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Anti-metabolites

Chemotherapy + Veliparib for Pancreatic Cancer

Phase 2
Waitlist Available
Led By Elena G Chiorean
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must have had one and only one prior regimen of systemic therapy for metastatic disease unless the patient meets the criteria below
Patients must be able to swallow whole capsule
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing whether adding veliparib to a standard chemotherapy regimen for pancreatic cancer that has come back after a period of improvement (metastatic) is more effective than the standard regimen alone.

Who is the study for?
This trial is for patients with metastatic pancreatic cancer who have had one prior chemotherapy regimen but not irinotecan-based therapy or PARP inhibitors. They must have measurable disease, no history of brain metastases or seizures, and be in good physical condition (Zubrod performance status of 0-1). Participants need to have recovered from previous treatments' side effects and cannot have significant medical conditions like uncontrolled heart failure.
What is being tested?
The study compares modified FOLFIRI (irinotecan hydrochloride, leucovorin calcium, fluorouracil) plus Veliparib against standard FOLFIRI alone as a second-line treatment for metastatic pancreatic cancer. The goal is to see if adding Veliparib improves outcomes by blocking enzymes that help tumor cells grow.
What are the potential side effects?
Potential side effects include those common to chemotherapy such as nausea, vomiting, diarrhea, fatigue, blood cell count changes leading to increased infection risk or bleeding problems. Veliparib may also cause digestive issues and can affect blood counts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have had only one treatment for my cancer since it spread.
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I can swallow pills whole.
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I can carry out all my normal activities without help.
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I have not had chemotherapy with irinotecan.
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I have never been treated with PARP inhibitors like olaparib or talazoparib.
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I don't have any major uncontrolled health issues that could affect my participation.
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I have never had a seizure.
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I do not have Gilbert's syndrome.
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I am not allergic to irinotecan, fluorouracil, or leucovorin.
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I agree to a biopsy and will provide tumor and blood samples.
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I have been diagnosed with pancreatic adenocarcinoma.
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I have never had cancer spread to my brain.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Overall Survival (OS)
Secondary study objectives
Disease Control Rate
Duration of Response (DoR)
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
+2 more
Other study objectives
Homologous Recombination Deficiency (HRD) Score
BRCA1 gene

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm I (veliparib and mFOLFIRI)Experimental Treatment5 Interventions
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.
Group II: Arm II (FOLFIRI)Active Control4 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Irinotecan Hydrochloride
2010
Completed Phase 3
~2050
Leucovorin Calcium
2011
Completed Phase 3
~12500
Fluorouracil
2014
Completed Phase 3
~11700
Veliparib
2012
Completed Phase 3
~4780

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,906 Previous Clinical Trials
41,011,909 Total Patients Enrolled
Elena G ChioreanPrincipal InvestigatorSWOG Cancer Research Network

Media Library

Fluorouracil (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT02890355 — Phase 2
Pancreatic Cancer Research Study Groups: Arm I (veliparib and mFOLFIRI), Arm II (FOLFIRI)
Pancreatic Cancer Clinical Trial 2023: Fluorouracil Highlights & Side Effects. Trial Name: NCT02890355 — Phase 2
Fluorouracil (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02890355 — Phase 2
~13 spots leftby Nov 2025