Clinical Study of HEC68498 in Patients With Advanced Refractory Solid Tumors
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|ClinicalTrials.gov Identifier: NCT04324372|
Recruitment Status : Recruiting
First Posted : March 27, 2020
Last Update Posted : March 27, 2020
|Condition or disease||Intervention/treatment||Phase|
|Advanced Refractory Solid Tumors||Drug: HEC68498||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||72 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open Label Multicentric Phase 1 Study of HEC68498 in Patients With Advanced Refractory Solid Tumors.|
|Actual Study Start Date :||February 27, 2019|
|Estimated Primary Completion Date :||February 27, 2021|
|Estimated Study Completion Date :||October 17, 2021|
HEC68498 will be administered daily
HEC68498 is a potent,highly selective inhibitor of class 1 isozymes of phosphoinositide 3-kinase/mammalian(PI3K) and of the mammalian target of rapamycin (mTOR). It has shown good activity against fibrosis and inflammation in vitro and in vivo, with a lower effective dose and better efficacy than pirfenidone and nintedanib.
- Maximum tolerated dose [ Time Frame: 28 days ]Patients will receive study drug on a daily basis for 28 days according to the dose and schedule specified for a particular cohort of therapy. Toxicities observed in Cycle 0&1 will be considered for dose limiting toxicity (DLT) and Maximum tolerated dose (MTD)determination
- Number of subject with adverse events [ Time Frame: up to 4 weeks after last dose ]The toxic effects of the drug would be assessed from adverse events, vital signs and by clinically significant changes in the laboratory evaluations.
- Objective response [ Time Frame: up to approximately 24 months ]Evaluation of Response: Clinical responses will be presented patient wise for different dose levels.
- AUC0-∞ [ Time Frame: up to approximately 4 weeks ]area under the concentration versus time curve (AUC) from time zero to infinity
- AUC0-t [ Time Frame: up to approximately 4 weeks ]AUC from time zero to the time of the last quantifiable concentration time zero to the time of the last quantifiable concentration
- Cmax [ Time Frame: up to approximately 4 weeks ]maximum observed plasma concentration
- tmax [ Time Frame: up to approximately 4 weeks ]time of the maximum observed plasma concentration
- t½ [ Time Frame: up to approximately 4 weeks ]apparent terminal elimination half-life
- Vz/F [ Time Frame: up to approximately 4 weeks ]apparent volume of distribution
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): NCT04324372
|Contact: xu jianming, PHDfirstname.lastname@example.org|
|The Fifth Medical Center of PLA Ceneral Hospital||Recruiting|
|Beijing, China/BEIJING, China, 100071|
|Contact: XU JIANMING, phd 010-66947178 email@example.com|