Safety and Pharmacokinetic Study of CVM-1118 Extended-Release in Advanced Cancer Patients
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.
Timeline
- Start
- 2020-05-25
- Primary completion
- 2021-02-08
- Completion
- 2022-04-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CVM-1118 | Small molecule | 400 mg | Oral |
| Subject | CVM-1118 | Small molecule | 600 mg | Oral |
| Subject | CVM-1118 | Small molecule | 800 mg | Oral |
| Subject | CVM-1118 | Small molecule | 1200 mg | Oral |