StudyFinder
Phase 1b/3 global, randomized, controlled, open-label trial comparing treatment with RYZ101 to standard of care (SoC) therapy in subjects with inoperable, advanced, somatostatin receptor expressing (SSTR+), well-differentiated gastro-enteropancreatic neuroendocrine tumors (GEP-NETs) that have progressed following prior 177Lu-labelled somatostatin analogue (177Lu-SSA) therapy (ACTION-1)
Status: Recruiting
The main purpose of this the study is to find out if a new investigational drug RYZ101 more effectively treats your cancer than the standard therapy, and to see if it is safe, tolerable, and to learn the pharmacokinetics (PK).
Sex: Male or Female
Age Group: 18 years and over
Inclusion Criteria:
• diagnosis of inoperable, advanced, well-differentiated, somatostatin receptor expressing (SSTR+) gastroenteropancreatic neuroendocrine cancer
• able to walk and complete all self care but unable to carry out any work activities; up and about more than 50% of waking hours
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
Exclusion Criteria:
• significant cardiovascular disease such as heart failure
• hypertension that isn't controlled by medication
• uncontrolled diabetes
• history of liver cirrhosis
Interventions:
Drug: Everolimus, Drug: Lanreotide, Drug: Octreotide, Drug: RYZ101, Drug: Sunitinib
Conditions:
Cancer
Keywords:
Clinics and Surgery Center (CSC), Gastric Cancer, Neuroendocrine tumors, Pancreas, Pancreatic Cancer, Stomach Cancer
Study Contact: Edward Greeno - green048@umn.edu
Principal Investigator: Edward Greeno, M.D.
Phase: PHASE3
IRB Number: STUDY00021459
See this study on ClinicalTrials.gov