Ongoing, recruitingPhase II and Phase III (Integrated)Interventional

A Randomized, Double-Blind, Placebo-Controlled Study of Nab-Paclitaxel and Gemcitabine With Or Without SBP-101 in Subjects Previously Untreated for Metastatic Pancreatic Ductal Adenocarcinoma

This study is looking into a new treatment called SBP-101 for people with advanced pancreatic cancer that has spread to other parts of the body and hasn't been treated before. Participants will receive either the new drug SBP-101 or a dummy drug (placebo) alongside two standard chemotherapy medicines, Nab-paclitaxel and Gemcitabine. The main goal is to see if adding SBP-101 helps people live longer. Researchers will also check how long people's cancer stays stable or shrinks, how many people see their cancer respond to treatment, and how their quality of life is affected. This is a crucial step in finding potentially better ways to treat this type of cancer.

At a glance

Status

Ongoing, recruiting

Phase

Phase II and Phase III (Integrated)

Sponsor

Panbela Therapeutics Inc.

Enrolment target

407

Start

20 Nov 2024

Metastatic Pancreatic Ductal Adenocarcinoma

What is this study about?

This research study is focused on a type of advanced pancreatic cancer that has spread to other parts of the body and that hasn't been treated with medication before. It's called "Metastatic Pancreatic Ductal Adenocarcinoma." Researchers are testing a new potential drug, SBP-101, to see if adding it to current standard treatments can make a difference for patients.

Participants in the study will be split into groups. Some will receive SBP-101 along with two established chemotherapy drugs called Nab-paclitaxel (sometimes known by a brand name like Abraxane) and Gemcitabine. Other participants will receive a dummy drug (placebo) along with the same two standard chemotherapy drugs. Neither the patients nor their doctors will know who is getting the new drug and who is getting the placebo, which helps ensure the study results are fair and accurate.

The main aim of the study is to find out if people live longer when SBP-101 is added to their treatment. They will also look at other important things, like how long it takes for the cancer to potentially grow again or get worse, how much the cancer shrinks or stops growing, and how patients' overall well-being and quality of life are affected. This research is important because it could lead to new, more effective treatment options for people with this challenging cancer.

Key takeaways

This study is for advanced pancreatic cancer that hasn't been treated before.
It tests a new drug, SBP-101, combined with standard chemotherapy.
The main goal is to see if SBP-101 helps patients live longer.
Patients receive either SBP-101 or a dummy drug (placebo).
Both men and women, aged 18 and over, can take part.
Quality of life is also an important aspect being measured.

Who may be eligible?

To join this study, people must be 18 years old or older. There is no upper age limit, meaning older adults can also take part.

The study is open to both men and women.

Crucially, you must have advanced pancreatic cancer that has spread to other parts of your body, and you must not have received any drug treatment for this widespread cancer before.

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.

Are you 18 years old or older?
Do you have pancreatic cancer that has spread to other parts of your body?
Have you *not* received any drug treatment for your widespread pancreatic cancer yet?
Are you able to regularly attend hospital visits for treatments and assessments?

Answer every question to see your result.

What does participation involve?

Taking part in this study would involve regular hospital visits for treatments and checks. You would receive infusions (medication given through a drip) of SBP-101 or a placebo, along with your Nab-paclitaxel and Gemcitabine treatments. Doctors and nurses would closely monitor your health, how you are responding to treatment, and any side effects. You would also fill out questionnaires to assess your quality of life. The total duration of your participation would depend on how your cancer responds to the treatment.

Potential risks and benefits

Potential benefits of joining could include getting access to a new experimental drug, SBP-101, that might be more effective than standard treatment alone. You would also receive very close medical care and monitoring. However, there are potential risks, as experimental drugs can have side effects that are not fully known. The standard chemotherapy drugs also have known side effects. It's important to remember that you can decide to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (6)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Italy
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Unverified
Belgium
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Unverified
Germany
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Unverified
Austria
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Unverified
Spain
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Unverified
France

Common questions

What is pancreatic cancer?

Pancreatic cancer is a disease where abnormal cells in the pancreas grow out of control. When it's 'metastatic,' it means the cancer has spread from the pancreas to other parts of the body.

What does 'placebo-controlled' mean?

It means some people get the new drug being tested, and others get a 'dummy' treatment (a placebo) that looks the same but contains no active medicine. This helps researchers fairly compare the new drug's effects.

What does 'quality of life' mean in a study?

It refers to how patients feel physically and emotionally, their ability to do daily activities, and their overall well-being. Researchers use questionnaires to measure this.

Will I know if I'm getting the new drug or the placebo?

No, this is a 'double-blind' study, meaning neither you nor your doctors will know if you're receiving SBP-101 or the placebo. This helps prevent bias in the results.

Is this study meant to find a cure?

Clinical trials like this aim to find better treatments that can improve outcomes, such as living longer or having a better quality of life. Sometimes, new treatments can lead to long periods of stability, but a 'cure' for metastatic pancreatic cancer is not the primary aim of this specific study.