Clinical Study of Oral IGF-1R Inhibitor in Subjects With Advanced Refractory Solid Tumors
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|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|