A Phase I Multicenter Study of Antroquinonol in Patients with Metastatic Non-Small-Cell Lung Cancer Who Have Received at Least Two Prior Systemic Treatment Regimens, Including One Platinum-Based Chemotherapy Regimen

Authors: Yu-Chin Lee, Ching-Liang Ho, Woei-Yau Kao, and Yuh-Min Chen

Journal: Molecular and Clinical Oncology

Study Design: Open-label, dose-escalation, pharmacokinetic (PK) study

Participants: 13 patients with metastatic non-small-cell lung cancer (NSCLC) who had received at least two prior systemic treatment regimens

Intervention: Escalating doses of once-daily antroquinonol in 4-week cycles (up to 3 cycles). The escalated doses were 50-600 mg.

Outcome Measures:

• Maximum tolerable dose (MTD)
• Dose-limiting toxicities (DLTs)
• Safety and tolerability
• Pharmacokinetics
• Preliminary efficacy

Summary:

This phase I clinical trial evaluated the safety, tolerability, pharmacokinetics, and preliminary efficacy of antroquinonol, a compound derived from Antrodia camphorata, in patients with metastatic NSCLC. The study involved escalating doses of antroquinonol administered once daily for 4-week cycles. No DLTs were observed at any dose level. Antroquinonol was well-tolerated, with the most common adverse events being diarrhea, vomiting, and nausea. The best tumor response observed was stable disease in 3 patients. The study concluded that antroquinonol was safe and well-tolerated at all tested doses, and the recommended dose for a phase II study is ≥600 mg daily. Sources and related content