Phase 3 study in patients previously Untreated for Metastatic Pancreatic Ductal Adenocarcinoma
Research type
Research Study
Full title
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
IRAS ID
1005200
Contact name
Rachel Bragg
Contact email
Sponsor organisation
Panbela Therapeutics, Inc
Eudract number
2021-005790-60
Clinicaltrials.gov Identifier
Research summary
Metastatic pancreatic ductal adenocarcinoma is a type of cancer of the pancreas. The pancreas is a small organ under the liver in the belly that produces hormones (substances that circulate in the blood and help the body's organs work) and enzymes (proteins that help break down food). Metastatic pancreatic ductal adenocarcinoma is when cancer begins in the ducts (tubes) of the pancreas and spreads to the other organs. Patients can join this study if they have not received any treatment for their adenocarcinoma since it was determined that the cancer had spread to other organs, and they are expected to receive standard treatment with gemcitabine and nab-paclitaxel. Chemotherapy or radiation therapy before or after surgery but before the cancer had spread to other organs is allowed. About 150 adults will take part in this study. This study will be done at 60 sites in the United States, Europe, and Australia.
The study will test the standard treatment of nab-paclitaxel and gemcitabine with or without the study medication called SBP-101.
The goal of the study is to see if SBP-101 combined with nab-paclitaxel and gemcitabine works well to treat adenocarcinoma. The study also wants to figure out if SBP-101 combined with nab-paclitaxel and gemcitabine is safe and well tolerated by patients with adenocarcinoma.
Studies in animals have shown that SBP-101 may be effective in the treatment of adenocarcinoma. There have been 2 previous human clinical trials with SBP-101.
SBP-101 or placebo will be administered at the clinic or at the participant`s home as an under the skin (subcutaneous) injection into the thigh or abdomen once daily from Monday through Friday.
The total time participants spend in the study will depend on how long they will receive the study treatment and when their study doctor decides whether the study drug needs to be stopped.REC name
North East - York Research Ethics Committee
REC reference
22/NE/0099
Date of REC Opinion
5 Aug 2022
REC opinion
Further Information Unfavourable Opinion