Back to resultsA Study of TL-895 With Standard Available Treatment Versus Standard Available Treatment for the Treatment of COVID-19 in Patients With Cancer
Primary Purpose
COVID-19, Sars-CoV2, Cancer
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
TL-895
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19 focused on measuring TKI, Tyrosine Kinase Inhibitor
Eligibility Criteria
Inclusion Criteria:
- Known diagnosis of active cancer that is not considered cured or disease free.
- Confirmed COVID-19 infection as per World Health Organization (WHO) criteria with suspected pneumonia requiring hospitalization and oxygen saturation < 94% on room air or requires supplemental oxygen.
- Adequate hematological, hepatic and renal function as would be medically expected of a cancer patient population.
- Able to swallow and absorb oral medications.
Exclusion Criteria:
- Current active treatment with medications contraindicated for receipt of investigational product.
- Require chemotherapy or urgent systemic therapy for active cancer that cannot be withheld.
- No remaining available therapies for advanced or metastatic malignancies.
- Participation in another clinical study with therapeutic intent for COVID-19
- Require artificial ventilation at screening.
- Life expectancy less than 6 months.
- Medical conditions that make it unsafe to receive investigational product (for example, heart attack in the last 6 mos, unstable angina, uncontrolled arrhythmia, heart failure class 3/4, QTC interval > 480 msec; known bleeding disorders, stroke or intracranial hemorrhage in the last 6 mos; active HBV, HCV or history of HIV; GI malabsorption syndrome, small bowel resection, poorly controlled IBS; untreated/actively progressing known CNS lesions).
- Receipt of radiation therapy to the lung or mediastinum for treatment of COVID-19
Sites / Locations
- Georgia Cancer Center
- The Ohio State Comprehensive Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Dose Finding - 200mg BID
Arm Description
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).
Outcomes
Primary Outcome Measures
Recommended dose of TL-895
To determine the recommended dose of TL-895 to be based on the observed dose limiting toxicity
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04419623
Brief Title
A Study of TL-895 With Standard Available Treatment Versus Standard Available Treatment for the Treatment of COVID-19 in Patients With Cancer
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
July 9, 2020 (Actual)
Primary Completion Date
September 22, 2020 (Actual)
Study Completion Date
December 15, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Telios Pharma, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19, Sars-CoV2, Cancer, Solid Tumor, Carcinoma, Blood Cancer
Keywords
TKI, Tyrosine Kinase Inhibitor
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dose Finding - 200mg BID
Arm Type
Experimental
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
TL-895
Intervention Description
TL-895, administered by mouth
Primary Outcome Measure Information:
Title
Recommended dose of TL-895
Description
To determine the recommended dose of TL-895 to be based on the observed dose limiting toxicity
Time Frame
After the day 14 of the 6th subject per dose level
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Known diagnosis of active cancer that is not considered cured or disease free.
Confirmed COVID-19 infection as per World Health Organization (WHO) criteria with suspected pneumonia requiring hospitalization and oxygen saturation < 94% on room air or requires supplemental oxygen.
Adequate hematological, hepatic and renal function as would be medically expected of a cancer patient population.
Able to swallow and absorb oral medications.
Exclusion Criteria:
Current active treatment with medications contraindicated for receipt of investigational product.
Require chemotherapy or urgent systemic therapy for active cancer that cannot be withheld.
No remaining available therapies for advanced or metastatic malignancies.
Participation in another clinical study with therapeutic intent for COVID-19
Require artificial ventilation at screening.
Life expectancy less than 6 months.
Medical conditions that make it unsafe to receive investigational product (for example, heart attack in the last 6 mos, unstable angina, uncontrolled arrhythmia, heart failure class 3/4, QTC interval > 480 msec; known bleeding disorders, stroke or intracranial hemorrhage in the last 6 mos; active HBV, HCV or history of HIV; GI malabsorption syndrome, small bowel resection, poorly controlled IBS; untreated/actively progressing known CNS lesions).
Receipt of radiation therapy to the lung or mediastinum for treatment of COVID-19
Facility Information:
Facility Name
Georgia Cancer Center
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
The Ohio State Comprehensive Cancer Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
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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