Study of Quemliclustat and Chemotherapy Versus Placebo and Chemotherapy in Patients With Metastatic Pancreatic Ductal Adenocarcinoma
This study is for people with pancreatic cancer that has spread to other parts of the body (metastatic pancreatic ductal adenocarcinoma) and who haven't received treatment for the spread yet. The main goal is to find out if adding a new investigational drug called quemliclustat to standard chemotherapy (nab-paclitaxel and gemcitabine) helps patients live longer compared to receiving chemotherapy with a dummy drug (placebo). This is a 'Phase 3' study, which means it's a large, final stage trial designed to confirm if the new drug is effective and safe. Participants will be randomly assigned to one of two groups: one receiving quemliclustat plus chemotherapy, and the other receiving a placebo plus chemotherapy.
At a glance
What is this study about?
Imagine you have pancreatic cancer that has spread to other parts of your body. Doctors are always looking for better ways to treat this type of cancer. This study is testing a new drug called quemliclustat to see if it can improve how well current chemotherapy works.
The study aims to compare two treatment approaches. One group of patients will receive the combination of quemliclustat along with two standard chemotherapy drugs, nab-paclitaxel and gemcitabine. The other group will receive a placebo (a dummy drug with no active ingredients) in addition to the same two chemotherapy drugs. By comparing these two groups, doctors hope to learn if quemliclustat can help people live longer.
This kind of research is really important because it helps us find new and potentially more effective treatments for serious illnesses like pancreatic cancer. The study is in its final stages of testing (called Phase 3), which means it has already shown some promise in earlier studies and now needs to be looked at in a larger group of people to confirm its benefits and risks.
Key takeaways
- This study is testing a new drug (quemliclustat) for advanced pancreatic cancer.
- It compares quemliclustat plus chemotherapy to chemotherapy with a dummy drug (placebo).
- The main goal is to see if quemliclustat helps people live longer.
- This is a large, Phase 3 trial, meaning it's a final step before potential approval.
- Participants will have regular check-ups and follow-up.
Who may be eligible?
To join this study, people must have pancreatic cancer that has spread to other parts of the body and have not yet been treated for this spread. If you've had surgery or chemotherapy/radiotherapy for your pancreatic cancer in the past, that's generally okay, as long as it was completed at least a year ago and any side effects have settled down. Your general health and fitness, as assessed by your doctor, are also important.
There are some reasons why someone might not be able to join. For instance, if you've had specific types of pancreatic cancer treatment that didn't fully remove the cancer but wasn't spread, or if the cancer has spread to your brain or the lining of your brain, you wouldn't be eligible. Also, if you've previously taken a similar type of drug to quemliclustat, you wouldn't be able to participate. The study doctors need to make sure it's safe for you to take part given your full medical history.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Do I have pancreatic cancer that has spread?
- Have I already started treatment for my widespread pancreatic cancer?
- Have I had other treatments for pancreatic cancer in the past?
- Is my general health good enough for a clinical trial?
What does participation involve?
If you join this study, you'll be randomly assigned to one of two groups, like flipping a coin. You'll either receive the new drug (quemliclustat) plus standard chemotherapy, or a dummy drug (placebo) plus standard chemotherapy. Neither you nor your doctor will usually know which group you are in.
You will have regular appointments and tests, including scans (like CT or MRI) to check on your cancer, blood tests, and physical examinations. These visits will help doctors monitor your health, how you are responding to treatment, and any side effects you might experience. The total duration of your participation will depend on how you respond to the treatment, but monitoring will continue regularly after treatment stops.
Potential risks and benefits
Locations (111)
- Research SiteVerified postcodePhoenix, United States
- Research SiteVerified postcodeTucson, United States
- Research SiteVerified postcodeLa Jolla, United States
- Research SiteVerified postcodeLos Alamitos, United States
- Research SiteVerified postcodeLos Angeles, United States
- Research SiteVerified postcodeRoseville, United States
- Research SiteVerified postcodeSan Francisco, United States
- Research SiteVerified postcodeSanta Monica, United States
- Research SiteVerified postcodeDenver, United States
- Research SiteVerified postcodeNew Haven, United States
- Research SiteVerified postcodeJacksonville, United States
- Research SiteVerified postcodeMiami, United States
Common questions
What is a 'Phase 3' study?
Phase 3 is the final stage of testing a new drug before it can be approved. It involves a large number of patients to confirm if the drug is effective and safe.
What is a 'placebo'?
A placebo is a 'dummy' drug that looks like the real thing but has no active ingredients. It helps researchers understand if the new drug is truly making a difference.
Will I know if I'm getting the new drug or the placebo?
In this study, neither you nor your doctor will typically know whether you are receiving quemliclustat or the placebo. This helps ensure the study results are fair and unbiased.
What if my cancer has been treated before?
If you've had treatment for pancreatic cancer in the past (like surgery or chemotherapy/radiotherapy) but it wasn't for cancer that had spread, you might still be able to join, especially if it was completed a while ago.
Can I leave the study if I change my mind?
Yes, you are free to leave the study at any time, for any reason. Your decision will not affect your future medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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