Pancreaze for Pancreatic Cancer
(PANCAX-3 Trial)
What You Need to Know Before You Apply
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.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, you cannot use other pancreatic enzyme supplements or over-the-counter supplements containing lipase, protease, and amylase while participating.
What 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.12345
Is Pancreaze (pancrelipase) safe for humans?
Pancreaze, also known as pancrelipase, has been shown to be generally safe in humans when used for conditions like exocrine pancreatic insufficiency. Common side effects include stomach issues and skin reactions, but serious problems are rare. It has been well tolerated in clinical studies with few people stopping treatment due to side effects.12345
Is 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.12367
How does the drug Pancreaze differ from other treatments for pancreatic cancer?
Pancreaze is a pancreatic enzyme replacement therapy (PERT) typically used for conditions like cystic fibrosis and chronic pancreatitis to aid digestion by replacing enzymes the pancreas cannot produce. Its use in pancreatic cancer is unique as it may help manage digestive issues related to the disease, but it is not a direct cancer treatment like chemotherapy or targeted therapies.12367
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.12689
Who Is on the Research Team?
Andrew Hendifar, MD
Principal Investigator
Cedars-Sinai Medical Center
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Pancreaze (pancrelipase) capsules in addition to standard of care for pancreatic adenocarcinoma
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Pancrelipase
Find a Clinic Near You
Who Is Running the Clinical Trial?
Andrew Hendifar, MD
Lead Sponsor
VIVUS LLC
Industry Sponsor