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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

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