C-SMART.COVID-19 Prevention and Treatment in Cancer. Arm 3: treatment among cancer patients with moderate COVID-19 infection.

Phase 3

Completed

• Conditions: Infection - Other infectious diseases; COVID-19; Respiratory - Other respiratory disorders / diseases; Cancer; Cancer - Any cancer

• Registration Number: ACTRN12620000841976
• Lead Sponsor: Peter MacCallum Cancer Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-08-26
• Study Completion: 2022-03-30
• Last Update Posted: 12 December 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 3

Inclusion Criteria

ARM 3
1. Age equal to or greater than 18 years of age.
2. Any haematological or solid tumour
3. Current or within the last 12 months received cancer related treatment such as chemotherapy, radiotherapy or targeted small molecule, cellular therapy or immune-modulating therapy
4. Signed written and verbal informed consent
5. Laboratory confirmation of SARS-CoV-2 by PCR as per local laboratory assays
6. Hospitalised
7. Symptoms of COVID-19 such as:
a. Fever equal to or greater than 38 degrees Celsius OR
b. Tachypnoea respiratory rate equal to or greater than 20 breaths/min OR
c. Pulse Oxygen saturation (SpO2) equal to or less than 94%
8. Concurrent standard of care antimicrobials, antivirals are allowed.
9. Female and male patients of child bearing potential will use highly effective contraception. In female child bearing potential participants a negative urine pregnancy test will be required.

Exclusion Criteria

ARM 3
1. Unable to take oral medication
2. Any known allergic reactions to selinexor or concomitant medication-related contra-indications to selinexor.
3. Severe critical COVID-19 infection defined as:
a) Requiring invasive or non-invasive mechanical ventilation, ECMO
b) Anticipated unlikely to survive within 48 hours
4. In the opinion of the investigator and primary oncologist, participation in the study would not be in the best interests of the participant
5. Severe renal impairment defined as creatinine clearance (CrCL) < 20ml/min as calculated using the Cockcroft Gault formula
6. Severe hepatic impairment defined as aspartate transaminase (AST) or alanine transaminase (ALT) > 5 x upper limit of normal (ULN)

Study & Design

• Study Type: Interventional
• Study Design: Not specified