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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

Study 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.Check my eligibility
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.See study design
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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall Survival (OS)
Secondary outcome measures
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 outcome measures
Genomic Alterations Identified by the BROCA-homologous Recombinant (HR) Assay
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
Leucovorin Calcium
2011
Completed Phase 3
~12290
Irinotecan Hydrochloride
2010
Completed Phase 3
~1940
Fluorouracil
2014
Completed Phase 3
~11540
Veliparib
2012
Completed Phase 3
~4820

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,654 Previous Clinical Trials
40,933,030 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is Veliparib associated with any adverse outcomes for patients?

"Our internal assessment of Veliparib's safety is a 2 as the available evidence only supports its security, not yet its efficacy."

Answered by AI

Is enrollment open for this experiment yet?

"The trial is not currently open for recruitment. It was placed on clinicaltrials.gov on September 1st 2016 and last updated November 15th 2022. To find other studies, there are 592 trials searching for participants with pancreatic carcinoma and another 536 inquiring about Veliparib patients at this time."

Answered by AI

How many different venues is the trial being conducted in?

"This trial is welcoming patients to join at Queen's Cancer Centre - POB I in Honolulu, Hawaii; Rocky Mountain Cancer Centres-Penrose in Colorado Springs, CO; Kaiser Permanente-Santa Teresa-San Jose in San Jose, ME and a further 100 sites."

Answered by AI

Could you please provide details on other examinations of Veliparib's efficacy?

"At present, Veliparib is the subject of 536 ongoing clinical trials with 149 in Phase 3. Of these studies, 26363 are taking place around the world, a significant portion being held in Shanghai."

Answered by AI

How many participants are receiving treatment in this experiment?

"This trial has been concluded, with the last update on November 15th 2022. However, if you are still looking to participate in a clinical study related to pancreatic carcinoma or Veliparib there are currently 592 and 536 trials respectively that need participants."

Answered by AI

What conditions has Veliparib proved to be efficacious in treating?

"Veliparib is known to be effective for the treatment of actinic keratosis. Additionally, it has also been used in conjunction with other medical interventions, such as macrocytic anemia treatments, mineral supplementation therapy and malignant neoplasms therapies."

Answered by AI

Who else is applying?

What state do they live in?
Florida
California
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
What site did they apply to?
Kaiser Permanente-Riverside
MedStar Georgetown University Hospital
How many prior treatments have patients received?
1

Why did patients apply to this trial?

Current treatment has tumor markers going up despite chemotherapy. I was diagnosed with Pancreatic Cancer(Neuro Endocrine Carcinoma) with Mets in both lobes of liver few months back(April-2023) during routine checkup, Took 6 chemo cycles(Carboplatin + Etoposide) which completed in July2023 and taking Durvalumab Immunotherapy in parallel - Took 7 cycle of Immuno till today & still continuing. No physical or psychological problems. Perfectly fine to travel anywhere for treatment & trial and I hold a valid US visa also if travelling to hospital is required. Detailed Summary - > Patient Summary - > My name is Ankit Dubey, Male 39, residing in India, willing to travel for treatment at your centre. > > Let me give you the background - Mar-Apr 2023, during routine checkup, I was diagnosed with Pancreatic cancer in Lucknow, INDIA with Metastasis spread across both lobes of liver ( I guess, it's considered as stage 4 cancer). > > Next day I travelled to Tata Memorial hospital, Mumbai INDIA where they repeated all tests, including CT scan & BIOPSY. > > Since bilrubin was increasing and BIOPSY report was not finalized so they gave 1st round of Chemo on 26th March (only Carboplatin-5AUC) to control the disease/bilirubin since bilrubin was increased to 6 from 4 in 4days and came back to 4 in 2 days just after 1st small dose of chemo. > > In hystopathology/ biopsy report - they identified it as Neuroendocrine carcinoma (high grade) and then gave another round of full chemo(Carboplatin + Etoposide) on 11,12 &13th April (after around 2weeks interval from 1st small chemo and prescribed 4 more cycles of full chemo(Carboplatin + Etoposide) cycle at interval of every 21 days then after. > > Did PetSCAN just before the 2nd cycle of full Chemo and found that Pancreatic Tumor was reduced from 6cm dia to around 1.5cm and METS in liver also shrunken significantly. (Initial CT & Pet SCAN report attached.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
FOLFIRI or Modified FOLFIRI and Veliparib as Second Line Therapy in Treating Patients With Metastatic Pancreatic Cancer
2016. "FOLFIRI or Modified FOLFIRI and Veliparib as Second Line Therapy in Treating Patients With Metastatic Pancreatic Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02890355.
All > Pancreatic Cancer
~14 spots leftby Apr 2025
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