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
Study Details
Study Description
Brief Summary
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 3 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
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. |
Drug: Paclitaxel
Administered by Intravenous infusion on Day 1 of each 21-day cycle
Drug: Carboplatin
Administered by Intravenous infusion on Day 1 of each 21-day cycle
Drug: Veliparib
Oral capsule, administered twice daily for 7 days in each 21-day cycle
Other Names:
Drug: Pemetrexed
Administered by Intravenous infusion on Day 1 of each 21-day cycle
Other Names:
|
Active Comparator: 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. |
Drug: Paclitaxel
Administered by Intravenous infusion on Day 1 of each 21-day cycle
Drug: Carboplatin
Administered by Intravenous infusion on Day 1 of each 21-day cycle
Drug: Cisplatin
Administered by Intravenous infusion on Day 1 of each 21-day cycle
Drug: Pemetrexed
Administered by Intravenous infusion on Day 1 of each 21-day cycle
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Overall Survival (OS) in the Lung Subtype Panel Positive Subgroup [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.
Secondary Outcome Measures
- Progression Free Survival (PFS) in the Lung Subtype Panel Positive Subgroup [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.
- Objective Response Rate (ORR) in the Lung Subtype Panel Positive Subgroup [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.
- Overall Survival in All Participants [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.
- Progression Free Survival (PFS) in All Participants [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.
- Objective Response Rate (ORR) in All Participants [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.
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Clearview Cancer Institute /ID# 131434 | Huntsville | Alabama | United States | 35805 |
2 | University of South Alabama /ID# 131518 | Mobile | Alabama | United States | 36617 |
3 | Highlands Oncology Group /ID# 131250 | Springdale | Arkansas | United States | 72762 |
4 | CBCC Global Research, Inc. at /ID# 132709 | Bakersfield | California | United States | 93309 |
5 | California Cancer Assoc. R&E /ID# 131392 | Encinitas | California | United States | 92024 |
6 | California Cancer Assoc. R&E /ID# 131949 | Encinitas | California | United States | 92024 |
7 | LA Hem-Oncology Med Group /ID# 131639 | Los Angeles | California | United States | 90017 |
8 | St Jude Hospital dba St Joseph /ID# 132943 | Santa Rosa | California | United States | 95403 |
9 | Icri /Id# 132942 | Whittier | California | United States | 90603 |
10 | University of Florida - Archer /ID# 132408 | Gainesville | Florida | United States | 32610 |
11 | NorthShore University HealthSystem - Evanston Hospital /ID# 130200 | Evanston | Illinois | United States | 60201 |
12 | Goshen Center for Cancer Care /ID# 130216 | Goshen | Indiana | United States | 46526 |
13 | University of Louisville /ID# 130217 | Louisville | Kentucky | United States | 40202 |
14 | Cancer Center of Acadiana /ID# 133611 | Lafayette | Louisiana | United States | 70503 |
15 | Henry Ford Health System /ID# 130234 | Detroit | Michigan | United States | 48202 |
16 | Herbert Herman Cancer Center /ID# 130239 | Lansing | Michigan | United States | 48912 |
17 | Washington University-School of Medicine /ID# 131651 | Saint Louis | Missouri | United States | 63110 |
18 | MD Anderson Cancer Center at Cooper - Camden /ID# 131490 | Camden | New Jersey | United States | 08103 |
19 | Gabrail Cancer Center Research /ID# 130205 | Canton | Ohio | United States | 44718 |
20 | Univ Oklahoma HSC /ID# 132888 | Oklahoma City | Oklahoma | United States | 73104 |
21 | Albert Einstein Medical Center /ID# 134498 | Philadelphia | Pennsylvania | United States | 19141 |
22 | Allegheny General Hospital /ID# 134049 | Pittsburgh | Pennsylvania | United States | 15212 |
23 | The Jones Clinic, PC /ID# 130215 | Germantown | Tennessee | United States | 38138 |
24 | UT Southwestern Medical Center /ID# 130236 | Dallas | Texas | United States | 75390-7208 |
25 | Univ Texas HSC San Antonio /ID# 132972 | San Antonio | Texas | United States | 78229 |
26 | Coiba /Id# 132153 | Berazategui, Buenos Aires | Argentina | 1884 | |
27 | Centro Investigacion Pergamino /ID# 132152 | Pergamino | Argentina | 2700 | |
28 | Hospital Britanico /ID# 134874 | Rosario, Santa FE | Argentina | 2000 | |
29 | Instituto de Oncologia de Rosa /ID# 132150 | Rosario, Santa FE | Argentina | 2000 | |
30 | St George Hospital /ID# 132481 | Kogarah | New South Wales | Australia | 2217 |
31 | Southern Medical Day Care Ctr /ID# 132482 | Wollongong | New South Wales | Australia | 2500 |
32 | Flinders Centre for Innovation /ID# 134288 | Bedford Park | South Australia | Australia | 5042 |
33 | Royal Hobart Hospital /ID# 132477 | Hobart | Tasmania | Australia | 7000 |
34 | Qe Ii Hsc /Id# 133408 | Halifax | Nova Scotia | Canada | B3H 1V7 |
35 | Victoria Hospital /ID# 132161 | London | Ontario | Canada | N6A 4L6 |
36 | Windsor Regional Hospital /ID# 135989 | Windsor | Ontario | Canada | N9C 3Z4 |
37 | CSSS Alphonse-Desjardins, CHAU de Levis /ID# 132155 | Quebec City | Quebec | Canada | G6V 3Z1 |
38 | Krajska nemocnice Liberec a.s. /ID# 132694 | Liberec | Czechia | 602 00 | |
39 | Univ Hosp Ostrava-Poruba /ID# 132690 | Ostrava | Czechia | 708 52 | |
40 | Multiscan s.r.o. /ID# 132689 | Pardubice | Czechia | 532 03 | |
41 | Vseobecna Fakultni Nemocnice /ID# 135118 | Prague | Czechia | 128 08 | |
42 | Odense Universitets Hospital /ID# 131912 | Odense C | Syddanmark | Denmark | 5000 |
43 | Satakunnan Sairaanhoitopiiri /ID# 133632 | Pori | Finland | 28500 | |
44 | Vaasa Central Hospital /ID# 131930 | Vaasa | Finland | 65130 | |
45 | Charite-Univ. Berlin, Benjamin-Franklin /ID# 131927 | Berlin | Germany | 12203 | |
46 | Lungen Clinic Grosshansdorf /ID# 131928 | Grosshansdorf | Germany | 22927 | |
47 | Univ Klinik Eppendorf Hamburg /ID# 131926 | Hamburg | Germany | 20246 | |
48 | Klinik Loewenstein GmbH /ID# 131925 | Löwenstein | Germany | 74245 | |
49 | CRU Hungary Egeszsegugyi és Szolgaltato Kft. /ID# 133441 | Miskolc | Borsod-Abauj-Zemplen | Hungary | 3529 |
50 | Orszagos Koranyi Pulmonologiai Intezet /ID# 132738 | Budapest XII | Budapest | Hungary | 1122 |
51 | Debreceni Egyetem Klinikai Kozpont /ID# 132742 | Debrecen | Hungary | 4032 | |
52 | Koch Robert Hospital /ID# 133440 | Edelény | Hungary | 3780 | |
53 | Veszprem Megyei Tudogyogyintez /ID# 132739 | Farkasgyepu | Hungary | 8582 | |
54 | Petz Aladar Megyei Oktato Korh /ID# 132741 | Gyor | Hungary | 9023 | |
55 | Matrahaza Gyogyintezet /ID# 132743 | Kékesteto | Hungary | 3233 | |
56 | Assaf Harofeh Medical Center /ID# 132830 | Be'er Ya'akov | Israel | 70300 | |
57 | Shaare Zedek Medical Center /ID# 132834 | Jerusalem | Israel | 91031 | |
58 | Meir Medical Center /ID# 132832 | Kfar Saba | Israel | 4428164 | |
59 | Sheba Medical Center /ID# 132833 | Ramat Gan | Israel | 5239424 | |
60 | Aichi Cancer Center Hospital /ID# 134129 | Nagoya-shi | Aichi | Japan | 464-8681 |
61 | Kurume University Hospital /ID# 134117 | Kurume-shi | Fukuoka | Japan | 830-0011 |
62 | Hokkaido University Hospital /ID# 134123 | Sapporo-shi | Hokkaido | Japan | 060-8648 |
63 | Kanagawa Cardiovascular and Respiratory Center /ID# 134127 | Yokohama-shi | Kanagawa | Japan | 236-0051 |
64 | Sendai Kousei Hospital /ID# 135491 | Sendai-shi | Miyagi | Japan | 980-0873 |
65 | Kindai University Hospital /ID# 134112 | Osaka-sayama-shi | Osaka | Japan | 589-8511 |
66 | Osaka City General Hospital /ID# 134115 | Osaka-shi | Osaka | Japan | 534-0021 |
67 | National Cancer Center Hospital /ID# 135129 | Chuo-ku | Tokyo | Japan | 104-0045 |
68 | The Cancer Institute Hospital Of JFCR /ID# 135492 | Koto-ku | Tokyo | Japan | 135-8550 |
69 | Yamaguchi - Ube Medical Center /ID# 135284 | Ube-shi | Yamaguchi | Japan | 755-0241 |
70 | Hiroshima Citizens Hospital /ID# 135130 | Hiroshima | Japan | 730-8518 | |
71 | Kishiwada City Hospital /ID# 136548 | Kishiwada | Japan | 596-8501 | |
72 | Dong-A University Hospital /ID# 131609 | Busan | Busan Gwang Yeogsi | Korea, Republic of | 49201 |
73 | Seoul National Univ Bundang ho /ID# 131610 | Seongnam | Gyeonggido | Korea, Republic of | 13620 |
74 | Inha University Hospital /ID# 147924 | Jung-gu | Incheon Gwang Yeogsi | Korea, Republic of | 22332 |
75 | Chonnam National University Hospital /ID# 131612 | Gwangju | Jeonranamdo | Korea, Republic of | 61469 |
76 | Samsung Medical Center /ID# 132471 | Seoul | Seoul Teugbyeolsi | Korea, Republic of | 06351 |
77 | Chungbuk National Univ Hosp /ID# 131611 | Cheongju | Korea, Republic of | 28644 | |
78 | Vrije Universiteit Medisch Centrum /ID# 131967 | Amsterdam | Netherlands | 1081 HV | |
79 | Catharina Ziekenhuis /ID# 131966 | Eindhoven | Netherlands | 5623 EJ | |
80 | Ziekenhuis St. Jansdal /ID# 131965 | Harderwijk | Netherlands | 3844 DG | |
81 | St. Antonius Ziekenhuis /ID# 133635 | Nieuwegein | Netherlands | 3435 CM | |
82 | Jeroen Bosch Ziekenhuis /ID# 131968 | S Hertogenbosch | Netherlands | 5223 GZ | |
83 | Canterbury District Health Boa /ID# 132469 | Christchurch | New Zealand | 8011 | |
84 | Wellington Hospital (Capital and Coast District Health Board) /ID# 132470 | Wellington | New Zealand | 6021 | |
85 | Federal State Budgetary Scientific Institution N.N. Blokhin Russian Cancer Resea /ID# 137085 | Moscow | Moskva | Russian Federation | 115478 |
86 | Sverdlovsk Regional Oncology Center Dispensary /ID# 132375 | Ekaterinburg | Sverdlovskaya Oblast | Russian Federation | 620043 |
87 | archangel Clinical Oncology /ID# 132376 | Arkhangelsk | Russian Federation | 163045 | |
88 | Moscow Regional Onc Dispensary /ID# 132381 | Balashikha | Russian Federation | 143900 | |
89 | Belgorod Oncology Dispensary /ID# 142638 | Belgorod | Russian Federation | 308010 | |
90 | Moscow Res Onc Inst Hertsen /ID# 132370 | Moscow | Russian Federation | 125284 | |
91 | State Regional Budgetary Healthcare Institution " Murmansk Regional Oncology Dis /ID# 137087 | Murmansk | Russian Federation | 183047 | |
92 | Orenburg Regional Clinical Onc /ID# 132371 | Orenburg | Russian Federation | 460021 | |
93 | Strategic medical systems LLC /ID# 206383 | Sankt-Peterburg | Russian Federation | 192148 | |
94 | Ogarev Mordovia State Univ /ID# 132377 | Saransk | Russian Federation | 430005 | |
95 | LLC BioEq Ltd. /ID# 132372 | St. Petersburg | Russian Federation | 197342 | |
96 | N.N. Petrov Research Inst Onc /ID# 137084 | St. Petersburg | Russian Federation | 197758 | |
97 | GVI Oncology /ID# 133268 | Port Elizabeth | Eastern Cape | South Africa | 6006 |
98 | Dr Albert, Bouwer and Jordaan Incorporated /ID# 131775 | Pretoria | Gauteng | South Africa | 0044 |
99 | Mary Potter Oncology Centre /ID# 131776 | Pretoria | Gauteng | South Africa | 0181 |
100 | The Oncology Centre /ID# 131773 | Durban | Kwazulu-Natal | South Africa | 4091 |
101 | Netcare Oncology Intervent Ctr /ID# 131777 | Cape Town | Western Cape | South Africa | 7460 |
102 | Cape Town Oncology Trials /ID# 132734 | Cape Town | Western Cape | South Africa | 7570 |
103 | GVI Rondebosch Oncology Centre /ID# 132732 | Cape Town | Western Cape | South Africa | 7700 |
104 | Sandton Oncology Medical Group /ID# 131774 | Johannesburg | South Africa | 2196 | |
105 | Hospital Duran i Reynals /ID# 132879 | L'Hospitalet de Llobregat | Barcelona | Spain | 08907 |
106 | Hospital Universitario Fundacion Alcorcon /ID# 132909 | Alcorcon | Spain | 28922 | |
107 | Hospital General Universitario Alicante /ID# 132881 | Alicante | Spain | 03010 | |
108 | Hospital Universitario Dexeus - Grupo Quironsalud /ID# 132876 | Barcelona | Spain | 08028 | |
109 | Hospital Universitario Vall d'Hebron /ID# 132871 | Barcelona | Spain | 08035 | |
110 | MD Anderson Madrid /ID# 132905 | Madrid | Spain | 28033 | |
111 | Hospital Universitario La Paz /ID# 132870 | Madrid | Spain | 28046 | |
112 | Hospital Universitario HM Sanchinarro /ID# 132869 | Madrid | Spain | 28050 | |
113 | Hospital Clinico Universitario de Valencia /ID# 132873 | Valencia | Spain | 46010 | |
114 | China Medical University Hosp /ID# 131870 | Taichung City | Taichung | Taiwan | 40447 |
115 | Dalin Tzu Chi General Hospital /ID# 131872 | Dalin Township | Taiwan | 622 | |
116 | Taipei Medical University Hospital /ID# 133817 | Taipei City | Taiwan | 11031 | |
117 | Taipei Veterans General Hosp /ID# 131871 | Taipei City | Taiwan | 11217 | |
118 | Hacettepe University Medical Faculty /ID# 131913 | Ankara | Turkey | 06100 | |
119 | Ankara Univ Medical Faculty /ID# 131914 | Ankara | Turkey | 06590 | |
120 | Uludag University Medical Faculty /ID# 131915 | Bursa | Turkey | 16059 | |
121 | Dicle Universitesi Tip /ID# 136570 | Diyarbakir | Turkey | 21200 | |
122 | Gaziantep Universitesi Med /ID# 131917 | Gaziantep | Turkey | 27310 | |
123 | Dr. Suat Seren Gogus Has /ID# 136568 | Izmir | Turkey | 35110 | |
124 | Inonu University /ID# 136569 | Malatya | Turkey | 44280 | |
125 | Leicester Royal Infirmary /ID# 133930 | Leicester | England | United Kingdom | LE1 5WW |
126 | Cheltenham General Hospital /ID# 131951 | Cheltenham | Gloucestershire | United Kingdom | GL53 7AN |
127 | Norfolk and Norwich Univ Hosp /ID# 131953 | Norwich | Norfolk | United Kingdom | NR4 7UY |
128 | Royal United Hospitals Bath /ID# 132851 | Bath | United Kingdom | BA1 3NG | |
129 | Belfast City Hospital /ID# 132858 | Belfast | United Kingdom | BT9 7AB | |
130 | Heart of England NHS Foundation Trust /ID# 132855 | Birmingham | United Kingdom | B9 5SS | |
131 | Royal Blackburn Hospital /ID# 132853 | Blackburn | United Kingdom | BB2 3HH | |
132 | Colchester General Hospital /ID# 133929 | Colchester | United Kingdom | CO4 5JL | |
133 | Castle Hill Hospital /ID# 135489 | Cottingham | United Kingdom | HU16 5JQ | |
134 | Scunthorpe General Hospital /ID# 133931 | Doncaster | United Kingdom | DN15 7BH | |
135 | James Paget University Hosp /ID# 131954 | Great Yarmouth | United Kingdom | NR31 6LA | |
136 | Royal Gwent Hospital /ID# 133935 | Gwent | United Kingdom | NP20 2UB | |
137 | Huddersfield Royal Infirmary /ID# 132854 | Huddersfield | United Kingdom | HD3 3EA | |
138 | Charing Cross Hospital /ID# 131959 | London | United Kingdom | W6 8RF | |
139 | The Newcastle Upon Tyne Hospitals NHS Foundation Trust Freeman Hospital /ID# 131661 | Newcastle Upon Tyne | United Kingdom | NE7 7DN | |
140 | York Hospital /ID# 132859 | York | United Kingdom | YO31 8HE |
Sponsors and Collaborators
- AbbVie
Investigators
- Study Director: AbbVie Inc., AbbVie
Study Documents (Full-Text)
More Information
Publications
None provided.- M14-359
- 2014-002565-30
Study Results
Participant Flow
Recruitment Details | Participants were enrolled at 131 sites in 20 countries (Argentina, Australia, Canada, Czech Republic, Denmark, Finland, Germany, Hungary, Israel, Japan, South Korea, Netherlands, New Zealand, Russian Federation, South Africa, Spain, Taiwan, Turkey, United Kingdom, and United States). |
---|---|
Pre-assignment Detail | Participants were randomized in a 1:1 ratio to veliparib in combination with carboplatin and paclitaxel (C/P) or investigator's choice of platinum doublet chemotherapy. Randomization was stratified by smoking status (current versus former), by the investigators' preferred platinum doublet therapy (carboplatin/paclitaxel versus cisplatin/pemetrexed versus carboplatin/pemetrexed), by gender (male versus female) and by Eastern Cooperative Oncology Group (ECOG) performance status (0 versus 1). |
Arm/Group Title | Investigator's Choice Chemotherapy | Veliparib + Carboplatin + Paclitaxel |
---|---|---|
Arm/Group Description | 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 at an area under the curve (AUC) of 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. | Participants received 120 mg veliparib twice a day (BID) on Days -2 to 5 (7 days), carboplatin at an 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. |
Period Title: Overall Study | ||
STARTED | 297 | 298 |
Received Treatment | 288 | 293 |
Received Maintenance Therapy | 148 | 123 |
COMPLETED | 37 | 39 |
NOT COMPLETED | 260 | 259 |
Baseline Characteristics
Arm/Group Title | Investigator's Choice Chemotherapy | Veliparib + Carboplatin + Paclitaxel | Total |
---|---|---|---|
Arm/Group Description | 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. | Participants received 120 mg veliparib BID on Days -2 to 5 (7 days), carboplatin at an 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. | Total of all reporting groups |
Overall Participants | 297 | 298 | 595 |
Age (years) [Mean (Standard Deviation) ] | |||
Mean (Standard Deviation) [years] |
63.1
(8.99)
|
62.7
(9.02)
|
62.9
(9.0)
|
Age, Customized (Count of Participants) | |||
< 65 years |
153
51.5%
|
163
54.7%
|
316
53.1%
|
≥ 65 years |
144
48.5%
|
135
45.3%
|
279
46.9%
|
Sex: Female, Male (Count of Participants) | |||
Female |
90
30.3%
|
92
30.9%
|
182
30.6%
|
Male |
207
69.7%
|
206
69.1%
|
413
69.4%
|
Ethnicity (NIH/OMB) (Count of Participants) | |||
Hispanic or Latino |
22
7.4%
|
26
8.7%
|
48
8.1%
|
Not Hispanic or Latino |
275
92.6%
|
272
91.3%
|
547
91.9%
|
Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
Race/Ethnicity, Customized (Count of Participants) | |||
White |
233
78.5%
|
229
76.8%
|
462
77.6%
|
Black |
11
3.7%
|
11
3.7%
|
22
3.7%
|
Asian |
53
17.8%
|
57
19.1%
|
110
18.5%
|
Other |
0
0%
|
1
0.3%
|
1
0.2%
|
Region (Count of Participants) | |||
US and Western Europe and Australia and Canada |
177
59.6%
|
157
52.7%
|
334
56.1%
|
Eastern Europe/Russia |
68
22.9%
|
88
29.5%
|
156
26.2%
|
Japan |
37
12.5%
|
35
11.7%
|
72
12.1%
|
Other Asian |
15
5.1%
|
18
6%
|
33
5.5%
|
Smoking Status (Count of Participants) | |||
Current smoker |
153
51.5%
|
152
51%
|
305
51.3%
|
Past smoker |
144
48.5%
|
146
49%
|
290
48.7%
|
Investigators' Preferred Platinum Doublet Therapy (Count of Participants) | |||
Carboplatin/paclitaxel |
71
23.9%
|
70
23.5%
|
141
23.7%
|
Cisplatin/pemetrexed |
95
32%
|
100
33.6%
|
195
32.8%
|
Carboplatin/pemetrexed |
131
44.1%
|
128
43%
|
259
43.5%
|
Eastern Cooperative Oncology Group (ECOG) Performance Status (Count of Participants) | |||
Grade 0 (fully active) |
113
38%
|
116
38.9%
|
229
38.5%
|
Grade 1 (restricted but ambulatory) |
184
62%
|
182
61.1%
|
366
61.5%
|
Lung Subtype Panel (LSP) Assay Results (Count of Participants) | |||
LSP positive |
40
13.5%
|
40
13.4%
|
80
13.4%
|
LSP negative |
53
17.8%
|
74
24.8%
|
127
21.3%
|
Outcome Measures
Title | Overall Survival (OS) in the Lung Subtype Panel Positive Subgroup |
---|---|
Description | 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. |
Time Frame | 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. |
Outcome Measure Data
Analysis Population Description |
---|
Participants in the ITT population who were LSP positive (LSP+) |
Arm/Group Title | Investigator's Choice Chemotherapy | Veliparib + Carboplatin + Paclitaxel |
---|---|---|
Arm/Group Description | 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. | Participants received 120 mg veliparib BID on Days -2 to 5 (7 days), carboplatin at an 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. |
Measure Participants | 40 | 40 |
Median (95% Confidence Interval) [months] |
9.2
|
11.2
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Investigator's Choice Chemotherapy, Veliparib + Carboplatin + Paclitaxel |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | A fixed sequence testing procedure was used for analyses of the primary and secondary efficacy endpoints to control for the familywise error rate. If veliparib plus C/P treatment was not statistically significantly better compared to the investigators' choice of standard therapy for the primary efficacy endpoint of OS in LSP+ participants, then statistical significance would not be declared for any of the secondary efficacy endpoints. | |
Statistical Test of Hypothesis | p-Value | 0.113 |
Comments | Statistical significance was determined by a two-sided P value ≤ 0.05. | |
Method | Log Rank | |
Comments | Log rank test stratified by ECOG performance status, investigators' preferred platinum therapy, and gender. | |
Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
Estimated Value | 0.644 | |
Confidence Interval |
(2-Sided) 95% 0.396 to 1.048 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Hazard ratio obtained using the covariate adjusted Cox Proportional Hazard Model with covariates being ECOG performance status, investigators' preferred platinum therapy, and gender. |
Title | Progression Free Survival (PFS) in the Lung Subtype Panel Positive Subgroup |
---|---|
Description | 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. |
Time Frame | 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. |
Outcome Measure Data
Analysis Population Description |
---|
Participants in the ITT population who were LSP positive |
Arm/Group Title | Investigator's Choice Chemotherapy | Veliparib + Carboplatin + Paclitaxel |
---|---|---|
Arm/Group Description | 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. | Participants received 120 mg veliparib BID on Days -2 to 5 (7 days), carboplatin at an 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. |
Measure Participants | 40 | 40 |
Median (95% Confidence Interval) [months] |
5.2
|
6.3
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Investigator's Choice Chemotherapy, Veliparib + Carboplatin + Paclitaxel |
---|---|---|
Comments | ||
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.260 |
Comments | ||
Method | Log Rank | |
Comments | Log-rank test stratified by investigator's preferred platinum therapy, gender, and ECOG performance status. | |
Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
Estimated Value | 0.647 | |
Confidence Interval |
(2-Sided) 95% 0.388 to 1.080 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | The hazard ratio was obtained using the covariate adjusted Cox Proportional Hazard Model with covariates of ECOG performance status, investigators' preferred platinum therapy, and gender. |
Title | Objective Response Rate (ORR) in the Lung Subtype Panel Positive Subgroup |
---|---|
Description | 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. |
Time Frame | 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. |
Outcome Measure Data
Analysis Population Description |
---|
Participants in the ITT population who were LSP positive |
Arm/Group Title | Investigator's Choice Chemotherapy | Veliparib + Carboplatin + Paclitaxel |
---|---|---|
Arm/Group Description | 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. | Participants received 120 mg veliparib BID on Days -2 to 5 (7 days), carboplatin at an 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. |
Measure Participants | 40 | 40 |
Number (95% Confidence Interval) [percentage of participants] |
30.0
10.1%
|
22.5
7.6%
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Investigator's Choice Chemotherapy, Veliparib + Carboplatin + Paclitaxel |
---|---|---|
Comments | ||
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.455 |
Comments | ||
Method | Regression, Logistic | |
Comments | Logistic regression adjusted for the covariates of ECOG performance status, investigators' preferred platinum therapy, and gender. | |
Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
Estimated Value | 0.66 | |
Confidence Interval |
(2-Sided) 95% 0.23 to 1.90 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Odds ratio is from covariate adjusted logistic regression with the covariates being ECOG performance status, investigators' preferred platinum therapy, and gender. |
Title | Overall Survival in All Participants |
---|---|
Description | 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. |
Time Frame | 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. |
Outcome Measure Data
Analysis Population Description |
---|
Participants in the ITT population |
Arm/Group Title | Investigator's Choice Chemotherapy | Veliparib + Carboplatin + Paclitaxel |
---|---|---|
Arm/Group Description | 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. | Participants received 120 mg veliparib BID on Days -2 to 5 (7 days), carboplatin at an 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. |
Measure Participants | 297 | 298 |
Median (95% Confidence Interval) [months] |
12.1
|
12.1
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Investigator's Choice Chemotherapy, Veliparib + Carboplatin + Paclitaxel |
---|---|---|
Comments | ||
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.846 |
Comments | ||
Method | Log Rank | |
Comments | Log rank test stratified by LSP status, ECOG performance status, investigators' preferred platinum therapy, and gender. | |
Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
Estimated Value | 0.986 | |
Confidence Interval |
(2-Sided) 95% 0.827 to 1.176 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | The hazard ratio was obtained using the covariate adjusted Cox Proportional Hazard Model with covariates of LSP status, ECOG performance status, investigators' preferred platinum therapy, and gender. |
Title | Progression Free Survival (PFS) in All Participants |
---|---|
Description | 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. |
Time Frame | 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. |
Outcome Measure Data
Analysis Population Description |
---|
Participants in the ITT population |
Arm/Group Title | Investigator's Choice Chemotherapy | Veliparib + Carboplatin + Paclitaxel |
---|---|---|
Arm/Group Description | 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. | Participants received 120 mg veliparib BID on Days -2 to 5 (7 days), carboplatin at an 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. |
Measure Participants | 297 | 298 |
Median (95% Confidence Interval) [months] |
6.7
|
5.9
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Investigator's Choice Chemotherapy, Veliparib + Carboplatin + Paclitaxel |
---|---|---|
Comments | ||
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.473 |
Comments | ||
Method | Log Rank | |
Comments | Log rank test stratified by LSP status, ECOG performance status, investigators' preferred platinum therapy, and gender. | |
Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
Estimated Value | 1.035 | |
Confidence Interval |
(2-Sided) 95% 0.867 to 1.235 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | The hazard ratio was obtained using the covariate adjusted Cox Proportional Hazard Model with covariates of LSP status, ECOG performance status, investigators' preferred platinum therapy, and gender. |
Title | Objective Response Rate (ORR) in All Participants |
---|---|
Description | 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. |
Time Frame | 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. |
Outcome Measure Data
Analysis Population Description |
---|
Participants in the ITT population |
Arm/Group Title | Investigator's Choice Chemotherapy | Veliparib + Carboplatin + Paclitaxel |
---|---|---|
Arm/Group Description | 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. | Participants received 120 mg veliparib BID on Days -2 to 5 (7 days), carboplatin at an 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. |
Measure Participants | 297 | 298 |
Number (95% Confidence Interval) [percentage of participants] |
29.0
9.8%
|
26.2
8.8%
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Investigator's Choice Chemotherapy, Veliparib + Carboplatin + Paclitaxel |
---|---|---|
Comments | ||
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.409 |
Comments | ||
Method | Regression, Logistic | |
Comments | Logistic regression adjusted for the covariates of LSP status, ECOG performance status, investigators' preferred platinum therapy, and gender. | |
Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
Estimated Value | 0.86 | |
Confidence Interval |
(2-Sided) 95% 0.59 to 1.24 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Odds ratio is from covariate adjusted logistic regression with the covariates being LSP status, ECOG performance status, investigators' preferred platinum therapy, and gender. |
Adverse Events
Time Frame | All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment. | |||
---|---|---|---|---|
Adverse Event Reporting Description | All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy). | |||
Arm/Group Title | Investigator's Choice Chemotherapy | Veliparib + Carboplatin + Paclitaxel | ||
Arm/Group Description | 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. | Participants received 120 mg veliparib twice a day (BID) on Days -2 to 5 (7 days), carboplatin at an 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. | ||
All Cause Mortality |
||||
Investigator's Choice Chemotherapy | Veliparib + Carboplatin + Paclitaxel | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 255/297 (85.9%) | 250/298 (83.9%) | ||
Serious Adverse Events |
||||
Investigator's Choice Chemotherapy | Veliparib + Carboplatin + Paclitaxel | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 98/288 (34%) | 121/293 (41.3%) | ||
Blood and lymphatic system disorders | ||||
ANAEMIA | 15/288 (5.2%) | 17 | 7/293 (2.4%) | 8 |
FEBRILE NEUTROPENIA | 7/288 (2.4%) | 10 | 13/293 (4.4%) | 15 |
LEUKOPENIA | 0/288 (0%) | 0 | 2/293 (0.7%) | 2 |
LYMPHADENITIS | 0/288 (0%) | 0 | 1/293 (0.3%) | 1 |
NEUTROPENIA | 5/288 (1.7%) | 5 | 6/293 (2%) | 9 |
PANCYTOPENIA | 1/288 (0.3%) | 1 | 0/293 (0%) | 0 |
THROMBOCYTOPENIA | 6/288 (2.1%) | 6 | 2/293 (0.7%) | 2 |
Cardiac disorders | ||||
ARTERIOSPASM CORONARY | 0/288 (0%) | 0 | 1/293 (0.3%) | 1 |
ATRIAL FIBRILLATION | 2/288 (0.7%) | 2 | 4/293 (1.4%) | 4 |
ATRIAL FLUTTER | 0/288 (0%) | 0 | 1/293 (0.3%) | 1 |
CARDIAC ARREST | 2/288 (0.7%) | 2 | 0/293 (0%) | 0 |
CARDIAC FAILURE | 1/288 (0.3%) | 1 | 1/293 (0.3%) | 1 |
CARDIAC FAILURE ACUTE | 1/288 (0.3%) | 1 | 0/293 (0%) | 0 |
CARDIO-RESPIRATORY ARREST | 1/288 (0.3%) | 1 | 1/293 (0.3%) | 1 |
CARDIOPULMONARY FAILURE | 1/288 (0.3%) | 1 | 2/293 (0.7%) | 2 |
LEFT VENTRICULAR FAILURE | 0/288 (0%) | 0 | 1/293 (0.3%) | 1 |
PERICARDIAL EFFUSION | 0/288 (0%) | 0 | 7/293 (2.4%) | 7 |
PERICARDITIS | 1/288 (0.3%) | 2 | 0/293 (0%) | 0 |
SUPRAVENTRICULAR TACHYCARDIA | 0/288 (0%) | 0 | 1/293 (0.3%) | 1 |
Gastrointestinal disorders | ||||
ABDOMINAL PAIN | 2/288 (0.7%) | 4 | 2/293 (0.7%) | 2 |
APHTHOUS ULCER | 0/288 (0%) | 0 | 1/293 (0.3%) | 1 |
ASCITES | 1/288 (0.3%) | 1 | 0/293 (0%) | 0 |
COLITIS ISCHAEMIC | 0/288 (0%) | 0 | 1/293 (0.3%) | 1 |
COLITIS ULCERATIVE | 1/288 (0.3%) | 1 | 0/293 (0%) | 0 |
CONSTIPATION | 1/288 (0.3%) | 1 | 2/293 (0.7%) | 2 |
DIARRHOEA | 2/288 (0.7%) | 2 | 2/293 (0.7%) | 2 |
GASTRITIS | 0/288 (0%) | 0 | 1/293 (0.3%) | 1 |
HAEMATEMESIS | 1/288 (0.3%) | 1 | 0/293 (0%) | 0 |
INTESTINAL OBSTRUCTION | 1/288 (0.3%) | 1 | 0/293 (0%) | 0 |
MESENTERIC VEIN THROMBOSIS | 0/288 (0%) | 0 | 1/293 (0.3%) | 1 |
NAUSEA | 3/288 (1%) | 3 | 3/293 (1%) | 3 |
OESOPHAGEAL STENOSIS | 0/288 (0%) | 0 | 1/293 (0.3%) | 1 |
OESOPHAGITIS | 0/288 (0%) | 0 | 1/293 (0.3%) | 1 |
RECTAL HAEMORRHAGE | 1/288 (0.3%) | 1 | 0/293 (0%) | 0 |
VOMITING | 5/288 (1.7%) | 5 | 6/293 (2%) | 6 |
General disorders | ||||
ASTHENIA | 2/288 (0.7%) | 2 | 1/293 (0.3%) | 2 |
CATHETER SITE HAEMORRHAGE | 0/288 (0%) | 0 | 1/293 (0.3%) | 1 |
CHEST PAIN | 0/288 (0%) | 0 | 1/293 (0.3%) | 1 |
DISEASE PROGRESSION | 0/288 (0%) | 0 | 1/293 (0.3%) | 1 |
FATIGUE | 2/288 (0.7%) | 2 | 0/293 (0%) | 0 |
GENERAL PHYSICAL HEALTH DETERIORATION | 1/288 (0.3%) | 2 | 0/293 (0%) | 0 |
MALAISE | 3/288 (1%) | 6 | 0/293 (0%) | 0 |
MULTIPLE ORGAN DYSFUNCTION SYNDROME | 2/288 (0.7%) | 2 | 0/293 (0%) | 0 |
NON-CARDIAC CHEST PAIN | 0/288 (0%) | 0 | 2/293 (0.7%) | 2 |
PERIPHERAL SWELLING | 0/288 (0%) | 0 | 1/293 (0.3%) | 1 |
PYREXIA | 1/288 (0.3%) | 1 | 0/293 (0%) | 0 |
SUDDEN DEATH | 1/288 (0.3%) | 1 | 2/293 (0.7%) | 2 |
SYSTEMIC INFLAMMATORY RESPONSE SYNDROME | 0/288 (0%) | 0 | 1/293 (0.3%) | 1 |
Hepatobiliary disorders | ||||
HEPATIC FUNCTION ABNORMAL | 0/288 (0%) | 0 | 1/293 (0.3%) | 1 |
Immune system disorders | ||||
ANAPHYLACTIC SHOCK | 0/288 (0%) | 0 | 1/293 (0.3%) | 1 |
DRUG HYPERSENSITIVITY | 1/288 (0.3%) | 1 | 3/293 (1%) | 4 |
Infections and infestations | ||||
ABDOMINAL ABSCESS | 1/288 (0.3%) | 1 | 0/293 (0%) | 0 |
APPENDICITIS PERFORATED | 1/288 (0.3%) | 1 | 0/293 (0%) | 0 |
BACTERAEMIA | 0/288 (0%) | 0 | 1/293 (0.3%) | 1 |
BRONCHITIS | 1/288 (0.3%) | 1 | 1/293 (0.3%) | 1 |
CELLULITIS | 1/288 (0.3%) | 1 | 1/293 (0.3%) | 1 |
CLOSTRIDIUM DIFFICILE COLITIS | 0/288 (0%) | 0 | 1/293 (0.3%) | 1 |
DEVICE RELATED INFECTION | 1/288 (0.3%) | 1 | 0/293 (0%) | 0 |
DIARRHOEA INFECTIOUS | 0/288 (0%) | 0 | 1/293 (0.3%) | 1 |
EMPYEMA | 0/288 (0%) | 0 | 1/293 (0.3%) | 1 |
GASTROENTERITIS | 0/288 (0%) | 0 | 1/293 (0.3%) | 1 |
HERPES ZOSTER | 0/288 (0%) | 0 | 1/293 (0.3%) | 1 |
INFECTION | 2/288 (0.7%) | 2 | 0/293 (0%) | 0 |
INFLUENZA | 0/288 (0%) | 0 | 2/293 (0.7%) | 2 |
LOWER RESPIRATORY TRACT INFECTION | 1/288 (0.3%) | 1 | 4/293 (1.4%) | 4 |
LUNG INFECTION | 0/288 (0%) | 0 | 2/293 (0.7%) | 2 |
LYMPHANGITIS | 0/288 (0%) | 0 | 1/293 (0.3%) | 1 |
NEUTROPENIC SEPSIS | 0/288 (0%) | 0 | 1/293 (0.3%) | 1 |
PERITONSILLAR ABSCESS | 1/288 (0.3%) | 2 | 0/293 (0%) | 0 |
PNEUMONIA | 8/288 (2.8%) | 9 | 19/293 (6.5%) | 26 |
PNEUMONIA BACTERIAL | 0/288 (0%) | 0 | 1/293 (0.3%) | 1 |
PNEUMONIA PSEUDOMONAL | 0/288 (0%) | 0 | 1/293 (0.3%) | 1 |
PSEUDOMONAL SEPSIS | 0/288 (0%) | 0 | 1/293 (0.3%) | 1 |
PULMONARY SEPSIS | 0/288 (0%) | 0 | 1/293 (0.3%) | 1 |
PYELONEPHRITIS | 1/288 (0.3%) | 1 | 0/293 (0%) | 0 |
RESPIRATORY TRACT INFECTION | 1/288 (0.3%) | 1 | 1/293 (0.3%) | 1 |
SEPSIS | 4/288 (1.4%) | 5 | 1/293 (0.3%) | 1 |
SEPTIC SHOCK | 1/288 (0.3%) | 1 | 2/293 (0.7%) | 2 |
UPPER RESPIRATORY TRACT INFECTION | 0/288 (0%) | 0 | 1/293 (0.3%) | 2 |
URINARY TRACT INFECTION | 2/288 (0.7%) | 2 | 2/293 (0.7%) | 2 |
VASCULAR DEVICE INFECTION | 0/288 (0%) | 0 | 1/293 (0.3%) | 1 |
VIRAL UPPER RESPIRATORY TRACT INFECTION | 0/288 (0%) | 0 | 1/293 (0.3%) | 1 |
Injury, poisoning and procedural complications | ||||
FALL | 1/288 (0.3%) | 1 | 1/293 (0.3%) | 1 |
FEMORAL NECK FRACTURE | 1/288 (0.3%) | 1 | 0/293 (0%) | 0 |
HEART INJURY | 0/288 (0%) | 0 | 1/293 (0.3%) | 2 |
HIP FRACTURE | 0/288 (0%) | 0 | 1/293 (0.3%) | 1 |
LUMBAR VERTEBRAL FRACTURE | 0/288 (0%) | 0 | 1/293 (0.3%) | 1 |
RADIATION OESOPHAGITIS | 1/288 (0.3%) | 1 | 0/293 (0%) | 0 |
SPINAL COMPRESSION FRACTURE | 0/288 (0%) | 0 | 1/293 (0.3%) | 1 |
Investigations | ||||
C-REACTIVE PROTEIN INCREASED | 1/288 (0.3%) | 1 | 0/293 (0%) | 0 |
Metabolism and nutrition disorders | ||||
DECREASED APPETITE | 2/288 (0.7%) | 2 | 2/293 (0.7%) | 2 |
DEHYDRATION | 6/288 (2.1%) | 6 | 0/293 (0%) | 0 |
HYPOCALCAEMIA | 1/288 (0.3%) | 1 | 0/293 (0%) | 0 |
HYPOGLYCAEMIA | 1/288 (0.3%) | 1 | 1/293 (0.3%) | 1 |
HYPONATRAEMIA | 2/288 (0.7%) | 2 | 1/293 (0.3%) | 1 |
TYPE 2 DIABETES MELLITUS | 0/288 (0%) | 0 | 1/293 (0.3%) | 1 |
Musculoskeletal and connective tissue disorders | ||||
ARTHRALGIA | 0/288 (0%) | 0 | 1/293 (0.3%) | 1 |
BACK PAIN | 2/288 (0.7%) | 2 | 3/293 (1%) | 3 |
BONE PAIN | 1/288 (0.3%) | 1 | 0/293 (0%) | 0 |
MUSCULOSKELETAL CHEST PAIN | 1/288 (0.3%) | 2 | 1/293 (0.3%) | 1 |
MUSCULOSKELETAL PAIN | 1/288 (0.3%) | 1 | 0/293 (0%) | 0 |
PAIN IN EXTREMITY | 1/288 (0.3%) | 1 | 1/293 (0.3%) | 1 |
Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
CANCER PAIN | 0/288 (0%) | 0 | 1/293 (0.3%) | 1 |
GASTRIC CANCER | 0/288 (0%) | 0 | 1/293 (0.3%) | 1 |
MALIGNANT NEOPLASM PROGRESSION | 10/288 (3.5%) | 12 | 14/293 (4.8%) | 19 |
MALIGNANT PLEURAL EFFUSION | 1/288 (0.3%) | 1 | 0/293 (0%) | 0 |
METASTASES TO BONE | 0/288 (0%) | 0 | 1/293 (0.3%) | 1 |
METASTASES TO CENTRAL NERVOUS SYSTEM | 1/288 (0.3%) | 1 | 4/293 (1.4%) | 4 |
METASTASES TO MENINGES | 1/288 (0.3%) | 1 | 0/293 (0%) | 0 |
PERICARDIAL EFFUSION MALIGNANT | 0/288 (0%) | 0 | 1/293 (0.3%) | 1 |
Nervous system disorders | ||||
CEREBRAL INFARCTION | 0/288 (0%) | 0 | 2/293 (0.7%) | 2 |
CEREBRAL ISCHAEMIA | 0/288 (0%) | 0 | 1/293 (0.3%) | 2 |
CEREBROVASCULAR ACCIDENT | 1/288 (0.3%) | 1 | 0/293 (0%) | 0 |
COGNITIVE DISORDER | 0/288 (0%) | 0 | 1/293 (0.3%) | 1 |
PERIPHERAL SENSORY NEUROPATHY | 0/288 (0%) | 0 | 1/293 (0.3%) | 1 |
SPINAL CORD COMPRESSION | 1/288 (0.3%) | 1 | 1/293 (0.3%) | 1 |
Psychiatric disorders | ||||
CONFUSIONAL STATE | 1/288 (0.3%) | 1 | 1/293 (0.3%) | 1 |
DELIRIUM | 0/288 (0%) | 0 | 2/293 (0.7%) | 2 |
DEPRESSION | 0/288 (0%) | 0 | 1/293 (0.3%) | 1 |
DISORIENTATION | 0/288 (0%) | 0 | 1/293 (0.3%) | 1 |
Renal and urinary disorders | ||||
ACUTE KIDNEY INJURY | 1/288 (0.3%) | 1 | 1/293 (0.3%) | 1 |
AZOTAEMIA | 1/288 (0.3%) | 1 | 0/293 (0%) | 0 |
HAEMATURIA | 0/288 (0%) | 0 | 1/293 (0.3%) | 1 |
RENAL FAILURE | 1/288 (0.3%) | 1 | 0/293 (0%) | 0 |
RENAL IMPAIRMENT | 1/288 (0.3%) | 1 | 0/293 (0%) | 0 |
URINARY RETENTION | 1/288 (0.3%) | 1 | 0/293 (0%) | 0 |
Respiratory, thoracic and mediastinal disorders | ||||
ACUTE RESPIRATORY FAILURE | 1/288 (0.3%) | 2 | 2/293 (0.7%) | 2 |
CHRONIC OBSTRUCTIVE PULMONARY DISEASE | 1/288 (0.3%) | 1 | 2/293 (0.7%) | 2 |
DYSPNOEA | 7/288 (2.4%) | 9 | 8/293 (2.7%) | 8 |
DYSPNOEA EXERTIONAL | 1/288 (0.3%) | 1 | 0/293 (0%) | 0 |
HAEMOPTYSIS | 3/288 (1%) | 3 | 1/293 (0.3%) | 1 |
HYPOXIA | 1/288 (0.3%) | 1 | 0/293 (0%) | 0 |
ORGANISING PNEUMONIA | 0/288 (0%) | 0 | 1/293 (0.3%) | 1 |
PLEURAL EFFUSION | 6/288 (2.1%) | 9 | 5/293 (1.7%) | 7 |
PLEURITIC PAIN | 1/288 (0.3%) | 1 | 0/293 (0%) | 0 |
PNEUMONIA ASPIRATION | 0/288 (0%) | 0 | 1/293 (0.3%) | 1 |
PNEUMOTHORAX | 0/288 (0%) | 0 | 1/293 (0.3%) | 1 |
PRODUCTIVE COUGH | 1/288 (0.3%) | 1 | 0/293 (0%) | 0 |
PULMONARY EMBOLISM | 6/288 (2.1%) | 6 | 5/293 (1.7%) | 5 |
PULMONARY HAEMORRHAGE | 2/288 (0.7%) | 2 | 0/293 (0%) | 0 |
RESPIRATORY DISTRESS | 0/288 (0%) | 0 | 1/293 (0.3%) | 1 |
RESPIRATORY FAILURE | 2/288 (0.7%) | 3 | 2/293 (0.7%) | 2 |
RHINORRHOEA | 0/288 (0%) | 0 | 1/293 (0.3%) | 1 |
Skin and subcutaneous tissue disorders | ||||
SUBCUTANEOUS EMPHYSEMA | 0/288 (0%) | 0 | 1/293 (0.3%) | 1 |
Vascular disorders | ||||
ANEURYSM | 0/288 (0%) | 0 | 1/293 (0.3%) | 1 |
AXILLARY VEIN THROMBOSIS | 0/288 (0%) | 0 | 1/293 (0.3%) | 1 |
DEEP VEIN THROMBOSIS | 2/288 (0.7%) | 2 | 0/293 (0%) | 0 |
HYPOTENSION | 1/288 (0.3%) | 1 | 2/293 (0.7%) | 2 |
HYPOVOLAEMIC SHOCK | 1/288 (0.3%) | 1 | 0/293 (0%) | 0 |
ORTHOSTATIC HYPOTENSION | 2/288 (0.7%) | 2 | 0/293 (0%) | 0 |
VENOUS THROMBOSIS | 1/288 (0.3%) | 1 | 0/293 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||
Investigator's Choice Chemotherapy | Veliparib + Carboplatin + Paclitaxel | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 269/288 (93.4%) | 275/293 (93.9%) | ||
Blood and lymphatic system disorders | ||||
ANAEMIA | 107/288 (37.2%) | 197 | 112/293 (38.2%) | 212 |
LEUKOPENIA | 40/288 (13.9%) | 77 | 43/293 (14.7%) | 77 |
NEUTROPENIA | 89/288 (30.9%) | 175 | 104/293 (35.5%) | 210 |
THROMBOCYTOPENIA | 54/288 (18.8%) | 102 | 76/293 (25.9%) | 155 |
Gastrointestinal disorders | ||||
CONSTIPATION | 92/288 (31.9%) | 113 | 69/293 (23.5%) | 81 |
DIARRHOEA | 47/288 (16.3%) | 60 | 51/293 (17.4%) | 70 |
NAUSEA | 131/288 (45.5%) | 202 | 86/293 (29.4%) | 121 |
STOMATITIS | 30/288 (10.4%) | 32 | 19/293 (6.5%) | 24 |
VOMITING | 73/288 (25.3%) | 99 | 39/293 (13.3%) | 48 |
General disorders | ||||
ASTHENIA | 30/288 (10.4%) | 50 | 29/293 (9.9%) | 58 |
FATIGUE | 89/288 (30.9%) | 117 | 80/293 (27.3%) | 108 |
OEDEMA PERIPHERAL | 24/288 (8.3%) | 36 | 13/293 (4.4%) | 16 |
PYREXIA | 16/288 (5.6%) | 21 | 15/293 (5.1%) | 17 |
Investigations | ||||
WEIGHT DECREASED | 24/288 (8.3%) | 25 | 14/293 (4.8%) | 17 |
Metabolism and nutrition disorders | ||||
DECREASED APPETITE | 79/288 (27.4%) | 109 | 63/293 (21.5%) | 79 |
HYPERGLYCAEMIA | 11/288 (3.8%) | 15 | 24/293 (8.2%) | 24 |
HYPOMAGNESAEMIA | 16/288 (5.6%) | 19 | 21/293 (7.2%) | 22 |
HYPONATRAEMIA | 12/288 (4.2%) | 14 | 16/293 (5.5%) | 18 |
Musculoskeletal and connective tissue disorders | ||||
ARTHRALGIA | 26/288 (9%) | 35 | 39/293 (13.3%) | 45 |
BACK PAIN | 22/288 (7.6%) | 24 | 17/293 (5.8%) | 21 |
BONE PAIN | 9/288 (3.1%) | 13 | 15/293 (5.1%) | 21 |
MYALGIA | 17/288 (5.9%) | 22 | 38/293 (13%) | 50 |
PAIN IN EXTREMITY | 15/288 (5.2%) | 19 | 15/293 (5.1%) | 17 |
Nervous system disorders | ||||
DIZZINESS | 22/288 (7.6%) | 25 | 17/293 (5.8%) | 17 |
DYSGEUSIA | 29/288 (10.1%) | 33 | 19/293 (6.5%) | 20 |
PERIPHERAL SENSORY NEUROPATHY | 42/288 (14.6%) | 51 | 131/293 (44.7%) | 195 |
Psychiatric disorders | ||||
INSOMNIA | 30/288 (10.4%) | 30 | 37/293 (12.6%) | 39 |
Respiratory, thoracic and mediastinal disorders | ||||
COUGH | 29/288 (10.1%) | 31 | 27/293 (9.2%) | 32 |
DYSPNOEA | 25/288 (8.7%) | 30 | 42/293 (14.3%) | 46 |
HICCUPS | 21/288 (7.3%) | 29 | 17/293 (5.8%) | 27 |
OROPHARYNGEAL PAIN | 15/288 (5.2%) | 16 | 6/293 (2%) | 8 |
Skin and subcutaneous tissue disorders | ||||
ALOPECIA | 34/288 (11.8%) | 40 | 137/293 (46.8%) | 160 |
RASH | 25/288 (8.7%) | 29 | 13/293 (4.4%) | 16 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
Results Point of Contact
Name/Title | Global Medical Services |
---|---|
Organization | AbbVie |
Phone | 800-633-9110 |
abbvieclinicaltrials@abbvie.com |
- M14-359
- 2014-002565-30