Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02470585
Registration number
NCT02470585
Ethics application status
Date submitted
10/06/2015
Date registered
12/06/2015
Date last updated
30/10/2023
Titles & IDs
Public title
Veliparib With Carboplatin and Paclitaxel and as Continuation Maintenance Therapy in Adults With Newly Diagnosed Stage III or IV, High-grade Serous, Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Query!
Scientific title
A Phase 3 Placebo-Controlled Study of Carboplatin/Paclitaxel With or Without Concurrent and Continuation Maintenance Veliparib (PARP Inhibitor) in Subjects With Previously Untreated Stages III or IV High-Grade Serous Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Query!
Secondary ID [1]
0
0
2014-005070-11
Query!
Secondary ID [2]
0
0
M13-694
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
VELIA
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Ovarian Cancer
0
0
Query!
Ovarian Neoplasm
0
0
Query!
Condition category
Condition code
Cancer
0
0
0
0
Query!
Ovarian and primary peritoneal
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - Veliparib
Treatment: Drugs - Paclitaxel
Treatment: Drugs - Carboplatin
Other interventions - Placebo to Veliparib
Active Comparator: Placebo + Carboplatin + Paclitaxel -> Placebo - Participants will receive placebo to veliparib orally twice a day in combination with carboplatin/paclitaxel for six 21-day cycles followed by placebo monotherapy continuous dosing for an additional thirty 21-day cycles.
Experimental: Veliparib + Carboplatin + Paclitaxel -> Placebo - Participants will receive 150 mg veliparib orally twice a day in combination with carboplatin/paclitaxel for six 21-day cycles followed by placebo monotherapy continuous dosing for an additional thirty 21-day cycles.
Experimental: Veliparib + Carboplatin + Paclitaxel -> Veliparib - Participants will receive 150 mg veliparib orally twice a day in combination with carboplatin/paclitaxel for six 21-day cycles followed by 300/400 mg veliparib monotherapy orally twice a day for an additional thirty 21-day cycles.
Treatment: Drugs: Veliparib
Capsules for oral administration
Treatment: Drugs: Paclitaxel
Administered by intravenous infusion, either 80 mg/m² of body-surface area (BSA) on Days 1, 8, and 15 of each 21-day cycle (weekly dosing), or 175 mg/m² of BSA on Day 1 of each 21-day cycle (3-week dosing).
Treatment: Drugs: Carboplatin
Administered by intravenous infusion at an area under the curve (AUC) of 6 mg/mL/min every 3 weeks.
Other interventions: Placebo to Veliparib
Capsules for oral administration
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Intervention code [2]
0
0
Other interventions
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Progression-Free Survival (PFS) in the BRCA-deficient Population
Query!
Assessment method [1]
0
0
PFS was defined as the time from the date that the participant was randomized to the date the participant experienced an event of disease progression, according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.1 (as determined by the investigator) or to the date of death if disease progression was not reached. If the participant did not have an event of disease progression or death prior to the analysis cut-off date, the participant's data were censored at the date of their last evaluable disease assessment. PFS was estimated using the Kaplan-Meier method. The analysis of PFS occurred when the protocol-specified number of PFS events was reached.
Progressive Disease (PD): At least a 20% increase in the size of target lesions, compared with the smallest size recorded since the treatment started, and an absolute increase of = 5 mm, or unequivocal progression of existing non-target lesions or the appearance of new lesions.
Query!
Timepoint [1]
0
0
From randomization until the primary analysis data cut-off date of 03 May 2019, the median duration of follow-up was 28 months.
Query!
Primary outcome [2]
0
0
Progression-Free Survival (PFS) in the Homologous Recombination Deficiency Cohort
Query!
Assessment method [2]
0
0
PFS was defined as the time from the date that the participant was randomized to the date the participant experienced an event of disease progression, according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.1 (as determined by the investigator) or to the date of death if disease progression was not reached. If the participant did not have an event of disease progression or death, the participant's data were censored at the date of their last evaluable disease assessment. PFS was estimated using the Kaplan-Meier method. The primary analysis of PFS occurred when the protocol-specified number of PFS events was reached and was performed in 3 sequentially inclusive populations.
Progressive Disease (PD): At least a 20% increase in the size of target lesions, compared with the smallest size recorded since the treatment started, and an absolute increase of = 5 mm, or unequivocal progression of existing non-target lesions or the appearance of new lesions.
.
Query!
Timepoint [2]
0
0
From randomization until the primary analysis data cut-off date of 03 May 2019, the median duration of follow-up was 28 months.
Query!
Primary outcome [3]
0
0
Progression-Free Survival (PFS) in the Intention-to-treat Population
Query!
Assessment method [3]
0
0
PFS was defined as the time from the date that the participant was randomized to the date the participant experienced an event of disease progression, according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.1 (as determined by the investigator) or to the date of death (all causes of mortality) if disease progression was not reached. If the participant did not have an event of disease progression according to RECIST criteria (as or death, the participant's data were censored at the date of their last evaluable disease assessment. PFS was estimated using the Kaplan-Meier method.
Progressive Disease (PD): At least a 20% increase in the size of target lesions, compared with the smallest size recorded since the treatment started, and an absolute increase of = 5 mm, or unequivocal progression of existing non-target lesions or the appearance of new lesions.
The primary analysis of PFS occurred when the protocol-specified number of PFS events was reached.
Query!
Timepoint [3]
0
0
From randomization until the primary analysis data cut-off date of 03 May 2019, the median duration of follow-up was 28 months.
Query!
Secondary outcome [1]
0
0
Overall Survival (OS)
Query!
Assessment method [1]
0
0
OS is defined as the time from the day the participant was randomized to the date of death. All events of death will be included, regardless of whether the event occurs while the participant is still taking study drug, or after discontinuation of study drug. If a participant has not died, then the data will be censored at the date the participant is last known to be alive.
The final analysis of OS will occur when the pre-specified number of events has occurred in the ITT and HRD populations.
Query!
Timepoint [1]
0
0
Approximately 8 years from randomization.
Query!
Secondary outcome [2]
0
0
Change From Baseline in Disease Related Symptom (DRS) Score in the BRCA-mutation Population
Query!
Assessment method [2]
0
0
The Disease Related Symptom score is a subset of the National Comprehensive Cancer Network Functional Assessment of Cancer Therapy Ovarian Symptom Index-18 (NFOSI-18), which evaluates nine symptoms related to ovarian cancer. The NFOSI-18 DRS score ranges from 0 to 36, with higher scores indicating a lower burden of symptoms and a score of 0 being severely symptomatic. A 3-point difference was defined as clinically meaningful. A positive change from Baseline indicates improvement.
Change from Baseline was calculated using a used a mixed-model for repeated measures (MMRM) with treatment, stratification factors of residual disease and stage of disease, time point and treatment-by-time point interaction as fixed effect factors, and Baseline DRS score as a covariate.
DRS was not included in the fixed-sequence testing procedure.
Query!
Timepoint [2]
0
0
Baseline and Day 1 of Cycles 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, and 35
Query!
Secondary outcome [3]
0
0
Change From Baseline in Disease Related Symptom (DRS) Score in the HRD Population
Query!
Assessment method [3]
0
0
The Disease Related Symptom score is a subset of the National Comprehensive Cancer Network Functional Assessment of Cancer Therapy Ovarian Symptom Index-18 (NFOSI-18), which evaluates nine symptoms related to ovarian cancer. The NFOSI-18 DRS score ranges from 0 to 36, with higher scores indicating a lower burden of symptoms and a score of 0 being severely symptomatic. A 3-point difference was defined as clinically meaningful. A positive change from Baseline indicates improvement.
Change from Baseline was calculated using a used a mixed-model for repeated measures (MMRM) with treatment, stratification factors of residual disease and stage of disease, time point and treatment-by-time point interaction as fixed effect factors, and Baseline DRS score as a covariate.
DRS was not included in the fixed-sequence testing procedure.
Query!
Timepoint [3]
0
0
Baseline and Day 1 of Cycles 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, and 35
Query!
Secondary outcome [4]
0
0
Change From Baseline in Disease Related Symptom (DRS) Score in the ITT Population
Query!
Assessment method [4]
0
0
The Disease Related Symptom score is a subset of the National Comprehensive Cancer Network Functional Assessment of Cancer Therapy Ovarian Symptom Index-18 (NFOSI-18), which evaluates nine symptoms related to ovarian cancer. The NFOSI-18 DRS score ranges from 0 to 36, with higher scores indicating a lower burden of symptoms and a score of 0 being severely symptomatic. A 3-point difference was defined as clinically meaningful. A positive change from Baseline indicates improvement.
Change from Baseline was calculated using a used a mixed-model for repeated measures (MMRM) with treatment, stratification factors of residual disease, stage of disease, choice of paclitaxel dosing regimen and BRCA-deficient status, time point and treatment-by-time point interaction as fixed effect factors, and Baseline DRS score as a covariate.
DRS was not included in the fixed-sequence testing procedure.
Query!
Timepoint [4]
0
0
Baseline and Day 1 of Cycles 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, and 35
Query!
Eligibility
Key inclusion criteria
1. Histologic diagnosis of International Federation of Gynecology and Obstetrics (FIGO)
Stage III or IV epithelial ovarian, fallopian tube, or primary peritoneal carcinoma,
with the appropriate tissue available for histologic evaluation.
2. High-grade serous adenocarcinoma
3. Willing to undergo testing for gBRCA.
4. Adequate hematologic, renal, and hepatic function.
5. Neuropathy (sensory and motor) less than or equal to Grade 1.
6. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
7. Participants who undergo primary cytoreductive surgery must be entered between 1 and
12 weeks after surgery. Participants undergoing interval surgery must have a tumor
sample confirming the histological diagnosis prior to enrollment.
8. Participants with measurable disease or non-measurable disease are eligible.
Participants may or may not have cancer-related symptoms.
9. Participant has one of the following available for pharmacodynamic analyses including
somatic BRCA testing: Archived diagnostic formalin-fixed paraffin embedded (FFPE)
tumor tissue; or tumor tissue biopsy collected prior to Cycle 1 Day 1.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
1. Endometrioid adenocarcinoma, carcinosarcoma, undifferentiated carcinoma, mixed
epithelial adenocarcinoma, adenocarcinoma not otherwise specified, mucinous
adenocarcinoma, clear cell adenocarcinoma, low-grade serous adenocarcinoma, or
malignant Brenner's tumor.
2. Participants with synchronous primary endometrial cancer, or a past history of
endometrial cancer unless all of the following conditions are met: endometrial cancer
stage not greater than IA, no vascular or lymphatic invasion, no poorly differentiated
subtypes including serous, clear cell, or other FIGO grade 3 lesions.
3. Participants with any evidence of other invasive malignancy being present within the
last 3 years (with the exception of non-melanoma skin cancer). Participants are also
excluded if their previous cancer treatment contraindicates this protocol's therapy.
4. Received prior radiotherapy to any portion of the abdominal cavity or pelvis.
5. Received prior chemotherapy for any abdominal or pelvic tumor.
6. Clinically significant uncontrolled condition(s).
7. Known history of allergic reaction to Cremophor-paclitaxel, carboplatin, Azo-Colourant
Tartrazine (also known as FD&C Yellow 5 or E102), Azo-Colourant Orange Yellow-S (also
known as FD&C Yellow 6 or E110) or known contraindications to any study supplied drug.
8. History or evidence upon physical examination of central nervous system (CNS) disease,
including primary brain tumor, any brain metastases, or history of cerebrovascular
accident (CVA, stroke), transient ischemic attack (TIA) within 6 months of Cycle 1 Day
1.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Terminated
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
29/06/2015
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
5/10/2023
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
1140
Query!
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Query!
Recruitment hospital [1]
0
0
Coffs Harbour Health Campus /ID# 145132 - Coffs Harbour
Query!
Recruitment hospital [2]
0
0
Gosford Hospital /ID# 145299 - Gosford
Query!
Recruitment hospital [3]
0
0
St George Hospital /ID# 145138 - Kogarah
Query!
Recruitment hospital [4]
0
0
Newcastle Private Hospital /ID# 145834 - Lambton Heights
Query!
Recruitment hospital [5]
0
0
The Prince of Wales Hospital /ID# 145134 - Randwick
Query!
Recruitment hospital [6]
0
0
Northern Cancer Institute /ID# 145681 - St Leonards
Query!
Recruitment hospital [7]
0
0
Calvary Mater Newcastle /ID# 145139 - Waratah
Query!
Recruitment hospital [8]
0
0
Westmead Hospital /ID# 145137 - Westmead
Query!
Recruitment hospital [9]
0
0
Southern Medical Day Care Ctr /ID# 145133 - Wollongong
Query!
Recruitment hospital [10]
0
0
The Townsville Hospital /ID# 149163 - Douglas
Query!
Recruitment hospital [11]
0
0
Royal Brisbane and Women's Hospital /ID# 145135 - Herston
Query!
Recruitment hospital [12]
0
0
Icon Cancer Centre /ID# 148208 - South Brisbane
Query!
Recruitment hospital [13]
0
0
Mater Misericordiae Limited /ID# 145682 - South Brisbane
Query!
Recruitment hospital [14]
0
0
Royal Adelaide Hospital /ID# 150071 - Adelaide
Query!
Recruitment hospital [15]
0
0
Monash Health /ID# 145297 - Clayton
Query!
Recruitment hospital [16]
0
0
Cabrini Health /ID# 145142 - Malvern
Query!
Recruitment hospital [17]
0
0
Royal Womens Hospital /ID# 145136 - Parkville
Query!
Recruitment hospital [18]
0
0
Sir Charles Gairdner Hospital /ID# 145140 - Nedlands
Query!
Recruitment hospital [19]
0
0
St. John of God Subiaco Hosp /ID# 147742 - Subiaco
Query!
Recruitment postcode(s) [1]
0
0
2450 - Coffs Harbour
Query!
Recruitment postcode(s) [2]
0
0
2250 - Gosford
Query!
Recruitment postcode(s) [3]
0
0
2217 - Kogarah
Query!
Recruitment postcode(s) [4]
0
0
2305 - Lambton Heights
Query!
Recruitment postcode(s) [5]
0
0
2031 - Randwick
Query!
Recruitment postcode(s) [6]
0
0
2065 - St Leonards
Query!
Recruitment postcode(s) [7]
0
0
2298 - Waratah
Query!
Recruitment postcode(s) [8]
0
0
2145 - Westmead
Query!
Recruitment postcode(s) [9]
0
0
2500 - Wollongong
Query!
Recruitment postcode(s) [10]
0
0
4814 - Douglas
Query!
Recruitment postcode(s) [11]
0
0
4029 - Herston
Query!
Recruitment postcode(s) [12]
0
0
4101 - South Brisbane
Query!
Recruitment postcode(s) [13]
0
0
5000 - Adelaide
Query!
Recruitment postcode(s) [14]
0
0
3168 - Clayton
Query!
Recruitment postcode(s) [15]
0
0
3144 - Malvern
Query!
Recruitment postcode(s) [16]
0
0
3052 - Parkville
Query!
Recruitment postcode(s) [17]
0
0
6009 - Nedlands
Query!
Recruitment postcode(s) [18]
0
0
6008 - Subiaco
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alabama
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Alaska
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Arizona
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Arkansas
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
California
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Colorado
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Connecticut
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Florida
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Georgia
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Hawaii
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Illinois
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Indiana
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Iowa
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Kansas
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Kentucky
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
Maine
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
Maryland
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
Massachusetts
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
Michigan
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
Minnesota
Query!
Country [21]
0
0
United States of America
Query!
State/province [21]
0
0
Mississippi
Query!
Country [22]
0
0
United States of America
Query!
State/province [22]
0
0
Missouri
Query!
Country [23]
0
0
United States of America
Query!
State/province [23]
0
0
Nebraska
Query!
Country [24]
0
0
United States of America
Query!
State/province [24]
0
0
Nevada
Query!
Country [25]
0
0
United States of America
Query!
State/province [25]
0
0
New Hampshire
Query!
Country [26]
0
0
United States of America
Query!
State/province [26]
0
0
New Jersey
Query!
Country [27]
0
0
United States of America
Query!
State/province [27]
0
0
New Mexico
Query!
Country [28]
0
0
United States of America
Query!
State/province [28]
0
0
New York
Query!
Country [29]
0
0
United States of America
Query!
State/province [29]
0
0
North Carolina
Query!
Country [30]
0
0
United States of America
Query!
State/province [30]
0
0
Ohio
Query!
Country [31]
0
0
United States of America
Query!
State/province [31]
0
0
Oklahoma
Query!
Country [32]
0
0
United States of America
Query!
State/province [32]
0
0
Oregon
Query!
Country [33]
0
0
United States of America
Query!
State/province [33]
0
0
Pennsylvania
Query!
Country [34]
0
0
United States of America
Query!
State/province [34]
0
0
Rhode Island
Query!
Country [35]
0
0
United States of America
Query!
State/province [35]
0
0
South Carolina
Query!
Country [36]
0
0
United States of America
Query!
State/province [36]
0
0
South Dakota
Query!
Country [37]
0
0
United States of America
Query!
State/province [37]
0
0
Tennessee
Query!
Country [38]
0
0
United States of America
Query!
State/province [38]
0
0
Texas
Query!
Country [39]
0
0
United States of America
Query!
State/province [39]
0
0
Utah
Query!
Country [40]
0
0
United States of America
Query!
State/province [40]
0
0
Vermont
Query!
Country [41]
0
0
United States of America
Query!
State/province [41]
0
0
Virginia
Query!
Country [42]
0
0
United States of America
Query!
State/province [42]
0
0
Washington
Query!
Country [43]
0
0
United States of America
Query!
State/province [43]
0
0
Wisconsin
Query!
Country [44]
0
0
Brazil
Query!
State/province [44]
0
0
Minas Gerais
Query!
Country [45]
0
0
Brazil
Query!
State/province [45]
0
0
Rio Grande Do Sul
Query!
Country [46]
0
0
Brazil
Query!
State/province [46]
0
0
Sao Paulo
Query!
Country [47]
0
0
Brazil
Query!
State/province [47]
0
0
Rio de Janeiro
Query!
Country [48]
0
0
Denmark
Query!
State/province [48]
0
0
Syddanmark
Query!
Country [49]
0
0
Denmark
Query!
State/province [49]
0
0
Herning
Query!
Country [50]
0
0
Israel
Query!
State/province [50]
0
0
Haifa
Query!
Country [51]
0
0
Israel
Query!
State/province [51]
0
0
Jerusalem
Query!
Country [52]
0
0
Israel
Query!
State/province [52]
0
0
Kfar Saba
Query!
Country [53]
0
0
Israel
Query!
State/province [53]
0
0
Ramat Gan
Query!
Country [54]
0
0
Israel
Query!
State/province [54]
0
0
Rehovot
Query!
Country [55]
0
0
Japan
Query!
State/province [55]
0
0
Aichi
Query!
Country [56]
0
0
Japan
Query!
State/province [56]
0
0
Fukuoka
Query!
Country [57]
0
0
Japan
Query!
State/province [57]
0
0
Iwate
Query!
Country [58]
0
0
Japan
Query!
State/province [58]
0
0
Kumamoto
Query!
Country [59]
0
0
Japan
Query!
State/province [59]
0
0
Mie
Query!
Country [60]
0
0
Japan
Query!
State/province [60]
0
0
Miyagi
Query!
Country [61]
0
0
Japan
Query!
State/province [61]
0
0
Niigata
Query!
Country [62]
0
0
Japan
Query!
State/province [62]
0
0
Osaka
Query!
Country [63]
0
0
Japan
Query!
State/province [63]
0
0
Shizuoka
Query!
Country [64]
0
0
Japan
Query!
State/province [64]
0
0
Tokyo
Query!
Country [65]
0
0
Japan
Query!
State/province [65]
0
0
Yamagata
Query!
Country [66]
0
0
Japan
Query!
State/province [66]
0
0
Akashi
Query!
Country [67]
0
0
Japan
Query!
State/province [67]
0
0
Amagasaki
Query!
Country [68]
0
0
Japan
Query!
State/province [68]
0
0
Kashiwa-shi
Query!
Country [69]
0
0
Japan
Query!
State/province [69]
0
0
Kawasaki
Query!
Country [70]
0
0
Japan
Query!
State/province [70]
0
0
Kure
Query!
Country [71]
0
0
Japan
Query!
State/province [71]
0
0
Matsuyama
Query!
Country [72]
0
0
Japan
Query!
State/province [72]
0
0
Sapporo
Query!
Country [73]
0
0
Korea, Republic of
Query!
State/province [73]
0
0
Gyeonggido
Query!
Country [74]
0
0
Korea, Republic of
Query!
State/province [74]
0
0
Seoul Teugbyeolsi
Query!
Country [75]
0
0
Korea, Republic of
Query!
State/province [75]
0
0
Seoul
Query!
Country [76]
0
0
New Zealand
Query!
State/province [76]
0
0
Auckland
Query!
Country [77]
0
0
Poland
Query!
State/province [77]
0
0
Gdansk
Query!
Country [78]
0
0
Spain
Query!
State/province [78]
0
0
Barcelona
Query!
Country [79]
0
0
Spain
Query!
State/province [79]
0
0
Madrid
Query!
Country [80]
0
0
Spain
Query!
State/province [80]
0
0
Valencia
Query!
Country [81]
0
0
United Kingdom
Query!
State/province [81]
0
0
Norfolk
Query!
Country [82]
0
0
United Kingdom
Query!
State/province [82]
0
0
Scotland
Query!
Country [83]
0
0
United Kingdom
Query!
State/province [83]
0
0
Dundee
Query!
Country [84]
0
0
United Kingdom
Query!
State/province [84]
0
0
Great Yarmouth
Query!
Country [85]
0
0
United Kingdom
Query!
State/province [85]
0
0
London
Query!
Country [86]
0
0
United Kingdom
Query!
State/province [86]
0
0
Oxford
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
AbbVie
Query!
Address
Query!
Country
Query!
Other collaborator category [1]
0
0
Other
Query!
Name [1]
0
0
Gynecologic Oncology Group;Australia New Zealand Gynaecological Oncology Group
Query!
Address [1]
0
0
Query!
Country [1]
0
0
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
The primary objective of the study was to evaluate whether progression-free survival (PFS)
was prolonged with the addition of veliparib to standard platinum-based chemotherapy
(carboplatin/paclitaxel [C/P]) and continued as maintenance therapy compared with
chemotherapy alone.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT02470585
Query!
Trial related presentations / publications
Coleman RL, Fleming GF, Brady MF, Swisher EM, Steffensen KD, Friedlander M, Okamoto A, Moore KN, Efrat Ben-Baruch N, Werner TL, Cloven NG, Oaknin A, DiSilvestro PA, Morgan MA, Nam JH, Leath CA 3rd, Nicum S, Hagemann AR, Littell RD, Cella D, Baron-Hay S, Garcia-Donas J, Mizuno M, Bell-McGuinn K, Sullivan DM, Bach BA, Bhattacharya S, Ratajczak CK, Ansell PJ, Dinh MH, Aghajanian C, Bookman MA. Veliparib with First-Line Chemotherapy and as Maintenance Therapy in Ovarian Cancer. N Engl J Med. 2019 Dec 19;381(25):2403-2415. doi: 10.1056/NEJMoa1909707. Epub 2019 Sep 28.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
AbbVie Inc.
Query!
Address
0
0
AbbVie
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02470585
Download to PDF