Untreated metastatic pancreatic ductal adenocarcinoma
Adult patients with this disease can join a randomized, blinded, phase 2/3 study testing polyamine inhibitor SBP-101 (diethyl dihydroxyhomospermine) in combination with standard-of-care therapies gemcitabine (Gemzar) and nab-paclitaxel (Abraxane). Polyamine metabolism is central to cellular growth and proliferation.
SBP-101 inhibited pancreatic tumor growth in its phase 1 trial. In the phase 2/3 study, all participants will receive gemcitabine and nab-paclitaxel for up to 3 years; those in the experimental group will also receive SBP-101. The trial began recruiting an initial 150 participants in Arkansas, Texas, and Wisconsin in August, with the option to recruit additional patients on the basis of an interim analysis when 104 patients have either died or the disease has progressed. The primary outcome is overall survival, and the secondary outcome is quality of life. More details at clinicaltrials.gov.
Previously treated unresectable, locally advanced or metastatic liver cancer
People with this type of liver cancer are eligible for a randomized, phase 2 study to determine whether survival can be improved by combining the immunotherapy atezolizumab with a targeted therapy – carbozantinib or lenvatinib. All participants will take carbozantinib or lenvatinib capsules daily for up to 3 years. Half the group will also receive intravenous atezolizumab every 3 weeks. The University Medical Center New Orleans started recruiting 122 participants in May, and study sites are gearing up in eight more states. Overall survival and progression-free survival are primary endpoints; quality of life will not be tracked. More details at clinicaltrials.gov.
All trial information is from the National Institutes of Health U.S. National Library of Medicine (online at clinicaltrials.gov).
A version of this article first appeared on Medscape.com.