A Study of TL-895 With Standard Available Treatment Versus Standard Available Treatment for the Treatment of COVID-19 in Patients With Cancer
Purpose
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.
Conditions
- COVID-19
- Sars-CoV2
- Cancer
- Solid Tumor
- Carcinoma
- Blood Cancer
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- N/A
- 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.
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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). |
|
More Details
- Status
- Completed
- Sponsor
- Telios Pharma, Inc.