A Phase I/II Design to Identify Optimal Biological Dose for Molecularly Targeted Agents

PID: 964; V1.0.4.0; Last Updated: 03/19/2019

Rongji Mu1, Ying Yuan2, J. Jack Lee2 and Ying-Wei Kuo2

1School of Statistics, East China Normal University, Shanghai 200241, China

2Department of Biostatistics, MD Anderson Cancer Center, Houston, TX 77030



Trial Setting



The value must be grater than 0.

The value must be less than 1.

A dose is deemed unaccepbly if \(\ Pr\) ( \(p_j\)> \(\phi\) | \(data\) ) > \(p_E\)


Enter Simulation Scenario



Scenario 1

Dose
True Toxicity Rate
True Efficacy Rate
1
2
3
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5

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Trial Setting



The value must be grater than 0.

The value must be less than 1.

Current dose level must be less than or equal to the total number of doses.

Current dose level must be greater than 0.

A dose is deemed unaccepbly if \(\ Pr\) ( \(p_j\)> \(\phi\) | \(data\) ) > \(p_E\)





Error:You already reached the maximum number of doses you can Input!

Enter Trial Data



Dose Level
# of Pts treated
# of DLT
# of response 






                  

                  

                

                

                  

                  

                

              

            

          

        

        

          

            

          

          

            

              Zang, Y., Lee, J. and Yuan, Y. (2014) Adaptive Designs for Identifying Optimal Biological Dose for Molecularly Targeted Agents, Clinical Trials, 11, 319-327.
            

          

          

            
Note: The results in the application were based on the 'double-sided isotonic regression' in the paper.