A Study of TL-895 With Standard Available Treatment Versus Standard Available Treatment for the Treatment of COVID-19 in Patients With Cancer
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|ClinicalTrials.gov Identifier: NCT04419623|
Recruitment Status : Completed
First Posted : June 5, 2020
Last Update Posted : May 12, 2021
This study evaluates TL-895, a tyrosine kinase inhibitor (TKI). This is a study comprising a Phase 1 safety assessment. TL-895 open-label will be administered orally at an assigned dose continuously in 7-day cycles for 2 cycles. Up to 3 dose levels will be evaluated.
Only Phase 1 of the study was enrolled and the study did not proceed into Phase 2.
|Condition or disease||Intervention/treatment||Phase|
|COVID-19 Sars-CoV2 Cancer Solid Tumor Carcinoma Blood Cancer||Drug: TL-895||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||7 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Up to 18 subjects will participate in a dose-finding safety lead-in to determine the recommended TL-895 dose.|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1/2, Double-Blind, Randomized, Placebo-Controlled Study of TL-895 With Standard Available Treatment Versus Standard Available Treatment for the Treatment of COVID-19 in Patients With Cancer|
|Actual Study Start Date :||July 9, 2020|
|Actual Primary Completion Date :||September 22, 2020|
|Actual Study Completion Date :||December 15, 2020|
Experimental: Dose Finding - 200mg BID
200mg TL-895 orally BID taken continuously in 7-day cycles for 2 - 4 cycles with SAT for COVID-19 (14 - 28 days of treatment).
TL-895, administered by mouth
- Recommended dose of TL-895 [ Time Frame: After the day 14 of the 6th subject per dose level ]To determine the recommended dose of TL-895 to be based on the observed dose limiting toxicity
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): NCT04419623
|United States, Georgia|
|Georgia Cancer Center|
|Augusta, Georgia, United States, 30912|
|United States, Ohio|
|The Ohio State Comprehensive Cancer Center|
|Columbus, Ohio, United States, 43210|