This study is designed to test an investigational drug called Minnelide in patients with cancer. Minnelide releases the active compound triptolide when exposed to the blood stream; laboratory experiments suggest that triptolide could be effective in killing tumor cells. There are two parts to the study: Regimen A and Regimen B. Regimen A focuses on patients who have cancer that has continued to grow despite treatment. Researchers aim to evaluate the safety and effects of Minnelide, as well as determine the dose that should be used in future studies and the best way to give the drug.
Regimen B focuses on patients who have pancreas or breast cancer that has continued to grow despite treatment. The study will evaluate Minnelide when given in combination with a drug called protein-bound paclitaxel. Researchers will determine the maximum dose of Minnelide that can be tolerated when given with protein-bound paclitaxel and whether it has any effect in patients with breast and/or pancreas cancer. While protein-bound paclitaxel is approved by the U.S. Food and Drug Administration for treatment of pancreas and breast cancer, it has not been approved for use in combination with Minnelide.
What is the full name of this clinical trial?
MINNELIDE101: A Phase 1, Multi-Center, Open-Label, Dose-Escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of Minnelide Capsules given alone or in combination with Protein-Bound Paclitaxel in patients with Advanced Solid Tumors
Alain Mita, Andrew Hendifar, Bobbie Jo Rimel, Edwin Posadas, Heather McArthur, Jun Gong, Ronald Natale, Sukhmani Padda