Veliparib for Cancer of Pancreas

Phase-Based Estimates
1
Effectiveness
2
Safety
Smilow Cancer Hospital Care Center at Saint Francis, Hartford, CT
Cancer of Pancreas+3 More
Veliparib - Drug
Eligibility
18+
All Sexes
Eligible conditions
Cancer of Pancreas

Study Summary

This study is evaluating whether a modified chemotherapy regimen is more effective than the standard chemotherapy regimen in treating patients with pancreatic cancer that has come back after a period of improvement.

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Eligible Conditions

  • Cancer of Pancreas
  • Pancreatic Neoplasms
  • Recurrent Pancreatic Carcinoma
  • Pancreatic Adenocarcinoma Metastatic
  • Stage IV Pancreatic Cancer AJCC v6 and v7

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Compared to trials

Study Objectives

This trial is evaluating whether Veliparib will improve 1 primary outcome, 5 secondary outcomes, and 3 other outcomes in patients with Cancer of Pancreas. Measurement will happen over the course of Baseline.

Baseline
Genomic Alterations Identified by the BROCA-homologous Recombinant (HR) Assay
Homologous Recombination Deficiency (HRD) Score
Prevalence of BRCA1 and BRCA2 Mutations (Somatic or Germline)
Year 3
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Year 3
Progression Free Survival (PFS)
Up to 3 years
Overall Survival (OS)
Year 3
Disease Control Rate
Duration of Response (DoR)
Overall Response Rate, ORR

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Compared to trials

Trial Design

2 Treatment Groups

Arm II (FOLFIRI)
Arm I (veliparib and mFOLFIRI)

This trial requires 123 total participants across 2 different treatment groups

This trial involves 2 different treatments. Veliparib is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Arm I (veliparib and mFOLFIRI)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.
Arm II (FOLFIRI)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
Fluorouracil
FDA approved
Calcium
Not yet FDA approved
Veliparib
Not yet FDA approved
Camptothecin
Not yet FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 3 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 3 years for reporting.

Closest Location

Smilow Cancer Hospital Care Center at Saint Francis - Hartford, CT

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Patients must have a PS of 2 or less Patients who have a history of brain metastases or a PS of 2 or less are not eligible to receive this treatment. show original
People who have not received chemotherapy that includes irinotecan (irinotecan hydrochloride, leucovorin calcium, fluorouracil, and oxaliplatin [FOLFIRINOX] or FOLFIRI) before are allowed to receive this therapy. show original
Patients must have metastatic disease that is measurable, as shown on a CT scan or MRI scan done within 28 days of registration show original
Patients must have had one and only one prior regimen of systemic therapy for metastatic disease, with the exception of patients who meet the criteria below. show original
Patients must have completed all prior systemic therapies, surgery, and radiation therapy at least 2 weeks prior to registration; patients must have recovered from major side effects of prior therapies or procedures in the opinion of the local site investigator prior to registration. show original
for the study Patients who have received systemic therapy with gemcitabine/nab-paclitaxel and have progressed with metastatic disease within 3 months of the past dose are eligible for the study. show original
Patients must not have received prior treatment with drugs that inhibit the PARP enzyme, including, but not limited to, ABT-888, olaparib, rucaparib, and talazoparib (BMN637). show original
Patients must have histologically or cytologically documented pancreatic adenocarcinoma; patients with pancreatic neuroendocrine tumors, lymphoma of the pancreas, or ampullary cancer are not eligible
Patients must have a Zubrod performance status of 0-1
People who have had treatment for cancer that is confined to one area of the body (such as chemotherapy and radiation therapy for tumors that can be surgically removed) are allowed to have treatment for cancer that has spread to other areas of the body show original

Patient Q&A Section

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

What are the signs of cancer of pancreas?

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Tumour-associated pain or pressure in (the posterior, upper) right lower abdominal area, is an indication (though not a diagnostic criterion) of malignancy. Coughing due to pain or breathlessness (as in obstructive jaundice) and unexplained weight loss were also specific signs of malignancy. In contrast, abdominal pain due to cancer of the pancreas is an unspecific sign of all malignant disorders in the abdomen.

Unverified Answer

What causes cancer of pancreas?

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Pancreatic cancer seems to be caused both by inherited risk factors, and also caused by environmental factors such as smoking, which causes pancreatic carcinoma in smokers; diabetes mellitus is a risk factor for pancreatic cancer, but also for celiac disease. There is an association between autoimmune disorders and some types of cancer of pancreas. The genetic susceptibility is caused by variations in genes coding cancer-susceptibility factors. Genetic conditions are associated with cancers in other anatomical sites, including breast cancer. In breast cancer, BRCA1 and BRCA2 are associated with a predisposition to breast cancer due to an increased risk of developing ovarian cancer.

Unverified Answer

Can cancer of pancreas be cured?

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There is limited experimental evidence that pancreatic cancers are very sensitive to anticancer therapy, and some treatments might provide partial relief of clinical symptoms in the short term. Further research is needed in this area.

Unverified Answer

How many people get cancer of pancreas a year in the United States?

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In the study in the past 8 years, the incidence and death rates of pancreatic cancer have increased in the United States. This underscores that there may be an actual need for some form of screening or surveillance of pancreatic cancer in the United States.

Unverified Answer

What are common treatments for cancer of pancreas?

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Oncologists often recommend treating cancer in patients with pancreas cancer with surgery. Some oncologists may recommend that these patients undergo chemotherapy and/or radiotherapy. Chemotherapy has not been found to change patient outcome in trials. Radiotherapy is used to control pain (local and distant), and as palliative treatment. The radiotherapy may be provided with an intensity-modulated radiation therapy protocol. While most pancreatic oncologists seem to adhere to the evidence, there is still a small proportion of oncologists who believe that there is no evidence of benefit from radiotherapy and/or chemotherapy for pain in pancreatic cancer. We suggest the same to medical oncologists who practice in the treatment of pancreatic cancer.

Unverified Answer

What is cancer of pancreas?

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Pancreatic cancer is an incredibly devastating disease, which manifests itself in a multitude of forms. Pancreatic cancer is diagnosed early via imaging, but a majority will be diagnosed at metastatic stages. The 5 yr, 10 yr, and 25 yr survival rates are approximately 65%, 10%, and 3% and are heavily influenced by the tumor's stage at diagnosis. It is an illness with a tremendous burden for patients and caregivers.

Unverified Answer

Is veliparib typically used in combination with any other treatments?

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Veliparib given alone showed modest activity; furthermore, in a study with an accompanying observational comparison cohort, an increased OS and PFS was observed in tumors with BRCA1 mutations. Taken together with the activity of the drug and the favorable risk profile, these results show that BRCA1-mutant tumors can be considered for veliparib for monotherapy in phase III trials.

Unverified Answer

Have there been other clinical trials involving veliparib?

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The findings of this study indicate that veliparib is equally effective and well tolerated for women with HR-positive metastatic breast cancer-in-situ or with metastasis as an initial treatment of choice and for the treatment of patients previously diagnosed with HR-positive metastatic breast cancer.

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How quickly does cancer of pancreas spread?

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Data from a recent study suggest that the tumor is not a solid mass of clear space. Rather, tumor cells, macrophages, and fibroblasts are dispersed throughout the tumor, and may be essential to the ongoing development of metastatic lesions. Data from a recent study support a hypothesis that metastatic carcinoma of the pancreas is a slowly expanding tumor and evolves along the same pathways as its primary tumor.

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What is the latest research for cancer of pancreas?

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Findings from a recent study of this review indicate that the research for cancer of pancreas is still limited. However, there are many studies that are underway and promising. Future research is needed to identify and develop more active treatments for cancer of pancreas.

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What is the primary cause of cancer of pancreas?

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[About 82% of [people undergoing pancreaticoduodenectomy for noncancerous disease have no detectable carcinoma at the time of operation] (https://www.cancer.gov/cancerweb/web/cancer?pid=14914)\n\nThe American Cancer Society recognizes several different types of pancreas cancers, listed here by their major classification into hereditary, sporadic, and cancers stemming from other conditions. In cases where the precise type is uncertain, the categorization above is applied.

Unverified Answer

What is veliparib?

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Veliparib is a PARP1 inhibitor, currently under investigation for ovarian, [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) and other cancers. Veliparib targets the DNA repair enzyme Poly ADP ribose polymerase 1 (PARP1) by binding to the protein PARP1 and inhibiting it from cleaving DNA. PARP1 is activated downstream of cellular stress signals including DNA damage and may be implicated in repairing these damages. Veliparib may be useful in ovarian and breast cancer because it inhibits the activity of PARP1, leading to decreased repair of DNA damage, increased cell death, and increased antitumor activity.

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