Pancreaze for Pancreatic Cancer
(PANCAX-3 Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Waitlist Available
Sponsor: Andrew Hendifar, MD
No Placebo Group
Prior Safety Data
Approved in 2 jurisdictions
Trial Summary
What is the purpose of this trial?This trial tests Pancreaze capsules in pancreatic cancer patients who have trouble digesting food. The medication provides missing enzymes to help them digest food better and improve their quality of life. Pancreatic enzyme supplementation is an important part of management for a number of gastrointestinal conditions.
Do I have to stop taking my current medications for the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, you cannot use pancreatic enzyme supplements or over-the-counter supplements containing lipase, protease, and amylase during the trial.
What data supports the idea that Pancreaze for Pancreatic Cancer is an effective drug?
The available research does not provide direct evidence that Pancreaze is effective for treating pancreatic cancer. Instead, the studies focus on its use for conditions like cystic fibrosis and pancreatic insufficiency. For example, one study compared Pancrease and Creon in children with cystic fibrosis and found no significant differences in effectiveness. Another study showed that Creon significantly reduced fat malabsorption in patients with chronic pancreatitis. However, these studies do not address pancreatic cancer specifically.
12345What safety data is available for Pancreaze and similar treatments?
Safety data for Pancreaze and similar treatments, such as CREON and Zenpep, show that these pancreatic enzyme replacement therapies (PERT) are generally well-tolerated. Common adverse events include gastrointestinal disorders and allergic skin reactions. Clinical trials have demonstrated their safety in patients with exocrine pancreatic insufficiency (EPI) due to conditions like cystic fibrosis and chronic pancreatitis. The risk of fibrosing colonopathy and viral transmission from porcine-derived products is monitored. Overall, these treatments have a favorable risk-benefit profile.
24678Is Pancreaze a promising drug for pancreatic cancer?
The information provided does not directly address Pancreaze as a treatment for pancreatic cancer. The studies focus on pancreatic enzyme replacement therapies like Pancrelipase for conditions like cystic fibrosis and chronic pancreatitis, not cancer. Therefore, we cannot conclude that Pancreaze is a promising drug for pancreatic cancer based on this information.
12469Eligibility Criteria
This trial is for adults with pancreatic cancer who are experiencing weight loss and digestive issues due to the cancer affecting their pancreas' ability to aid in digestion. They should be relatively active, not have severe liver or heart conditions, and expect to live more than 3 months. Pregnant women or those unable to use birth control are excluded.Inclusion Criteria
I have lost at least 5% of my weight in the last 6 months due to a chronic illness.
Absolute Neutrophil Count (ANC) ≥ 500/mcL
My organ and bone marrow functions are normal.
+12 more
Exclusion Criteria
I cannot swallow whole capsules.
Pregnancy, breastfeeding, or of childbearing potential and not willing to use methods of birth control during the study
I am able to understand and give consent for my treatment.
+8 more
Participant Groups
The study tests whether Pancreaze (pancrelipase), a medication helping with digestion, can stabilize weight and improve life quality when added to standard care in patients whose pancreas doesn't produce enough digestive enzymes due to cancer.
1Treatment groups
Experimental Treatment
Group I: Standard of care treatment with Pancreaze (pancrelipase)Experimental Treatment1 Intervention
Pancrelipase capsules; 84,000 IU lipase units per main meal and 42,000 IU lipase units per snack; for 24 weeks
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Cedars-Sinai Medical CenterLos Angeles, CA
Loading ...
Who Is Running the Clinical Trial?
Andrew Hendifar, MDLead Sponsor
VIVUS LLCIndustry Sponsor
References
Two enteric coated microspheres in cystic fibrosis. [2019]In a randomised single blind crossover study in children with cystic fibrosis and pancreatic insufficiency, two enteric coated microsphere preparations of pancreatin were compared on a capsule for capsule basis, by measuring the coefficient of fat absorption, nitrogen excretion, weight change, and symptom scores after four weeks' treatment with each preparation. Thirty nine subjects were randomly allocated to receive Pancrease followed by Creon or vice versa. Each individual subject received the same number of capsules per day in each study period. Data from 27 children (Pancrease/Creon, n = 13 and Creon/Pancrease, n = 14) wer suitable for analysis. Results showed no significant differences between the two preparations in any variable studied. We conclude that there is no significant difference between Pancrease and Creon when compared on a capsule for capsule basis.
EUR-1008 pancreatic enzyme replacement is safe and effective in patients with cystic fibrosis and pancreatic insufficiency. [2021]EUR-1008 (Zenpep [pancrelipase]) is a new, enteric-coated, porcine-derived pancreatic enzyme product (PEP) developed for the treatment of cystic fibrosis (CF) patients with malabsorption associated with exocrine pancreatic insufficiency (EPI). Unlike currently marketed PEPs, EUR-1008 contains the label-claimed lipase content. Safety and efficacy were assessed in younger ( or =7 years) CF patients with EPI.
[Efficacy of a new microencapsulated pancreatin versus a conventional preparation, in the treatment of steatorrhea of pancreatic origin]. [2009]Malabsorption of pancreatic origin has been traditionally treated with pancreatic enzymes, but the effectiveness of treatment has been limited, related to the scant enzymatic activity of preparations, enzyme lability to acid attack and deficient mixing with the intestinal bolus, among other factors. We studied the efficacy of a new pancreatic enzyme preparation in the form of pellets, which mix easily with the intestinal bolus, are protected against gastric acid attack and have a high lipase concentration (Creon, Kalichemie-Pharma), as compared to traditional unprotected pancreatin in the form of tablets (Pankreon 700). The study was open, comparative and crossover, and included 12 patients. The diagnosis was chronic alcoholic pancreatitis in 10 cases and idiopathic pancreatitis in 2, with a steatorrhea of more than 10 g/24 h and a basal gastric pH less than 2.5. The duration of treatment was 3 weeks, using a diet containing 100 g of fat. The first week served as a control, and in the 2nd and 3rd treatment was given in the form of 7 capsules of Creon (2.1 g pancreatin and 70,000 UFIP lipase) or 17 tablets of Pankreon 700 (11.9 g pancreatin and 476,000 UFIP lipase) by randomized assignment. Our results confirm the beneficial effects observed by others. Steatorrhea was significantly reduced, up to 45.6% with Pankreon 700 and 57% with Creon, in spite of a dose that had 6.8 times less lipase activity, 5.6 times less pancreatin weight and 2.4 times fewer units ingested (capsules/tablets). Patients showed significant weight gain. At 30 days of treatment with Creon, steatorrhea had declined 70% and the weight gain was significant.(ABSTRACT TRUNCATED AT 250 WORDS)
Pancrelipase delayed-release capsules (CREON) for exocrine pancreatic insufficiency due to chronic pancreatitis or pancreatic surgery: A double-blind randomized trial. [2022]Pancreatic-enzyme replacement therapy (PERT) is the standard of care to prevent maldigestion, malnutrition, and excessive weight loss in patients with exocrine pancreatic insufficiency (EPI) due to chronic pancreatitis (CP) or pancreatic surgery (PS). Our objective was to assess the efficacy and safety of a new formulation of pancrelipase (pancreatin) delayed-release 12,000-lipase unit capsules (CREON) in patients with EPI due to CP or PS.
Comparison of two pancreatic enzyme products for exocrine insufficiency in patients with cystic fibrosis. [2018]Zenpep (APT-1008) is a pancreatic enzyme product for the treatment of exocrine pancreatic insufficiency (EPI) associated with cystic fibrosis (CF).
CREON (Pancrelipase Delayed-Release Capsules) for the treatment of exocrine pancreatic insufficiency. [2022]Exocrine pancreatic insufficiency (EPI) is associated with conditions including cystic fibrosis (CF), chronic pancreatitis (CP), and pancreatic surgery (PS). The symptoms include maldigestion, malnutrition, weight loss, flatulence, and steatorrhea. Pancreatic enzyme replacement therapy (PERT) is the standard treatment for EPI; it is regulated in many countries and most recently in the USA following a US FDA mandate for all PERT manufacturers to submit new drug applications. Pancrelipase delayed-release capsules (CREON®, Abbott, Marietta, GA, USA) have been available in Europe since 1984 and in the USA since 1987; a new formulation was the first PERT to gain approval in the USA in 2009. The efficacy and safety of CREON have been demonstrated in double-blind, randomized, placebo-controlled trials in patients with CF aged ≥7 years and in patients with CP or post-PS. The data consistently demonstrate significantly better fat and nitrogen absorption with CREON versus placebo, and improvements in clinical symptoms, stool frequency, and body weight. Additionally, efficacy and safety of CREON have been shown in open-label studies in young children with CF (aged 1 month to 6 years), with control of fat malabsorption and control of clinical symptoms. The most commonly reported adverse events (AEs) with PERT are gastrointestinal disorders and allergic skin reactions. In clinical studies, CREON was well tolerated with very few withdrawals due to AEs and a low frequency of AEs judged treatment related, regardless of patient age. To further support the known safety profile of PERT, all manufacturers are required to investigate risk factors for fibrosing colonopathy, a rare gastrointestinal complication of CF, and the theoretical risk of viral transmission from porcine-derived PERT products. Together, the clinical study data and wealth of clinical experience suggest that CREON is effective and safe in patients with EPI regardless of etiology, with a very favorable risk-benefit profile.
Efficacy of a novel pancreatic enzyme product, EUR-1008 (Zenpep), in patients with exocrine pancreatic insufficiency due to chronic pancreatitis. [2021]EUR-1008 (ZENPEP® [pancrelipase] Delayed-Release Capsules) delayed-release capsules is a novel, enteric-coated, porcine-derived pancreatic enzyme product. This study evaluated the efficacy and safety of 2 doses of ZENPEP in patients with chronic pancreatitis (CP) and exocrine pancreatic insufficiency (EPI).
Pancreatic enzyme products: digesting the changes. [2011]To review the pharmacology, dosage regimens, efficacy, and safety of currently marketed pancreatic enzyme products (PEPs).
[The effectiveness of pancreatic enzyme replacement therapy using microencapsulated pancreatin preparations in the correction of nutritional status in patients with chronic pancreatitis: a prospective observational study]. [2020]The goal is to evaluate the effectiveness of pancreatic enzyme replacement therapy (PERT) using microencapsulated pancreatin preparations for the correction of nutritional status in patients with chronic pancreatitis (CP) and associated exocrine pancreatic insufficiency (EPI).