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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
Date last updated
26/10/2024

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
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 (Arm 3 vs Arm 1)
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 (Arm 3 vs Arm 1)
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 (Arm 3 vs Arm 1)
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
Progression-Free Survival (PFS) in the BRCA-deficient Population (Arm 2 vs Arm 1)
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.
Secondary outcome [2] 0 0
Progression-Free Survival (PFS) in the Homologous Recombination Deficiency Cohort (Arm 2 vs Arm 1)
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.
Secondary outcome [3] 0 0
Progression-Free Survival (PFS) in the Intention-to-treat Population (Arm 2 vs Arm 1)
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 [4] 0 0
Overall Survival (OS) in the BRCA-deficient Population
Timepoint [4] 0 0
From the time of randomization to the end of the study, up to 98 months
Secondary outcome [5] 0 0
Overall Survival (OS) in the Homologous Recombination Deficiency Population
Timepoint [5] 0 0
From the time of randomization to the end of the study, up to 98 months
Secondary outcome [6] 0 0
Overall Survival (OS) in the Whole Population
Timepoint [6] 0 0
From the time of randomization to the end of the study, up to 98 months
Secondary outcome [7] 0 0
Change From Baseline in Disease Related Symptom (DRS) Score in the BRCA-mutation Population
Timepoint [7] 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 [8] 0 0
Change From Baseline in Disease Related Symptom (DRS) Score in the HRD Population
Timepoint [8] 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 [9] 0 0
Change From Baseline in Disease Related Symptom (DRS) Score in the Whole Population
Timepoint [9] 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
Sex
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
Stopped early
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
Recruitment hospital [14] 0 0
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
Recruitment hospital [17] 0 0
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
Recruitment postcode(s) [4] 0 0
2305 - Lambton Heights
Recruitment postcode(s) [5] 0 0
2031 - Randwick
Recruitment postcode(s) [6] 0 0
2065 - St Leonards
Recruitment postcode(s) [7] 0 0
2298 - Waratah
Recruitment postcode(s) [8] 0 0
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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Alabama
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Alaska
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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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Korea, Republic of
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Seoul Teugbyeolsi
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Auckland
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Gdansk
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Barcelona
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Madrid
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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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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/study/NCT02470585
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.
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

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02470585