrid, Spanje, 28911
    • Tarragona
      • Reus, Tarragona, Spanje, 43204
    • Tenerife
      • La Laguna, Tenerife, Spanje, 38320
      • Santa Cruz de Tenerife, Tenerife, Spanje, 38010
    • Valencia
      • San Juan, Valencia, Spanje, 03550
    • Vizcaya
      • Barakaldo, Vizcaya, Spanje, 48903
      • Bilbao, Vizcaya, Spanje, 48013
  • Taiwan
      • Taipei City, Taiwan, 110
      • Taipei City, Taiwan, 112
      • Taoyuan Hsien, Taiwan, 333
  • Uruguay
      • Montevideo, Uruguay, 11600
  • Zuid-Afrika
      • Durban, Zuid-Afrika, 4058
      • Johannesburg, Zuid-Afrika, 2193
      • Sandton, Zuid-Afrika, 2196
  • Zweden
      • Eskilstuna, Zweden, 63188
      • Falun, Zweden, 79182
      • Karlstad, Zweden, 65185
      • Umeå, Zweden
      • Uppsala, Zweden, 75185
      • Örebro, Zweden, 701 85
  • Zwitserland
      • Aarau, Zwitserland, 5001
      • Baden, Zwitserland, 5405
      • Bellinzona, Zwitserland, 6500
      • Bern, Zwitserland, 3010
      • Genève 14, Zwitserland, 1211
      • Zürich, Zwitserland, 8091

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:

  • Histologically confirmed epithelial ovarian carcinoma, fallopian tube carcinoma, primary peritoneal carcinoma or clear cell carcinoma or carcinosarcoma. Participants with recurrent ovarian cancer who have been previously treated with surgery alone for their early stage disease are eligible.
  • Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0, 1 or 2
  • Life expectancy greater than or equal to (>=3) months

Exclusion Criteria:

  • Participants with non-epithelial ovarian cancer, ovarian tumors with low malignant potential (i.e., borderline tumors), or synchronous primary endometrial carcinoma
  • Previous systemic therapy for ovarian cancer. Prior neo-adjuvant chemotherapy is allowed
  • Planned intraperitoneal cytotoxic chemotherapy
  • Radiotherapy within 28 days of Day 1, Cycle 1
  • Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to first dose of Avastin
  • History or evidence of National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Grade >=1 arterial thromboembolic event or Grade >=3 venous thromboembolic event within 6 months prior to enrollment

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: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Bevacizumab + Paclitaxel + Carboplatin
Participants will receive bevacizumab 15 mg/kg IV on Day 1 every 3 weeks from Cycle 1 to Cycle 36 (initially concurrent with chemotherapy, then continued as a single agent following the completion of chemotherapy), or until protocol defined disease progression or until unacceptable toxicity (whichever occurred first). Participants will receive paclitaxel 175 mg/m^2 IV on Day 1 every 3 weeks or 80 mg/m^2 IV every week and carboplatin (AUC 5-6) IV on Day 1 every 3 weeks for a minimum of 4 and maximum of 8 cycles (including up to 4 pre-surgical cycles), or until protocol defined disease progression, or unacceptable toxicity (whichever occurred first).
Geneesmiddel: Paclitaxel
175 mg/m^2 on Day 1 every 3 weeks or at a dose of 80 mg/m^2 every week for a minimum of 4 cycles and not more than 8 cycles or until disease progression or unacceptable toxicity, whichever occurs first
Geneesmiddel: Bevacizumab
15 mg/kg intravenously on Day 1 of every cycle for up to 36 cycles of 3 weeks each or until disease progression or unacceptable toxicity, whichever occurs first
Andere namen:
  • Avastin
Geneesmiddel: Carboplatin
AUC 5-6 mg/ml/min on Day 1 every 3 weeks for a minimum of 4 cycles and not more than 8 cycles or until disease progression or unacceptable toxicity, whichever occurs first

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Percentage of Participants With at Least One Adverse Event (AE)
Tijdsspanne: Day 1 up to 30 days after last dose of study treatment (until data cutoff 07 December 2014, up to 4 years)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
Day 1 up to 30 days after last dose of study treatment (until data cutoff 07 December 2014, up to 4 years)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Progression-Free Survival (PFS)
Tijdsspanne: Day 1, at end of Cycles 3 and 6, then every 6 cycles while receiving bevacizumab, and then at bevacizumab cessation, every 26 weeks after cessation of bevacizumab until disease progression or death until data cutoff 07 December 2014, up to 4 years
PFS was defined as the time between the date of first administration of any study treatment and the date of first documented protocol-defined disease progression (that is [i.e.], radiologically by Response Evaluation Criteria In Solid Tumors [RECIST], clinical, or symptomatic) or death, whichever occurred first. Participants who had neither progressed nor died at the time of data cut-off (07 December 2014), or participants who were withdrawn from study, or lost to follow-up without documented progression, were censored. Kaplan-Meier estimation was used for median time to PFS.
Day 1, at end of Cycles 3 and 6, then every 6 cycles while receiving bevacizumab, and then at bevacizumab cessation, every 26 weeks after cessation of bevacizumab until disease progression or death until data cutoff 07 December 2014, up to 4 years
Percentage of Participants Achieving Best Overall Response of Complete Response (CR) or Partial Response (PR) According to RECIST Version 1.0
Tijdsspanne: Day 1, at end of Cycles 3 and 6, then every 6 cycles while receiving bevacizumab, and then at bevacizumab cessation, every 26 weeks (Q26W) after cessation of bevacizumab until disease progression or death until data cutoff 07 December 2014, up to 4 years
Best overall response (BOR) according to RECIST Version 1.0 was categorized as: CR, PR, progressive disease (PD), stable disease (SD). CR: disappearance of all target lesions and non-target lesions. PR: >=30% decrease in sum of the longest diameters (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST associated to non-progressive disease response for non-target lesions. PD: Natural progression or deterioration of the malignancy under study (including new sites of metastasis). SD: neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum longest diameter since the treatment started. Participants with a BOR of CR and PR were defined as responders, while participants with a BOR of SD, PD, or unable to assess were defined as non-responders.
Day 1, at end of Cycles 3 and 6, then every 6 cycles while receiving bevacizumab, and then at bevacizumab cessation, every 26 weeks (Q26W) after cessation of bevacizumab until disease progression or death until data cutoff 07 December 2014, up to 4 years
Percentage of Participants Achieving an Overall Response by 50% Carcinoma Antigen 125 (CA-125) Response Criteria
Tijdsspanne: 3 days prior to Day 1 of every cycle, then every 6 weeks (Q6W) during the first year, every 3 months (Q3M) in the second and third year, every 6 months (Q6M) in the fourth year of the study (until data cutoff 07 December 2014, up to 4 years)
CA-125 responders: Participants with the value of CA-125 reduced by at least 50% and confirmed with a consecutive CA-125 assessment performed at an interval of at least 28 days. Overall response according to CA-125 was only evaluated for participants with a pre-treatment CA-125 within 3 days prior to start of any study treatment of at least twice the upper limit of normal (ULN).
3 days prior to Day 1 of every cycle, then every 6 weeks (Q6W) during the first year, every 3 months (Q3M) in the second and third year, every 6 months (Q6M) in the fourth year of the study (until data cutoff 07 December 2014, up to 4 years)
Percentage of Participants Achieving an Overall Response by RECIST Version 1.0 and/or 50% CA-125 Response Criteria
Tijdsspanne: RECIST: Day 1, at end of Cycles 3 and 6, then every 6 cycles, at bevacizumab cessation, Q26W after cessation; CA-125: 3 days before Day 1 of every cycle, then Q6W(1st year), Q3M(2nd-3rd year), Q6M(4th year); until data cutoff 07Dec2014, up to 4 years
Overall response was only evaluated for participants who were evaluable according to RECIST v1.0 with a measurable disease at baseline and/or according to CA-125 with a pre-treatment CA-125 within 3 days prior to start of any study treatment of at least twice the ULN. RECIST responders: Participants achieving an overall response of CR (disappearance of all target lesions and non-target lesions) or PR (>=30% decrease in sum of the LD of the target lesions taking as a reference the baseline sum LD according to RECIST associated to non-progressive disease response for non target lesions). CA-125 responders: Participants with the value of CA-125 reduced by at least 50% and confirmed with a consecutive CA-125 assessment performed at an interval of at least 28 days.
RECIST: Day 1, at end of Cycles 3 and 6, then every 6 cycles, at bevacizumab cessation, Q26W after cessation; CA-125: 3 days before Day 1 of every cycle, then Q6W(1st year), Q3M(2nd-3rd year), Q6M(4th year); until data cutoff 07Dec2014, up to 4 years
Duration of Objective Response (DOR)
Tijdsspanne: Day 1, at end of Cycles 3 and 6, then every 6 cycles while receiving bevacizumab, and then at bevacizumab cessation, every 26 weeks after cessation of bevacizumab until disease progression or death until data cutoff 07 December 2014, up to 4 years
DOR was defined as the time from the first documented response (CR or PR per RECIST v1.0), to the first documented protocol-defined disease progression (i.e., radiologically by RECIST, clinical, or symptomatic) or death, whichever occurred first. Participants who had neither progressed nor died at the time of data cut-off (07 December 2014), or participants who were withdrawn from study, or lost to follow-up without documented progression, were censored. RECIST responders: Participants achieving an overall response of CR (disappearance of all target lesions and non-target lesions) or PR (>=30% decrease in sum of the LD of the target lesions taking as a reference the baseline sum LD according to RECIST associated to non-progressive disease response for non-target lesions). Disease progression: Natural progression or deterioration of the malignancy under study (including new sites of metastasis).
Day 1, at end of Cycles 3 and 6, then every 6 cycles while receiving bevacizumab, and then at bevacizumab cessation, every 26 weeks after cessation of bevacizumab until disease progression or death until data cutoff 07 December 2014, up to 4 years
Overall Survival (OS)
Tijdsspanne: First administration of any study treatment until death or data cutoff 07 December 2014, up to 4 years
OS was defined as the time from the date of the first administration of any study treatment to the date of death, regardless of the cause of death. Participants without the event of death were censored at the last date in the study, defined as the latest date of the following: the date of first administration of study treatment, date of last study treatment, date of last visit, or date last known to be alive. Kaplan-Meier estimation was used for OS.
First administration of any study treatment until death or data cutoff 07 December 2014, up to 4 years
Biological Progression-free Interval
Tijdsspanne: 3 days prior to Day 1 of every cycle, then every 6 weeks during the first year, every 3 months in the second and third year, every 6 months in the fourth year of the study (until data cutoff 07 December 2014, up to 4 years)
Biological progression-free interval is defined as the interval from the date of the first administration of any study treatment to the date of the first documented serial elevation of the ovarian cancer mucin CA-125. More precisely, this is defined as the first documented increase in CA-125 levels as follows: (1) CA-125 greater than or equal to 2 times the upper level of normal (ULN) on 2 occasions at least 1 week apart (for participants with CA-125 within normal range pre-treatment) or (2) CA-125 greater than or equal to 2 times the ULN on 2 occasions at least 1 week apart (for participants with elevated CA-125 pre-treatment and initial normalization of CA-125 on-treatment) or (3) CA-125 greater than or equal to 2 times the nadir value, which is the lowest observed CA-125 value per participant on 2 occasions at least 1 week apart (for participants with elevated CA-125 pre-treatment which never normalized).
3 days prior to Day 1 of every cycle, then every 6 weeks during the first year, every 3 months in the second and third year, every 6 months in the fourth year of the study (until data cutoff 07 December 2014, up to 4 years)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Hoffmann-La Roche

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

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

1 december 2010

Primaire voltooiing (Werkelijk)

1 maart 2015

Studie voltooiing (Werkelijk)

1 maart 2015

Studieregistratiedata

Eerst ingediend

10 november 2010

Eerst ingediend dat voldeed aan de QC-criteria

10 november 2010

Eerst geplaatst (Schatting)

11 november 2010

Updates van studierecords

Laatste update geplaatst (Schatting)

10 juni 2016

Laatste update ingediend die voldeed aan QC-criteria

3 mei 2016

Laatst geverifieerd

1 mei 2016

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • MO22923
  • 2010-019525-34 (EudraCT-nummer)

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