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NCT02470585 · CITED IN SOURCE DOCUMENTS

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

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
PHASE3
Status at capture
TERMINATED
Registry last update
2024-10-26

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Progression-Free Survival (PFS) in the BRCA-deficient Population (Arm 3 vs Arm 1)

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outcome · POSTED

Progression-Free Survival (PFS) in the Homologous Recombination Deficiency Cohort (Arm 3 vs Arm 1)

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outcome · POSTED

Progression-Free Survival (PFS) in the Intention-to-treat Population (Arm 3 vs Arm 1)

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outcome · POSTED

Progression-Free Survival (PFS) in the BRCA-deficient Population (Arm 2 vs Arm 1)

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outcome · POSTED

Progression-Free Survival (PFS) in the Homologous Recombination Deficiency Cohort (Arm 2 vs Arm 1)

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outcome · POSTED

Progression-Free Survival (PFS) in the Intention-to-treat Population (Arm 2 vs Arm 1)

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outcome · POSTED

Overall Survival (OS) in the BRCA-deficient Population

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outcome · POSTED

Overall Survival (OS) in the Homologous Recombination Deficiency Population

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outcome · POSTED

Overall Survival (OS) in the Whole Population

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outcome · POSTED

Change From Baseline in Disease Related Symptom (DRS) Score in the BRCA-mutation Population

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outcome · POSTED

Change From Baseline in Disease Related Symptom (DRS) Score in the HRD Population

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outcome · POSTED

Change From Baseline in Disease Related Symptom (DRS) Score in the Whole Population

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
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. 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.
healthy Volunteers
false
minimum Age
18 Years
sex
FEMALE
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    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.
    intervention Names
    1. Drug: Paclitaxel
    2. Drug: Carboplatin
    3. Other: Placebo to Veliparib
    label
    Placebo + Carboplatin + Paclitaxel -> Placebo
    type
    ACTIVE_COMPARATOR
  2. description
    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.
    intervention Names
    1. Drug: Veliparib
    2. Drug: Paclitaxel
    3. Drug: Carboplatin
    4. Other: Placebo to Veliparib
    label
    Veliparib + Carboplatin + Paclitaxel -> Placebo
    type
    EXPERIMENTAL
  3. description
    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.
    intervention Names
    1. Drug: Veliparib
    2. Drug: Paclitaxel
    3. Drug: Carboplatin
    label
    Veliparib + Carboplatin + Paclitaxel -> Veliparib
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Veliparib + Carboplatin + Paclitaxel -> Placebo
    2. Veliparib + Carboplatin + Paclitaxel -> Veliparib
    description
    Capsules for oral administration
    name
    Veliparib
    other Names
    1. ABT-888
    type
    DRUG
  2. arm Group Labels
    1. Placebo + Carboplatin + Paclitaxel -> Placebo
    2. Veliparib + Carboplatin + Paclitaxel -> Placebo
    3. Veliparib + Carboplatin + Paclitaxel -> Veliparib
    description
    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).
    name
    Paclitaxel
    type
    DRUG
  3. arm Group Labels
    1. Placebo + Carboplatin + Paclitaxel -> Placebo
    2. Veliparib + Carboplatin + Paclitaxel -> Placebo
    3. Veliparib + Carboplatin + Paclitaxel -> Veliparib
    description
    Administered by intravenous infusion at an area under the curve (AUC) of 6 mg/mL/min every 3 weeks.
    name
    Carboplatin
    type
    DRUG
  4. arm Group Labels
    1. Placebo + Carboplatin + Paclitaxel -> Placebo
    2. Veliparib + Carboplatin + Paclitaxel -> Placebo
    description
    Capsules for oral administration
    name
    Placebo to Veliparib
    type
    OTHER
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
DOUBLE
who Masked
  1. PARTICIPANT
  2. INVESTIGATOR
primary Purpose
TREATMENT
Enrollment
count
1140
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    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.
    measure
    Progression-Free Survival (PFS) in the BRCA-deficient Population (Arm 3 vs Arm 1)
    time Frame
    From randomization until the primary analysis data cut-off date of 03 May 2019, the median duration of follow-up was 28 months.
  2. description
    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. .
    measure
    Progression-Free Survival (PFS) in the Homologous Recombination Deficiency Cohort (Arm 3 vs Arm 1)
    time Frame
    From randomization until the primary analysis data cut-off date of 03 May 2019, the median duration of follow-up was 28 months.
  3. description
    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.
    measure
    Progression-Free Survival (PFS) in the Intention-to-treat Population (Arm 3 vs Arm 1)
    time Frame
    From randomization until the primary analysis data cut-off date of 03 May 2019, the median duration of follow-up was 28 months.
secondary Outcomes
  1. description
    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.
    measure
    Progression-Free Survival (PFS) in the BRCA-deficient Population (Arm 2 vs Arm 1)
    time Frame
    From randomization until the primary analysis data cut-off date of 03 May 2019, the median duration of follow-up was 28 months.
  2. description
    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. .
    measure
    Progression-Free Survival (PFS) in the Homologous Recombination Deficiency Cohort (Arm 2 vs Arm 1)
    time Frame
    From randomization until the primary analysis data cut-off date of 03 May 2019, the median duration of follow-up was 28 months.
  3. description
    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.
    measure
    Progression-Free Survival (PFS) in the Intention-to-treat Population (Arm 2 vs Arm 1)
    time Frame
    From randomization until the primary analysis data cut-off date of 03 May 2019, the median duration of follow-up was 28 months.
  4. description
    OS is defined as the time from the day the participant was randomized to the date of death, and was calculated using Kaplan-Meier methods. 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.
    measure
    Overall Survival (OS) in the BRCA-deficient Population
    time Frame
    From the time of randomization to the end of the study, up to 98 months
  5. description
    OS is defined as the time from the day the participant was randomized to the date of death, and was calculated using Kaplan-Meier methods. 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.
    measure
    Overall Survival (OS) in the Homologous Recombination Deficiency Population
    time Frame
    From the time of randomization to the end of the study, up to 98 months
  6. description
    OS is defined as the time from the day the participant was randomized to the date of death, and was calculated using Kaplan-Meier methods. 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.
    measure
    Overall Survival (OS) in the Whole Population
    time Frame
    From the time of randomization to the end of the study, up to 98 months
  7. description
    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.
    measure
    Change From Baseline in Disease Related Symptom (DRS) Score in the BRCA-mutation Population
    time Frame
    Baseline and Day 1 of Cycles 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, and 35
  8. description
    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.
    measure
    Change From Baseline in Disease Related Symptom (DRS) Score in the HRD Population
    time Frame
    Baseline and Day 1 of Cycles 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, and 35
  9. description
    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.
    measure
    Change From Baseline in Disease Related Symptom (DRS) Score in the Whole Population
    time Frame
    Baseline and Day 1 of Cycles 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, and 35
Full study description
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.
detailed Description
Participants were randomized in a 1:1:1 ratio to one of three arms. Randomization in the entire population was stratified according to the timing of surgery and residual disease status (any residual disease after primary surgery vs. no residual disease after primary surgery vs. interval surgery) and the paclitaxel schedule (weekly vs. every 3 -weeks), stage of disease (III vs. IV), geographic region (Japan vs. North America and rest of world \[ROW\]), and germline breast cancer susceptibility gene (BRCA) mutation status (positive versus negative or Unknown). Cytoreductive surgery could be performed before randomization and the initiation of study treatment (primary) or after 3 cycles of study treatment (interval). The weekly or every-3-week paclitaxel schedule and the choice of primary or interval cytoreductive surgery were determined at the discretion of the investigator. The primary objective was evaluated in the BRCA-deficient cohort, participants with homologous recombination deficiency (HRD), and the intention-to-treat (ITT) population. These populations were sequentially inclusive, with the HRD population including the BRCA-deficient population, and the ITT population including the HRD and BRCA-deficient populations. The BRCA-deficient population was defined as participants with either a germline (gBRCA) and/or tissue-based (tBRCA) deleterious or suspected deleterious mutation in BRCA1 or BRCA2 confirmed by centralized testing. The HRD population was defined as participants with HRD tumors based on HRD score or presence of a deleterious or suspected deleterious mutation in BRCA1 or BRCA2 as determined by centralized testing.
Source references
references
  1. citation
    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.
    pmid
    31562800
    type
    BACKGROUND
  2. citation
    Lafferty J, Secord AA, Bookman M, Coleman RL, Dinh MH, Khandelwal N, Kamalakar R, Cella D. Quality-adjusted progression-free survival analysis of veliparib and carboplatin/paclitaxel compared with chemotherapy alone in patients with newly diagnosed ovarian cancer (VELIA/GOG3005): ancillary analysis of a placebo-controlled, phase 3 randomized trial. Int J Gynecol Cancer. 2026 May;36(5):102819. doi: 10.1016/j.ijgc.2025.102819. Epub 2025 Nov 21.
    pmid
    41565553
    type
    DERIVED
  3. citation
    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.
    pmid
    34906376
    type
    DERIVED
  4. citation
    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.
    pmid
    33369580
    type
    DERIVED
  5. citation
    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.
    pmid
    28665051
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
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        discontinuations of niraparib were caused by adverse events versus 5 of 175 discontinuations of the placebo. </li></ol></div></li><li><a href="/clinicaltrials/NCT02470585">VELIA/GOG-3005</a> (NCT02470585), a phase III placebo-controlled study, assessed the efficacy of oral veliparib added to first-line induction chemotherapy wit
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        re caused by adverse events versus 5 of 175 discontinuations of the placebo. </li></ol></div></li><li><a href="/clinicaltrials/NCT02470585">VELIA/GOG-3005</a> (NCT02470585), a phase III placebo-controlled study, assessed the efficacy of oral veliparib added to first-line induction chemotherapy with carboplatin/paclitaxel and cont
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      source update dates
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        Updated: May 14, 2025
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        May 14, 2025

    Preserved source evidence · Not medical advice