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

Sponsor
Telios Pharma, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT04419623
Collaborator
(none)
7
Enrollment
2
Locations
1
Arm
5.2
Actual Duration (Months)
3.5
Patients Per Site
0.7
Patients Per Site Per Month

Study Details

Study Description

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 DiseaseIntervention/TreatmentPhase
Phase 1

Study Design

Study Type:
Interventional
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.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 :
Jul 9, 2020
Actual Primary Completion Date :
Sep 22, 2020
Actual Study Completion Date :
Dec 15, 2020

Arms and Interventions

ArmIntervention/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

Outcome Measures

Primary Outcome Measures

  1. Recommended dose of TL-895 [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Georgia Cancer CenterAugustaGeorgiaUnited States30912
2The Ohio State Comprehensive Cancer CenterColumbusOhioUnited States43210

Sponsors and Collaborators

  • Telios Pharma, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Telios Pharma, Inc.
ClinicalTrials.gov Identifier:
NCT04419623
Other Study ID Numbers:
  • TL-895-202
First Posted:
Jun 5, 2020
Last Update Posted:
May 12, 2021
Last Verified:
May 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Telios Pharma, Inc.
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 12, 2021