Everolimus in Patients With Advanced Solid Malignancies With TSC1, TSC2, NF1, NF2, or STK11 Mutations
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|ClinicalTrials.gov Identifier: NCT02352844|
Recruitment Status : Completed
First Posted : February 2, 2015
Results First Posted : October 2, 2018
Last Update Posted : October 2, 2018
|Condition or disease||Intervention/treatment||Phase|
|Solid Malignancy Solid Tumor||Drug: Everolimus||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Everolimus in Patients With Advanced Solid Malignancies With TSC1, TSC2, NF1, NF2, or STK11 Mutations|
|Actual Study Start Date :||October 7, 2015|
|Actual Primary Completion Date :||August 15, 2017|
|Actual Study Completion Date :||August 15, 2017|
Experimental: Arm 1 (everolimus)
Everolimus is an oral drug which will be administered on an outpatient basis at a dose of 10 mg daily on a 28-day cycle.
- Response Rate (RR) [ Time Frame: Completion of treatment (estimated average of 6 months) ]The primary endpoint will be to describe the response rate using RECIST 1.1. Response rate will be defined as complete response (disappearance of all target lesion) plus partial response (a least a 30% decrease in the sum of diameters of target lesions).
- Mutations Associated With Therapeutic Response [ Time Frame: Completion of treatment (estimated average of 6 months) ]-To correlate mutations in the mTOR pathway with therapeutic response with everolimus
- Genetic Changes Associated With Disease Progression [ Time Frame: Completion of treatment (estimated average of 6 months) ]-To investigate the genetic changes associated with disease progression following treatment with everolimus.
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): NCT02352844
|United States, Missouri|
|Washington University School of Medicine|
|Saint Louis, Missouri, United States, 63110|
|Principal Investigator:||Saiama Waqar, M.D.||Washington University School of Medicine|