Trial Outcomes & Findings for FOLFIRI or Modified FOLFIRI and Veliparib as Second Line Therapy in Treating Patients With Metastatic Pancreatic Cancer (NCT NCT02890355)

Last Updated: 2025-11-10

Results Overview

OS: time to death by any cause from randomized treatment arm assignment. The log-rank test with stratification was used by prior systemic treatment for metastatic disease. Distributions of overall survival in arms 1 and 2 were estimated using the method of Kaplan-Meier.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2

Target enrollment

123 participants

Primary outcome timeframe

Up to 3 years

Results posted on

2025-11-10

Participant Flow

The trial was designed to enroll 143 patients, but was closed early based on the results of a planned interim futility analysis. Thus, only 123 patients were enrolled on the study.

123 participants were enrolled, but 4 were ineligible and 2 refused assigned FOLFIRI treatment. Thus, 117 were eligible for analyses.

Participant milestones

Participant milestones
Measure	Arm I (Veliparib and mFOLFIRI) Participants receive veliparib PO BID every 12 hours on days 1-7, irinotecan hydrochloride IV over 90-120 minutes on day 3, leucovorin calcium IV over 90-120 minutes on day 3, and fluorouracil IV over 46 hours on days 3-5. Fluorouracil: Given IV Irinotecan Hydrochloride: Given IV Laboratory Biomarker Analysis: Correlative studies Leucovorin Calcium: Given IV Veliparib: Given PO	Arm II (FOLFIRI) Participants receive irinotecan hydrochloride IV over 90-120 minutes on day 1, leucovorin calcium IV over 90-120 minutes on day 1, and fluorouracil IV bolus over 15 minutes on days 1 and then over 46 hours on days 1-3. Fluorouracil: Given IV Fluorouracil: Given IV bolus Irinotecan Hydrochloride: Given IV Laboratory Biomarker Analysis: Correlative studies Leucovorin Calcium: Given IV
Overall Study STARTED	59	58
Overall Study Treated & Assessed for AEs	56	50
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	59	58

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm I (Veliparib and mFOLFIRI) Participants receive veliparib PO BID every 12 hours on days 1-7, irinotecan hydrochloride IV over 90-120 minutes on day 3, leucovorin calcium IV over 90-120 minutes on day 3, and fluorouracil IV over 46 hours on days 3-5. Fluorouracil: Given IV Irinotecan Hydrochloride: Given IV Laboratory Biomarker Analysis: Correlative studies Leucovorin Calcium: Given IV Veliparib: Given PO	Arm II (FOLFIRI) Participants receive irinotecan hydrochloride IV over 90-120 minutes on day 1, leucovorin calcium IV over 90-120 minutes on day 1, and fluorouracil IV bolus over 15 minutes on days 1 and then over 46 hours on days 1-3. Fluorouracil: Given IV Fluorouracil: Given IV bolus Irinotecan Hydrochloride: Given IV Laboratory Biomarker Analysis: Correlative studies Leucovorin Calcium: Given IV
Overall Study Adverse Event	5	5
Overall Study Refusal unrelated to adverse event	5	10
Overall Study Progression/relapse	46	39
Overall Study Not protocol specified	3	4

Baseline Characteristics

FOLFIRI or Modified FOLFIRI and Veliparib as Second Line Therapy in Treating Patients With Metastatic Pancreatic Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm I (Veliparib and mFOLFIRI) n=59 Participants Participants receive veliparib PO BID every 12 hours on days 1-7, irinotecan hydrochloride IV over 90-120 minutes on day 3, leucovorin calcium IV over 90-120 minutes on day 3, and fluorouracil IV over 46 hours on days 3-5. Fluorouracil: Given IV Irinotecan Hydrochloride: Given IV Laboratory Biomarker Analysis: Correlative studies Leucovorin Calcium: Given IV Veliparib: Given PO	Arm II (FOLFIRI) n=58 Participants Participants receive irinotecan hydrochloride IV over 90-120 minutes on day 1, leucovorin calcium IV over 90-120 minutes on day 1, and fluorouracil IV bolus over 15 minutes on days 1 and then over 46 hours on days 1-3. Fluorouracil: Given IV Fluorouracil: Given IV bolus Irinotecan Hydrochloride: Given IV Laboratory Biomarker Analysis: Correlative studies Leucovorin Calcium: Given IV	Total n=117 Participants Total of all reporting groups
Age, Continuous	67 years n=5 Participants	67 years n=20 Participants	67 years n=40 Participants
Sex: Female, Male Female	28 Participants n=5 Participants	25 Participants n=20 Participants	53 Participants n=40 Participants
Sex: Female, Male Male	31 Participants n=5 Participants	33 Participants n=20 Participants	64 Participants n=40 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=20 Participants	1 Participants n=40 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	1 Participants n=20 Participants	2 Participants n=40 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants	5 Participants n=20 Participants	9 Participants n=40 Participants
Race (NIH/OMB) White	52 Participants n=5 Participants	47 Participants n=20 Participants	99 Participants n=40 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	5 Participants n=20 Participants	6 Participants n=40 Participants
Prior treatment for metastic pancreatic adenocarcinoma Yes	53 Participants n=5 Participants	52 Participants n=20 Participants	105 Participants n=40 Participants
Prior treatment for metastic pancreatic adenocarcinoma No	6 Participants n=5 Participants	6 Participants n=20 Participants	12 Participants n=40 Participants
Zubrod (ECOG) Performance Status 0	14 Participants n=5 Participants	23 Participants n=20 Participants	37 Participants n=40 Participants
Zubrod (ECOG) Performance Status 1	45 Participants n=5 Participants	35 Participants n=20 Participants	80 Participants n=40 Participants

PRIMARY outcome

Timeframe: Up to 3 years

Population: All eligible participants according to the intent-to-treat principle.

Outcome measures

Outcome measures
Measure	Arm I (Veliparib and mFOLFIRI) n=59 Participants Participants receive veliparib PO BID every 12 hours on days 1-7, irinotecan hydrochloride IV over 90-120 minutes on day 3, leucovorin calcium IV over 90-120 minutes on day 3, and fluorouracil IV over 46 hours on days 3-5. Fluorouracil: Given IV Irinotecan Hydrochloride: Given IV Laboratory Biomarker Analysis: Correlative studies Leucovorin Calcium: Given IV Veliparib: Given PO	Arm II (FOLFIRI) n=58 Participants Participants receive irinotecan hydrochloride IV over 90-120 minutes on day 1, leucovorin calcium IV over 90-120 minutes on day 1, and fluorouracil IV bolus over 15 minutes on days 1 and then over 46 hours on days 1-3. Fluorouracil: Given IV Fluorouracil: Given IV bolus Irinotecan Hydrochloride: Given IV Laboratory Biomarker Analysis: Correlative studies Leucovorin Calcium: Given IV
Overall Survival (OS)	5.4 months Interval 3.7 to 7.2	6.5 months Interval 5.6 to 7.8

SECONDARY outcome

Timeframe: Duration of treatment and follow up until death or 3 years post registration

Population: Patients who received at least one dose of protocol treatment.

Adverse Events (AEs) are reported by CTCAE Version 4.0. Only adverse events that are possibly, probably or definitely related to study drug are reported.

Outcome measures

Outcome measures
Measure	Arm I (Veliparib and mFOLFIRI) n=56 Participants Participants receive veliparib PO BID every 12 hours on days 1-7, irinotecan hydrochloride IV over 90-120 minutes on day 3, leucovorin calcium IV over 90-120 minutes on day 3, and fluorouracil IV over 46 hours on days 3-5. Fluorouracil: Given IV Irinotecan Hydrochloride: Given IV Laboratory Biomarker Analysis: Correlative studies Leucovorin Calcium: Given IV Veliparib: Given PO	Arm II (FOLFIRI) n=50 Participants Participants receive irinotecan hydrochloride IV over 90-120 minutes on day 1, leucovorin calcium IV over 90-120 minutes on day 1, and fluorouracil IV bolus over 15 minutes on days 1 and then over 46 hours on days 1-3. Fluorouracil: Given IV Fluorouracil: Given IV bolus Irinotecan Hydrochloride: Given IV Laboratory Biomarker Analysis: Correlative studies Leucovorin Calcium: Given IV
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Sepsis	1 Participants	0 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Thromboembolic event	1 Participants	0 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Vascular disorders - Other, specify	1 Participants	0 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Vomiting	5 Participants	2 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs White blood cell decreased	7 Participants	3 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Abdominal infection	0 Participants	1 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Abdominal pain	2 Participants	1 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Acute coronary syndrome	1 Participants	0 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Alanine aminotransferase increased	2 Participants	0 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Alkaline phosphatase increased	2 Participants	3 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Anemia	4 Participants	5 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Anorexia	3 Participants	0 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Aspartate aminotransferase increased	1 Participants	1 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Atrial fibrillation	0 Participants	1 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Atrial flutter	0 Participants	1 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Blood bilirubin increased	4 Participants	5 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Cardiac disorders - Other, specify	1 Participants	0 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Catheter related infection	1 Participants	0 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Confusion	0 Participants	1 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Cough	0 Participants	1 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Dehydration	6 Participants	1 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Device related infection	1 Participants	0 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Diarrhea	6 Participants	3 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Dyspnea	1 Participants	0 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Enterocolitis infectious	0 Participants	1 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Fall	0 Participants	1 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Fatigue	10 Participants	3 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Febrile neutropenia	1 Participants	1 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Fever	0 Participants	1 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Generalized muscle weakness	2 Participants	1 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Hyperglycemia	1 Participants	1 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Hypertension	1 Participants	2 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Hypokalemia	2 Participants	1 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Hyponatremia	2 Participants	3 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Hypotension	0 Participants	1 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Infections and infestations - Other, specify	2 Participants	1 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Lymphocyte count decreased	3 Participants	6 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Mucositis oral	0 Participants	1 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Nausea	7 Participants	2 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Neutrophil count decreased	20 Participants	11 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Platelet count decreased	4 Participants	0 Participants

SECONDARY outcome

Timeframe: From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause, assessed up to 3 years

Population: All eligible participants according to the intent-to-treat principle.

From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive without report of progression are censored at date of last contact.

Outcome measures

Outcome measures
Measure	Arm I (Veliparib and mFOLFIRI) n=59 Participants Participants receive veliparib PO BID every 12 hours on days 1-7, irinotecan hydrochloride IV over 90-120 minutes on day 3, leucovorin calcium IV over 90-120 minutes on day 3, and fluorouracil IV over 46 hours on days 3-5. Fluorouracil: Given IV Irinotecan Hydrochloride: Given IV Laboratory Biomarker Analysis: Correlative studies Leucovorin Calcium: Given IV Veliparib: Given PO	Arm II (FOLFIRI) n=58 Participants Participants receive irinotecan hydrochloride IV over 90-120 minutes on day 1, leucovorin calcium IV over 90-120 minutes on day 1, and fluorouracil IV bolus over 15 minutes on days 1 and then over 46 hours on days 1-3. Fluorouracil: Given IV Fluorouracil: Given IV bolus Irinotecan Hydrochloride: Given IV Laboratory Biomarker Analysis: Correlative studies Leucovorin Calcium: Given IV
Progression Free Survival (PFS)	2.1 months Interval 1.9 to 2.4	2.9 months Interval 2.2 to 4.2

SECONDARY outcome

Timeframe: Up to 3 years post registration

Population: Eligible participants with measurable disease.

Overall response rate (ORR) is defined as the proportion of participants who have a confirmed and unconfirmed, partial or complete response to therapy.

Outcome measures

Outcome measures
Measure	Arm I (Veliparib and mFOLFIRI) n=57 Participants Participants receive veliparib PO BID every 12 hours on days 1-7, irinotecan hydrochloride IV over 90-120 minutes on day 3, leucovorin calcium IV over 90-120 minutes on day 3, and fluorouracil IV over 46 hours on days 3-5. Fluorouracil: Given IV Irinotecan Hydrochloride: Given IV Laboratory Biomarker Analysis: Correlative studies Leucovorin Calcium: Given IV Veliparib: Given PO	Arm II (FOLFIRI) n=51 Participants Participants receive irinotecan hydrochloride IV over 90-120 minutes on day 1, leucovorin calcium IV over 90-120 minutes on day 1, and fluorouracil IV bolus over 15 minutes on days 1 and then over 46 hours on days 1-3. Fluorouracil: Given IV Fluorouracil: Given IV bolus Irinotecan Hydrochloride: Given IV Laboratory Biomarker Analysis: Correlative studies Leucovorin Calcium: Given IV
Overall Response Rate, ORR	0.09 proportion of participants Interval 0.01 to 0.16	0.10 proportion of participants Interval 0.02 to 0.18

SECONDARY outcome

Timeframe: Up to 3 years post registration

Population: Eligible participants with measurable disease.

Disease control rate (DCR) is defined as the proportion of participants who have a confirmed and unconfirmed, partial, complete or stable response to therapy.

Outcome measures

Outcome measures
Measure	Arm I (Veliparib and mFOLFIRI) n=57 Participants Participants receive veliparib PO BID every 12 hours on days 1-7, irinotecan hydrochloride IV over 90-120 minutes on day 3, leucovorin calcium IV over 90-120 minutes on day 3, and fluorouracil IV over 46 hours on days 3-5. Fluorouracil: Given IV Irinotecan Hydrochloride: Given IV Laboratory Biomarker Analysis: Correlative studies Leucovorin Calcium: Given IV Veliparib: Given PO	Arm II (FOLFIRI) n=51 Participants Participants receive irinotecan hydrochloride IV over 90-120 minutes on day 1, leucovorin calcium IV over 90-120 minutes on day 1, and fluorouracil IV bolus over 15 minutes on days 1 and then over 46 hours on days 1-3. Fluorouracil: Given IV Fluorouracil: Given IV bolus Irinotecan Hydrochloride: Given IV Laboratory Biomarker Analysis: Correlative studies Leucovorin Calcium: Given IV
Disease Control Rate	0.32 proportion of participants Interval 0.19 to 0.44	0.47 proportion of participants Interval 0.33 to 0.61

SECONDARY outcome

Timeframe: Up to 3 years post registration

Population: Eligible participants with measurable disease, and who had confirmed partial response.

DoR: time from date of first documentation of response (complete response, CR, or partial response, PR) to date of first documentation of progression or symptomatic deterioration, or death due to any cause among participants, who achieve a response (CR or PR). The distribution of DoR in each treatment arm will be estimated using the Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	Arm I (Veliparib and mFOLFIRI) n=3 Participants Participants receive veliparib PO BID every 12 hours on days 1-7, irinotecan hydrochloride IV over 90-120 minutes on day 3, leucovorin calcium IV over 90-120 minutes on day 3, and fluorouracil IV over 46 hours on days 3-5. Fluorouracil: Given IV Irinotecan Hydrochloride: Given IV Laboratory Biomarker Analysis: Correlative studies Leucovorin Calcium: Given IV Veliparib: Given PO	Arm II (FOLFIRI) n=3 Participants Participants receive irinotecan hydrochloride IV over 90-120 minutes on day 1, leucovorin calcium IV over 90-120 minutes on day 1, and fluorouracil IV bolus over 15 minutes on days 1 and then over 46 hours on days 1-3. Fluorouracil: Given IV Fluorouracil: Given IV bolus Irinotecan Hydrochloride: Given IV Laboratory Biomarker Analysis: Correlative studies Leucovorin Calcium: Given IV
Duration of Response (DoR)	3.4 months Interval 2.6 to 3.4	5.1 months Interval 2.2 to 5.2

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

BRCA1/2 mutations will be associated with clinical outcomes (OS, PFS, and overall response rate \[ORR\]).

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

The impact of HRD positivity will be evaluated on clinical outcomes in each treatment arm. The HRD score is the unweighted sum of loss of heterozygosity footprint, telomeric allelic imbalance, and large-scale state transitions measurements on a scale from 0-100. The HRD score threshold for positivity in this population will be estimated by applying receiver operating characteristic curves, classifying patients by overall disease response.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

Outcome measures

Outcome data not reported

Adverse Events

Arm I Veliparib and mFOLFIRI

Serious events: 23 serious events

Other events: 55 other events

Deaths: 56 deaths

Arm II FOLFIRI

Serious events: 6 serious events

Other events: 49 other events

Deaths: 56 deaths

Serious adverse events

Other adverse events

Additional Information

SWOG Statistician

SWOG Statistical Center

Phone: 2066674623

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60