Related Experiment Video

Updated: Jun 15, 2026

Testing Targeted Therapies in Cancer using Structural DNA Alteration Analysis and Patient-Derived Xenografts
10:27

Testing Targeted Therapies in Cancer using Structural DNA Alteration Analysis and Patient-Derived Xenografts

Published on: July 25, 2020

Phase II clinical trials in oncology: are we hitting the target?

Mei-Kim Ang1, Say-Beng Tan, Wan-Teck Lim

  • 1National Cancer Centre Singapore, 11 Hospital Drive, Singapore. ang.mei.kim@nccs.com.sg

Expert Review of Anticancer Therapy
|March 11, 2010
PubMed

Insights

Novel cancer therapies require advanced Phase II trial designs. This review explores innovative approaches, including biomarkers and Bayesian methods, to assess cytostatic agents effectively and optimize patient treatment strategies.

Area of Science:

  • Oncology
  • Clinical Trial Design
  • Pharmacology

Background:

  • Increasing development of novel molecularly targeted agents.
  • Challenges in assessing cytostatic agents with traditional Phase II trial designs.
  • Need for optimized dosing and predictive markers for new therapies.

Purpose of the Study:

  • Review available options for Phase II trial designs.
  • Discuss endpoints, study structures, and statistical approaches.
  • Provide guidance for selecting appropriate Phase II designs for novel agents.

Main Methods:

  • Literature review of Phase II trial designs.
  • Analysis of different endpoints and study structures (single-arm, multiarm, randomized).
  • Evaluation of biomarker utilization and Bayesian statistical methods.

Main Results:

  • Traditional designs are insufficient for cytostatic agents.
  • Biomarkers and Bayesian approaches offer improved evaluation methods.
  • No single design fits all studies; selection is context-dependent.

Conclusions:

  • Phase II trial designs must adapt to novel therapeutic strategies.
  • Careful consideration of endpoints, design, and statistical methods is crucial.
  • Tailored Phase II designs are essential for evaluating new molecularly targeted agents.

More Related Videos

Testing Cancer Immunotherapeutics in a Humanized Mouse Model Bearing Human Tumors15:24

Testing Cancer Immunotherapeutics in a Humanized Mouse Model Bearing Human Tumors

Published on: December 16, 2022

Intramucosal Inoculation of Squamous Cell Carcinoma Cells in Mice for Tumor Immune Profiling and Treatment Response Assessment07:29

Intramucosal Inoculation of Squamous Cell Carcinoma Cells in Mice for Tumor Immune Profiling and Treatment Response Assessment

Published on: April 22, 2019

Related Concept Videos

Targeted Cancer Therapies02:57

Targeted Cancer Therapies

The targeted cancer therapies, also known as “molecular targeted therapies,” take advantage of the molecular and genetic differences between the cancer cells and the normal cells. It needs a thorough understanding of the cancer cells to develop drugs that can target specific molecular aspects that drive the growth, progression, and spread of cancer cells without affecting the growth and survival of other normal cells in the body.
There are several types of targeted therapies against specific...
Targeted Cancer Therapies02:57

Targeted Cancer Therapies

The targeted cancer therapies, also known as “molecular targeted therapies,” take advantage of the molecular and genetic differences between the cancer cells and the normal cells. It needs a thorough understanding of the cancer cells to develop drugs that can target specific molecular aspects that drive the growth, progression, and spread of cancer cells without affecting the growth and survival of other normal cells in the body.
There are several types of targeted therapies against specific...
Clinical Trials: Overview01:11

Clinical Trials: Overview

Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
Clinical Trials01:16

Clinical Trials

Clinical trials are prospective experimental studies conducted on humans to determine the safety and efficacy of treatments, drugs, diet methods, and medical devices. Using statistics in clinical trials enables researchers to derive reasonable and accurate conclusions from the collected data, allowing them to make wise decisions in uncertain situations. In medical research, statistical methods are crucial for preventing errors and bias.
There are four phases in a clinical trial. A phase one...
Treatment Resistent Cancers02:56

Treatment Resistent Cancers

Cancer is the second leading cause of death in the United States. A cancer cell is genetically unstable and hence can mutate faster. They can also modify their microenvironment and escape immune surveillance. The difficulties in treating cancer are further compounded by the emergence of rapid resistance to anticancer drugs. The most common ways to attain resistance in cancer cells include alteration in drug transport and metabolism, modification of drug target, elevated DNA damage response, or...
Treatment Resistant Cancers02:56

Treatment Resistant Cancers

Cancer is the second leading cause of death in the United States. A cancer cell is genetically unstable and hence can mutate faster. They can also modify their microenvironment and escape immune surveillance. The difficulties in treating cancer are further compounded by the emergence of rapid resistance to anticancer drugs. The most common ways to attain resistance in cancer cells include alteration in drug transport and metabolism, modification of drug target, elevated DNA damage response, or...