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
Study of Drug - SBP-101 Alone or in Combination with Chemotherapy in Patients with Untreated Pancreatic Ductal Adenocarcinoma (PDAC)
Sponsor: Panbela Therapeutics, Inc.
Enrolling: Male and Female Patients
IRB Number: AAAU1236
U.S. Govt. ID: NCT05254171
Contact: Research Nurse Navigator: 212-342-5162 / cancerclinicaltrials@cumc.columbia.edu
Additional Study Information: The purpose of this study is to investigate how well SBP-101, the study drug, or a placebo works in combination with nap-paclixatel and gemcitabine to treat adenocarcinoma in study participants who have never received treatment for their cancer. A placebo is an inert substance that does not contain any study drug and has no therapeutic value. Placebos are used in studies to help the study team determine if any progress occurs due to the study treatment or due to another outside factor that is not being studied in this research. Participants will be randomized (randomly assigned by a computer) to the study drug group or the placebo group. The study also aims to determine how safe and well-tolerated the combination of study drugs are in patients with adenocarcinoma. SBP-101 is not FDA-approved. On the contrary, nap-paclitaxel and gemcitabine are approved by the FDA and are typically the standard of care treatment for your type of cancer. This study aims to see if adding SBP-101 to the standard of care treatments is a better approach than the standard of care treatments alone.
Investigator
Gulam Manji, MD, PhD
Do You Qualify?
Are you at least 18 years old? Yes No
Have you been diagnosed with pancreatic ductal adenocarcinoma? Yes No
Have you had treatment for your cancer? Yes No
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For more information, please contact:
Research Nurse Navigator
cancerclinicaltrials@cumc.columbia.edu
212-342-5162