Nab-Paclitaxel + Gemcitabine +/- SBP-101 for Pancreatic Cancer
(ASPIRE Trial)
Trial Summary
What is the purpose of this trial?
This trial is testing a new drug called SBP-101 combined with two existing cancer drugs, nab-paclitaxel and gemcitabine, in patients with advanced pancreatic cancer. The goal is to see if adding SBP-101 can help these patients live longer and improve their quality of life. SBP-101 might work by making cancer cells easier to kill with the other drugs.
Will I have to stop taking my current medications?
The trial requires that you stop taking metformin (a diabetes medication) at least 5 days before starting the study and not use it during the trial. Other diabetic medications are allowed, but the protocol does not specify about other medications.
What data supports the effectiveness of the drug Nab-Paclitaxel + Gemcitabine +/- SBP-101 for Pancreatic Cancer?
Research shows that combining nab-paclitaxel (a form of chemotherapy) with gemcitabine significantly improves survival in patients with advanced pancreatic cancer compared to using gemcitabine alone. This combination has become a standard treatment option for metastatic pancreatic cancer due to its demonstrated effectiveness.12345
Is the combination of Nab-Paclitaxel and Gemcitabine safe for treating pancreatic cancer?
The combination of Nab-Paclitaxel and Gemcitabine for pancreatic cancer has been studied and generally has a manageable safety profile. Common side effects include neutropenia (low white blood cell count) and peripheral neuropathy (nerve damage), which were mostly mild and resolved with treatment adjustments.14567
What makes the drug combination of nab-paclitaxel, gemcitabine, and SBP-101 unique for pancreatic cancer?
This drug combination is unique because it includes nab-paclitaxel, a novel formulation of paclitaxel that avoids certain toxicities, and is combined with gemcitabine, a standard treatment for pancreatic cancer, potentially enhancing effectiveness. The addition of SBP-101, which is not commonly used in standard regimens, may offer a new approach to treatment.12458
Research Team
Michael J Walker, MD
Principal Investigator
Panbela Therapeutics, Inc.
Eligibility Criteria
This trial is for adults with newly diagnosed metastatic pancreatic ductal adenocarcinoma who haven't been treated for it yet. They should be able to perform daily activities with ease or have only slight limitations (ECOG 0-1), and their major organs must function well. Pregnant women, those with certain genetic mutations (BRCA positive), severe diseases, recent major surgery, or a history of specific drug use are excluded.Inclusion Criteria
Exclusion Criteria
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive nab-paclitaxel and gemcitabine with or without SBP-101
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Gemcitabine (Anti-metabolites)
- Nab-paclitaxel (Anti-metabolites)
- SBP-101 (Other)
Gemcitabine is already approved in Canada, Japan for the following indications:
- Pancreatic cancer
- Breast cancer
- Ovarian cancer
- Non-small cell lung cancer
- Pancreatic cancer
- Breast cancer
- Ovarian cancer
- Non-small cell lung cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
Panbela Therapeutics, Inc.
Lead Sponsor