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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04419623
Recruitment Status : Completed
First Posted : June 5, 2020
Last Update Posted : May 12, 2021
Sponsor:
Information provided by (Responsible Party):
Telios Pharma, Inc.

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.


Condition or disease Intervention/treatment Phase
COVID-19 Sars-CoV2 Cancer Solid Tumor Carcinoma Blood Cancer Drug: TL-895 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
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.
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : July 9, 2020
Actual Primary Completion Date : September 22, 2020
Actual Study Completion Date : December 15, 2020

Arm Intervention/treatment
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).
Drug: TL-895
TL-895, administered by mouth




Primary Outcome Measures :
  1. Recommended dose of TL-895 [ Time Frame: After the day 14 of the 6th subject per dose level ]
    To determine the recommended dose of TL-895 to be based on the observed dose limiting toxicity



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04419623


Locations
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United States, Georgia
Georgia Cancer Center
Augusta, Georgia, United States, 30912
United States, Ohio
The Ohio State Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Telios Pharma, Inc.
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Responsible Party: Telios Pharma, Inc.
ClinicalTrials.gov Identifier: NCT04419623    
Other Study ID Numbers: TL-895-202
First Posted: June 5, 2020    Key Record Dates
Last Update Posted: May 12, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Telios Pharma, Inc.:
TKI
Tyrosine Kinase Inhibitor
Additional relevant MeSH terms:
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COVID-19
Hematologic Neoplasms
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Neoplasms by Site
Neoplasms
Hematologic Diseases