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Related Experiment Video

Updated: Jun 22, 2026

Preclinical Assessment of the Bioactivity of the Anticancer Coumarin OT48 by Spheroids, Colony Formation Assays, and Zebrafish Xenografts

Preclinical Assessment of the Bioactivity of the Anticancer Coumarin OT48 by Spheroids, Colony Formation Assays, and Zebrafish Xenografts

Published on: June 26, 2018

Phase II designs for anticancer botanicals and supplements.

Andrew J Vickers¹

¹Department of Epidemiology, Memorial Sloan-Kettering Cancer Center, New York, NY 10021, USA. vickersa@mskcc.org

Journal of the Society for Integrative Oncology

|May 30, 2009

Summary

This study proposes a new phase II trial design for anticancer botanicals and supplements. It uses historical data to assess if these agents improve patient survival, guiding further phase III studies.

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Area of Science:

Oncology
Clinical Trial Design
Pharmacology

Background:

Traditional phase II trials assess anticancer agents using tumor response (e.g., 50% size reduction).
Anticancer botanicals and supplements may not cause rapid tumor regression but could improve survival.
Existing phase II designs are not optimal for evaluating botanicals and supplements based on survival endpoints.

Purpose of the Study:

To present a novel phase II trial design for evaluating anticancer botanicals and supplements.
To establish a methodology for using historical data to predict and assess patient outcomes.
To determine if a new agent warrants further investigation in phase III trials based on survival benefits.

Main Methods:

Utilizes historical data to create a statistical prediction model for patient outcomes.
Adjusts predictions for sampling variation and patient case mix.
Compares predicted survival outcomes with observed results in the phase II study cohort.

Main Results:

The proposed design allows for the evaluation of survival endpoints, such as 6-month progression-free survival.
It provides a framework for comparing observed patient outcomes against statistically predicted results.
The approach facilitates the identification of promising agents for further clinical development.

Conclusions:

The presented phase II design is suitable for anticancer botanicals and supplements, focusing on survival rather than tumor response.
This method appropriately uses historical data to assess the efficacy of novel agents.
Positive results from this design indicate the potential for agents to advance to phase III randomized controlled trials.