Determine MTD and to Evaluate pk, Safety/Tolerability and Efficacy Profiles of Hocena® in NSCLC Subjects

PHASE1CompletedINTERVENTIONAL
Enrollment

13

Participants

Timeline

Start Date

December 31, 2010

Primary Completion Date

June 30, 2013

Study Completion Date

June 30, 2013

Conditions
Non-small Cell Lung Cancer
Interventions
DRUG

Antroquinonol

"Antroquinonol was taken orally, daily, within 15 minutes after a breakfast at the assigned dose level: 50, 100, 200, 300, 450, 600 mg/day for 4 weeks.~Dose Level 1 (4 weeks) : 50 mg Antroquinonol; Dose Level 2 (4 weeks) : 100mg Antroquinonol; Dose Level 3 (4 weeks) : 200mg Antroquinonol; Dose Level 4 (4 weeks) : 300mg Antroquinonol; Dose Level 5 (4 weeks) : 450mg Antroquinonol; Dose Level 6 (4 weeks) : 600mg Antroquinonol.~The accelerated phase ended when either 1 DLT or MT was observed to start standard phase. Study ended when reach the highest dose level or DLT founded."

Trial Locations (2)

201

Taipei Veterans General Hospital, Taipei

11490

Tri-Service General Hospital, Taipei

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

PharmaNet

INDUSTRY

lead

Golden Biotechnology Corporation

INDUSTRY