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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

2021年2月8日 更新者：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.

研究概览

地位

完全的

条件

干预/治疗

研究类型

介入性

注册 (实际的)

595

阶段

  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

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

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：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.
药品：Paclitaxel
Administered by Intravenous infusion on Day 1 of each 21-day cycle
药品：Carboplatin
Administered by Intravenous infusion on Day 1 of each 21-day cycle
药品：Veliparib
Oral capsule, administered twice daily for 7 days in each 21-day cycle
其他名称：
  • ABT-888
药品：Pemetrexed
Administered by Intravenous infusion on Day 1 of each 21-day cycle
其他名称：
  • 力比泰
有源比较器：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.
药品：Paclitaxel
Administered by Intravenous infusion on Day 1 of each 21-day cycle
药品：Carboplatin
Administered by Intravenous infusion on Day 1 of each 21-day cycle
药品：Pemetrexed
Administered by Intravenous infusion on Day 1 of each 21-day cycle
其他名称：
  • 力比泰
药品：Cisplatin
Administered by Intravenous infusion on Day 1 of each 21-day cycle

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Overall Survival (OS) in the Lung Subtype Panel Positive Subgroup
大体时间：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.

次要结果测量

结果测量
措施说明
大体时间
Progression Free Survival (PFS) in the Lung Subtype Panel Positive Subgroup
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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.

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AbbVie

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研究记录日期

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研究主要日期

学习开始 (实际的)

2014年9月30日

初级完成 (实际的)

2019年11月14日

研究完成 (实际的)

2020年2月21日

研究注册日期

首次提交

2014年10月9日

首先提交符合 QC 标准的

2014年10月9日

首次发布 (估计)

2014年10月15日

研究记录更新

最后更新发布 (实际的)

2021年2月26日

上次提交的符合 QC 标准的更新

2021年2月8日

最后验证

2021年2月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

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

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

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.

IPD 共享时间框架

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

IPD 共享访问标准

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.

IPD 共享支持信息类型

  • 研究方案
  • 树液
  • 分析代码
  • 企业社会责任

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

不

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