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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
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 belowSelect...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
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 moreOther study objectives
Homologous Recombination Deficiency (HRD) Score
BRCA1 gene
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
13,842 Previous Clinical Trials
41,002,877 Total Patients Enrolled
Elena G ChioreanPrincipal InvestigatorSWOG Cancer Research Network
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had only one treatment for my cancer since it spread.Your blood levels of certain substances must be tested within 14 days before joining the study.I finished my last cancer treatment 14 days ago and have recovered from major side effects.Your platelet count is at least 100,000 per microliter within the last 14 days before joining the trial.Your bilirubin levels are within a certain range for the past 14 days.Your blood protein level (serum albumin) must be at least 3.0 g/dL within 14 days before joining the study.Your liver function tests should be within a certain range, unless you have cancer that has spread to your liver.Your blood test for creatinine, a waste product in the blood, needs to be less than 2.0 mg/dL within 14 days before joining the study.Before joining the study, you need to have a blood test called CA19-9 or a blood test called CEA.I can swallow pills whole.I had a full physical exam and discussed my medical history with a doctor within the last 28 days.I agree to a biopsy and will provide tumor and blood samples.I am willing to provide a sample of my tumor if it is available.I have never been treated with PARP inhibitors like olaparib or talazoparib.I have never had a seizure.I can carry out all my normal activities without help.I do not have Gilbert's syndrome.My metastatic disease can be measured and has been assessed within the last 28 days.I am not allergic to irinotecan, fluorouracil, or leucovorin.I am not pregnant or nursing and will use effective birth control during and 6 months after the study.My cancer worsened within 3 months after my last gemcitabine/nab-paclitaxel treatment.I have not had chemotherapy with irinotecan.I don't have any major uncontrolled health issues that could affect my participation.Your hemoglobin level is at least 9 grams per deciliter within the past 14 days before joining the study.I've had treatments for cancer that couldn't be removed by surgery, but not for cancer that has spread.I have been diagnosed with pancreatic adenocarcinoma.Your white blood cell count needs to be above a certain level 14 days before joining the study.I have never had cancer spread to my brain.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I (veliparib and mFOLFIRI)
- Group 2: Arm II (FOLFIRI)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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