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Alkylating agent
Gemcitabine + Cisplatin +/- Veliparib for Pancreatic Cancer
Phase 2
Waitlist Available
Led By Eileen M O'Reilly
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is studying veliparib in combination with gemcitabine hydrochloride and cisplatin to see how well it works compared to gemcitabine hydrochloride and cisplatin alone in treating patients with pancreatic cancer.
Who is the study for?
This trial is for adults with advanced or metastatic pancreatic cancer. Eligible participants include those who have not had prior treatment for advanced disease, or if they've had adjuvant therapy, it must be at least 6 months since completion. Participants need a confirmed BRCA1/2 or PALB2 mutation and should not be pregnant, as the drugs could harm the fetus. They must also agree to use contraception.
What is being tested?
The study tests whether adding Veliparib to standard chemotherapy (Gemcitabine Hydrochloride and Cisplatin) improves outcomes in patients with pancreatic cancer that has spread. Patients are randomly assigned to receive either the combination of all three drugs or just the chemotherapy alone.
What are the potential side effects?
Potential side effects may include nausea, fatigue, low blood counts leading to increased infection risk, kidney issues from Cisplatin, and possible allergic reactions. The specific side effects of Veliparib are unknown but may increase these risks.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Response rate of single-agent veliparib (Part II)
Response rate to gemcitabine hydrochloride and cisplatin with versus without veliparib (randomized Part I)
Secondary study objectives
Disease control rate (complete response + partial response + stable disease) and duration of response (Parts I and II)
Incidence of adverse events (Parts I and II)
Overall survival (Parts I and II)
+1 moreOther study objectives
Change in PAR levels
Differentially expressed genes found
Molecular and genetic phenotype of tumors
+2 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Arm C (veliparib)Experimental Treatment4 Interventions
Patients receive veliparib PO BID on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI throughout study. Patients also undergo tumor tissue and blood sample collection throughout the trial.
Group II: Arm A (veliparib, gemcitabine hydrochloride, cisplatin)Experimental Treatment8 Interventions
Patients receive veliparib PO BID on days 1-12 or 1-21 of each cycle. Patients also receive gemcitabine hydrochloride IV over 30 minutes and cisplatin IV over 30 minutes on days 3 and 10 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI throughout study. Patients also undergo tumor tissue and blood sample collection throughout the trial and undergo tumor biopsy during screening and on study.
Group III: Arm B (gemcitabine hydrochloride, cisplatin)Active Control7 Interventions
Patients receive gemcitabine hydrochloride IV and cisplatin IV as patients in arm A. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI throughout study. Patients also undergo tumor tissue and blood sample collection throughout the trial and undergo tumor biopsy during screening and on study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Computed Tomography
2017
Completed Phase 2
~2740
Magnetic Resonance Imaging
2017
Completed Phase 3
~1160
Biospecimen Collection
2004
Completed Phase 3
~2020
Cisplatin
2013
Completed Phase 3
~3120
Biopsy
2014
Completed Phase 4
~1090
Gemcitabine Hydrochloride
2005
Completed Phase 3
~5420
Gemcitabine
2017
Completed Phase 3
~1920
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
41,011,916 Total Patients Enrolled
Eileen M O'ReillyPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had PARP inhibitor therapy and have had up to two prior cancer treatments.I do not have any serious illnesses or social situations that would stop me from following the study's requirements.I haven't had chemotherapy or radiotherapy in the last 3 weeks, or I've recovered from its side effects.I am allergic to veliparib or similar medications.My brain metastases are stable, and I haven't taken steroids for over 3 months.I do not have AML/MDS or signs suggesting I might have it.I have an active infection like hepatitis or HIV but my immune system is not significantly compromised.I have never had a seizure.I had gemcitabine or fluoropyrimidine therapy over 6 months ago and have never had PARP inhibitor therapy.I have advanced pancreatic cancer with a confirmed BRCA or PALB2 mutation.I am not pregnant or breastfeeding.Your platelet count is at least 100,000 per microliter within 14 days before taking ABT-888.Your total bilirubin levels should be within a certain range, as determined by the hospital, before starting the treatment.Your white blood cell count is at least 1,500 per microliter.I have a confirmed BRCA 1, BRCA 2, or PALB2 mutation.I have pancreas cancer, treated up to 2 times before, but not with PARP inhibitors.I am mostly active and can care for myself.Your hemoglobin level is at least 9.0 grams per deciliter.Your creatinine levels should be within a certain range measured within 14 days before starting the medication ABT-888.Your liver enzyme levels must not be too high, unless you have evidence of liver cancer, in which case they can be a little higher.My cancer can be measured or evaluated using specific criteria.I have a BRCA 1, BRCA 2, or PALB2 mutation, or a family history suggesting I might.I have advanced pancreatic cancer and haven't been treated for it yet, but I may have had adjuvant therapy if it was over 6 months ago.I have not had an allogeneic bone marrow or double umbilical cord blood transplant.I can swallow pills or capsules.I am not allergic or unable to tolerate platinum-based cancer drugs.I had cancer before, but it's now under control without ongoing treatment.My doctor expects me to live more than 3 months.
Research Study Groups:
This trial has the following groups:- Group 1: Arm B (gemcitabine hydrochloride, cisplatin)
- Group 2: Arm C (veliparib)
- Group 3: Arm A (veliparib, gemcitabine hydrochloride, cisplatin)
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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