NCT02890355|Active Not RecruitingPhase 2Results

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

Randomized Phase II Study of 2nd Line FOLFIRI Versus Modified FOLFIRI With PARP Inhibitor ABT-888 (Veliparib) (NSC-737664) in Metastatic Pancreatic Cancer

National Cancer Institute (NCI)ClinicalTrials.gov

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3 other identifiers

NCI-2015-02248S1513U10CA180888

Study Type

interventional

Target

123

Locations

1 country

Sites

783

Timeline

RegisteredSep 2016

StartedSep 2016

CompletionMar 2026

Brief Summary

This randomized phase II trial studies how well modified irinotecan hydrochloride, leucovorin calcium, fluorouracil (FOLFIRI) and veliparib as a second line of therapy work compared to FOLFIRI in treating patients with pancreatic cancer that has come back after a period of improvement (metastatic). Drugs used in chemotherapy, such as irinotecan hydrochloride, leucovorin calcium, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether modified FOLFIRI and veliparib as second line therapy is more effective than FOLFIRI alone in treating metastatic pancreatic cancer.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

123

participants targeted

Target at P75+ for phase_2

Timeline

Completed

Started Sep 2016

Longer than P75 for phase_2

Geographic Reach

1 country

783 active sites

Status

active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

9.5 years study duration

First Submitted

Initial submission to the registry

August 31, 2016

Completed

1 day until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed

6 days until next milestone

First Posted

Study publicly available on registry

September 7, 2016

Completed

2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2019

Completed

1.4 years until next milestone

Results Posted

Study results publicly available

September 29, 2020

Completed

5.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 17, 2026

Completed

Last Updated

March 5, 2026

Status Verified

September 1, 2025

Enrollment Period

2.7 years

First QC Date

August 31, 2016

Results QC Date

July 14, 2020

Last Update Submit

March 4, 2026

Conditions

Metastatic Pancreatic Adenocarcinoma Recurrent Pancreatic Carcinoma Stage IV Pancreatic Cancer AJCC v6 and v7

Outcome Measures

Primary Outcomes (1)

Overall Survival (OS)
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.
Up to 3 years

Secondary Outcomes (5)

Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Duration of treatment and follow up until death or 3 years post registration
Progression Free Survival (PFS)
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
Overall Response Rate, ORR
Up to 3 years post registration
Disease Control Rate
Up to 3 years post registration
Duration of Response (DoR)
Up to 3 years post registration

Other Outcomes (3)

Prevalence of BRCA1 and BRCA2 Mutations (Somatic or Germline)
Baseline
Homologous Recombination Deficiency (HRD) Score
Baseline
Genomic Alterations Identified by the BROCA-homologous Recombinant (HR) Assay
Baseline

Study Arms (2)

Arm I (veliparib and mFOLFIRI)

EXPERIMENTAL

Patients 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.

Drug: FluorouracilDrug: Irinotecan HydrochlorideOther: Laboratory Biomarker AnalysisDrug: Leucovorin CalciumDrug: Veliparib

Arm II (FOLFIRI)

ACTIVE COMPARATOR

Patients 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.

Drug: FluorouracilDrug: Irinotecan HydrochlorideOther: Laboratory Biomarker AnalysisDrug: Leucovorin Calcium

Interventions

FluorouracilDRUG

Given IV

Also known as: 5 Fluorouracil, 5 Fluorouracilum, 5 FU, 5-Fluoro-2,4(1H, 3H)-pyrimidinedione, 5-Fluorouracil, 5-Fluracil, 5-Fu, 5FU, AccuSite, Carac, Fluoro Uracil, Fluouracil, Flurablastin, Fluracedyl, Fluracil, Fluril, Fluroblastin, Ribofluor, Ro 2-9757, Ro-2-9757

Arm I (veliparib and mFOLFIRI)Arm II (FOLFIRI)

Irinotecan HydrochlorideDRUG

Given IV

Also known as: Campto, Camptosar, Camptothecin 11, Camptothecin-11, CPT 11, CPT-11, CPT11, Irinomedac, Irinotecan Hydrochloride Trihydrate, Irinotecan Monohydrochloride Trihydrate, U 101440E, U-101440E, U101440E

Arm I (veliparib and mFOLFIRI)Arm II (FOLFIRI)

Laboratory Biomarker AnalysisOTHER

Correlative studies

Arm I (veliparib and mFOLFIRI)Arm II (FOLFIRI)

Leucovorin CalciumDRUG

Given IV

Also known as: Adinepar, Calcifolin, Calcium (6S)-Folinate, Calcium Folinate, Calcium Leucovorin, Calfolex, Calinat, Cehafolin, Citofolin, Citrec, Citrovorum Factor, Cromatonbic Folinico, Dalisol, Disintox, Divical, Ecofol, Emovis, Factor, Citrovorum, Flynoken A, Folaren, Folaxin, FOLI-cell, Foliben, Folidan, Folidar, Folinac, Folinate Calcium, folinic acid, Folinic Acid Calcium Salt Pentahydrate, Folinoral, Folinvit, Foliplus, Folix, Imo, Lederfolat, Lederfolin, Leucosar, leucovorin, Rescufolin, Rescuvolin, Tonofolin, Wellcovorin

Arm I (veliparib and mFOLFIRI)Arm II (FOLFIRI)

VeliparibDRUG

Given PO

Also known as: ABT 888, ABT-888, ABT888, PARP-1 inhibitor ABT-888

Arm I (veliparib and mFOLFIRI)

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Patients must have histologically or cytologically documented pancreatic adenocarcinoma; patients with pancreatic neuroendocrine tumors, lymphoma of the pancreas, or ampullary cancer are not eligible
Patients must have metastatic disease that is measurable; computed tomography (CT) scans or magnetic resonance imaging (MRI)s used to assess measurable disease must have been completed within 28 days prior to registration; CT scans or MRIs used to assess non-measurable disease must have been completed within 42 days prior to registration; all disease must be assessed and documented on the Baseline Tumor Assessment Form
Patients must not have history of brain metastases
Patients must have had one and only one prior regimen of systemic therapy for metastatic disease unless the patient meets the criteria below
Prior systemic therapy and chemoradiotherapy for treatment of resectable, borderline resectable or locally advanced unresectable disease is allowed and does not count toward prior therapy for metastatic disease
Patients who received systemic therapy with gemcitabine/nab-paclitaxel for resectable or borderline/locally advanced unresectable disease and progressed with metastatic disease within 3 months of the past dose of systemic therapy are eligible
Patients must have completed systemic therapy at least 14 days prior to registration, any surgical procedure must have been performed at least 14 days prior to registration, and radiation therapy must be completed at least 7 days prior to registration; patients must have recovered from major side effects of prior therapies or procedures in the opinion of the local site investigator prior to registration
Patients must not have received prior irinotecan-based chemotherapy (e.g. irinotecan hydrochloride, leucovorin calcium, fluorouracil, and oxaliplatin \[FOLFIRINOX\] or FOLFIRI)
Patients must not have received prior PARP inhibitor therapy including, but not limited to ABT-888, olaparib, rucaparib, and talazoparib (BMN637)
Patients must have a Zubrod performance status of 0-1
Within 14 days prior to registration: Absolute neutrophil count (ANC) \>= 1,500/mcL
Within 14 days prior to registration: Hemoglobin \>= 9 g/dL
Within 14 days prior to registration: Platelets \>= 100,000/mcL
Within 14 days prior to registration: Total bilirubin =\< 1.5 x institutional upper limit of normal (IULN)
Within 14 days prior to registration: Serum albumin \>= 3.0 g/dL
+16 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

National Cancer Institute (NCI)lead

Study Sites (783)

University of South Alabama Mitchell Cancer Institute

Mobile, Alabama, 36688, United States

Location

Anchorage Associates in Radiation Medicine

Anchorage, Alaska, 98508, United States

Location

Anchorage Radiation Therapy Center

Anchorage, Alaska, 99504, United States

Location

Alaska Breast Care and Surgery LLC