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Study Comparing Veliparib Plus Carboplatin and Paclitaxel Versus Investigator's Choice of Standard Chemotherapy in Adults Receiving First Cytotoxic Chemotherapy for Metastatic or Advanced Non-Squamous Non-Small Cell Lung Cancer (NSCLC) and Who Are Current or Former Smokers

8 de febrero de 2021 actualizado por: AbbVie

A Randomized, Open-Label, Multicenter, Phase 3 Trial Comparing Veliparib Plus Carboplatin and Paclitaxel Versus Investigator's Choice of Standard Chemotherapy in Subjects Receiving First Cytotoxic Chemotherapy for Metastatic or Advanced Non-Squamous Non-Small Cell Lung Cancer (NSCLC) and Who Are Current or Former Smokers

The purpose of this study is to evaluate the safety and efficacy of veliparib plus carboplatin and paclitaxel versus the Investigator's choice of standard chemotherapy in adults with metastatic or advanced non-squamous non-small cell lung cancer.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

595

Fase

  • Fase 3

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Alemania
      • Berlin, Alemania, 12203
        • Charite-Univ. Berlin, Benjamin-Franklin /ID# 131927
      • Grosshansdorf, Alemania, 22927
        • Lungen Clinic Grosshansdorf /ID# 131928
      • Hamburg, Alemania, 20246
        • Univ Klinik Eppendorf Hamburg /ID# 131926
      • Löwenstein, Alemania, 74245
        • Klinik Loewenstein GmbH /ID# 131925
  • Argentina
      • Berazategui, Buenos Aires, Argentina, 1884
        • Coiba /Id# 132153
      • Pergamino, Argentina, 2700
        • Centro Investigacion Pergamino /ID# 132152
      • Rosario, Santa FE, Argentina, 2000
        • Hospital Britanico /ID# 134874
      • Rosario, Santa FE, Argentina, 2000
        • Instituto de Oncologia de Rosa /ID# 132150
  • Australia
    • New South Wales
      • Kogarah, New South Wales, Australia, 2217
        • St George Hospital /ID# 132481
      • Wollongong, New South Wales, Australia, 2500
        • Southern Medical Day Care Ctr /ID# 132482
    • South Australia
      • Bedford Park, South Australia, Australia, 5042
        • Flinders Centre for Innovation /ID# 134288
    • Tasmania
      • Hobart, Tasmania, Australia, 7000
        • Royal Hobart Hospital /ID# 132477
  • Canadá
    • Nova Scotia
      • Halifax, Nova Scotia, Canadá, B3H 1V7
        • Qe Ii Hsc /Id# 133408
    • Ontario
      • London, Ontario, Canadá, N6A 4L6
        • Victoria Hospital /ID# 132161
      • Windsor, Ontario, Canadá, N9C 3Z4
        • Windsor Regional Hospital /ID# 135989
    • Quebec
      • Quebec City, Quebec, Canadá, G6V 3Z1
        • CSSS Alphonse-Desjardins, CHAU de Levis /ID# 132155
  • Chequia
      • Liberec, Chequia, 602 00
        • Krajska nemocnice Liberec a.s. /ID# 132694
      • Ostrava, Chequia, 708 52
        • Univ Hosp Ostrava-Poruba /ID# 132690
      • Pardubice, Chequia, 532 03
        • Multiscan s.r.o. /ID# 132689
      • Prague, Chequia, 128 08
        • Vseobecna Fakultni Nemocnice /ID# 135118
  • Corea, república de
      • Cheongju, Corea, república de, 28644
        • Chungbuk National Univ Hosp /ID# 131611
    • Busan Gwang Yeogsi
      • Busan, Busan Gwang Yeogsi, Corea, república de, 49201
        • Dong-A University Hospital /ID# 131609
    • Gyeonggido
      • Seongnam, Gyeonggido, Corea, república de, 13620
        • Seoul National Univ Bundang ho /ID# 131610
    • Incheon Gwang Yeogsi
      • Jung-gu, Incheon Gwang Yeogsi, Corea, república de, 22332
        • Inha University Hospital /ID# 147924
    • Jeonranamdo
      • Gwangju, Jeonranamdo, Corea, república de, 61469
        • Chonnam National University Hospital /ID# 131612
    • Seoul Teugbyeolsi
      • Seoul, Seoul Teugbyeolsi, Corea, república de, 06351
        • Samsung Medical Center /ID# 132471
  • Dinamarca
    • Syddanmark
      • Odense C, Syddanmark, Dinamarca, 5000
        • Odense Universitets Hospital /ID# 131912
  • España
      • Alcorcon, España, 28922
        • Hospital Universitario Fundacion Alcorcon /ID# 132909
      • Alicante, España, 03010
        • Hospital General Universitario Alicante /ID# 132881
      • Barcelona, España, 08028
        • Hospital Universitario Dexeus - Grupo Quironsalud /ID# 132876
      • Barcelona, España, 08035
        • Hospital Universitario Vall d'Hebron /ID# 132871
      • Madrid, España, 28033
        • MD Anderson Madrid /ID# 132905
      • Madrid, España, 28046
        • Hospital Universitario La Paz /ID# 132870
      • Madrid, España, 28050
        • Hospital Universitario HM Sanchinarro /ID# 132869
      • Valencia, España, 46010
        • Hospital Clinico Universitario de Valencia /ID# 132873
    • Barcelona
      • L'Hospitalet de Llobregat, Barcelona, España, 08907
        • Hospital Duran i Reynals /ID# 132879
  • Estados Unidos
    • Alabama
      • Huntsville, Alabama, Estados Unidos, 35805
        • Clearview Cancer Institute /ID# 131434
      • Mobile, Alabama, Estados Unidos, 36617
        • University of South Alabama /ID# 131518
    • Arkansas
      • Springdale, Arkansas, Estados Unidos, 72762
        • Highlands Oncology Group /ID# 131250
    • California
      • Bakersfield, California, Estados Unidos, 93309
        • CBCC Global Research, Inc. at /ID# 132709
      • Encinitas, California, Estados Unidos, 92024
        • California Cancer Assoc. R&E /ID# 131392
      • Encinitas, California, Estados Unidos, 92024
        • California Cancer Assoc. R&E /ID# 131949
      • Los Angeles, California, Estados Unidos, 90017
        • LA Hem-Oncology Med Group /ID# 131639
      • Santa Rosa, California, Estados Unidos, 95403
        • St Jude Hospital dba St Joseph /ID# 132943
      • Whittier, California, Estados Unidos, 90603
        • Icri /Id# 132942
    • Florida
      • Gainesville, Florida, Estados Unidos, 32610
        • University of Florida - Archer /ID# 132408
    • Illinois
      • Evanston, Illinois, Estados Unidos, 60201
        • NorthShore University HealthSystem - Evanston Hospital /ID# 130200
    • Indiana
      • Goshen, Indiana, Estados Unidos, 46526
        • Goshen Center for Cancer Care /ID# 130216
    • Kentucky
      • Louisville, Kentucky, Estados Unidos, 40202
        • University of Louisville /ID# 130217
    • Louisiana
      • Lafayette, Louisiana, Estados Unidos, 70503
        • Cancer Center of Acadiana /ID# 133611
    • Michigan
      • Detroit, Michigan, Estados Unidos, 48202
        • Henry Ford Health System /ID# 130234
      • Lansing, Michigan, Estados Unidos, 48912
        • Herbert Herman Cancer Center /ID# 130239
    • Missouri
      • Saint Louis, Missouri, Estados Unidos, 63110
        • Washington University-School of Medicine /ID# 131651
    • New Jersey
      • Camden, New Jersey, Estados Unidos, 08103
        • MD Anderson Cancer Center at Cooper - Camden /ID# 131490
    • Ohio
      • Canton, Ohio, Estados Unidos, 44718
        • Gabrail Cancer Center Research /ID# 130205
    • Oklahoma
      • Oklahoma City, Oklahoma, Estados Unidos, 73104
        • Univ Oklahoma HSC /ID# 132888
    • Pennsylvania
      • Philadelphia, Pennsylvania, Estados Unidos, 19141
        • Albert Einstein Medical Center /ID# 134498
      • Pittsburgh, Pennsylvania, Estados Unidos, 15212
        • Allegheny General Hospital /ID# 134049
    • Tennessee
      • Germantown, Tennessee, Estados Unidos, 38138
        • The Jones Clinic, PC /ID# 130215
    • Texas
      • Dallas, Texas, Estados Unidos, 75390-7208
        • UT Southwestern Medical Center /ID# 130236
      • San Antonio, Texas, Estados Unidos, 78229
        • Univ Texas HSC San Antonio /ID# 132972
  • Federación Rusa
      • Arkhangelsk, Federación Rusa, 163045
        • archangel Clinical Oncology /ID# 132376
      • Balashikha, Federación Rusa, 143900
        • Moscow Regional Onc Dispensary /ID# 132381
      • Belgorod, Federación Rusa, 308010
        • Belgorod Oncology Dispensary /ID# 142638
      • Moscow, Federación Rusa, 125284
        • Moscow Res Onc Inst Hertsen /ID# 132370
      • Murmansk, Federación Rusa, 183047
        • State Regional Budgetary Healthcare Institution " Murmansk Regional Oncology Dis /ID# 137087
      • Orenburg, Federación Rusa, 460021
        • Orenburg Regional Clinical Onc /ID# 132371
      • Sankt-Peterburg, Federación Rusa, 192148
        • Strategic medical systems LLC /ID# 206383
      • Saransk, Federación Rusa, 430005
        • Ogarev Mordovia State Univ /ID# 132377
      • St. Petersburg, Federación Rusa, 197342
        • LLC BioEq Ltd. /ID# 132372
      • St. Petersburg, Federación Rusa, 197758
        • N.N. Petrov Research Inst Onc /ID# 137084
    • Moskva
      • Moscow, Moskva, Federación Rusa, 115478
        • Federal State Budgetary Scientific Institution N.N. Blokhin Russian Cancer Resea /ID# 137085
    • Sverdlovskaya Oblast
      • Ekaterinburg, Sverdlovskaya Oblast, Federación Rusa, 620043
        • Sverdlovsk Regional Oncology Center Dispensary /ID# 132375
  • Finlandia
      • Pori, Finlandia, 28500
        • Satakunnan Sairaanhoitopiiri /ID# 133632
      • Vaasa, Finlandia, 65130
        • Vaasa Central Hospital /ID# 131930
  • Hungría
      • Debrecen, Hungría, 4032
        • Debreceni Egyetem Klinikai Kozpont /ID# 132742
      • Edelény, Hungría, 3780
        • Koch Robert Hospital /ID# 133440
      • Farkasgyepu, Hungría, 8582
        • Veszprem Megyei Tudogyogyintez /ID# 132739
      • Gyor, Hungría, 9023
        • Petz Aladar Megyei Oktato Korh /ID# 132741
      • Kékesteto, Hungría, 3233
        • Matrahaza Gyogyintezet /ID# 132743
    • Borsod-Abauj-Zemplen
      • Miskolc, Borsod-Abauj-Zemplen, Hungría, 3529
        • CRU Hungary Egeszsegugyi és Szolgaltato Kft. /ID# 133441
    • Budapest
      • Budapest XII, Budapest, Hungría, 1122
        • Orszagos Koranyi Pulmonologiai Intezet /ID# 132738
  • Israel
      • Be'er Ya'akov, Israel, 70300
        • Assaf Harofeh Medical Center /ID# 132830
      • Jerusalem, Israel, 91031
        • Shaare Zedek Medical Center /ID# 132834
      • Kfar Saba, Israel, 4428164
        • Meir Medical Center /ID# 132832
      • Ramat Gan, Israel, 5239424
        • Sheba Medical Center /ID# 132833
  • Japón
      • Hiroshima, Japón, 730-8518
        • Hiroshima Citizens Hospital /ID# 135130
      • Kishiwada, Japón, 596-8501
        • Kishiwada City Hospital /ID# 136548
    • Aichi
      • Nagoya-shi, Aichi, Japón, 464-8681
        • Aichi Cancer Center Hospital /ID# 134129
    • Fukuoka
      • Kurume-shi, Fukuoka, Japón, 830-0011
        • Kurume University Hospital /ID# 134117
    • Hokkaido
      • Sapporo-shi, Hokkaido, Japón, 060-8648
        • Hokkaido University Hospital /ID# 134123
    • Kanagawa
      • Yokohama-shi, Kanagawa, Japón, 236-0051
        • Kanagawa Cardiovascular and Respiratory Center /ID# 134127
    • Miyagi
      • Sendai-shi, Miyagi, Japón, 980-0873
        • Sendai Kousei Hospital /ID# 135491
    • Osaka
      • Osaka-sayama-shi, Osaka, Japón, 589-8511
        • Kindai University Hospital /ID# 134112
      • Osaka-shi, Osaka, Japón, 534-0021
        • Osaka City General Hospital /ID# 134115
    • Tokyo
      • Chuo-ku, Tokyo, Japón, 104-0045
        • National Cancer Center Hospital /ID# 135129
      • Koto-ku, Tokyo, Japón, 135-8550
        • The Cancer Institute Hospital Of JFCR /ID# 135492
    • Yamaguchi
      • Ube-shi, Yamaguchi, Japón, 755-0241
        • Yamaguchi - Ube Medical Center /ID# 135284
  • Nueva Zelanda
      • Christchurch, Nueva Zelanda, 8011
        • Canterbury District Health Boa /ID# 132469
      • Wellington, Nueva Zelanda, 6021
        • Wellington Hospital (Capital and Coast District Health Board) /ID# 132470
  • Pavo
      • Ankara, Pavo, 06100
        • Hacettepe University Medical Faculty /ID# 131913
      • Ankara, Pavo, 06590
        • Ankara Univ Medical Faculty /ID# 131914
      • Bursa, Pavo, 16059
        • Uludag University Medical Faculty /ID# 131915
      • Diyarbakir, Pavo, 21200
        • Dicle Universitesi Tip /ID# 136570
      • Gaziantep, Pavo, 27310
        • Gaziantep Universitesi Med /ID# 131917
      • Izmir, Pavo, 35110
        • Dr. Suat Seren Gogus Has /ID# 136568
      • Malatya, Pavo, 44280
        • Inonu University /ID# 136569
  • Países Bajos
      • Amsterdam, Países Bajos, 1081 HV
        • Vrije Universiteit Medisch Centrum /ID# 131967
      • Eindhoven, Países Bajos, 5623 EJ
        • Catharina Ziekenhuis /ID# 131966
      • Harderwijk, Países Bajos, 3844 DG
        • Ziekenhuis St. Jansdal /ID# 131965
      • Nieuwegein, Países Bajos, 3435 CM
        • St. Antonius Ziekenhuis /ID# 133635
      • S Hertogenbosch, Países Bajos, 5223 GZ
        • Jeroen Bosch Ziekenhuis /ID# 131968
  • Reino Unido
      • Bath, Reino Unido, BA1 3NG
        • Royal United Hospitals Bath /ID# 132851
      • Belfast, Reino Unido, BT9 7AB
        • Belfast City Hospital /ID# 132858
      • Birmingham, Reino Unido, B9 5SS
        • Heart of England NHS Foundation Trust /ID# 132855
      • Blackburn, Reino Unido, BB2 3HH
        • Royal Blackburn Hospital /ID# 132853
      • Colchester, Reino Unido, CO4 5JL
        • Colchester General Hospital /ID# 133929
      • Cottingham, Reino Unido, HU16 5JQ
        • Castle Hill Hospital /ID# 135489
      • Doncaster, Reino Unido, DN15 7BH
        • Scunthorpe General Hospital /ID# 133931
      • Great Yarmouth, Reino Unido, NR31 6LA
        • James Paget University Hosp /ID# 131954
      • Gwent, Reino Unido, NP20 2UB
        • Royal Gwent Hospital /ID# 133935
      • Huddersfield, Reino Unido, HD3 3EA
        • Huddersfield Royal Infirmary /ID# 132854
      • London, Reino Unido, W6 8RF
        • Charing Cross Hospital /ID# 131959
      • Newcastle Upon Tyne, Reino Unido, NE7 7DN
        • The Newcastle Upon Tyne Hospitals NHS Foundation Trust Freeman Hospital /ID# 131661
      • York, Reino Unido, YO31 8HE
        • York Hospital /ID# 132859
    • England
      • Leicester, England, Reino Unido, LE1 5WW
        • Leicester Royal Infirmary /ID# 133930
    • Gloucestershire
      • Cheltenham, Gloucestershire, Reino Unido, GL53 7AN
        • Cheltenham General Hospital /ID# 131951
    • Norfolk
      • Norwich, Norfolk, Reino Unido, NR4 7UY
        • Norfolk and Norwich Univ Hosp /ID# 131953
  • Sudáfrica
      • Johannesburg, Sudáfrica, 2196
        • Sandton Oncology Medical Group /ID# 131774
    • Eastern Cape
      • Port Elizabeth, Eastern Cape, Sudáfrica, 6006
        • GVI Oncology /ID# 133268
    • Gauteng
      • Pretoria, Gauteng, Sudáfrica, 0044
        • Dr Albert, Bouwer and Jordaan Incorporated /ID# 131775
      • Pretoria, Gauteng, Sudáfrica, 0181
        • Mary Potter Oncology Centre /ID# 131776
    • Kwazulu-Natal
      • Durban, Kwazulu-Natal, Sudáfrica, 4091
        • The Oncology Centre /ID# 131773
    • Western Cape
      • Cape Town, Western Cape, Sudáfrica, 7460
        • Netcare Oncology Intervent Ctr /ID# 131777
      • Cape Town, Western Cape, Sudáfrica, 7570
        • Cape Town Oncology Trials /ID# 132734
      • Cape Town, Western Cape, Sudáfrica, 7700
        • GVI Rondebosch Oncology Centre /ID# 132732
  • Taiwán
      • Dalin Township, Taiwán, 622
        • Dalin Tzu Chi General Hospital /ID# 131872
      • Taipei City, Taiwán, 11031
        • Taipei Medical University Hospital /ID# 133817
      • Taipei City, Taiwán, 11217
        • Taipei Veterans General Hosp /ID# 131871
    • Taichung
      • Taichung City, Taichung, Taiwán, 40447
        • China Medical University Hosp /ID# 131870

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Subject must be ≥ 18 years of age with life expectancy > 12 weeks.
  • Subject must have cytologically or histologically confirmed advanced or metastatic non-squamous NSCLC and are current or former smokers.
  • Subject must have NSCLC that is not amenable to surgical resection or radiation with curative intent at time of screening.
  • Subject must have at least 1 unidimensional measurable NSCLC lesion on a computed tomography (CT) scan as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

Exclusion Criteria:

  • Subject has a known hypersensitivity to paclitaxel or to other drugs formulated with polyethoxylated castor oil (Cremophor).
  • Subject has a known hypersensitivity to platinum compounds.
  • Subject has peripheral neuropathy ≥ grade 2.
  • Subject has squamous NSCLC, or an untreated known epidermal growth factor receptor (EGFR) mutation of exon 19 deletion or L858R mutation in exon 21, or a known anaplastic lymphoma kinase (ALK) gene rearrangement.
  • Subject has received prior cytotoxic chemotherapy or chemoradiotherapy for NSCLC.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Veliparib + Carboplatin + Paclitaxel

Participants received 120 mg veliparib twice a day (BID) on Days -2 to 5 (7 days), carboplatin at an area under the curve (AUC) of 6 mg/mL*min on Day 1 and paclitaxel 200 mg/m² on Day 1 of each 21-day cycle for a maximum of 6 cycles.

After completion of up to 6 cycles, optional maintenance pemetrexed was administered as 500 mg/m² on Day 1 of each 21-day cycle until toxicity required cessation of therapy, or radiographic progression occurred.
Droga: Paclitaxel
Administered by Intravenous infusion on Day 1 of each 21-day cycle
Droga: Carboplatin
Administered by Intravenous infusion on Day 1 of each 21-day cycle
Droga: Veliparib
Oral capsule, administered twice daily for 7 days in each 21-day cycle
Otros nombres:
  • ABT-888
Droga: Pemetrexed
Administered by Intravenous infusion on Day 1 of each 21-day cycle
Otros nombres:
  • Alimata
Comparador activo: Investigator's Choice Chemotherapy

Participants received Investigator's choice of standard doublet chemotherapy consisting of 1 of the following 3 options, administered on Day 1 of each 21-day cycle for a maximum of 6 cycles:

  • Carboplatin AUC 6 mg/mL*min + paclitaxel 200 mg/m²
  • Cisplatin 75 mg/m² + pemetrexed 500 mg/m²
  • Carboplatin AUC 6 or AUC 5 mg/mL*min + pemetrexed 500 mg/m²

After completion of up to 6 cycles, optional maintenance pemetrexed was administered as 500 mg/m² on Day 1 of each 21-day cycle until toxicity required cessation of therapy, or radiographic progression occurred.
Droga: Paclitaxel
Administered by Intravenous infusion on Day 1 of each 21-day cycle
Droga: Carboplatin
Administered by Intravenous infusion on Day 1 of each 21-day cycle
Droga: Pemetrexed
Administered by Intravenous infusion on Day 1 of each 21-day cycle
Otros nombres:
  • Alimata
Droga: Cisplatin
Administered by Intravenous infusion on Day 1 of each 21-day cycle

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Overall Survival (OS) in the Lung Subtype Panel Positive Subgroup
Periodo de tiempo: From randomization up to the data cut-off date of 15 July 2019; median follow-up time was 44.5 and 45.3 months in LSP+ participants for the investigator's choice chemotherapy and veliparib + C/P arms, respectively.
Overall survival is defined as the time from the date that the participant was randomized to the date of the participant's death. Overall survival was estimated using Kaplan-Meier methodology. Participants still alive at the data cut-off date were censored at the date they were last known to be alive.
From randomization up to the data cut-off date of 15 July 2019; median follow-up time was 44.5 and 45.3 months in LSP+ participants for the investigator's choice chemotherapy and veliparib + C/P arms, respectively.

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Progression Free Survival (PFS) in the Lung Subtype Panel Positive Subgroup
Periodo de tiempo: From randomization up to the data cut-off date of 15 July 2019; the median follow-up time was 44.5 and 45.3 months in LSP+ participants for the investigator's choice chemotherapy and veliparib + C/P arms, respectively.

Progression-free survival is defined as the time from the date of randomization to the date of disease progression (PD) per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 or death (all causes of mortality), whichever occurred first.

PD: At least a 20% increase in the size of target lesions, taking as reference the smallest size recorded since the treatment started (Baseline or after) with an absolute increase of at least 5 mm, the appearance of one or more new lesions, or unequivocal progression of existing non-target lesions.

PFS was estimated using Kaplan-Meier methodology. Participants who did not have an event of disease progression or had not died on or before the cutoff date were censored at the date of their last disease progression assessment on or before the cut-off date. Any PD and death occurring > 26 weeks and > 12 weeks after the previous assessment, respectively, were excluded and patients were censored at last assessment before PD or death.
From randomization up to the data cut-off date of 15 July 2019; the median follow-up time was 44.5 and 45.3 months in LSP+ participants for the investigator's choice chemotherapy and veliparib + C/P arms, respectively.
Objective Response Rate (ORR) in the Lung Subtype Panel Positive Subgroup
Periodo de tiempo: Assessed on Day 1 of Cycles 3 and 5 then every 9 weeks for 1 year or until maintenance therapy was discontinued, then every 12 weeks until radiographic progression or death; median time on follow-up was 5.2 and 6.3 months in each group, respectively.

Objective response rate is defined as the percentage of participants with a complete response (CR) or partial response (PR) per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 criteria. Response must have been confirmed at a consecutive assessment 28 days or more after the assessment at which response was first observed.

CR: The disappearance of all target and non-target lesions and no new lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.

PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the Baseline sum diameters, persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits, or any new lesions.
Assessed on Day 1 of Cycles 3 and 5 then every 9 weeks for 1 year or until maintenance therapy was discontinued, then every 12 weeks until radiographic progression or death; median time on follow-up was 5.2 and 6.3 months in each group, respectively.
Overall Survival in All Participants
Periodo de tiempo: From randomization up to the data cut-off date of 15 July 2019; the median OS follow-up time was 45.4 and 44.6 months in all participants for the investigator's choice chemotherapy and veliparib + C/P arms, respectively.
Overall survival is defined as the time from the date that the participant was randomized to the date of the participant's death. OS was estimated using Kaplan-Meier methodology. Participants still alive at the data cut-off date were censored at the date they were last known to be alive.
From randomization up to the data cut-off date of 15 July 2019; the median OS follow-up time was 45.4 and 44.6 months in all participants for the investigator's choice chemotherapy and veliparib + C/P arms, respectively.
Progression Free Survival (PFS) in All Participants
Periodo de tiempo: From randomization up to the data cut-off date of 15 July 2019; the median follow-up time was 45.4 and 44.6 months in all participants for the investigator's choice chemotherapy and veliparib + C/P arms, respectively.

Progression-free survival is defined as the time from the date of randomization to the date of disease progression (PD) per RECIST version 1.1 or death (all causes of mortality), whichever occurred first.

PD: At least a 20% increase in the size of target lesions, taking as reference the smallest size recorded since the treatment started (Baseline or after) with an absolute increase of at least 5 mm, the appearance of one or more new lesions, or unequivocal progression of existing non-target lesions.

PFS was estimated using Kaplan-Meier methodology. Participants who did not have an event of disease progression or had not died on or before the cut-off date were censored at the date of their last disease progression assessment on or before the cut-off date. Any PD and death occurring > 26 weeks and > 12 weeks after the previous assessment, respectively, were excluded and patients were censored at last assessment before PD or death.
From randomization up to the data cut-off date of 15 July 2019; the median follow-up time was 45.4 and 44.6 months in all participants for the investigator's choice chemotherapy and veliparib + C/P arms, respectively.
Objective Response Rate (ORR) in All Participants
Periodo de tiempo: Assessed on Day 1 of Cycles 3 and 5 then every 9 weeks for 1 year or until maintenance therapy was discontinued, then every 12 weeks until radiographic progression or death; median time on follow-up was 6.7 and 5.9 months in each group, respectively.

Objective response rate is defined as the percentage of participants with a complete response (CR) or partial response (PR) per RECIST version 1.1 criteria. Response must have been confirmed at a consecutive assessment 28 days or more after the assessment at which response was first observed.

CR: The disappearance of all target and non-target lesions and no new lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.

PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the Baseline sum diameters, persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits, or any new lesions.
Assessed on Day 1 of Cycles 3 and 5 then every 9 weeks for 1 year or until maintenance therapy was discontinued, then every 12 weeks until radiographic progression or death; median time on follow-up was 6.7 and 5.9 months in each group, respectively.

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

AbbVie

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

30 de septiembre de 2014

Finalización primaria (Actual)

14 de noviembre de 2019

Finalización del estudio (Actual)

21 de febrero de 2020

Fechas de registro del estudio

Enviado por primera vez

9 de octubre de 2014

Primero enviado que cumplió con los criterios de control de calidad

9 de octubre de 2014

Publicado por primera vez (Estimar)

15 de octubre de 2014

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

26 de febrero de 2021

Última actualización enviada que cumplió con los criterios de control de calidad

8 de febrero de 2021

Última verificación

1 de febrero de 2021

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • M14-359
  • 2014-002565-30 (Número EudraCT)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

Marco de tiempo para compartir IPD

Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.

Criterios de acceso compartido de IPD

Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.

Tipo de información de apoyo para compartir IPD

  • PROTOCOLO DE ESTUDIO
  • SAVIA
  • CÓDIGO_ANALÍTICO
  • RSC

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

Sí

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

producto fabricado y exportado desde los EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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