Clinical Study of Oral PI3K/mTOR Inhibitor in Patients With Advanced Refractory Solid Tumors
|ClinicalTrials.gov Identifier: NCT01762410|
Recruitment Status : Suspended (Sponsor decision not related to patient safety)
First Posted : January 7, 2013
Last Update Posted : September 29, 2014
|Condition or disease||Intervention/treatment||Phase|
|Advanced Refractory Solid Tumors||Drug: P7170||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open Label Multicentric Phase 1 Study of Oral PI3K/mTOR Inhibitor P7170 in Patients With Advanced Refractory Solid Tumors.|
|Study Start Date :||September 2012|
|Estimated Primary Completion Date :||November 2015|
|Estimated Study Completion Date :||March 2016|
Patients will receive study drug on a daily basis until disease progression or unacceptable toxicity in sequential cohorts following accelerated titration design.
Patients will receive study drug on a daily basis for twenty-one days according to the dose and schedule specified for a particular cohort of therapy. This 21 day administration will define a treatment cycle. Patients may receive consecutive treatment cycles until evidence of disease progression, intolerance of therapy, death or withdrawal from the protocol as specified.
- Maximum tolerated dose [ Time Frame: End of Cycle 1 (i.e. 21 Days) ]Patients will receive study drug on a daily basis for twenty-one days according to the dose and schedule specified for a particular cohort of therapy. Toxicities observed in Cycle 1 will be considered for dose limiting toxicity (DLT) and Maximum tolerated dose (MTD)determination.
- 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 effect of dose for AUC0-t, AUC0-inf and Cmax. Tmax and T1/2 will be given as patient-wise narratives at each dose level.
- Activity of P7170 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 exploratory biomarkers that are found in plasma and levels of which are likely to change in response to P7170 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): NCT01762410
|United States, California|
|USC Norris Comprehensive Cancer Center|
|Los Angeles, California, United States, 90033|
|Medanta Duke Research Institute (MDRI)|
|Gurgaon, Haryana, India, 122001|
|Central India Cancer Research Institute|
|Nagpur, Maharashtra, India|
|Meenakshi Mission Hospital & Research Centre|
|Madurai, Tamil Nadu, India, 625107|
|Principal Investigator:||Anthony El-Khoueiry, MD||University of Southern California|