Clinical Study of Oral IGF-1R Inhibitor in Subjects With Advanced Refractory Solid Tumors
|ClinicalTrials.gov Identifier: NCT01779336|
Recruitment Status : Suspended (Sponsor decision not related to patient safety)
First Posted : January 30, 2013
Last Update Posted : September 29, 2014
|Condition or disease||Intervention/treatment||Phase|
|Advanced Refractory Solid Tumors||Drug: PL225B||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||70 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open Label Multicentre Phase 1 Study of Oral IGF-1R Inhibitor PL225B in Subjects With Advanced Refractory Solid Tumors.|
|Study Start Date :||December 2012|
|Estimated Primary Completion Date :||November 2014|
|Estimated Study Completion Date :||December 2014|
Patients will receive study drug on a daily basis until disease progression or unacceptable toxicity in sequential cohorts following accelerated titration design.
- Maximum tolerated dose [ Time Frame: End of Cycle 1 (i.e. 21 Days) ]Subjects will receive study drug on a daily basis for twenty-one (21) days according to the dose and schedule specified for a particular cohort of therapy.Toxicity profile of the drug will be assessed during Cycle 1 of subject treatment in each cohort for determination of Maximum Tolerated Dose (MTD).
- Number of subject with adverse events [ Time Frame: Until disease progression or unacceptable toxicity (expected to be 4-6 months) ]The toxic effects of the drug would be assessed from adverse events, vital signs and by clinically significant changes in the laboratory evaluations.
- Pharmacokinetic profile(Cmax,Tmax and AUC) [ Time Frame: Until disease progression or unacceptable toxicity (expected to be 4-6 months) ]The following PK parameters will be calculated: Cmax (peak plasma concentration), Tmax (time to peak plasma concentration), AUC0-t (area under the plasma concentration curve from time zero to time of last quantifiable concentration), AUC0-12, AUC0-inf (area under the plasma concentration curve from time zero extrapolated to infinity), percent AUC extrapolated, kel (elimination rate constant), t1/2 (elimination half-life), CL/F (oral clearance), Vz/F (oral apparent volume of distribution) and Racc (accumulation ratio).
- Activity of PL225B based on selected biomarkers [ Time Frame: Until disease progression or unacceptable toxicity (expected to be 4-6 months) ]Plasma samples will be used for analysis of circulating exploratory biomarkers which are likely to change in response to PL225B administration.
- Objective response [ Time Frame: Until disease progression or unacceptable toxicity (expected to be 4-6 months) ]Evaluation of Response: Clinical responses will be presented patient wise for different dose levels.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01779336
|United States, California|
|USC Norris Comprehensive Cancer Center|
|Los Angeles, California, United States, 90033|
|Central India Cancer Research Institute|
|Nagpur, Maharashtra, India, 440010|
|Curie Manavata Cancer Centre|
|Nashik, Maharashtra, India, 422004|
|Ruby Hall Clinic|
|Pune, Maharashtra, India, 411001|
|Meenakshi Mission Hospital and Research Centre|
|Madurai, Tamil Nadu, India, 625107|
|Principal Investigator:||Dr Anthony El-Khoueiry, MD||University of Southern California|