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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02470585




Registration number
NCT02470585
Ethics application status
Date submitted
10/06/2015
Date registered
12/06/2015
Date last updated
14/09/2020

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
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
Secondary ID [1] 0 0
2014-005070-11
Secondary ID [2] 0 0
M13-694
Universal Trial Number (UTN)
Trial acronym
VELIA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ovarian Cancer 0 0
Ovarian Neoplasm 0 0
Condition category
Condition code
Cancer 0 0 0 0
Ovarian and primary peritoneal

Intervention/exposure
Study type
Interventional(has expanded access)
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

Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-Free Survival (PFS) in the BRCA-deficient Population - 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.
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.
Primary outcome [2] 0 0
Progression-Free Survival (PFS) in the Homologous Recombination Deficiency Cohort - 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.
.
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.
Primary outcome [3] 0 0
Progression-Free Survival (PFS) in the Intention-to-treat Population - 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.
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.
Secondary outcome [1] 0 0
Overall Survival (OS) - 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.
Timepoint [1] 0 0
Approximately 8 years from randomization.
Secondary outcome [2] 0 0
Change From Baseline in Disease Related Symptom (DRS) Score in the BRCA-mutation Population - 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.
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
Secondary outcome [3] 0 0
Change From Baseline in Disease Related Symptom (DRS) Score in the HRD Population - 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.
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
Secondary outcome [4] 0 0
Change From Baseline in Disease Related Symptom (DRS) Score in the ITT Population - 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.
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

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.
Minimum age
18 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Coffs Harbour Health Campus /ID# 145132 - Coffs Harbour
Recruitment hospital [2] 0 0
Gosford Hospital /ID# 145299 - Gosford
Recruitment hospital [3] 0 0
St George Hospital /ID# 145138 - Kogarah
Recruitment hospital [4] 0 0
Newcastle Private Hospital /ID# 145834 - Lambton Heights
Recruitment hospital [5] 0 0
The Prince of Wales Hospital /ID# 145134 - Randwick
Recruitment hospital [6] 0 0
Northern Cancer Institute /ID# 145681 - St Leonards
Recruitment hospital [7] 0 0
Calvary Mater Newcastle /ID# 145139 - Waratah
Recruitment hospital [8] 0 0
Westmead Hospital /ID# 145137 - Westmead
Recruitment hospital [9] 0 0
Southern Medical Day Care Ctr /ID# 145133 - Wollongong
Recruitment hospital [10] 0 0
The Townsville Hospital /ID# 149163 - Douglas
Recruitment hospital [11] 0 0
Royal Brisbane and Women's Hospital /ID# 145135 - Herston
Recruitment hospital [12] 0 0
Icon Cancer Centre /ID# 148208 - South Brisbane
Recruitment hospital [13] 0 0
Mater Misericordiae Limited /ID# 145682 - South Brisbane
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Royal Adelaide Hospital /ID# 150071 - Adelaide
Recruitment hospital [15] 0 0
Monash Health /ID# 145297 - Clayton
Recruitment hospital [16] 0 0
Cabrini Health /ID# 145142 - Malvern
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Royal Womens Hospital /ID# 145136 - Parkville
Recruitment hospital [18] 0 0
Sir Charles Gairdner Hospital /ID# 145140 - Nedlands
Recruitment hospital [19] 0 0
St. John of God Subiaco Hosp /ID# 147742 - Subiaco
Recruitment postcode(s) [1] 0 0
2450 - Coffs Harbour
Recruitment postcode(s) [2] 0 0
2250 - Gosford
Recruitment postcode(s) [3] 0 0
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
Recruitment postcode(s) [9] 0 0
2500 - Wollongong
Recruitment postcode(s) [10] 0 0
4814 - Douglas
Recruitment postcode(s) [11] 0 0
4029 - Herston
Recruitment postcode(s) [12] 0 0
4101 - South Brisbane
Recruitment postcode(s) [13] 0 0
5000 - Adelaide
Recruitment postcode(s) [14] 0 0
3168 - Clayton
Recruitment postcode(s) [15] 0 0
3144 - Malvern
Recruitment postcode(s) [16] 0 0
3052 - Parkville
Recruitment postcode(s) [17] 0 0
6009 - Nedlands
Recruitment postcode(s) [18] 0 0
6008 - Subiaco
Recruitment outside Australia
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Alaska
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Kfar Saba
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Ramat Gan
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Aichi
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Fukuoka
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Iwate
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Kumamoto
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Mie
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Niigata
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Osaka
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Tokyo
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Yamagata
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Akashi
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Amagasaki
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Kashiwa-shi
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Kawasaki
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Kure
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Matsuyama
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Sapporo
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Korea, Republic of
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Gyeonggido
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Seoul Teugbyeolsi
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Auckland
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Poland
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Gdansk
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Valencia
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Dundee
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Great Yarmouth
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London
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Oxford

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
AbbVie
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Gynecologic Oncology Group;Australia New Zealand Gynaecological Oncology Group
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT02470585
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
AbbVie Inc.
Address 0 0
AbbVie
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications