Trial | NCT04419623  Report issue

Title

A Study of TL-895 With Standard Available Treatment Versus Standard Available Treatment for the Treatment of COVID-19 in Patients With Cancer
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

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    tl-895 ...

  • Study Participants

    7
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.
Study Started
Jul 09
2020
Primary Completion
Sep 22
2020
Study Completion
Dec 15
2020
Last Update
May 12
2021

Drug TL-895

TL-895, administered by mouth

Dose Finding - 200mg BID Experimental

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).

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
No Results Posted