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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02470585
Registration number
NCT02470585
Ethics application status
Date submitted
10/06/2015
Date registered
12/06/2015
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
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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
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Secondary ID [1]
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2014-005070-11
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Secondary ID [2]
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M13-694
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Universal Trial Number (UTN)
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Trial acronym
VELIA
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Ovarian Cancer
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Ovarian Neoplasm
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Condition category
Condition code
Cancer
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Ovarian and primary peritoneal
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Progression-Free Survival (PFS) in the BRCA-deficient Population
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Assessment method [1]
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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.
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Timepoint [1]
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From randomization until the primary analysis data cut-off date of 03 May 2019, the median duration of follow-up was 28 months.
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Primary outcome [2]
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Progression-Free Survival (PFS) in the Homologous Recombination Deficiency Cohort
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Assessment method [2]
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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.
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Timepoint [2]
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From randomization until the primary analysis data cut-off date of 03 May 2019, the median duration of follow-up was 28 months.
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Primary outcome [3]
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Progression-Free Survival (PFS) in the Intention-to-treat Population
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Assessment method [3]
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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.
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Timepoint [3]
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From randomization until the primary analysis data cut-off date of 03 May 2019, the median duration of follow-up was 28 months.
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Secondary outcome [1]
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Overall Survival (OS)
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Assessment method [1]
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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.
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Timepoint [1]
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Approximately 8 years from randomization.
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Secondary outcome [2]
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Change From Baseline in Disease Related Symptom (DRS) Score in the BRCA-mutation Population
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Assessment method [2]
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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.
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Timepoint [2]
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Baseline and Day 1 of Cycles 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, and 35
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Secondary outcome [3]
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Change From Baseline in Disease Related Symptom (DRS) Score in the HRD Population
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Assessment method [3]
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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.
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Timepoint [3]
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Baseline and Day 1 of Cycles 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, and 35
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Secondary outcome [4]
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Change From Baseline in Disease Related Symptom (DRS) Score in the ITT Population
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Assessment method [4]
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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.
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Timepoint [4]
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Baseline and Day 1 of Cycles 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, and 35
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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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Stopped early
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
29/06/2015
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
5/10/2023
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Sample size
Target
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Accrual to date
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Final
1140
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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Coffs Harbour Health Campus /ID# 145132 - Coffs Harbour
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Gosford Hospital /ID# 145299 - Gosford
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St George Hospital /ID# 145138 - Kogarah
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Newcastle Private Hospital /ID# 145834 - Lambton Heights
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The Prince of Wales Hospital /ID# 145134 - Randwick
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Northern Cancer Institute /ID# 145681 - St Leonards
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Calvary Mater Newcastle /ID# 145139 - Waratah
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Westmead Hospital /ID# 145137 - Westmead
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Southern Medical Day Care Ctr /ID# 145133 - Wollongong
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The Townsville Hospital /ID# 149163 - Douglas
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Royal Brisbane and Women's Hospital /ID# 145135 - Herston
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Icon Cancer Centre /ID# 148208 - South Brisbane
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Mater Misericordiae Limited /ID# 145682 - South Brisbane
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Royal Adelaide Hospital /ID# 150071 - Adelaide
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Monash Health /ID# 145297 - Clayton
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Cabrini Health /ID# 145142 - Malvern
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Royal Womens Hospital /ID# 145136 - Parkville
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Sir Charles Gairdner Hospital /ID# 145140 - Nedlands
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St. John of God Subiaco Hosp /ID# 147742 - Subiaco
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Recruitment postcode(s) [1]
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2450 - Coffs Harbour
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2250 - Gosford
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2217 - Kogarah
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2305 - Lambton Heights
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2031 - Randwick
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2065 - St Leonards
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2298 - Waratah
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2145 - Westmead
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2500 - Wollongong
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4814 - Douglas
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4029 - Herston
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4101 - South Brisbane
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5000 - Adelaide
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3168 - Clayton
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3144 - Malvern
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3052 - Parkville
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6009 - Nedlands
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6008 - Subiaco
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Recruitment outside Australia
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Japan
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Akashi
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Japan
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Amagasaki
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Japan
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Kashiwa-shi
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Japan
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Kawasaki
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Japan
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Kure
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Japan
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Matsuyama
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Japan
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Sapporo
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Korea, Republic of
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Gyeonggido
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Korea, Republic of
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Seoul Teugbyeolsi
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Korea, Republic of
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Seoul
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New Zealand
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Auckland
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Poland
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Gdansk
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Spain
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Barcelona
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Spain
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Madrid
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Spain
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Valencia
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United Kingdom
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Norfolk
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United Kingdom
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Scotland
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United Kingdom
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Dundee
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United Kingdom
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Great Yarmouth
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United Kingdom
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London
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United Kingdom
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Oxford
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
AbbVie
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Address
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Other collaborator category [1]
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Other
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Gynecologic Oncology Group;Australia New Zealand Gynaecological Oncology Group
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Ethics approval
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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.
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Trial website
https://clinicaltrials.gov/study/NCT02470585
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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. Swisher EM, Aghajanian C, O'Malley DM, Fleming GF, Kaufmann SH, Levine DA, Birrer MJ, Moore KN, Spirtos NM, Shahin MS, Reid TJ, Friedlander M, Steffensen KD, Okamoto A, Sehgal V, Ansell PJ, Dinh MH, Bookman MA, Coleman RL. Impact of homologous recombination status and responses with veliparib combined with first-line chemotherapy in ovarian cancer in the Phase 3 VELIA/GOG-3005 study. Gynecol Oncol. 2022 Feb;164(2):245-253. doi: 10.1016/j.ygyno.2021.12.003. Epub 2021 Dec 11. Washington CR, Moore KN. PARP inhibitors in the treatment of ovarian cancer: a review. Curr Opin Obstet Gynecol. 2021 Feb 1;33(1):1-6. doi: 10.1097/GCO.0000000000000675. Nishikawa T, Matsumoto K, Tamura K, Yoshida H, Imai Y, Miyasaka A, Onoe T, Yamaguchi S, Shimizu C, Yonemori K, Shimoi T, Yunokawa M, Xiong H, Nuthalapati S, Hashiba H, Kiriyama T, Leahy T, Komarnitsky P, Fujiwara K. Phase 1 dose-escalation study of single-agent veliparib in Japanese patients with advanced solid tumors. Cancer Sci. 2017 Sep;108(9):1834-1842. doi: 10.1111/cas.13307. Epub 2017 Aug 5.
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Public notes
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Contacts
Principal investigator
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AbbVie Inc.
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AbbVie
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
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.
Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
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When will data be available (start and end dates)?
For details on when studies are available for sharing, please refer to the link below.
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Available to whom?
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.
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://vivli.org/ourmember/abbvie/
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What supporting documents are/will be available?
No Supporting Document Provided
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Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/85/NCT02470585/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/85/NCT02470585/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT02470585