CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 13 enrolled
Drug / intervention
Antroquinonoldrug
Likely dose
Antroquinonol 600 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01134016
NCT01134016Phase 1Completed
CompareCT.gov

Determine MTD and to Evaluate PK, Safety/Tolerability and Efficacy Profiles of Antroquinonol (Hocena®) in NSCLC Patients Refractory to Conventional Treatment Modalities

Golden Biotechnology Corporation·interventional·Posted May 31, 2010·Updated Jun 21, 2016

In Brief

A Phase 1 clinical trial evaluating Antroquinonol for Non-small Cell Lung Cancer. Completed, enrolled 13 participants across 2 sites.

Detailed Summary

A phase I study to determine the maximum tolerable dose (MTD) and to evaluate pharmacokinetic, safety/tolerability and efficacy profiles of antroquinonol (Hocena®) in non-small cell lung cancer (NSCLC) subjects refractory to conventional treatment modalities

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon-small Cell Lung Cancer
CountriesTaiwan
CollaboratorsPharmaNet

Timeline

Phase 1CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMay 31, 2010
Enrollment StartDec 1, 2010
Primary CompletionJun 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 16.1 years ago

Interventions

Antroquinonoldrug

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.