Adults 18 to 99, any sex, with Untreated Metastatic Colorectal Cancer. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Progression-Free Survival (PFS): Time to EventPrimary· Every 8 weeks from Cycle 1, Day 1 until radiographic progression was observed. The maximum observed follow up duration at the progression-free survival analysis time was 579 days.
PFS was defined as the number of days from the date the participant was randomized to the date the participant experienced an event of disease progression or death, whichever occurred first. All events of disease progression were included, whether the participant was still taking or had discontinued study drug. Events of death were included for participants who had not experienced an event of disease progression, if the death occurred within 8 weeks of the last evaluable disease progression assessment. If the participant did not have an event of disease progression and the participant had not
25th Quartile
Group
Value
95% CI
Veliparib + Modified FOLFIRI ± Bevacizumab
221
120 – 295
Placebo + FOLFIRI ± Bevacizumab
213
121 – 233
50th Quartile
Group
Value
95% CI
Veliparib + Modified FOLFIRI ± Bevacizumab
361
289 – 453
Placebo + FOLFIRI ± Bevacizumab
337
233 – 421
75th Quartile
Group
Value
95% CI
Veliparib + Modified FOLFIRI ± Bevacizumab
534
453 – NA
Placebo + FOLFIRI ± Bevacizumab
512
421 – NA
Overall Survival (OS): Time to EventSecondary· Survival information was to be collected 4 wks after the last study visit, continuing every 4 wks for 1 yr, then every 8 wks for up to 2 more yrs or until death. The maximum observed follow up duration at the overall survival analysis time was 914 days.
Overall survival was defined as the number of days from the date that the participant was randomized to the date of the participant's death. All events of death were included, regardless of whether the event occurred while the participant was still taking or had discontinued study drug. If a participant had not died, the data were censored at the date last known to be alive. The OS distribution was estimated using Kaplan-Meier methodology. Point estimates and 95% confidence intervals (95% CIs) for the OS distribution quartiles are provided.
25th Quartile
Group
Value
95% CI
Veliparib + Modified FOLFIRI ± Bevacizumab
557
391 – 616
Placebo + FOLFIRI ± Bevacizumab
512
326 – 655
50th Quartile
Group
Value
95% CI
Veliparib + Modified FOLFIRI ± Bevacizumab
770
609 – NA
Placebo + FOLFIRI ± Bevacizumab
811
678 – NA
75th Quartile
Group
Value
95% CI
Veliparib + Modified FOLFIRI ± Bevacizumab
NA
784 – NA
Placebo + FOLFIRI ± Bevacizumab
NA
811 – NA
Objective Response Rate (ORR)Secondary· Per protocol, post-baseline tumor assessment was conducted every 8 weeks from Cycle 1 Day 1 until radiographic progression. The maximum observed follow up duration at the progression-free survival analysis time was 579 days.
ORR was defined as the proportion of participants with a complete (CR) or partial response (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1) for target lesions, assessed by computed tomography (CT). Complete response (CR) was defined as disappearance of all target lesions; partial response (PR) ≥30% decrease in the the sum of diameters of target lesions, taking as reference the baseline sum diameters. For participants who underwent surgery, ORR was not evaluated after surgery.
Group
Value
95% CI
Veliparib + Modified FOLFIRI ± Bevacizumab
37
Placebo + FOLFIRI ± Bevacizumab
40
Adverse events — posted to ClinicalTrials.gov
Time frame: Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of veliparib/placebo administration until 30 days after the last dose of veliparib/placebo (up to 396 days)..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Veliparib + Modified FOLFIRI ± Bevacizumab
Serious: 30/65 (46%)
Deaths: 27/65
Placebo + FOLFIRI ± Bevacizumab
Serious: 33/65 (51%)
Deaths: 27/65
Serious adverse events (66 terms)
Reaction
System
Veliparib + Modified FOLFI…
Placebo + FOLFIRI ± Bevaci…
DIARRHOEA
Gastrointestinal disorders
—
—
FEBRILE NEUTROPENIA
Blood and lymphatic system disorders
—
—
INTESTINAL OBSTRUCTION
Gastrointestinal disorders
—
—
NEUTROPENIA
Blood and lymphatic system disorders
—
—
CARDIAC ARREST
Cardiac disorders
—
—
ABDOMINAL PAIN
Gastrointestinal disorders
—
—
LARGE INTESTINAL OBSTRUCTION
Gastrointestinal disorders
—
—
VOMITING
Gastrointestinal disorders
—
—
PYREXIA
General disorders
—
—
BILE DUCT STENOSIS
Hepatobiliary disorders
—
—
PNEUMONIA
Infections and infestations
—
—
MALIGNANT NEOPLASM PROGRESSION
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
This was a blinded, randomized, placebo-controlled Phase 2 multicenter study evaluating the efficacy and tolerability of veliparib plus irinotecan, fluorouracil, and leucovorin chemotherapy regimen (FOLFIRI) compared to placebo plus FOLFIRI in participants with previously untreated metastatic colorectal cancer. Participants could also have been treated with bevacizumab at the discretion of the Investigator.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT03581292 — Veliparib, Radiation Therapy, and Temozolomide in Treating Patients With Newly Diagnosed Malignant Glioma Without H3 K27
· Phase 2
· active not recruiting
NCT03289910 — Topotecan Hydrochloride and Carboplatin With or Without Veliparib in Treating Advanced Myeloproliferative Disorders and
· Phase 2
· active not recruiting
NCT03032614 — Combination of Carboplatin, Eribulin and Veliparib in Stage IV Cancer Patients
· Phase 2
· withdrawn
NCT02631733 — Liposomal Irinotecan and Veliparib in Treating Patients With Solid Tumors
· Phase 1
· completed
NCT03061188 — Phase I/Ib Study of Nivolumab & Veliparib in Patients With Advanced Solid Tumors & Lymphoma
· Phase 1
· completed
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· completed
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by AbbVie
Last refreshed: 20 November 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02305758.