Clinical Study of Oral PI3K/mTOR Inhibitor in Patients With Advanced Refractory Solid Tumors
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|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.
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): 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|