Trial Outcomes & Findings for Selinexor in Treating Patients With Abiraterone Acetate and/or Enzalutamide Refractory Metastatic Castration-Resistant Prostate Cancer (NCT NCT02215161)

Last Updated: 2018-06-26

Results Overview

Defined as the time from study start until one of the following events occurs: \>= 2 new bone lesions on technetium bone scan; Response Evaluation Criteria in Solid Tumors (RECIST)-defined tumor progression; clinical deterioration requiring a change in prostate cancer therapy, or at clinician discretion; surgery or radiation to treat a prostate cancer related indication; or death from any cause.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

14 participants

Primary outcome timeframe

From study start up to 3 years

Results posted on

2018-06-26

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment (Selinexor) BID: twice a day D: day PO: oral 1 cycle = 4 weeks, 28 days Premedication: * Ondansetron 8 mg PO every 8 hours on day prior to and day of dosing (D0-D3) * Olanzapine 5 mg PO at bedtime or 2.5 mg PO BID on day of dosing (D1, D3) Study drug: \- Selinexor PO on D1 and D3 of weeks 1-3 of each cycle. Drug holiday on week 4. Courses repeat every 28 days in absence of disease progression or unacceptable toxicity.
Overall Study STARTED	14
Overall Study COMPLETED	14
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Selinexor in Treating Patients With Abiraterone Acetate and/or Enzalutamide Refractory Metastatic Castration-Resistant Prostate Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Selinexor) n=14 Participants BID: twice a day D: day PO: oral 1 cycle = 4 weeks, 28 days Premedication: * Ondansetron 8 mg PO every 8 hours on day prior to and day of dosing (D0-D3) * Olanzapine 5 mg PO at bedtime or 2.5 mg PO BID on day of dosing (D1, D3) Study drug: \- Selinexor PO on D1 and D3 of weeks 1-3 of each cycle. Drug holiday on week 4. Courses repeat every 28 days in absence of disease progression or unacceptable toxicity.
Age, Customized Age Group · 50 - 59	1 Participants n=5 Participants
Age, Customized Age Group · 60 - 69	3 Participants n=5 Participants
Age, Customized Age Group · 70 - 79	10 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	11 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	14 Participants n=5 Participants

PRIMARY outcome

Timeframe: From study start up to 3 years

Outcome measures

Outcome measures
Measure	Treatment (Selinexor) n=14 Participants BID: twice a day D: day PO: oral 1 cycle = 4 weeks, 28 days Premedication: * 8mg Ondansetron PO every 8 hours on day prior to and day of dosing (D0-D3) * 5mg Olanzapine PO at bedtime or 2.5 mg PO BID on day of dosing (D1, D3) Study drug: \- 60mg Selinexor PO on D1 and D3 of weeks 1-3 of each cycle. Drug holiday on week 4. Courses repeat every 28 days in absence of disease progression or unacceptable toxicity.	Aquired Abiraterone Resistance BID: twice a day D: day PO: oral 1 cycle = 4 weeks, 28 days Premedication: * 8mg Ondansetron PO every 8 hours on day prior to and day of dosing (D0-D3) * 5mg Olanzapine PO at bedtime or 2.5 mg PO BID on day of dosing (D1, D3) Study drug: \- 60mg Selinexor PO on D1 and D3 of weeks 1-3 of each cycle. Drug holiday on week 4. Courses repeat every 28 days in absence of disease progression or unacceptable toxicity.	Selinexor Day 1, Course 2 BID: twice a day D: day PO: oral 1 cycle = 4 weeks, 28 days Premedication: * 8mg Ondansetron PO every 8 hours on day prior to and day of dosing (D0-D3) * 5mg Olanzapine PO at bedtime or 2.5 mg PO BID on day of dosing (D1, D3) Study drug: \- 60mg Selinexor PO on D1 and D3 of weeks 1-3 of each cycle. Drug holiday on week 4. Courses repeat every 28 days in absence of disease progression or unacceptable toxicity.	Selinexor Day 1, Course 3 BID: twice a day D: day PO: oral 1 cycle = 4 weeks, 28 days Premedication: * 8mg Ondansetron PO every 8 hours on day prior to and day of dosing (D0-D3) * 5mg Olanzapine PO at bedtime or 2.5 mg PO BID on day of dosing (D1, D3) Study drug: \- 60mg Selinexor PO on D1 and D3 of weeks 1-3 of each cycle. Drug holiday on week 4. Courses repeat every 28 days in absence of disease progression or unacceptable toxicity.
Radiographic Progression Free Survival (rPFS)	31 weeks Interval 7.0 to 47.0	—	—	—

SECONDARY outcome

Timeframe: At baseline

Population: The study was terminated due to unacceptable toxicity. Data on resistance type was not collected.

Comparison of radiographic progression free survival between patients with primary abiraterone resistance and acquired abiraterone resistance using a Cox proportional hazards model.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Time between the first evaluation at which the response criteria are met and the first documentation of PSA progression or death or up to 3 years

Time between the first evaluation at which the response criteria are met and the first documentation of PSA (Prostate-Specific Antigen) progression or death. Progression is defined as a rise in PSA of 50% above nadir value or 25% above baseline if there is no decline.

Outcome measures

Outcome measures
Measure	Treatment (Selinexor) n=14 Participants BID: twice a day D: day PO: oral 1 cycle = 4 weeks, 28 days Premedication: * 8mg Ondansetron PO every 8 hours on day prior to and day of dosing (D0-D3) * 5mg Olanzapine PO at bedtime or 2.5 mg PO BID on day of dosing (D1, D3) Study drug: \- 60mg Selinexor PO on D1 and D3 of weeks 1-3 of each cycle. Drug holiday on week 4. Courses repeat every 28 days in absence of disease progression or unacceptable toxicity.	Aquired Abiraterone Resistance BID: twice a day D: day PO: oral 1 cycle = 4 weeks, 28 days Premedication: * 8mg Ondansetron PO every 8 hours on day prior to and day of dosing (D0-D3) * 5mg Olanzapine PO at bedtime or 2.5 mg PO BID on day of dosing (D1, D3) Study drug: \- 60mg Selinexor PO on D1 and D3 of weeks 1-3 of each cycle. Drug holiday on week 4. Courses repeat every 28 days in absence of disease progression or unacceptable toxicity.	Selinexor Day 1, Course 2 BID: twice a day D: day PO: oral 1 cycle = 4 weeks, 28 days Premedication: * 8mg Ondansetron PO every 8 hours on day prior to and day of dosing (D0-D3) * 5mg Olanzapine PO at bedtime or 2.5 mg PO BID on day of dosing (D1, D3) Study drug: \- 60mg Selinexor PO on D1 and D3 of weeks 1-3 of each cycle. Drug holiday on week 4. Courses repeat every 28 days in absence of disease progression or unacceptable toxicity.	Selinexor Day 1, Course 3 BID: twice a day D: day PO: oral 1 cycle = 4 weeks, 28 days Premedication: * 8mg Ondansetron PO every 8 hours on day prior to and day of dosing (D0-D3) * 5mg Olanzapine PO at bedtime or 2.5 mg PO BID on day of dosing (D1, D3) Study drug: \- 60mg Selinexor PO on D1 and D3 of weeks 1-3 of each cycle. Drug holiday on week 4. Courses repeat every 28 days in absence of disease progression or unacceptable toxicity.
Time to PSA Progression	12 weeks Interval 7.0 to 14.0	—	—	—

SECONDARY outcome

Timeframe: Up to 3 years after treatment start

Incidence of non-serious adverse events, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0

Outcome measures

Outcome measures
Measure	Treatment (Selinexor) n=14 Participants BID: twice a day D: day PO: oral 1 cycle = 4 weeks, 28 days Premedication: * 8mg Ondansetron PO every 8 hours on day prior to and day of dosing (D0-D3) * 5mg Olanzapine PO at bedtime or 2.5 mg PO BID on day of dosing (D1, D3) Study drug: \- 60mg Selinexor PO on D1 and D3 of weeks 1-3 of each cycle. Drug holiday on week 4. Courses repeat every 28 days in absence of disease progression or unacceptable toxicity.	Aquired Abiraterone Resistance BID: twice a day D: day PO: oral 1 cycle = 4 weeks, 28 days Premedication: * 8mg Ondansetron PO every 8 hours on day prior to and day of dosing (D0-D3) * 5mg Olanzapine PO at bedtime or 2.5 mg PO BID on day of dosing (D1, D3) Study drug: \- 60mg Selinexor PO on D1 and D3 of weeks 1-3 of each cycle. Drug holiday on week 4. Courses repeat every 28 days in absence of disease progression or unacceptable toxicity.	Selinexor Day 1, Course 2 BID: twice a day D: day PO: oral 1 cycle = 4 weeks, 28 days Premedication: * 8mg Ondansetron PO every 8 hours on day prior to and day of dosing (D0-D3) * 5mg Olanzapine PO at bedtime or 2.5 mg PO BID on day of dosing (D1, D3) Study drug: \- 60mg Selinexor PO on D1 and D3 of weeks 1-3 of each cycle. Drug holiday on week 4. Courses repeat every 28 days in absence of disease progression or unacceptable toxicity.	Selinexor Day 1, Course 3 BID: twice a day D: day PO: oral 1 cycle = 4 weeks, 28 days Premedication: * 8mg Ondansetron PO every 8 hours on day prior to and day of dosing (D0-D3) * 5mg Olanzapine PO at bedtime or 2.5 mg PO BID on day of dosing (D1, D3) Study drug: \- 60mg Selinexor PO on D1 and D3 of weeks 1-3 of each cycle. Drug holiday on week 4. Courses repeat every 28 days in absence of disease progression or unacceptable toxicity.
Incidence of Non-serious Adverse Events Anorexia	14 events	—	—	—
Incidence of Non-serious Adverse Events Hypophosphatemia	3 events	—	—	—
Incidence of Non-serious Adverse Events Metabolism and nutrition disorders - Other	2 events	—	—	—
Incidence of Non-serious Adverse Events Hypocalcemia	1 events	—	—	—
Incidence of Non-serious Adverse Events Hyponatremia	2 events	—	—	—
Incidence of Non-serious Adverse Events Weight loss	7 events	—	—	—
Incidence of Non-serious Adverse Events Platelet count decreased	6 events	—	—	—
Incidence of Non-serious Adverse Events INR increased	3 events	—	—	—
Incidence of Non-serious Adverse Events Investigations - Other	3 events	—	—	—
Incidence of Non-serious Adverse Events Neutrophil count decreased	1 events	—	—	—
Incidence of Non-serious Adverse Events Nausea	14 events	—	—	—
Incidence of Non-serious Adverse Events Vomiting	7 events	—	—	—
Incidence of Non-serious Adverse Events Constipation	5 events	—	—	—
Incidence of Non-serious Adverse Events Diarrhea	6 events	—	—	—
Incidence of Non-serious Adverse Events Abdominal distension	1 events	—	—	—
Incidence of Non-serious Adverse Events Abdominal pain	2 events	—	—	—
Incidence of Non-serious Adverse Events Flatulence	1 events	—	—	—
Incidence of Non-serious Adverse Events Gastrointestinal disorders - Other	1 events	—	—	—
Incidence of Non-serious Adverse Events Fatigue	11 events	—	—	—
Incidence of Non-serious Adverse Events Pain	3 events	—	—	—
Incidence of Non-serious Adverse Events Localized edema	1 events	—	—	—
Incidence of Non-serious Adverse Events Anemia	10 events	—	—	—
Incidence of Non-serious Adverse Events Blood and lymphatic system disorders - Other	4 events	—	—	—
Incidence of Non-serious Adverse Events Bone pain	2 events	—	—	—
Incidence of Non-serious Adverse Events Pain in extremity	3 events	—	—	—
Incidence of Non-serious Adverse Events Arthralgia	1 events	—	—	—
Incidence of Non-serious Adverse Events Musculoskeletal/connective tissue disorder, other	1 events	—	—	—
Incidence of Non-serious Adverse Events Dizziness	2 events	—	—	—
Incidence of Non-serious Adverse Events Presyncope	3 events	—	—	—
Incidence of Non-serious Adverse Events Headache	1 events	—	—	—
Incidence of Non-serious Adverse Events Hypotension	5 events	—	—	—
Incidence of Non-serious Adverse Events Hot flashes	1 events	—	—	—
Incidence of Non-serious Adverse Events Blurred vision	3 events	—	—	—
Incidence of Non-serious Adverse Events Eye pain	1 events	—	—	—
Incidence of Non-serious Adverse Events Night blindness	1 events	—	—	—
Incidence of Non-serious Adverse Events Watering eyes	2 events	—	—	—
Incidence of Non-serious Adverse Events Lung infection	1 events	—	—	—
Incidence of Non-serious Adverse Events Upper respiratory infection	1 events	—	—	—
Incidence of Non-serious Adverse Events Urinary tract infection	1 events	—	—	—
Incidence of Non-serious Adverse Events Insomnia	3 events	—	—	—
Incidence of Non-serious Adverse Events Psychosis	1 events	—	—	—
Incidence of Non-serious Adverse Events Cough	1 events	—	—	—
Incidence of Non-serious Adverse Events Dyspnea	1 events	—	—	—
Incidence of Non-serious Adverse Events Voice alteration	1 events	—	—	—
Incidence of Non-serious Adverse Events Cardiac disorders - Other	1 events	—	—	—
Incidence of Non-serious Adverse Events Chest pain - cardiac	1 events	—	—	—
Incidence of Non-serious Adverse Events Skin and subcutaneous tissue disorders - Other	2 events	—	—	—
Incidence of Non-serious Adverse Events Alopecia	2 events	—	—	—
Incidence of Non-serious Adverse Events Hematuria	1 events	—	—	—

SECONDARY outcome

Timeframe: On days 1 and 15 of course 1 and on day 1 of courses 2 and 3

Population: The study was terminated due to unacceptable toxicity. Data was not collected.

Total RNA isolated from leukocytes of patients will be used for quantitative polymerase chain reaction analysis (qPCR) in order to compare expression levels of XPO-1 and MIC-1 as a function of selinexor dose and total time on treatment.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At 12 weeks post therapy initiation

The number of patients experiencing a PSA decline from baseline of at least 50% in PSA at 12 weeks following the initiation of study therapy.

Outcome measures

Outcome measures
Measure	Treatment (Selinexor) n=14 Participants BID: twice a day D: day PO: oral 1 cycle = 4 weeks, 28 days Premedication: * 8mg Ondansetron PO every 8 hours on day prior to and day of dosing (D0-D3) * 5mg Olanzapine PO at bedtime or 2.5 mg PO BID on day of dosing (D1, D3) Study drug: \- 60mg Selinexor PO on D1 and D3 of weeks 1-3 of each cycle. Drug holiday on week 4. Courses repeat every 28 days in absence of disease progression or unacceptable toxicity.	Aquired Abiraterone Resistance BID: twice a day D: day PO: oral 1 cycle = 4 weeks, 28 days Premedication: * 8mg Ondansetron PO every 8 hours on day prior to and day of dosing (D0-D3) * 5mg Olanzapine PO at bedtime or 2.5 mg PO BID on day of dosing (D1, D3) Study drug: \- 60mg Selinexor PO on D1 and D3 of weeks 1-3 of each cycle. Drug holiday on week 4. Courses repeat every 28 days in absence of disease progression or unacceptable toxicity.	Selinexor Day 1, Course 2 BID: twice a day D: day PO: oral 1 cycle = 4 weeks, 28 days Premedication: * 8mg Ondansetron PO every 8 hours on day prior to and day of dosing (D0-D3) * 5mg Olanzapine PO at bedtime or 2.5 mg PO BID on day of dosing (D1, D3) Study drug: \- 60mg Selinexor PO on D1 and D3 of weeks 1-3 of each cycle. Drug holiday on week 4. Courses repeat every 28 days in absence of disease progression or unacceptable toxicity.	Selinexor Day 1, Course 3 BID: twice a day D: day PO: oral 1 cycle = 4 weeks, 28 days Premedication: * 8mg Ondansetron PO every 8 hours on day prior to and day of dosing (D0-D3) * 5mg Olanzapine PO at bedtime or 2.5 mg PO BID on day of dosing (D1, D3) Study drug: \- 60mg Selinexor PO on D1 and D3 of weeks 1-3 of each cycle. Drug holiday on week 4. Courses repeat every 28 days in absence of disease progression or unacceptable toxicity.
PSA Decline of ≥50% at 12 Weeks Post Therapy Initiation	1 Participants	—	—	—

SECONDARY outcome

Timeframe: At baseline and day 1 of every following cycle until end of treatment or 3 years after study start

Population: The study was terminated due to unacceptable toxicity. Only baseline data was collected.

The effect of selinexor on persistent pain associated with bone metastasis, measured using the Brief Pain Inventory (BPI), Short Form. 0 denotes ''no pain'' and 10, ''pain as bad as you can imagine".

Outcome measures

Outcome measures
Measure	Treatment (Selinexor) n=8 Participants BID: twice a day D: day PO: oral 1 cycle = 4 weeks, 28 days Premedication: * 8mg Ondansetron PO every 8 hours on day prior to and day of dosing (D0-D3) * 5mg Olanzapine PO at bedtime or 2.5 mg PO BID on day of dosing (D1, D3) Study drug: \- 60mg Selinexor PO on D1 and D3 of weeks 1-3 of each cycle. Drug holiday on week 4. Courses repeat every 28 days in absence of disease progression or unacceptable toxicity.	Aquired Abiraterone Resistance BID: twice a day D: day PO: oral 1 cycle = 4 weeks, 28 days Premedication: * 8mg Ondansetron PO every 8 hours on day prior to and day of dosing (D0-D3) * 5mg Olanzapine PO at bedtime or 2.5 mg PO BID on day of dosing (D1, D3) Study drug: \- 60mg Selinexor PO on D1 and D3 of weeks 1-3 of each cycle. Drug holiday on week 4. Courses repeat every 28 days in absence of disease progression or unacceptable toxicity.	Selinexor Day 1, Course 2 BID: twice a day D: day PO: oral 1 cycle = 4 weeks, 28 days Premedication: * 8mg Ondansetron PO every 8 hours on day prior to and day of dosing (D0-D3) * 5mg Olanzapine PO at bedtime or 2.5 mg PO BID on day of dosing (D1, D3) Study drug: \- 60mg Selinexor PO on D1 and D3 of weeks 1-3 of each cycle. Drug holiday on week 4. Courses repeat every 28 days in absence of disease progression or unacceptable toxicity.	Selinexor Day 1, Course 3 BID: twice a day D: day PO: oral 1 cycle = 4 weeks, 28 days Premedication: * 8mg Ondansetron PO every 8 hours on day prior to and day of dosing (D0-D3) * 5mg Olanzapine PO at bedtime or 2.5 mg PO BID on day of dosing (D1, D3) Study drug: \- 60mg Selinexor PO on D1 and D3 of weeks 1-3 of each cycle. Drug holiday on week 4. Courses repeat every 28 days in absence of disease progression or unacceptable toxicity.
Reduction in Pain for Symptomatic Patients, Measured Using the Brief Pain Inventory (BPI), Short Form	1.34 units on a scale Interval 1.0 to 4.0	—	—	—

SECONDARY outcome

Timeframe: At day 1 of course 1, each treatment day until end of treatment up to 3 years

Population: The study was terminated due to unacceptable toxicity. Data was not collected.

Serum selinexor trough levels as a function of dose and time since last dose

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At week 8, 16, 24, and every 12 weeks thereafter up to 3 years after treatment start

Population: The study was terminated due to unacceptable toxicity. Data was not collected.

Defined as time interval between the date of treatment initiation and the date of documented new lesions. Evaluation criteria is defined by the PSAWG2 (Prostate-Specific Antigen Working Group 2) criteria for bone scan evaluation. The time will be 'backdated' to when the \>= 2 new lesions were detected if a second scan is done to confirm progression.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 3 years after treatment start

Incidence of serious adverse events, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0

Outcome measures

Outcome measures
Measure	Treatment (Selinexor) n=14 Participants BID: twice a day D: day PO: oral 1 cycle = 4 weeks, 28 days Premedication: * 8mg Ondansetron PO every 8 hours on day prior to and day of dosing (D0-D3) * 5mg Olanzapine PO at bedtime or 2.5 mg PO BID on day of dosing (D1, D3) Study drug: \- 60mg Selinexor PO on D1 and D3 of weeks 1-3 of each cycle. Drug holiday on week 4. Courses repeat every 28 days in absence of disease progression or unacceptable toxicity.	Aquired Abiraterone Resistance BID: twice a day D: day PO: oral 1 cycle = 4 weeks, 28 days Premedication: * 8mg Ondansetron PO every 8 hours on day prior to and day of dosing (D0-D3) * 5mg Olanzapine PO at bedtime or 2.5 mg PO BID on day of dosing (D1, D3) Study drug: \- 60mg Selinexor PO on D1 and D3 of weeks 1-3 of each cycle. Drug holiday on week 4. Courses repeat every 28 days in absence of disease progression or unacceptable toxicity.	Selinexor Day 1, Course 2 BID: twice a day D: day PO: oral 1 cycle = 4 weeks, 28 days Premedication: * 8mg Ondansetron PO every 8 hours on day prior to and day of dosing (D0-D3) * 5mg Olanzapine PO at bedtime or 2.5 mg PO BID on day of dosing (D1, D3) Study drug: \- 60mg Selinexor PO on D1 and D3 of weeks 1-3 of each cycle. Drug holiday on week 4. Courses repeat every 28 days in absence of disease progression or unacceptable toxicity.	Selinexor Day 1, Course 3 BID: twice a day D: day PO: oral 1 cycle = 4 weeks, 28 days Premedication: * 8mg Ondansetron PO every 8 hours on day prior to and day of dosing (D0-D3) * 5mg Olanzapine PO at bedtime or 2.5 mg PO BID on day of dosing (D1, D3) Study drug: \- 60mg Selinexor PO on D1 and D3 of weeks 1-3 of each cycle. Drug holiday on week 4. Courses repeat every 28 days in absence of disease progression or unacceptable toxicity.
Incidence of Serious Adverse Events Anemia	1 events	—	—	—
Incidence of Serious Adverse Events Eye disorders - Other	2 events	—	—	—

Adverse Events

Treatment (Selinexor)

Serious events: 4 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Treatment (Selinexor) n=14 participants at risk BID: twice a day D: day PO: oral 1 cycle = 4 weeks, 28 days Premedication: * Ondansetron 8 mg PO every 8 hours on day prior to and day of dosing (D0-D3) * Olanzapine 5 mg PO at bedtime or 2.5 mg PO BID on day of dosing (D1, D3) Study drug: \- Selinexor PO on D1 and D3 of weeks 1-3 of each cycle. Drug holiday on week 4. Courses repeat every 28 days in absence of disease progression or unacceptable toxicity.
Blood and lymphatic system disorders Anemia	7.1% 1/14 • 2 years, 6 months
Blood and lymphatic system disorders Blood and lymphatic system disorders - Other, specify	7.1% 1/14 • 2 years, 6 months
Eye disorders Eye disorders - Other, specify	7.1% 1/14 • 2 years, 6 months
Metabolism and nutrition disorders Anorexia	7.1% 1/14 • Number of events 1 • 2 years, 6 months

Other adverse events

Other adverse events
Measure	Treatment (Selinexor) n=14 participants at risk BID: twice a day D: day PO: oral 1 cycle = 4 weeks, 28 days Premedication: * Ondansetron 8 mg PO every 8 hours on day prior to and day of dosing (D0-D3) * Olanzapine 5 mg PO at bedtime or 2.5 mg PO BID on day of dosing (D1, D3) Study drug: \- Selinexor PO on D1 and D3 of weeks 1-3 of each cycle. Drug holiday on week 4. Courses repeat every 28 days in absence of disease progression or unacceptable toxicity.
Metabolism and nutrition disorders Anorexia	71.4% 10/14 • 2 years, 6 months
Metabolism and nutrition disorders Hypophosphatemia	21.4% 3/14 • 2 years, 6 months
Metabolism and nutrition disorders Metabolism and nutrition disorders - Other, specify	14.3% 2/14 • 2 years, 6 months
Metabolism and nutrition disorders Hypocalcemia	7.1% 1/14 • 2 years, 6 months
Metabolism and nutrition disorders Hyponatremia	7.1% 1/14 • 2 years, 6 months
Investigations Weight loss	42.9% 6/14 • 2 years, 6 months
Investigations Platelet count decreased	28.6% 4/14 • 2 years, 6 months
Investigations INR increased	7.1% 1/14 • 2 years, 6 months
Investigations Investigations - Other, specify	7.1% 1/14 • 2 years, 6 months
Investigations Neutrophil count decreased	7.1% 1/14 • 2 years, 6 months
Gastrointestinal disorders Nausea	50.0% 7/14 • 2 years, 6 months
Gastrointestinal disorders Vomiting	28.6% 4/14 • 2 years, 6 months
Gastrointestinal disorders Constipation	21.4% 3/14 • 2 years, 6 months
Gastrointestinal disorders Diarrhea	21.4% 3/14 • 2 years, 6 months
Gastrointestinal disorders Abdominal distension	7.1% 1/14 • 2 years, 6 months
Gastrointestinal disorders Abdominal pain	7.1% 1/14 • 2 years, 6 months
Gastrointestinal disorders Flatulence	7.1% 1/14 • 2 years, 6 months
Gastrointestinal disorders Gastrointestinal disorders - Other, specify	7.1% 1/14 • 2 years, 6 months
General disorders Fatigue	42.9% 6/14 • 2 years, 6 months
General disorders Pain	14.3% 2/14 • 2 years, 6 months
General disorders Localized edema	7.1% 1/14 • 2 years, 6 months
Blood and lymphatic system disorders Anemia	35.7% 5/14 • 2 years, 6 months
Blood and lymphatic system disorders Blood and lymphatic system disorders - Other, specify	21.4% 3/14 • 2 years, 6 months
Musculoskeletal and connective tissue disorders Bone pain	14.3% 2/14 • 2 years, 6 months
Musculoskeletal and connective tissue disorders Pain in extremity	14.3% 2/14 • 2 years, 6 months
Musculoskeletal and connective tissue disorders Arthralgia	7.1% 1/14 • 2 years, 6 months
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, specify	7.1% 1/14 • 2 years, 6 months
Nervous system disorders Dizziness	14.3% 2/14 • 2 years, 6 months
Nervous system disorders Presyncope	14.3% 2/14 • 2 years, 6 months
Nervous system disorders Headache	7.1% 1/14 • 2 years, 6 months
Vascular disorders Hypotension	35.7% 5/14 • 2 years, 6 months
Vascular disorders Hot flashes	28.6% 4/14 • 2 years, 6 months
Eye disorders Blurred vision	7.1% 1/14 • 2 years, 6 months
Eye disorders Eye pain	14.3% 2/14 • 2 years, 6 months
Eye disorders Night blindness	7.1% 1/14 • 2 years, 6 months
Eye disorders Watering eyes	7.1% 1/14 • 2 years, 6 months
Infections and infestations Lung infection	7.1% 1/14 • 2 years, 6 months
Infections and infestations Upper respiratory infection	7.1% 1/14 • 2 years, 6 months
Infections and infestations Urinary tract infection	7.1% 1/14 • 2 years, 6 months
Psychiatric disorders Insomnia	7.1% 1/14 • 2 years, 6 months
Psychiatric disorders Psychosis	21.4% 3/14 • 2 years, 6 months
Respiratory, thoracic and mediastinal disorders Cough	14.3% 2/14 • 2 years, 6 months
Respiratory, thoracic and mediastinal disorders Dyspnea	7.1% 1/14 • 2 years, 6 months
Respiratory, thoracic and mediastinal disorders Voice alteration	7.1% 1/14 • 2 years, 6 months
Cardiac disorders Cardiac disorders - Other, specify	7.1% 1/14 • 2 years, 6 months
Cardiac disorders Chest pain - cardiac	7.1% 1/14 • 2 years, 6 months
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify	14.3% 2/14 • 2 years, 6 months
Skin and subcutaneous tissue disorders Alopecia	7.1% 1/14 • 2 years, 6 months
Renal and urinary disorders Hematuria	7.1% 1/14 • 2 years, 6 months

Additional Information

Charles Ryan, MD

University of California, San Francisco

Phone: 877-827-3222

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place