COVID-19 trials registries data warehouse

https://anzctr.org.au/ACTRN12620000841976.aspx

Prof Monica Slavin

monica.slavin@petermac.org

2020-08-26

Not recruiting

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

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.

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)

2

Peter MacCallum Cancer Centre

18

100

Australia

Moderate disease at enrollment

3: Moderate disease at enrollment

126

ARM 3 Primary outcome.composite outcome: incidence of death and/or need for invasive or non-invasive ventilation.assessed using medical records[60 days from baseline]

Phase 3

[{"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}, {"arm_notes": "", "treatment_id": 1182, "treatment_name": "Selinexor", "treatment_type": "Others pharmacological treatment", "pharmacological_treatment": "Pharmacological treatment"}]