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Gemcitabine + Cisplatin +/- Veliparib for Pancreatic Cancer
Study 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.
Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- 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.
- Group 1: Arm B (gemcitabine hydrochloride, cisplatin)
- Group 2: Arm C (veliparib)
- Group 3: Arm A (veliparib, gemcitabine hydrochloride, cisplatin)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
Frequently Asked Questions
In how many different medical facilities is this research project being conducted today?
"Ingalls Memorial Hospital in Harvey, Memorial Sloan Kettering Nassau in Uniondale, and University Health Network-Princess Margaret Hospital in Toronto are 3 of the 10 total hospitals participating in this study."
Has the FDA cleared Gemcitabine Hydrochloride for use?
"While there is some evidence to support the safety of Gemcitabine Hydrochloride, it only received a score of 2 because this drug is still in Phase 2 clinical trials."
How many individuals are given the opportunity to participate in this clinical trial?
"Unfortunately, this study is not currently taking applications. It was originally posted on April 18th, 2012 and was updated for the last time on June 28th, 2022. However, there are 1287 other trials recruiting patients with pancreatic carcinoma and 1084 studies involving Gemcitabine Hydrochloride that are actively enrolling participants."
Could you please detail other research studies that have used Gemcitabine Hydrochloride?
"Gemcitabine Hydrochloride is being studied in 1084 active trials, many of which are based in Shanghai. There are a total of 56311 locations running these trials globally, with 364 currently in Phase 3."
Which diseases or conditions does Gemcitabine Hydrochloride help to alleviate?
"While commonly used to treat neoplasm metastasis, gemcitabine hydrochloride is also an effective intervention for a variety of other conditions like urinary bladder cancer, advanced testicular cancer, and small cell lung cancer."
Are new volunteers being accepted for this clinical trial?
"Currently, this trial is not enrolling patients. However, it's worth noting that the last time this study was edited on clinicaltrials.gov was June 28th, 2022. Additionally, if you are looking for other clinical trials, there are 1287 actively recruiting patients with pancreatic carcinoma and 1084 for Gemcitabine Hydrochloride."
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