Safety and Pharmacokinetic Study of CVM-1118 Extended-Release in Advanced Cancer Patients
Status:
Active, not recruiting
Trial end date:
2022-04-01
Target enrollment:
Participant gender:
Summary
CVM-1118 Immediate-release (IR) Capsule and CVM-1118 Extended-release (ER) Capsule are
proprietary oncology products developed by TaiRx, Inc. for the treatment of patients
suffering from advanced cancer. Due to the short elimination half-life of CVM-1118 IR
capsules, the extended release (ER) formulation, containing mini-tablets in hard capsule, has
been developed to prolong the drug absorption and longer exposure after oral administration.
The designed dose of CVM-1118 ER was 200 mg per capsule to provide a more patient-compliant
and safe dosage of CVM-1118. The clinical study CVMEX-001 is therefore designed to evaluate
the safety and pharmacokinetics of CVM-1118 extend release (ER) Capsule (200 mg/capsule) in
patients with advanced cancer.