Trial · NCT02470585

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

NCT02470585, Phase 3, Terminated, AbbVie; results first posted 2020-09-14

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. 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. Trials, record NCT02470585. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02470585

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

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
NCT number: NCT02470585
Status: Terminated
Phases: Phase 3
Enrollment: 1,140 participants, actual
Lead sponsor: AbbVie
Conditions: Ovarian Cancer, Ovarian Neoplasm
Interventions: Veliparib, Paclitaxel, Carboplatin, Placebo to Veliparib
First posted: 2015-06-12
Last updated: 2024-10-26
Other registries' IDs: eudract:2014-005070-11
Results first posted: 2020-09-14

Source ClinicalTrials.gov

Registered outcomes12

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Progression-Free Survival (PFS) in the BRCA-deficient Population (Arm 3 vs Arm 1)	From randomization until the primary analysis data cut-off date of 03 May 2019, the median duration of follow-up was 28 months.	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.
Primary	Progression-Free Survival (PFS) in the Homologous Recombination Deficiency Cohort (Arm 3 vs Arm 1)	From randomization until the primary analysis data cut-off date of 03 May 2019, the median duration of follow-up was 28 months.	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. .
Primary	Progression-Free Survival (PFS) in the Intention-to-treat Population (Arm 3 vs Arm 1)	From randomization until the primary analysis data cut-off date of 03 May 2019, the median duration of follow-up was 28 months.	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.
Secondary	Progression-Free Survival (PFS) in the BRCA-deficient Population (Arm 2 vs Arm 1)	From randomization until the primary analysis data cut-off date of 03 May 2019, the median duration of follow-up was 28 months.	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.
Secondary	Progression-Free Survival (PFS) in the Homologous Recombination Deficiency Cohort (Arm 2 vs Arm 1)	From randomization until the primary analysis data cut-off date of 03 May 2019, the median duration of follow-up was 28 months.	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. .
Secondary	Progression-Free Survival (PFS) in the Intention-to-treat Population (Arm 2 vs Arm 1)	From randomization until the primary analysis data cut-off date of 03 May 2019, the median duration of follow-up was 28 months.	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.
Secondary	Overall Survival (OS) in the BRCA-deficient Population	From the time of randomization to the end of the study, up to 98 months	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.
Secondary	Overall Survival (OS) in the Homologous Recombination Deficiency Population	From the time of randomization to the end of the study, up to 98 months	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.
Secondary	Overall Survival (OS) in the Whole Population	From the time of randomization to the end of the study, up to 98 months	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.
Secondary	Change From Baseline in Disease Related Symptom (DRS) Score in the BRCA-mutation Population	Baseline and Day 1 of Cycles 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, and 35	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.

1 to 10 of 12Source ClinicalTrials.gov

See all 12 registered outcomes

Outcomes12

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Progression-Free Survival (PFS) in the BRCA-deficient Population (Arm 3 vs Arm 1)	From randomization until the primary analysis data cut-off date of 03 May 2019, the median duration of follow-up was 28 months.	Analyses were performed in 3 sequentially inclusive populations. The first analysis was conducted using the BRCA-mutation cohort which included participants with either a gBRCA and/or tBRCA deleterious or suspected deleterious mutation in BRCA1 or BRCA2.	months	MEDIAN
PRIMARY	Progression-Free Survival (PFS) in the Homologous Recombination Deficiency Cohort (Arm 3 vs Arm 1)	From randomization until the primary analysis data cut-off date of 03 May 2019, the median duration of follow-up was 28 months.	Analyses were performed in 3 sequentially inclusive populations. The second analysis was conducted using the HRD cohort which included participants in the BRCA-mutation cohort and those determined to have HRD tumors.	months	MEDIAN
PRIMARY	Progression-Free Survival (PFS) in the Intention-to-treat Population (Arm 3 vs Arm 1)	From randomization until the primary analysis data cut-off date of 03 May 2019, the median duration of follow-up was 28 months.	Analyses were performed in 3 sequentially inclusive populations. The third analysis was conducted using the intention-to-treat (ITT) population (all randomized participants).	months	MEDIAN
SECONDARY	Progression-Free Survival (PFS) in the BRCA-deficient Population (Arm 2 vs Arm 1)	From randomization until the primary analysis data cut-off date of 03 May 2019, the median duration of follow-up was 28 months.	Analyses were performed in 3 sequentially inclusive populations. The first analysis was conducted using the BRCA-mutation cohort which included participants with either a gBRCA and/or tBRCA deleterious or suspected deleterious mutation in BRCA1 or BRCA2.	months	MEDIAN
SECONDARY	Progression-Free Survival (PFS) in the Homologous Recombination Deficiency Cohort (Arm 2 vs Arm 1)	From randomization until the primary analysis data cut-off date of 03 May 2019, the median duration of follow-up was 28 months.	Analyses were performed in 3 sequentially inclusive populations. The second analysis was conducted using the HRD cohort which included participants in the BRCA-mutation cohort and those determined to have HRD tumors.	months	MEDIAN
SECONDARY	Progression-Free Survival (PFS) in the Intention-to-treat Population (Arm 2 vs Arm 1)	From randomization until the primary analysis data cut-off date of 03 May 2019, the median duration of follow-up was 28 months.	Analyses were performed in 3 sequentially inclusive populations. The third analysis was conducted using the intention-to-treat (ITT) population (all randomized participants).	months	MEDIAN
SECONDARY	Overall Survival (OS) in the BRCA-deficient Population	From the time of randomization to the end of the study, up to 98 months	BRCA-Deficient population: All randomized participants with germline and/or tissue deleterious/suspected deleterious BRCA1/2 mutation	months	MEDIAN
SECONDARY	Overall Survival (OS) in the Homologous Recombination Deficiency Population	From the time of randomization to the end of the study, up to 98 months	All randomized participants considered BRCA-Deficient and those determined to have HRD tumors based on HRD score	months	MEDIAN
SECONDARY	Overall Survival (OS) in the Whole Population	From the time of randomization to the end of the study, up to 98 months	All randomized participants	months	MEDIAN
SECONDARY	Change From Baseline in Disease Related Symptom (DRS) Score in the BRCA-mutation Population	Baseline and Day 1 of Cycles 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, and 35	BRCA-mutation population, participants with available data at each time point.	score on a scale	LEAST_SQUARES_MEAN

1 to 10 of 12Source ClinicalTrials.gov

See all 12 outcomes

Results by group180

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Progression-Free Survival (PFS) in the BRCA-deficient Population (Arm 3 vs Arm 1)	Placebo + Carboplatin + Paclitaxel -> Placebo	22.0	95% Confidence Interval 17.8 to 29.1	months
Progression-Free Survival (PFS) in the BRCA-deficient Population (Arm 3 vs Arm 1)	Veliparib + Carboplatin + Paclitaxel -> Placebo	21.1	95% Confidence Interval 17.0 to 25.5	months
Progression-Free Survival (PFS) in the BRCA-deficient Population (Arm 3 vs Arm 1)	Veliparib + Carboplatin + Paclitaxel -> Veliparib	34.7	95% Confidence Interval 31.8 to NA	months
Progression-Free Survival (PFS) in the Homologous Recombination Deficiency Cohort (Arm 3 vs Arm 1)	Placebo + Carboplatin + Paclitaxel -> Placebo	20.5	95% Confidence Interval 17.8 to 22.8	months
Progression-Free Survival (PFS) in the Homologous Recombination Deficiency Cohort (Arm 3 vs Arm 1)	Veliparib + Carboplatin + Paclitaxel -> Placebo	18.1	95% Confidence Interval 16.4 to 22.7	months
Progression-Free Survival (PFS) in the Homologous Recombination Deficiency Cohort (Arm 3 vs Arm 1)	Veliparib + Carboplatin + Paclitaxel -> Veliparib	31.9	95% Confidence Interval 25.8 to 38.0	months
Progression-Free Survival (PFS) in the Intention-to-treat Population (Arm 3 vs Arm 1)	Placebo + Carboplatin + Paclitaxel -> Placebo	17.3	95% Confidence Interval 15.1 to 19.1	months
Progression-Free Survival (PFS) in the Intention-to-treat Population (Arm 3 vs Arm 1)	Veliparib + Carboplatin + Paclitaxel -> Placebo	15.2	95% Confidence Interval 14.1 to 17.3	months
Progression-Free Survival (PFS) in the Intention-to-treat Population (Arm 3 vs Arm 1)	Veliparib + Carboplatin + Paclitaxel -> Veliparib	23.5	95% Confidence Interval 19.3 to 26.3	months
Progression-Free Survival (PFS) in the BRCA-deficient Population (Arm 2 vs Arm 1)	Placebo + Carboplatin + Paclitaxel -> Placebo	22.0	95% Confidence Interval 17.8 to 29.1	months

1 to 10 of 180Source ClinicalTrials.gov

See all 180 results by group

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo + Carboplatin + Paclitaxel -> Placebo	375
Overall Study	STARTED	Veliparib + Carboplatin + Paclitaxel -> Placebo	383
Overall Study	STARTED	Veliparib + Carboplatin + Paclitaxel -> Veliparib	382
Overall Study	COMPLETED	Placebo + Carboplatin + Paclitaxel -> Placebo	0
Overall Study	COMPLETED	Veliparib + Carboplatin + Paclitaxel -> Placebo	0
Overall Study	COMPLETED	Veliparib + Carboplatin + Paclitaxel -> Veliparib	0
Overall Study	NOT COMPLETED	Placebo + Carboplatin + Paclitaxel -> Placebo	375
Overall Study	NOT COMPLETED	Veliparib + Carboplatin + Paclitaxel -> Placebo	383
Overall Study	NOT COMPLETED	Veliparib + Carboplatin + Paclitaxel -> Veliparib	382

Source ClinicalTrials.gov

Adverse events954

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	ANAEMIA	Blood and lymphatic system disorders	Placebo + Carboplatin + Paclitaxel -> Placebo	191	375	514
other	ANAEMIA	Blood and lymphatic system disorders	Veliparib + Carboplatin + Paclitaxel -> Placebo	232	383	603
other	ANAEMIA	Blood and lymphatic system disorders	Veliparib + Carboplatin + Paclitaxel -> Veliparib	226	382	672
other	LEUKOPENIA	Blood and lymphatic system disorders	Placebo + Carboplatin + Paclitaxel -> Placebo	89	375	223
other	LEUKOPENIA	Blood and lymphatic system disorders	Veliparib + Carboplatin + Paclitaxel -> Placebo	87	383	261
other	LEUKOPENIA	Blood and lymphatic system disorders	Veliparib + Carboplatin + Paclitaxel -> Veliparib	114	382	333
other	LYMPHOPENIA	Blood and lymphatic system disorders	Placebo + Carboplatin + Paclitaxel -> Placebo	15	375	28
other	LYMPHOPENIA	Blood and lymphatic system disorders	Veliparib + Carboplatin + Paclitaxel -> Placebo	15	383	20
other	LYMPHOPENIA	Blood and lymphatic system disorders	Veliparib + Carboplatin + Paclitaxel -> Veliparib	26	382	57
other	NEUTROPENIA	Blood and lymphatic system disorders	Placebo + Carboplatin + Paclitaxel -> Placebo	247	375	673

1 to 10 of 954Source ClinicalTrials.gov

See all 954 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo + Carboplatin + Paclitaxel -> Placebo	228	375
Total, all-cause mortality	Veliparib + Carboplatin + Paclitaxel -> Placebo	234	383
Total, all-cause mortality	Veliparib + Carboplatin + Paclitaxel -> Veliparib	209	382
Total, other adverse events	Placebo + Carboplatin + Paclitaxel -> Placebo	369	375
Total, other adverse events	Veliparib + Carboplatin + Paclitaxel -> Placebo	375	383
Total, other adverse events	Veliparib + Carboplatin + Paclitaxel -> Veliparib	376	382
Total, serious adverse events	Placebo + Carboplatin + Paclitaxel -> Placebo	143	375
Total, serious adverse events	Veliparib + Carboplatin + Paclitaxel -> Placebo	130	383
Total, serious adverse events	Veliparib + Carboplatin + Paclitaxel -> Veliparib	146	382

Source ClinicalTrials.gov

Papers5

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
28665051	DERIVED	PubMed
31562800	BACKGROUND	PubMed
33369580	DERIVED	PubMed
34906376	DERIVED	PubMed
41565553	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02470585

GET https://conductscience.org/api/trials/v1/NCT02470585/results?page=2

API reference For AI assistants