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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

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ClinicalTrials.gov Identifier: NCT04419623
Recruitment Status : Recruiting
First Posted : June 5, 2020
Last Update Posted : September 25, 2020
Sponsor:
Information provided by (Responsible Party):
Telios Pharma, Inc.

Brief Summary:

This study evaluates TL-895, a tyrosine kinase inhibitor (TKI). This is a 2-part study comprising a Phase 1 safety lead-in (Part 1) that will determine the recommended TL-895 dose for Phase 2 (Part 2).

In Part 1, 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.

In Part 2, eligible subjects will be randomized in a 1:1 ratio to TL-895 with standard available treatment (SAT), or placebo with SAT. Investigators and Sponsor will be blinded to each subject's assigned study intervention throughout the course of the study.


Condition or disease Intervention/treatment Phase
COVID-19 Sars-CoV2 Cancer Solid Tumor Carcinoma Blood Cancer Drug: Part 1 - TL-895 Drug: Part 2 - TL-895 Drug: Part 2 - Placebo Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 146 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention Model Description:

In Part 1, up to 18 subjects will participate in a dose-finding safety lead-in to determine the recommended TL-895 dose.

In Part 2, 64 subjects will be randomized to the recommended TL-895 dose w/ SAT (Arm 1), and 64 subjects will be randomized to Placebo w/ SAT (Arm 2).

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:

The control product in this study is placebo. The placebo will only be used in Part 2. Placebo will be matched in appearance and packaging to active investigational product TL-895.

Investigators and Sponsor will be blinded to each subject's assigned study treatment in Part 2 (the double-blind, placebo-controlled portion of the study) via unique kit numbers on study drug cartons.

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
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2021

Arm Intervention/treatment
Experimental: Part 1 - Dose Finding
TL-895 orally BID at up to 3 dose levels taken continuously in 7-day cycles for 2 - 4 cycles with SAT for COVID-19 (14 - 28 days of treatment).
Drug: Part 1 - TL-895
TL-895, administered by mouth

Experimental: Part 2 - Arm 1 - TL-895 at recommended dose
TL-895 orally BID at the recommended dose continuously in 7-day cycles for 2 - 4 cycles with SAT for COVID-19 (14 - 28 days of treatment).
Drug: Part 2 - TL-895
TL-895, administered by mouth

Placebo Comparator: Part 2 - Arm 2 - Placebo at recommended dose
Placebo orally BID at the recommended dose continuously in 7-day cycles for 2 - 4 cycles with standard available treatment for COVID-19 (14 - 28 days of treatment).
Drug: Part 2 - Placebo
Matching Placebo (dummy pill), administered by mouth




Primary Outcome Measures :
  1. Part 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 used in Part 2 based on the observed dose limiting toxicity per dose level

  2. Part 2 - Change in the need for artificial ventilation or death [ Time Frame: Day 29 ]
    The proportion of subjects in Arm 1 vs Arm 2 requiring artificial ventilation (intubation and mechanical ventilation [MV], extracorporeal membrane oxygenation [ECMO], heated, humidified high-flow nasal cannula oxygen [HFNC], noninvasive positive pressure ventilation [NiPPV]) or death


Secondary Outcome Measures :
  1. Part 2 - Change in respiratory failure events that require invasive ventilation or death [ Time Frame: 4 months ]
    The proportion of subjects in Arm 1 vs Arm 2 requiring artificial ventilation (intubation and mechanical ventilation [MV], extracorporeal membrane oxygenation [ECMO], heated, humidified high-flow nasal cannula oxygen [HFNC], noninvasive positive pressure ventilation [NiPPV]) or death



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, except where patients are receiving hydroxychloroquine or chloroquine and/or azithromycin and/or remdesivir.
  • Require artificial ventilation at screening.
  • Life expectancy less than 6 months.
  • Advanced healthcare directive that includes do not intubate (DNI) or do not resuscitate (DNR) orders
  • 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


Contacts
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Contact: John Mei 650-542-0136 jmei@teliospharma.com

Locations
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United States, Florida
University of Miami Recruiting
Miami, Florida, United States, 33136
United States, Georgia
Georgia Cancer Center Recruiting
Augusta, Georgia, United States, 30912
United States, Illinois
Rush University Medical Center Recruiting
Chicago, Illinois, United States, 60612
United States, Indiana
Community Health Network Active, not recruiting
Indianapolis, Indiana, United States, 46250
United States, Kentucky
Norton Cancer Institute Recruiting
Louisville, Kentucky, United States, 40207
United States, Louisiana
Tulane Medical Center Recruiting
New Orleans, Louisiana, United States, 70112
United States, Michigan
Barbara Ann Karmanos Cancer Institute - Wertz Clinic Recruiting
Detroit, Michigan, United States, 48201
Barbara Ann Karmanos Cancer Institute Recruiting
Detroit, Michigan, United States, 48201
United States, Ohio
University of Cincinnati Medical Center Active, not recruiting
Cincinnati, Ohio, United States, 45267
The Ohio State Comprehensive Cancer Center Recruiting
Columbus, Ohio, United States, 43210
OhioHealth - Riverside Methodist Hospital Recruiting
Columbus, Ohio, United States, 43214
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: September 25, 2020
Last Verified: September 2020

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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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Hematologic Neoplasms
Neoplasms by Site
Neoplasms
Hematologic Diseases