1 Primary · 12 Secondary · Reporting Duration: Every 12 weeks during study period, at PD and post PD at 3 and 6 months (approximately 12 months after the last participant enrolled)

Month 12

Health-Related Quality of Life (HR-QoL): Measured by European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30

Health-Related Quality of Life: Measured by EORTC QLQ-EN24

Health-Related Quality of Life: Measured by EuroQol-5 Dimensions-5 Levels (EQ-5D-5L)

Month 12

Number of Participants with Significant Physical Examination, Clinical Laboratory, and Vital Signs Results

Number of Participants with Treatment Emergent Adverse Events (TEAEs), Occurrence, Nature, and Severity of AEs

Month 12

Progression Free Survival: Assessed by Blinded Independent Central Review (BICR), per RECIST v1.1

Month 12

Overall Survival (OS)

Month 12

Disease Specific Survival (DSS)

Month 12

Progression Free Survival (PFS)

Month 12

Time to First Subsequent Treatment (TFST)

Month 12

Progression-free Survival After Subsequent Treatment (PFS2)

Month 12

Time to Second Subsequent Treatment (TSST)

Week 16

Disease Control Rate (DCR)

Trial Safety

Safety Progress

3 of 3

This is further along than 85% of similar trials

Similar Trials

1

Metronomic dosing

1

Selinexor

1

Selinexor

Side Effects for

Part 1: Cohort A-Ovarian Carcinoma: Selinexor up to 60 mg/m^2 BIW

88%Nausea

72%Vomiting

52%Anaemia

48%Weight Decreased

48%Fatigue

48%Decreased Appetite

48%Thrombocytopenia

28%Vision Blurred

28%Dizziness

28%Abdominal Pain

28%Dysgeusia

28%Constipation

28%Asthenia

28%Insomnia

24%Diarrhoea

24%Hypokalaemia

24%Dyspnoea

16%Hyponatraemia

16%Urinary Tract Infection

12%Anxiety

12%Oedema Peripheral

12%Hypomagnesaemia

12%Abdominal Distension

12%Stomatitis

12%Malaise

12%Pyrexia

12%Pulmonary Embolism

12%Headache

12%Cough

8%Hyperglycaemia

8%Ascites

8%Cystitis

8%Laryngitis

8%Visual Impairment

8%Muscular Weakness

8%Pleural Effusion

8%Ileus

8%Dehydration

8%Hydronephrosis

8%Device Occlusion

8%Face Oedema

8%Somnolence

8%Back Pain

8%Agitation

8%Hypotension

8%Oedema

8%Neutropenia

8%Lung Infection

4%Pneumonia

4%Device Related Infection

4%Hypertension

4%Vertigo

4%Pneumothorax

4%Embolism

4%Depression

4%Haematuria

4%Alopecia

4%Arthralgia

4%Vaginal Haemorrhage

4%Dry Mouth

4%Dysuria

4%Contusion

4%Hallucination

4%Confusional State

4%Peripheral Sensory Neuropathy

4%Muscle Spasms

4%Acute Kidney Injury

This histogram enumerates side effects from a completed 2017 Phase 2 trial (NCT02025985) in the Part 1: Cohort A-Ovarian Carcinoma: Selinexor up to 60 mg/m^2 BIW ARM group. Side effects include: Nausea with 88%, Vomiting with 72%, Anaemia with 52%, Weight Decreased with 48%, Fatigue with 48%.

Trial Design

2 Treatment Groups

Selinexor

1 of 2

Matching placebo for selinexor

1 of 2

Experimental Treatment

Non-Treatment Group

248 Total Participants · 2 Treatment Groups

Primary Treatment: Selinexor · Has Placebo Group · Phase 3

Selinexor

Drug

Experimental Group · 1 Intervention: Selinexor · Intervention Types: Drug

Matching placebo for selinexor

Drug

PlaceboComparator Group · 1 Intervention: Matching placebo for selinexor · Intervention Types: Drug

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Selinexor

FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks

Treatment: Varies

Reporting: every 12 weeks during study period, at pd and post pd at 3 and 6 months (approximately 12 months after the last participant enrolled)