Status:
COMPLETED
A Study of TL-895 With Standard Available Treatment Versus Standard Available Treatment for the Treatment of COVID-19 in Patients With Cancer
Lead Sponsor:
Telios Pharma, Inc.
Conditions:
COVID-19
Sars-CoV2
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 i...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 9 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 15 2020
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT04419623
Start Date
July 9 2020
End Date
December 15 2020
Last Update
May 12 2021
Active Locations (2)
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1
Georgia Cancer Center
Augusta, Georgia, United States, 30912
2
The Ohio State Comprehensive Cancer Center
Columbus, Ohio, United States, 43210