A Phase I/II Study of Antroquinonol in Combination with Nab-Paclitaxel and Gemcitabine for Patients with Metastatic Pancreatic Cancer

Authors: Yan-Shen Shan, Chung-Pin Li, Gazala Khan, Woo Jin Lee, Hye Jin Choi, Heung-Moon Chang, Moon Hee Lee, John M. Wallmark, Pei-Ni Chen

Journal: Pancreatic Cancer

Study Design: Phase I/II clinical trial

Participants: Patients with chemo-naive, metastatic pancreatic ductal adenocarcinoma (PDAC)

Intervention:

• Phase I: Dose escalation of antroquinonol in combination with gemcitabine and nab-paclitaxel (Gem/Nab-P) to determine the maximum tolerated dose (MTD)
• Phase II: Antroquinonol at the MTD in combination with Gem/Nab-P

Outcome Measures:

• Phase I: MTD, safety, and tolerability
• Phase II: Median progression-free survival (PFS), 6-month PFS rate, median overall survival (OS), 12-month OS rate, adverse events

Summary:

This phase I/II clinical trial investigated the safety and efficacy of antroquinonol, a novel anti-cancer compound, in combination with Gem/Nab-P for patients with metastatic PDAC. In phase I, the MTD of antroquinonol was determined to be 300 mg three times a day. In phase II, the combination therapy showed promising results, with a median PFS of 5.3 months, a 6-month PFS rate of 40%, a median OS of 12.6 months, and a 12-month OS rate of 59.9%. The adverse events were manageable, with the combination therapy showing a decrease in hematological and non-hematological toxicities compared to Gem/Nab-P alone. The study concluded that antroquinonol plus Gem/Nab-P is a safe and effective treatment option for patients with metastatic PDAC.   Sources and related content