Trial Outcomes & Findings for Selinexor in Myelofibrosis Refractory or Intolerant to JAK1/2 Inhibitors (NCT NCT03627403)
NCT ID: NCT03627403
Last Updated: 2025-06-19
Results Overview
To assess the efficacy of selinexor on spleen volume reduction in subjects with myelofibrosis (PMF, PET-MF, or PPV-MF) refractory or intolerant to ruxolitinib and/or any other experimental JAK1/2 inhibitors. This outcome will report the number of subjects with ≥ 35% reduction in spleen volume as measured by MRI or CT abdomen from baseline to after six cycles of treatment or end of treatment. Patients who did not complete six cycles of treatment received an MRI at discontinuation of therapy. Patients who died prior to completing six cycles of treatment or a follow-up scan were considered non-responders.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
17 participants
Primary outcome timeframe
Up to 5.5 months
Results posted on
2025-06-19
Participant Flow
Participant milestones
| Measure |
Selinexor, All Patients
Single Arm Study, all patients received selinexor.
Selinexor: Selinexor was administered weekly until IWG-MR disease progression, intolerable toxicity, or no clinical benefit per treating physician's discretion whichever occurs first.
For patients enrolled after Protocol v7, Selinexor was administered by oral route beginning at 40mg once weekly. Prior to protocol version 7, the starting dose of Selinexor was 60 mg and 80 mg once weekly.
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|---|---|
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Overall Study
STARTED
|
17
|
|
Overall Study
COMPLETED
|
17
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Selinexor in Myelofibrosis Refractory or Intolerant to JAK1/2 Inhibitors
Baseline characteristics by cohort
| Measure |
Selinexor, All Patients
n=17 Participants
Single Arm Study, all patients received selinexor.
Selinexor: Selinexor was administered weekly until IWG-MR disease progression, intolerable toxicity, or no clinical benefit per treating physician's discretion whichever occurs first.
For patients enrolled after Protocol v7, Selinexor was administered by oral route beginning at 40mg once weekly. Prior to protocol version 7, the starting dose of Selinexor was 60 mg and 80 mg once weekly.
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|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=93 Participants
|
|
Age, Continuous
|
64.82 years
STANDARD_DEVIATION 11.05 • n=93 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
17 participants
n=93 Participants
|
|
Diagnosis
Primary Myelofibrosis (PMF)
|
8 Participants
n=93 Participants
|
|
Diagnosis
Post-Essential Thrombocytosis (PET-MF)
|
4 Participants
n=93 Participants
|
|
Diagnosis
Post-Polycythemia Vera (PPV-MF)
|
5 Participants
n=93 Participants
|
|
Hemoglobin
>= 10 g/dL
|
8 Participants
n=93 Participants
|
|
Hemoglobin
< 10 g/dL
|
9 Participants
n=93 Participants
|
|
WBC
<= 25 cells x 10^9/L ( <= 25 k/uL)
|
17 Participants
n=93 Participants
|
|
WBC
> 25 cells x 10^9/L) ( > 25 k/uL)
|
0 Participants
n=93 Participants
|
|
Peripheral blood blast
< 1 %
|
8 Participants
n=93 Participants
|
|
Peripheral blood blast
>= 1 %
|
9 Participants
n=93 Participants
|
|
Constitutional symptoms
Yes
|
7 Participants
n=93 Participants
|
|
Constitutional symptoms
No
|
10 Participants
n=93 Participants
|
|
DIPSS Risk Group
Low
|
1 Participants
n=93 Participants
|
|
DIPSS Risk Group
Intermediate-1 (INT-1)
|
7 Participants
n=93 Participants
|
|
DIPSS Risk Group
Intermediate-2 (INT-2)
|
9 Participants
n=93 Participants
|
|
DIPSS Risk Group
High
|
0 Participants
n=93 Participants
|
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Weight
|
85.17 kg
STANDARD_DEVIATION 19.13 • n=93 Participants
|
|
Height
|
173.19 cm
STANDARD_DEVIATION 11.17 • n=93 Participants
|
|
BMI
|
28.36 kg/m^2
STANDARD_DEVIATION 5.79 • n=93 Participants
|
PRIMARY outcome
Timeframe: Up to 5.5 monthsTo assess the efficacy of selinexor on spleen volume reduction in subjects with myelofibrosis (PMF, PET-MF, or PPV-MF) refractory or intolerant to ruxolitinib and/or any other experimental JAK1/2 inhibitors. This outcome will report the number of subjects with ≥ 35% reduction in spleen volume as measured by MRI or CT abdomen from baseline to after six cycles of treatment or end of treatment. Patients who did not complete six cycles of treatment received an MRI at discontinuation of therapy. Patients who died prior to completing six cycles of treatment or a follow-up scan were considered non-responders.
Outcome measures
| Measure |
Selinexor, All Patients
n=17 Participants
Single Arm Study, all patients received selinexor.
Selinexor: Selinexor was administered weekly until IWG-MR disease progression, intolerable toxicity, or no clinical benefit per treating physician's discretion whichever occurs first.
For patients enrolled after Protocol v7, Selinexor was administered by oral route beginning at 40mg once weekly. Prior to protocol version 7, the starting dose of Selinexor was 60 mg and 80 mg once weekly.
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|---|---|
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Count of Participants With Reduction in Spleen Volume
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3 Participants
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SECONDARY outcome
Timeframe: Up to 24 monthsTo assess the safety/tolerability and further characterize the safety profile of selinexor in PMF, PET-MF, or PPV-MF patients refractory or intolerant to ruxolitinib and/or any other experimental JAK1/2 inhibitors. Secondary Endpoints: rate of adverse events (AEs) and serious adverse events (SAEs).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 5.5 monthsPopulation: One participant did not reach this endpoint. This participant only completed a baseline disease assessment.
To further assess the efficacy and clinical activity of selinexor (by means of overall response) in subjects with myelofibrosis (PMF, PET-MF, or PPV-MF) refractory or intolerant to ruxolitinib and/or any other experimental JAK1/2 inhibitors. This outcome will report the mean percent change of spleen volume as measured by MRI or CT abdomen from baseline to after six cycles of treatment or end of treatment. Patients who did not complete six cycles of treatment received an MRI at discontinuation of therapy. Patients who died prior to completing six cycles of treatment or a follow-up scan were not included in this endpoint. The mean and standard will be reported for the change in spleen volume.
Outcome measures
| Measure |
Selinexor, All Patients
n=16 Participants
Single Arm Study, all patients received selinexor.
Selinexor: Selinexor was administered weekly until IWG-MR disease progression, intolerable toxicity, or no clinical benefit per treating physician's discretion whichever occurs first.
For patients enrolled after Protocol v7, Selinexor was administered by oral route beginning at 40mg once weekly. Prior to protocol version 7, the starting dose of Selinexor was 60 mg and 80 mg once weekly.
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|---|---|
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Percent Change of Spleen Volume
|
2.96 percent (%) change of spleen volume
Standard Deviation 37.64
|
SECONDARY outcome
Timeframe: Up to 5.5 monthsPopulation: One participant was not evaluable for this endpoint; this participant did not complete a baseline assessment.
To further assess the efficacy and clinical activity of selinexor (by means of reduction in symptoms) in subjects with myelofibrosis (PMF, PET-MF, or PPV-MF) refractory or intolerant to ruxolitinib and/or any other experimental JAK1/2 inhibitors. This outcome reports the count of patients with ≥ 50% reduction of total symptoms scores as measured by the Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF) from baseline after 6 cycles of treatment. Patients who did not complete 6 cycles of treatment will receive the MPN-SAF assessment at discontinuation of therapy. The MPN-SAF is a symptom assessment completed by the patients including fatigue, concentration, early satiety, inactivity, night sweats, itching, bone pain, abdominal discomfort, weight loss, and fevers. Scoring is from 0 (absent/as good as it can be) to 10 (worst imaginable/as bad as it can be) for each item. The MPN-SAF TSS is the sum of all the individual scores (0-100 scale).
Outcome measures
| Measure |
Selinexor, All Patients
n=16 Participants
Single Arm Study, all patients received selinexor.
Selinexor: Selinexor was administered weekly until IWG-MR disease progression, intolerable toxicity, or no clinical benefit per treating physician's discretion whichever occurs first.
For patients enrolled after Protocol v7, Selinexor was administered by oral route beginning at 40mg once weekly. Prior to protocol version 7, the starting dose of Selinexor was 60 mg and 80 mg once weekly.
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|---|---|
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Change in Symptoms Score
≥ 50% Reduction of MPN-SAF TSS Score
|
2 Participants
|
|
Change in Symptoms Score
< 50% Reduction of MPN-SAF TSS Score
|
14 Participants
|
SECONDARY outcome
Timeframe: Up to 24 monthsTo further assess the efficacy and clinical activity of selinexor (by means of overall response) in subjects with myelofibrosis (PMF, PET-MF, or PPV-MF) refractory or intolerant to ruxolitinib and/or any other experimental JAK1/2 inhibitors. Overall response according to the 2013 International Working Group-Myeloproliferative Neoplasms Research and Treatment (IWG-MRT) consensus criteria for treatment response in primary and secondary MF (post-PV and post-ET). The IWG-MRT response categories are CR (Complete Response), PR (Partial Response), CI (Clinical Improvement), Anemia Response, Spleen Response, Symptoms Response, Progressive Disease, Stable Disease, Relapse.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 24 monthsOverall survival at 24 months from the initiation of study therapy.
Outcome measures
Outcome data not reported
Adverse Events
Selinexor, All Patients
Serious events: 7 serious events
Other events: 17 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
Selinexor, All Patients
n=17 participants at risk
Single Arm Study, all patients received selinexor.
Selinexor: Selinexor was administered weekly until IWG-MR disease progression, intolerable toxicity, or no clinical benefit per treating physician's discretion whichever occurs first.
For patients enrolled after Protocol v7, Selinexor was administered by oral route beginning at 40mg once weekly. Prior to protocol version 7, the starting dose of Selinexor was 60 mg and 80 mg once weekly.
Participants experienced dose escalations and reductions based on their individual responses. Subjects were not assigned to fixed-dosing cohorts as dosing ranged from 20mg once weekly to 80 mg once weekly. Adverse Events were not collected specific to dose.
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|---|---|
|
Renal and urinary disorders
Acute kidney injury
|
5.9%
1/17 • Number of events 1 • Adverse event data was collected from the first dose of study until end of treatment (up to 16.6 months). Currently three subjects are still on treatment and adverse event collection is still ongoing.
|
|
Blood and lymphatic system disorders
Anemia
|
5.9%
1/17 • Number of events 1 • Adverse event data was collected from the first dose of study until end of treatment (up to 16.6 months). Currently three subjects are still on treatment and adverse event collection is still ongoing.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
5.9%
1/17 • Number of events 1 • Adverse event data was collected from the first dose of study until end of treatment (up to 16.6 months). Currently three subjects are still on treatment and adverse event collection is still ongoing.
|
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Blood and lymphatic system disorders
Hemolysis
|
5.9%
1/17 • Number of events 1 • Adverse event data was collected from the first dose of study until end of treatment (up to 16.6 months). Currently three subjects are still on treatment and adverse event collection is still ongoing.
|
|
Infections and infestations
Hepatic infection
|
5.9%
1/17 • Number of events 2 • Adverse event data was collected from the first dose of study until end of treatment (up to 16.6 months). Currently three subjects are still on treatment and adverse event collection is still ongoing.
|
|
General disorders
Non-cardiac chest pain
|
5.9%
1/17 • Number of events 1 • Adverse event data was collected from the first dose of study until end of treatment (up to 16.6 months). Currently three subjects are still on treatment and adverse event collection is still ongoing.
|
|
Infections and infestations
Peritoneal infection
|
5.9%
1/17 • Number of events 2 • Adverse event data was collected from the first dose of study until end of treatment (up to 16.6 months). Currently three subjects are still on treatment and adverse event collection is still ongoing.
|
Other adverse events
| Measure |
Selinexor, All Patients
n=17 participants at risk
Single Arm Study, all patients received selinexor.
Selinexor: Selinexor was administered weekly until IWG-MR disease progression, intolerable toxicity, or no clinical benefit per treating physician's discretion whichever occurs first.
For patients enrolled after Protocol v7, Selinexor was administered by oral route beginning at 40mg once weekly. Prior to protocol version 7, the starting dose of Selinexor was 60 mg and 80 mg once weekly.
Participants experienced dose escalations and reductions based on their individual responses. Subjects were not assigned to fixed-dosing cohorts as dosing ranged from 20mg once weekly to 80 mg once weekly. Adverse Events were not collected specific to dose.
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|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
17.6%
3/17 • Number of events 3 • Adverse event data was collected from the first dose of study until end of treatment (up to 16.6 months). Currently three subjects are still on treatment and adverse event collection is still ongoing.
|
|
Gastrointestinal disorders
Abdominal pain
|
41.2%
7/17 • Number of events 21 • Adverse event data was collected from the first dose of study until end of treatment (up to 16.6 months). Currently three subjects are still on treatment and adverse event collection is still ongoing.
|
|
Renal and urinary disorders
Acute kidney injury
|
5.9%
1/17 • Number of events 1 • Adverse event data was collected from the first dose of study until end of treatment (up to 16.6 months). Currently three subjects are still on treatment and adverse event collection is still ongoing.
|
|
Psychiatric disorders
Agitation
|
5.9%
1/17 • Number of events 1 • Adverse event data was collected from the first dose of study until end of treatment (up to 16.6 months). Currently three subjects are still on treatment and adverse event collection is still ongoing.
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|
Investigations
Alanine aminotransferase increased
|
5.9%
1/17 • Number of events 2 • Adverse event data was collected from the first dose of study until end of treatment (up to 16.6 months). Currently three subjects are still on treatment and adverse event collection is still ongoing.
|
|
Investigations
Alkaline phosphatase increased
|
5.9%
1/17 • Number of events 2 • Adverse event data was collected from the first dose of study until end of treatment (up to 16.6 months). Currently three subjects are still on treatment and adverse event collection is still ongoing.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
5.9%
1/17 • Number of events 1 • Adverse event data was collected from the first dose of study until end of treatment (up to 16.6 months). Currently three subjects are still on treatment and adverse event collection is still ongoing.
|
|
Blood and lymphatic system disorders
Anemia
|
29.4%
5/17 • Number of events 8 • Adverse event data was collected from the first dose of study until end of treatment (up to 16.6 months). Currently three subjects are still on treatment and adverse event collection is still ongoing.
|
|
Metabolism and nutrition disorders
Anorexia
|
64.7%
11/17 • Number of events 13 • Adverse event data was collected from the first dose of study until end of treatment (up to 16.6 months). Currently three subjects are still on treatment and adverse event collection is still ongoing.
|
|
Psychiatric disorders
Anxiety
|
5.9%
1/17 • Number of events 1 • Adverse event data was collected from the first dose of study until end of treatment (up to 16.6 months). Currently three subjects are still on treatment and adverse event collection is still ongoing.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
11.8%
2/17 • Number of events 2 • Adverse event data was collected from the first dose of study until end of treatment (up to 16.6 months). Currently three subjects are still on treatment and adverse event collection is still ongoing.
|
|
Gastrointestinal disorders
Ascites
|
5.9%
1/17 • Number of events 1 • Adverse event data was collected from the first dose of study until end of treatment (up to 16.6 months). Currently three subjects are still on treatment and adverse event collection is still ongoing.
|
|
Investigations
Aspartate aminotransferase increased
|
5.9%
1/17 • Number of events 2 • Adverse event data was collected from the first dose of study until end of treatment (up to 16.6 months). Currently three subjects are still on treatment and adverse event collection is still ongoing.
|
|
Cardiac disorders
Atrial fibrillation
|
11.8%
2/17 • Number of events 2 • Adverse event data was collected from the first dose of study until end of treatment (up to 16.6 months). Currently three subjects are still on treatment and adverse event collection is still ongoing.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.8%
2/17 • Number of events 3 • Adverse event data was collected from the first dose of study until end of treatment (up to 16.6 months). Currently three subjects are still on treatment and adverse event collection is still ongoing.
|
|
Gastrointestinal disorders
Belching
|
5.9%
1/17 • Number of events 3 • Adverse event data was collected from the first dose of study until end of treatment (up to 16.6 months). Currently three subjects are still on treatment and adverse event collection is still ongoing.
|
|
Gastrointestinal disorders
Bloating
|
17.6%
3/17 • Number of events 5 • Adverse event data was collected from the first dose of study until end of treatment (up to 16.6 months). Currently three subjects are still on treatment and adverse event collection is still ongoing.
|
|
Investigations
Blood bilirubin increased
|
5.9%
1/17 • Number of events 1 • Adverse event data was collected from the first dose of study until end of treatment (up to 16.6 months). Currently three subjects are still on treatment and adverse event collection is still ongoing.
|
|
Eye disorders
Blurred vision
|
5.9%
1/17 • Number of events 3 • Adverse event data was collected from the first dose of study until end of treatment (up to 16.6 months). Currently three subjects are still on treatment and adverse event collection is still ongoing.
|
|
Skin and subcutaneous tissue disorders
Body odor
|
5.9%
1/17 • Number of events 1 • Adverse event data was collected from the first dose of study until end of treatment (up to 16.6 months). Currently three subjects are still on treatment and adverse event collection is still ongoing.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
5.9%
1/17 • Number of events 1 • Adverse event data was collected from the first dose of study until end of treatment (up to 16.6 months). Currently three subjects are still on treatment and adverse event collection is still ongoing.
|
|
Injury, poisoning and procedural complications
Bruising
|
5.9%
1/17 • Number of events 1 • Adverse event data was collected from the first dose of study until end of treatment (up to 16.6 months). Currently three subjects are still on treatment and adverse event collection is still ongoing.
|
|
Eye disorders
Cataract
|
17.6%
3/17 • Number of events 3 • Adverse event data was collected from the first dose of study until end of treatment (up to 16.6 months). Currently three subjects are still on treatment and adverse event collection is still ongoing.
|
|
Cardiac disorders
Chest pain - cardiac
|
5.9%
1/17 • Number of events 1 • Adverse event data was collected from the first dose of study until end of treatment (up to 16.6 months). Currently three subjects are still on treatment and adverse event collection is still ongoing.
|
|
General disorders
Chills
|
17.6%
3/17 • Number of events 3 • Adverse event data was collected from the first dose of study until end of treatment (up to 16.6 months). Currently three subjects are still on treatment and adverse event collection is still ongoing.
|
|
Hepatobiliary disorders
Cholecystitis
|
5.9%
1/17 • Number of events 1 • Adverse event data was collected from the first dose of study until end of treatment (up to 16.6 months). Currently three subjects are still on treatment and adverse event collection is still ongoing.
|
|
Nervous system disorders
Concentration impairment
|
5.9%
1/17 • Number of events 1 • Adverse event data was collected from the first dose of study until end of treatment (up to 16.6 months). Currently three subjects are still on treatment and adverse event collection is still ongoing.
|
|
Psychiatric disorders
Confusion
|
11.8%
2/17 • Number of events 2 • Adverse event data was collected from the first dose of study until end of treatment (up to 16.6 months). Currently three subjects are still on treatment and adverse event collection is still ongoing.
|
|
Gastrointestinal disorders
Constipation
|
23.5%
4/17 • Number of events 4 • Adverse event data was collected from the first dose of study until end of treatment (up to 16.6 months). Currently three subjects are still on treatment and adverse event collection is still ongoing.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
17.6%
3/17 • Number of events 4 • Adverse event data was collected from the first dose of study until end of treatment (up to 16.6 months). Currently three subjects are still on treatment and adverse event collection is still ongoing.
|
|
Investigations
Creatinine increased
|
5.9%
1/17 • Number of events 1 • Adverse event data was collected from the first dose of study until end of treatment (up to 16.6 months). Currently three subjects are still on treatment and adverse event collection is still ongoing.
|
|
Psychiatric disorders
Delirium
|
5.9%
1/17 • Number of events 1 • Adverse event data was collected from the first dose of study until end of treatment (up to 16.6 months). Currently three subjects are still on treatment and adverse event collection is still ongoing.
|
|
Gastrointestinal disorders
Diarrhea
|
64.7%
11/17 • Number of events 14 • Adverse event data was collected from the first dose of study until end of treatment (up to 16.6 months). Currently three subjects are still on treatment and adverse event collection is still ongoing.
|
|
Nervous system disorders
Dizziness
|
41.2%
7/17 • Number of events 15 • Adverse event data was collected from the first dose of study until end of treatment (up to 16.6 months). Currently three subjects are still on treatment and adverse event collection is still ongoing.
|
|
Gastrointestinal disorders
Dry mouth
|
11.8%
2/17 • Number of events 2 • Adverse event data was collected from the first dose of study until end of treatment (up to 16.6 months). Currently three subjects are still on treatment and adverse event collection is still ongoing.
|
|
Nervous system disorders
Dysgeusia
|
47.1%
8/17 • Number of events 12 • Adverse event data was collected from the first dose of study until end of treatment (up to 16.6 months). Currently three subjects are still on treatment and adverse event collection is still ongoing.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
17.6%
3/17 • Number of events 5 • Adverse event data was collected from the first dose of study until end of treatment (up to 16.6 months). Currently three subjects are still on treatment and adverse event collection is still ongoing.
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Other, specify
|
5.9%
1/17 • Number of events 1 • Adverse event data was collected from the first dose of study until end of treatment (up to 16.6 months). Currently three subjects are still on treatment and adverse event collection is still ongoing.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
5.9%
1/17 • Number of events 1 • Adverse event data was collected from the first dose of study until end of treatment (up to 16.6 months). Currently three subjects are still on treatment and adverse event collection is still ongoing.
|
|
General disorders
Edema face
|
5.9%
1/17 • Number of events 1 • Adverse event data was collected from the first dose of study until end of treatment (up to 16.6 months). Currently three subjects are still on treatment and adverse event collection is still ongoing.
|
|
General disorders
Edema limbs
|
11.8%
2/17 • Number of events 2 • Adverse event data was collected from the first dose of study until end of treatment (up to 16.6 months). Currently three subjects are still on treatment and adverse event collection is still ongoing.
|
|
Investigations
Ejection fraction decreased
|
5.9%
1/17 • Number of events 2 • Adverse event data was collected from the first dose of study until end of treatment (up to 16.6 months). Currently three subjects are still on treatment and adverse event collection is still ongoing.
|
|
Infections and infestations
Enterocolitis infectious
|
17.6%
3/17 • Number of events 3 • Adverse event data was collected from the first dose of study until end of treatment (up to 16.6 months). Currently three subjects are still on treatment and adverse event collection is still ongoing.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.9%
1/17 • Number of events 1 • Adverse event data was collected from the first dose of study until end of treatment (up to 16.6 months). Currently three subjects are still on treatment and adverse event collection is still ongoing.
|
|
Nervous system disorders
Extrapyramidal disorder
|
5.9%
1/17 • Number of events 1 • Adverse event data was collected from the first dose of study until end of treatment (up to 16.6 months). Currently three subjects are still on treatment and adverse event collection is still ongoing.
|
|
Eye disorders
Eye disorders - Other, specify
|
29.4%
5/17 • Number of events 10 • Adverse event data was collected from the first dose of study until end of treatment (up to 16.6 months). Currently three subjects are still on treatment and adverse event collection is still ongoing.
|
|
Injury, poisoning and procedural complications
Fall
|
5.9%
1/17 • Number of events 1 • Adverse event data was collected from the first dose of study until end of treatment (up to 16.6 months). Currently three subjects are still on treatment and adverse event collection is still ongoing.
|
|
General disorders
Fatigue
|
70.6%
12/17 • Number of events 22 • Adverse event data was collected from the first dose of study until end of treatment (up to 16.6 months). Currently three subjects are still on treatment and adverse event collection is still ongoing.
|
|
General disorders
Fever
|
5.9%
1/17 • Number of events 1 • Adverse event data was collected from the first dose of study until end of treatment (up to 16.6 months). Currently three subjects are still on treatment and adverse event collection is still ongoing.
|
|
Eye disorders
Flashing lights
|
5.9%
1/17 • Number of events 1 • Adverse event data was collected from the first dose of study until end of treatment (up to 16.6 months). Currently three subjects are still on treatment and adverse event collection is still ongoing.
|
|
Gastrointestinal disorders
Flatulence
|
11.8%
2/17 • Number of events 4 • Adverse event data was collected from the first dose of study until end of treatment (up to 16.6 months). Currently three subjects are still on treatment and adverse event collection is still ongoing.
|
|
General disorders
Flu like symptoms
|
17.6%
3/17 • Number of events 4 • Adverse event data was collected from the first dose of study until end of treatment (up to 16.6 months). Currently three subjects are still on treatment and adverse event collection is still ongoing.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
17.6%
3/17 • Number of events 3 • Adverse event data was collected from the first dose of study until end of treatment (up to 16.6 months). Currently three subjects are still on treatment and adverse event collection is still ongoing.
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
17.6%
3/17 • Number of events 4 • Adverse event data was collected from the first dose of study until end of treatment (up to 16.6 months). Currently three subjects are still on treatment and adverse event collection is still ongoing.
|
|
Infections and infestations
Gum infection
|
5.9%
1/17 • Number of events 1 • Adverse event data was collected from the first dose of study until end of treatment (up to 16.6 months). Currently three subjects are still on treatment and adverse event collection is still ongoing.
|
|
Nervous system disorders
Headache
|
11.8%
2/17 • Number of events 2 • Adverse event data was collected from the first dose of study until end of treatment (up to 16.6 months). Currently three subjects are still on treatment and adverse event collection is still ongoing.
|
|
Hepatobiliary disorders
Hepatic failure
|
5.9%
1/17 • Number of events 1 • Adverse event data was collected from the first dose of study until end of treatment (up to 16.6 months). Currently three subjects are still on treatment and adverse event collection is still ongoing.
|
|
Infections and infestations
Herpes simplex reactivation
|
5.9%
1/17 • Number of events 1 • Adverse event data was collected from the first dose of study until end of treatment (up to 16.6 months). Currently three subjects are still on treatment and adverse event collection is still ongoing.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
5.9%
1/17 • Number of events 1 • Adverse event data was collected from the first dose of study until end of treatment (up to 16.6 months). Currently three subjects are still on treatment and adverse event collection is still ongoing.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
5.9%
1/17 • Number of events 1 • Adverse event data was collected from the first dose of study until end of treatment (up to 16.6 months). Currently three subjects are still on treatment and adverse event collection is still ongoing.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
41.2%
7/17 • Number of events 8 • Adverse event data was collected from the first dose of study until end of treatment (up to 16.6 months). Currently three subjects are still on treatment and adverse event collection is still ongoing.
|
|
Metabolism and nutrition disorders
Hyperphosphatemia
|
11.8%
2/17 • Number of events 2 • Adverse event data was collected from the first dose of study until end of treatment (up to 16.6 months). Currently three subjects are still on treatment and adverse event collection is still ongoing.
|
|
Vascular disorders
Hypertension
|
11.8%
2/17 • Number of events 2 • Adverse event data was collected from the first dose of study until end of treatment (up to 16.6 months). Currently three subjects are still on treatment and adverse event collection is still ongoing.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
29.4%
5/17 • Number of events 6 • Adverse event data was collected from the first dose of study until end of treatment (up to 16.6 months). Currently three subjects are still on treatment and adverse event collection is still ongoing.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
11.8%
2/17 • Number of events 2 • Adverse event data was collected from the first dose of study until end of treatment (up to 16.6 months). Currently three subjects are still on treatment and adverse event collection is still ongoing.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
11.8%
2/17 • Number of events 2 • Adverse event data was collected from the first dose of study until end of treatment (up to 16.6 months). Currently three subjects are still on treatment and adverse event collection is still ongoing.
|
|
Infections and infestations
Infections and infestations - Other, specify
|
5.9%
1/17 • Number of events 1 • Adverse event data was collected from the first dose of study until end of treatment (up to 16.6 months). Currently three subjects are still on treatment and adverse event collection is still ongoing.
|
|
Metabolism and nutrition disorders
Iron overload
|
5.9%
1/17 • Number of events 1 • Adverse event data was collected from the first dose of study until end of treatment (up to 16.6 months). Currently three subjects are still on treatment and adverse event collection is still ongoing.
|
|
General disorders
Malaise
|
5.9%
1/17 • Number of events 3 • Adverse event data was collected from the first dose of study until end of treatment (up to 16.6 months). Currently three subjects are still on treatment and adverse event collection is still ongoing.
|
|
Nervous system disorders
Memory impairment
|
5.9%
1/17 • Number of events 1 • Adverse event data was collected from the first dose of study until end of treatment (up to 16.6 months). Currently three subjects are still on treatment and adverse event collection is still ongoing.
|
|
Cardiac disorders
Mitral valve disease
|
5.9%
1/17 • Number of events 2 • Adverse event data was collected from the first dose of study until end of treatment (up to 16.6 months). Currently three subjects are still on treatment and adverse event collection is still ongoing.
|
|
Musculoskeletal and connective tissue disorders
Muscle cramp
|
11.8%
2/17 • Number of events 2 • Adverse event data was collected from the first dose of study until end of treatment (up to 16.6 months). Currently three subjects are still on treatment and adverse event collection is still ongoing.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
11.8%
2/17 • Number of events 4 • Adverse event data was collected from the first dose of study until end of treatment (up to 16.6 months). Currently three subjects are still on treatment and adverse event collection is still ongoing.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
17.6%
3/17 • Number of events 3 • Adverse event data was collected from the first dose of study until end of treatment (up to 16.6 months). Currently three subjects are still on treatment and adverse event collection is still ongoing.
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
5.9%
1/17 • Number of events 1 • Adverse event data was collected from the first dose of study until end of treatment (up to 16.6 months). Currently three subjects are still on treatment and adverse event collection is still ongoing.
|
|
Skin and subcutaneous tissue disorders
Nail discoloration
|
5.9%
1/17 • Number of events 1 • Adverse event data was collected from the first dose of study until end of treatment (up to 16.6 months). Currently three subjects are still on treatment and adverse event collection is still ongoing.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
5.9%
1/17 • Number of events 2 • Adverse event data was collected from the first dose of study until end of treatment (up to 16.6 months). Currently three subjects are still on treatment and adverse event collection is still ongoing.
|
|
Gastrointestinal disorders
Nausea
|
88.2%
15/17 • Number of events 20 • Adverse event data was collected from the first dose of study until end of treatment (up to 16.6 months). Currently three subjects are still on treatment and adverse event collection is still ongoing.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
5.9%
1/17 • Number of events 2 • Adverse event data was collected from the first dose of study until end of treatment (up to 16.6 months). Currently three subjects are still on treatment and adverse event collection is still ongoing.
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
5.9%
1/17 • Number of events 1 • Adverse event data was collected from the first dose of study until end of treatment (up to 16.6 months). Currently three subjects are still on treatment and adverse event collection is still ongoing.
|
|
Nervous system disorders
Paresthesia
|
11.8%
2/17 • Number of events 2 • Adverse event data was collected from the first dose of study until end of treatment (up to 16.6 months). Currently three subjects are still on treatment and adverse event collection is still ongoing.
|
|
Eye disorders
Periorbital edema
|
5.9%
1/17 • Number of events 1 • Adverse event data was collected from the first dose of study until end of treatment (up to 16.6 months). Currently three subjects are still on treatment and adverse event collection is still ongoing.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
5.9%
1/17 • Number of events 2 • Adverse event data was collected from the first dose of study until end of treatment (up to 16.6 months). Currently three subjects are still on treatment and adverse event collection is still ongoing.
|
|
Eye disorders
Photophobia
|
5.9%
1/17 • Number of events 1 • Adverse event data was collected from the first dose of study until end of treatment (up to 16.6 months). Currently three subjects are still on treatment and adverse event collection is still ongoing.
|
|
Investigations
Platelet count decreased
|
11.8%
2/17 • Number of events 4 • Adverse event data was collected from the first dose of study until end of treatment (up to 16.6 months). Currently three subjects are still on treatment and adverse event collection is still ongoing.
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
11.8%
2/17 • Number of events 3 • Adverse event data was collected from the first dose of study until end of treatment (up to 16.6 months). Currently three subjects are still on treatment and adverse event collection is still ongoing.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
23.5%
4/17 • Number of events 8 • Adverse event data was collected from the first dose of study until end of treatment (up to 16.6 months). Currently three subjects are still on treatment and adverse event collection is still ongoing.
|
|
Skin and subcutaneous tissue disorders
Purpura
|
5.9%
1/17 • Number of events 1 • Adverse event data was collected from the first dose of study until end of treatment (up to 16.6 months). Currently three subjects are still on treatment and adverse event collection is still ongoing.
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
5.9%
1/17 • Number of events 1 • Adverse event data was collected from the first dose of study until end of treatment (up to 16.6 months). Currently three subjects are still on treatment and adverse event collection is still ongoing.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
11.8%
2/17 • Number of events 2 • Adverse event data was collected from the first dose of study until end of treatment (up to 16.6 months). Currently three subjects are still on treatment and adverse event collection is still ongoing.
|
|
Infections and infestations
Rhinitis infective
|
5.9%
1/17 • Number of events 1 • Adverse event data was collected from the first dose of study until end of treatment (up to 16.6 months). Currently three subjects are still on treatment and adverse event collection is still ongoing.
|
|
Cardiac disorders
Sinus tachycardia
|
11.8%
2/17 • Number of events 2 • Adverse event data was collected from the first dose of study until end of treatment (up to 16.6 months). Currently three subjects are still on treatment and adverse event collection is still ongoing.
|
|
Infections and infestations
Sinusitis
|
5.9%
1/17 • Number of events 1 • Adverse event data was collected from the first dose of study until end of treatment (up to 16.6 months). Currently three subjects are still on treatment and adverse event collection is still ongoing.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
11.8%
2/17 • Number of events 2 • Adverse event data was collected from the first dose of study until end of treatment (up to 16.6 months). Currently three subjects are still on treatment and adverse event collection is still ongoing.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
5.9%
1/17 • Number of events 1 • Adverse event data was collected from the first dose of study until end of treatment (up to 16.6 months). Currently three subjects are still on treatment and adverse event collection is still ongoing.
|
|
Surgical and medical procedures
Surgical and medical procedures - Other, specify
|
5.9%
1/17 • Number of events 1 • Adverse event data was collected from the first dose of study until end of treatment (up to 16.6 months). Currently three subjects are still on treatment and adverse event collection is still ongoing.
|
|
Endocrine disorders
Testosterone deficiency
|
5.9%
1/17 • Number of events 1 • Adverse event data was collected from the first dose of study until end of treatment (up to 16.6 months). Currently three subjects are still on treatment and adverse event collection is still ongoing.
|
|
Infections and infestations
Thrush
|
5.9%
1/17 • Number of events 1 • Adverse event data was collected from the first dose of study until end of treatment (up to 16.6 months). Currently three subjects are still on treatment and adverse event collection is still ongoing.
|
|
Infections and infestations
Upper respiratory infection
|
5.9%
1/17 • Number of events 1 • Adverse event data was collected from the first dose of study until end of treatment (up to 16.6 months). Currently three subjects are still on treatment and adverse event collection is still ongoing.
|
|
Renal and urinary disorders
Urinary frequency
|
11.8%
2/17 • Number of events 2 • Adverse event data was collected from the first dose of study until end of treatment (up to 16.6 months). Currently three subjects are still on treatment and adverse event collection is still ongoing.
|
|
Renal and urinary disorders
Urinary incontinence
|
5.9%
1/17 • Number of events 2 • Adverse event data was collected from the first dose of study until end of treatment (up to 16.6 months). Currently three subjects are still on treatment and adverse event collection is still ongoing.
|
|
Infections and infestations
Urinary tract infection
|
5.9%
1/17 • Number of events 2 • Adverse event data was collected from the first dose of study until end of treatment (up to 16.6 months). Currently three subjects are still on treatment and adverse event collection is still ongoing.
|
|
Renal and urinary disorders
Urine discoloration
|
11.8%
2/17 • Number of events 2 • Adverse event data was collected from the first dose of study until end of treatment (up to 16.6 months). Currently three subjects are still on treatment and adverse event collection is still ongoing.
|
|
Cardiac disorders
Ventricular tachycardia
|
5.9%
1/17 • Number of events 1 • Adverse event data was collected from the first dose of study until end of treatment (up to 16.6 months). Currently three subjects are still on treatment and adverse event collection is still ongoing.
|
|
Ear and labyrinth disorders
Vertigo
|
5.9%
1/17 • Number of events 2 • Adverse event data was collected from the first dose of study until end of treatment (up to 16.6 months). Currently three subjects are still on treatment and adverse event collection is still ongoing.
|
|
Gastrointestinal disorders
Vomiting
|
41.2%
7/17 • Number of events 9 • Adverse event data was collected from the first dose of study until end of treatment (up to 16.6 months). Currently three subjects are still on treatment and adverse event collection is still ongoing.
|
|
Investigations
Weight loss
|
47.1%
8/17 • Number of events 33 • Adverse event data was collected from the first dose of study until end of treatment (up to 16.6 months). Currently three subjects are still on treatment and adverse event collection is still ongoing.
|
Additional Information
IIT Data Management Team
Research Compliance Office, Huntsman Cancer Institute
Phone: 801-213-6215
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place