Safety and Pharmacokinetic Study of CVM-1118 Extended-Release in Advanced Cancer Patients

PHASE1CompletedINTERVENTIONAL
Enrollment

5

Participants

Timeline

Start Date

May 25, 2020

Primary Completion Date

February 8, 2021

Study Completion Date

April 8, 2022

Conditions
Advanced Cancer
Interventions
DRUG

CVM-1118 Extended-Release (ER) Capsules (200 mg/capsule)

"Patients will receive initial dose regimen: 400 mg of CVM-1118 ER Capsule per day (200 mg BID) in a 28-day cycle for 4 cycles.~Dose escalates from 400, 600, 800, to 1200 mg of CVM-1118 ER capsules with either BID or TID dosing.~A single-patient cohort per dose level (accelerated titration design) will be applied to the first two cohorts, 400 and 600 mg daily, and followed by the conventional 3+3 dose escalation design from the dose level of 800 mg/day.~If 2 or more patients experience a DLT, no further dose escalation will occur."

Trial Locations (2)

704

National Cheng Kung University Hospital, Tainan City

Unknown

China Medical University Hospital, Taichung

All Listed Sponsors
lead

TaiRx, Inc.

INDUSTRY

NCT04336124 - Safety and Pharmacokinetic Study of CVM-1118 Extended-Release in Advanced Cancer Patients | Biotech Hunter | Biotech Hunter