Clinical trial NCT04419623: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: COVID-19
Sars-CoV2
Cancer
Solid Tumor
Carcinoma
Blood Cancer
Keywords: TKI
Tyrosine Kinase Inhibitor
Lead sponsor: Telios Pharma, Inc.
Sponsor class: INDUSTRY
First posted: 2020-06-05
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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

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.


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

Primary outcomes:
measure: Recommended dose of TL-895
timeFrame: After the day 14 of the 6th subject per dose level
Secondary outcomes:
Other outcomes:
Locations:
city: Augusta
country: United States
facility: Georgia Cancer Center
state: Georgia
city: Columbus
country: United States
facility: The Ohio State Comprehensive Cancer Center
state: Ohio
Study officials:
References: