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

Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04419623
• Other study ID #: TL-895-202
• Status: Completed
• Phase: Phase 1
• Start date: July 9, 2020
• Est. completion date: December 15, 2020

Study information

• Verified date: May 2021
• Source: Telios Pharma, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: December 15, 2020
• Est. primary completion date: September 22, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Blood Cancer
• Cancer
• Carcinoma
• COVID-19
• Hematologic Neoplasms
• Sars-CoV2
• Solid Tumor

Intervention

Drug:
• TL-895
TL-895, administered by mouth

Locations

Country	Name	City	State
United States	Georgia Cancer Center	Augusta	Georgia
United States	The Ohio State Comprehensive Cancer Center	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Telios Pharma, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recommended dose of TL-895	To determine the recommended dose of TL-895 to be based on the observed dose limiting toxicity	After the day 14 of the 6th subject per dose level