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Selinexor in Initial or Refractory and/or Relapsed Richter's Transformation (SIRRT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02138786
Recruitment Status : Terminated (Lack of efficacy at time of interim analysis)
First Posted : May 15, 2014
Results First Posted : February 11, 2020
Last Update Posted : January 26, 2023
Sponsor:
Information provided by (Responsible Party):
Karyopharm Therapeutics Inc

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Richter's Transformation
Intervention Drug: selinexor
Enrollment 27
Recruitment Details

This multicenter study was conducted at 30 clinical investigative sites in the United States and Europe. Of the 30 investigative sites, 15 sites enrolled a total of 27 patients in the study.

  • Date first patient enrolled: 14 November 2014
  • Date last patient completed: 31 August 2016
Pre-assignment Details Of the 35 total patients screened, 8 patients were screen-failures. Of the 27 enrolled patients, one patient withdrew from the study prior to receiving treatment. Therefore, a total of 26 patients comprised the Safety population.
Arm/Group Title Selinexor 60 mg/m² (8 Doses/Cycle) Selinexor 60 mg (6 Doses/Cycle) Selinexor 60 mg (8 Doses/Cycle)
Hide Arm/Group Description 60 mg/m² dose twice weekly for weeks 1-4 60 mg oral dose twice weekly for weeks 1-3 60 mg oral dose twice weekly for weeks 1-4
Period Title: Overall Study
Started 3 15 8
Completed 0 0 0
Not Completed 3 15 8
Reason Not Completed
Adverse Event             0             2             1
Death             1             7             2
Disease Progression             1             1             3
Withdrawal by Subject             1             2             0
Patient's Wish             0             2             0
Sponsor Terminated Study             0             1             1
Non-Compliance             0             0             1
Arm/Group Title Selinexor 60 mg/m² (8 Doses/Cycle) Selinexor 60 mg (6 Doses/Cycle) Selinexor 60 mg (8 Doses/Cycle) Total
Hide Arm/Group Description 60 mg/m² oral dose twice weekly for Weeks 1-4 60 mg oral dose twice weekly for Weeks 1-3 60 mg oral dose twice weekly for Weeks 1-4 Total of all reporting groups
Overall Number of Baseline Participants 3 15 8 26
Hide Baseline Analysis Population Description
Safety Population, consisting of all patients who received any amount of study medication.
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 3 participants 15 participants 8 participants 26 participants
68.0
(66 to 74)
68.0
(41 to 77)
69.0
(65 to 79)
68.0
(41 to 79)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 15 participants 8 participants 26 participants
Female
2
  66.7%
3
  20.0%
4
  50.0%
9
  34.6%
Male
1
  33.3%
12
  80.0%
4
  50.0%
17
  65.4%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 15 participants 8 participants 26 participants
Hispanic or Latino
1
  33.3%
1
   6.7%
0
   0.0%
2
   7.7%
Not Hispanic or Latino
1
  33.3%
14
  93.3%
8
 100.0%
23
  88.5%
Unknown or Not Reported
1
  33.3%
0
   0.0%
0
   0.0%
1
   3.8%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 15 participants 8 participants 26 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
White
3
 100.0%
15
 100.0%
8
 100.0%
26
 100.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
ECOG score   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 15 participants 8 participants 26 participants
Score=0
0
   0.0%
5
  33.3%
2
  25.0%
7
  26.9%
Score=1
3
 100.0%
6
  40.0%
4
  50.0%
13
  50.0%
Score=2
0
   0.0%
4
  26.7%
1
  12.5%
5
  19.2%
Missing
0
   0.0%
0
   0.0%
1
  12.5%
1
   3.8%
[1]
Measure Description:

Performance Status as measured by Eastern Cooperative Oncology Group (ECOG) Status Scale:

Score=0: Normal activity. Fully active, able to carry on all pre-disease performance without restriction.

Score=1: Symptoms, but ambulatory. Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature (e.g., light housework, office work).

Score=2: In bed < 50% of the time. Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours.
Weight   [1] 
Median (Full Range)
Unit of measure:  Kg
Number Analyzed 3 participants 15 participants 8 participants 26 participants
56.5
(52.3 to 96.0)
76.5
(51.9 to 115.5)
73.05
(46.4 to 88.1)
74.40
(46.4 to 115.5)
[1]
Measure Description: kilograms
1.Primary Outcome
Title Percentage of Participants With Overall Response (Overall Response Rate)
Hide Description Overall Response Rate (ORR) is defined as the point estimate of the percentage of patients who have complete response (CR) or partial response (PR). Disease response was assessed using the International Working Group (IWG) Response Criteria for non-Hodgkin's lymphoma (Cheson 2007), including assessment of lymph node, spleen and liver lesions by PET (positron emission tomography) scan and assessment of bone marrow biopsies by morphologic, immunohistochemistry, and flow cytometry tests. CR was defined as disappearance of all evidence of disease, and PR was defined as ≥ 50% regression of measurable disease and no new sites.
Time Frame Assessments were performed at Screening or Cycle 1/Day 1 prior to dosing and on Cycle 3/Day 1 and alternate cycles thereafter until disease progression, study drug intolerability had been reached, study withdrawal, or death.
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent to Treat (mITT) population, consisting of all patients who received at least one dose of selinexor and had at least one post-baseline efficacy evaluation. Patients without post-baseline efficacy follow-up information who discontinued the study due to toxicity, disease progression, or death were included in this population.
Arm/Group Title Selinexor
Hide Arm/Group Description:
All dosing groups
Overall Number of Participants Analyzed 25
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
4
(0.1 to 20.4)
2.Primary Outcome
Title Number of Participants With Complete Response (CR)
Hide Description Number of patients who achieved CR (complete disappearance of all detectable evidence of disease). Disease response was assessed using the International Working Group (IWG) Response Criteria for non-Hodgkin's lymphoma (Cheson 2007), including assessment of lymph node, spleen and liver lesions by PET (positron emission tomography) scan and assessment of bone marrow biopsies by morphologic, immunohistochemistry, and flow cytometry tests.
Time Frame Assessments were performed at Screening or Cycle 1/Day 1 prior to dosing and on Cycle 3/Day 1 and alternate cycles thereafter until disease progression, study drug intolerability had been reached, study withdrawal, or death.
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent to Treat (mITT) population, consisting of all patients who received at least one dose of selinexor and had at least one post-baseline efficacy evaluation. Patients without post-baseline efficacy follow-up information who discontinued the study due to toxicity, disease progression, or death were included in this population.
Arm/Group Title Selinexor
Hide Arm/Group Description:
All dosing groups
Overall Number of Participants Analyzed 25
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
3.Primary Outcome
Title Number of Participants With Partial Response (PR)
Hide Description Number of patients whose best overall response to study treatment was PR (≥ 50% regression of measurable disease and no new sites). Disease response was assessed using the International Working Group (IWG) Response Criteria for non-Hodgkin's lymphoma (Cheson 2007), including assessment of lymph node, spleen and liver lesions by PET (positron emission tomography) scan and assessment of bone marrow biopsies by morphologic, immunohistochemistry, and flow cytometry tests.
Time Frame Assessments were performed at Screening or Cycle 1/Day 1 prior to dosing and on Cycle 3/Day 1 and alternate cycles thereafter until disease progression, study drug intolerability had been reached, study withdrawal, or death.
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent to Treat (mITT) population, consisting of all patients who received at least one dose of selinexor and had at least one post-baseline efficacy evaluation. Patients without post-baseline efficacy follow-up information who discontinued the study due to toxicity, disease progression, or death were included in this population.
Arm/Group Title Selinexor
Hide Arm/Group Description:
All dosing groups
Overall Number of Participants Analyzed 25
Measure Type: Count of Participants
Unit of Measure: Participants
1
   4.0%
4.Primary Outcome
Title Number of Participants With Stable Disease (SD)
Hide Description Number of patients whose best overall response to study treatment was SD (failure to attain criteria for CR or PR, or to meet criteria for PD). Disease response was assessed using the International Working Group (IWG) Response Criteria for non-Hodgkin's lymphoma (Cheson 2007), including assessment of lymph node, spleen and liver lesions by PET (positron emission tomography) scan and assessment of bone marrow biopsies by morphologic, immunohistochemistry, and flow cytometry tests.
Time Frame Assessments were performed at Screening or Cycle 1/Day 1 prior to dosing and on Cycle 3/Day 1 and alternate cycles thereafter until disease progression, study drug intolerability had been reached, study withdrawal, or death.
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent to Treat (mITT) population, consisting of all patients who received at least one dose of selinexor and had at least one post-baseline efficacy evaluation. Patients without post-baseline efficacy follow-up information who discontinued the study due to toxicity, disease progression, or death were included in this population.
Arm/Group Title Selinexor
Hide Arm/Group Description:
All dosing groups
Overall Number of Participants Analyzed 25
Measure Type: Count of Participants
Unit of Measure: Participants
6
  24.0%
5.Primary Outcome
Title Number of Participants With Progressive Disease (PD)
Hide Description Number of patients whose best overall response to study treatment was PD (any new lesion or increase by ≥ 50% of previously involved sites from nadir). Disease response was assessed using the International Working Group (IWG) Response Criteria for non-Hodgkin's lymphoma (Cheson 2007), including assessment of lymph node, spleen and liver lesions by PET (positron emission tomography) scan and assessment of bone marrow biopsies by morphologic, immunohistochemistry, and flow cytometry tests.
Time Frame Assessments were performed at Screening or Cycle 1/Day 1 prior to dosing and on Cycle 3/Day 1 and alternate cycles thereafter until disease progression, study drug intolerability had been reached, study withdrawal, or death.
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent to Treat (mITT) population, consisting of all patients who received at least one dose of selinexor and had at least one post-baseline efficacy evaluation. Patients without post-baseline efficacy follow-up information who discontinued the study due to toxicity, disease progression, or death were included in this population.
Arm/Group Title Selinexor
Hide Arm/Group Description:
All dosing groups
Overall Number of Participants Analyzed 25
Measure Type: Count of Participants
Unit of Measure: Participants
7
  28.0%
6.Primary Outcome
Title Number of Participants With Not Evaluable (NE) Response
Hide Description Number of patients who could not be assessed quantitatively for disease response for any reason.
Time Frame Assessments were performed at Screening or Cycle 1/Day 1 prior to dosing and on Cycle 3/Day 1 and alternate cycles thereafter until disease progression, study drug intolerability had been reached, study withdrawal, or death.
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent to Treat (mITT) population, consisting of all patients who received at least one dose of selinexor and had at least one post-baseline efficacy evaluation. Patients without post-baseline efficacy follow-up information who discontinued the study due to toxicity, disease progression, or death were included in this population.
Arm/Group Title Selinexor
Hide Arm/Group Description:
All dosing groups
Overall Number of Participants Analyzed 25
Measure Type: Count of Participants
Unit of Measure: Participants
11
  44.0%
7.Secondary Outcome
Title Percentage of Participants With Disease Control (Disease Control Rate)
Hide Description Disease Control Rate (DCR) is defined as the percentage of patients who achieved CR, PR, or SD lasting for at least 8 weeks. CR was defined as disappearance of all evidence of disease. PR was defined as ≥ 50% regression of measurable disease and no new sites. SD was defined as failure to attain criteria for CR or PR, or to meet criteria for PD. Disease response was assessed using the International Working Group (IWG) Response Criteria for non-Hodgkin's lymphoma (Cheson 2007), including assessment of lymph node, spleen and liver lesions by PET (positron emission tomography) scan and assessment of bone marrow biopsies by morphologic, immunohistochemistry, and flow cytometry tests.
Time Frame Assessments were performed at Screening or Cycle 1/Day 1 prior to dosing and on Cycle 3/Day 1 and alternate cycles thereafter until disease progression, study drug intolerability had been reached, study withdrawal, or death.
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent to Treat (mITT) population, consisting of all patients who received at least one dose of selinexor and had at least one post-baseline efficacy evaluation. Patients without post-baseline efficacy follow-up information who discontinued the study due to toxicity, disease progression, or death were included in this population.
Arm/Group Title Selinexor
Hide Arm/Group Description:
All dosing groups
Overall Number of Participants Analyzed 25
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
28.0
(12.1 to 49.4)
8.Secondary Outcome
Title Duration of Progression Free Survival (PFS)
Hide Description

Number of days calculated from date of start of study therapy to date of progression based on IWG criteria, or date of death if progression did not occur. Patients who dropped out prior to study end without evidence of disease progression were censored at the day they were last known to be alive. Patients without documented disease progression or recurrence were censored at the date of last disease assessment. Disease response was assessed using the International Working Group (IWG) Response Criteria for non-Hodgkin's lymphoma (Cheson 2007), including assessment of lymph node, spleen and liver lesions by PET (positron emission tomography) scan and assessment of bone marrow biopsies by morphologic, immunohistochemistry, and flow cytometry tests.

.
Time Frame Assessments were performed at Screening or Cycle 1/Day 1 prior to dosing and on Cycle 3/Day 1 and alternate cycles thereafter until disease progression, study drug intolerability had been reached, study withdrawal, or death.
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent to Treat (mITT) population, consisting of all patients who received at least one dose of selinexor and had at least one post-baseline efficacy evaluation. Patients without post-baseline efficacy follow-up information who discontinued the study due to toxicity, disease progression, or death were included in this population.
Arm/Group Title Selinexor
Hide Arm/Group Description:
All dosing groups
Overall Number of Participants Analyzed 25
Median (95% Confidence Interval)
Unit of Measure: Days
38.0
(22.0 to 86.0)
Time Frame Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Selinexor 60 mg/m² (8 Doses/Cycle) Selinexor 60 mg (6 Doses/Cycle) Selinexor 60 mg (8 Doses/Cycle)
Hide Arm/Group Description 60 mg/m² oral dose twice weekly for Weeks 1-4 60 mg oral dose twice weekly for Weeks 1-3 60 mg oral dose twice weekly for Weeks 1-4
All-Cause Mortality
Selinexor 60 mg/m² (8 Doses/Cycle) Selinexor 60 mg (6 Doses/Cycle) Selinexor 60 mg (8 Doses/Cycle)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/3 (33.33%)   8/15 (53.33%)   2/8 (25.00%) 
Hide Serious Adverse Events
Selinexor 60 mg/m² (8 Doses/Cycle) Selinexor 60 mg (6 Doses/Cycle) Selinexor 60 mg (8 Doses/Cycle)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/3 (100.00%)   9/15 (60.00%)   5/8 (62.50%) 
Blood and lymphatic system disorders       
Febrile Neutropenia † 1  0/3 (0.00%)  1/15 (6.67%)  0/8 (0.00%) 
Thrombocytopenia † 1  0/3 (0.00%)  1/15 (6.67%)  0/8 (0.00%) 
Cardiac disorders       
Supraventricular Tachycardia † 1  0/3 (0.00%)  1/15 (6.67%)  0/8 (0.00%) 
General disorders       
Asthenia † 1  1/3 (33.33%)  0/15 (0.00%)  0/8 (0.00%) 
Fatigue † 1  1/3 (33.33%)  0/15 (0.00%)  0/8 (0.00%) 
General Physical Health Deterioration † 1  0/3 (0.00%)  1/15 (6.67%)  0/8 (0.00%) 
Mucosal Inflammation † 1  1/3 (33.33%)  0/15 (0.00%)  0/8 (0.00%) 
Pyrexia † 1  0/3 (0.00%)  1/15 (6.67%)  0/8 (0.00%) 
Infections and infestations       
Sepsis † 1  0/3 (0.00%)  1/15 (6.67%)  2/8 (25.00%) 
Pneumonia † 1  1/3 (33.33%)  0/15 (0.00%)  1/8 (12.50%) 
Staphylococcal Infection † 1  0/3 (0.00%)  1/15 (6.67%)  0/8 (0.00%) 
Investigations       
Clostridium Test Positive † 1  0/3 (0.00%)  0/15 (0.00%)  1/8 (12.50%) 
Metabolism and nutrition disorders       
Decreased Appetite † 1  0/3 (0.00%)  1/15 (6.67%)  0/8 (0.00%) 
Dehydration † 1  1/3 (33.33%)  0/15 (0.00%)  0/8 (0.00%) 
Food Intolerance † 1  0/3 (0.00%)  1/15 (6.67%)  0/8 (0.00%) 
Hypercalcaemia † 1  0/3 (0.00%)  1/15 (6.67%)  0/8 (0.00%) 
Musculoskeletal and connective tissue disorders       
Back Pain † 1  0/3 (0.00%)  1/15 (6.67%)  0/8 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Tumour Haemorrhage † 1  0/3 (0.00%)  0/15 (0.00%)  1/8 (12.50%) 
Nervous system disorders       
Cerebral Haemorrhage † 1  0/3 (0.00%)  1/15 (6.67%)  0/8 (0.00%) 
Haemorrhage Intracranial † 1  0/3 (0.00%)  1/15 (6.67%)  0/8 (0.00%) 
Neuropathy Peripheral † 1  0/3 (0.00%)  1/15 (6.67%)  0/8 (0.00%) 
Renal and urinary disorders       
Acute Kidney Injury † 1  1/3 (33.33%)  0/15 (0.00%)  0/8 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Dyspnoea † 1  1/3 (33.33%)  1/15 (6.67%)  0/8 (0.00%) 
Respiratory Failure † 1  0/3 (0.00%)  1/15 (6.67%)  0/8 (0.00%) 
Vascular disorders       
Deep Vein Thrombosis † 1  0/3 (0.00%)  0/15 (0.00%)  1/8 (12.50%) 
Embolism Arterial † 1  0/3 (0.00%)  1/15 (6.67%)  0/8 (0.00%) 
1
Term from vocabulary, MedDRA 20.1
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Selinexor 60 mg/m² (8 Doses/Cycle) Selinexor 60 mg (6 Doses/Cycle) Selinexor 60 mg (8 Doses/Cycle)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/3 (100.00%)   15/15 (100.00%)   7/8 (87.50%) 
Blood and lymphatic system disorders       
Thrombocytopenia † 1  1/3 (33.33%)  8/15 (53.33%)  5/8 (62.50%) 
Anaemia † 1  1/3 (33.33%)  5/15 (33.33%)  1/8 (12.50%) 
Neutropenia † 1  0/3 (0.00%)  3/15 (20.00%)  3/8 (37.50%) 
Leukopenia † 1  1/3 (33.33%)  2/15 (13.33%)  2/8 (25.00%) 
Leukocytosis † 1  0/3 (0.00%)  2/15 (13.33%)  0/8 (0.00%) 
Pancytopenia † 1  1/3 (33.33%)  1/15 (6.67%)  0/8 (0.00%) 
Febrile Neutropenia † 1  1/3 (33.33%)  0/15 (0.00%)  0/8 (0.00%) 
Cardiac disorders       
Tachycardia † 1  1/3 (33.33%)  0/15 (0.00%)  0/8 (0.00%) 
Ear and labyrinth disorders       
Deafness † 1  0/3 (0.00%)  1/15 (6.67%)  0/8 (0.00%) 
Vertigo † 1  1/3 (33.33%)  0/15 (0.00%)  0/8 (0.00%) 
Endocrine disorders       
Hypothyroidism † 1  0/3 (0.00%)  1/15 (6.67%)  0/8 (0.00%) 
Eye disorders       
Eye Irritation † 1  0/3 (0.00%)  1/15 (6.67%)  0/8 (0.00%) 
Ocular Toxicity † 1  0/3 (0.00%)  1/15 (6.67%)  0/8 (0.00%) 
Photophobia † 1  0/3 (0.00%)  0/15 (0.00%)  1/8 (12.50%) 
Vision Blurred † 1  0/3 (0.00%)  0/15 (0.00%)  1/8 (12.50%) 
Gastrointestinal disorders       
Nausea † 1  2/3 (66.67%)  8/15 (53.33%)  3/8 (37.50%) 
Diarrhea † 1  1/3 (33.33%)  5/15 (33.33%)  3/8 (37.50%) 
Vomiting † 1  1/3 (33.33%)  7/15 (46.67%)  1/8 (12.50%) 
Constipation † 1  1/3 (33.33%)  2/15 (13.33%)  2/8 (25.00%) 
Abdominal Pain † 1  0/3 (0.00%)  2/15 (13.33%)  0/8 (0.00%) 
Anal Incontinence † 1  0/3 (0.00%)  2/15 (13.33%)  0/8 (0.00%) 
Dry Mouth † 1  0/3 (0.00%)  2/15 (13.33%)  0/8 (0.00%) 
Abdominal Pain Lower † 1  0/3 (0.00%)  1/15 (6.67%)  0/8 (0.00%) 
Abdominal Pain Upper † 1  0/3 (0.00%)  1/15 (6.67%)  0/8 (0.00%) 
Dyspepsia † 1  0/3 (0.00%)  1/15 (6.67%)  0/8 (0.00%) 
Melaena † 1  0/3 (0.00%)  1/15 (6.67%)  0/8 (0.00%) 
Rectal Haemorrhage † 1  1/3 (33.33%)  0/15 (0.00%)  0/8 (0.00%) 
Stomatitis † 1  0/3 (0.00%)  0/15 (0.00%)  1/8 (12.50%) 
Tongue Coated † 1  0/3 (0.00%)  1/15 (6.67%)  0/8 (0.00%) 
General disorders       
Pyrexia † 1  1/3 (33.33%)  6/15 (40.00%)  2/8 (25.00%) 
Fatigue † 1  2/3 (66.67%)  4/15 (26.67%)  2/8 (25.00%) 
Asthenia † 1  1/3 (33.33%)  4/15 (26.67%)  2/8 (25.00%) 
Oedema Peripheral † 1  0/3 (0.00%)  5/15 (33.33%)  1/8 (12.50%) 
General Physical Health Deterioration † 1  1/3 (33.33%)  1/15 (6.67%)  0/8 (0.00%) 
Mucosal Inflammation † 1  1/3 (33.33%)  1/15 (6.67%)  0/8 (0.00%) 
Early Satiety † 1  0/3 (0.00%)  0/15 (0.00%)  1/8 (12.50%) 
Facial Pain † 1  0/3 (0.00%)  1/15 (6.67%)  0/8 (0.00%) 
Oedema † 1  0/3 (0.00%)  1/15 (6.67%)  0/8 (0.00%) 
Pain † 1  0/3 (0.00%)  1/15 (6.67%)  0/8 (0.00%) 
Hepatobiliary disorders       
Hyperbilirubinaemia † 1  0/3 (0.00%)  2/15 (13.33%)  0/8 (0.00%) 
Jaundice † 1  0/3 (0.00%)  1/15 (6.67%)  0/8 (0.00%) 
Infections and infestations       
Oral Candidiasis † 1  0/3 (0.00%)  1/15 (6.67%)  2/8 (25.00%) 
Urinary Tract Infection † 1  1/3 (33.33%)  1/15 (6.67%)  1/8 (12.50%) 
Oral Infection † 1  0/3 (0.00%)  2/15 (13.33%)  0/8 (0.00%) 
Upper Respiratory Tract Infection † 1  0/3 (0.00%)  1/15 (6.67%)  1/8 (12.50%) 
Bacteriuria † 1  0/3 (0.00%)  0/15 (0.00%)  1/8 (12.50%) 
Clostridium Difficile Infection † 1  0/3 (0.00%)  0/15 (0.00%)  1/8 (12.50%) 
Device Related Infection † 1  0/3 (0.00%)  1/15 (6.67%)  0/8 (0.00%) 
Herpes Ophthalmic † 1  0/3 (0.00%)  1/15 (6.67%)  0/8 (0.00%) 
Oral Herpes † 1  1/3 (33.33%)  0/15 (0.00%)  0/8 (0.00%) 
Osteomyelitis † 1  0/3 (0.00%)  1/15 (6.67%)  0/8 (0.00%) 
Pneumonia † 1  0/3 (0.00%)  1/15 (6.67%)  0/8 (0.00%) 
Respiratory Tract Infection † 1  0/3 (0.00%)  1/15 (6.67%)  0/8 (0.00%) 
Sepsis † 1  1/3 (33.33%)  0/15 (0.00%)  0/8 (0.00%) 
Sinusitis † 1  0/3 (0.00%)  0/15 (0.00%)  1/8 (12.50%) 
Injury, poisoning and procedural complications       
Fall † 1  0/3 (0.00%)  1/15 (6.67%)  0/8 (0.00%) 
Post Procedural Haematoma † 1  0/3 (0.00%)  1/15 (6.67%)  0/8 (0.00%) 
Skain Abrasion † 1  0/3 (0.00%)  0/15 (0.00%)  1/8 (12.50%) 
Investigations       
Blood Alkaline Phosphatase Increased † 1  1/3 (33.33%)  2/15 (13.33%)  1/8 (12.50%) 
Weight Decreased † 1  0/3 (0.00%)  0/15 (0.00%)  3/8 (37.50%) 
C-Reactive Protein Increased † 1  0/3 (0.00%)  2/15 (13.33%)  0/8 (0.00%) 
Gamma-Glutamyltransferase Increased † 1  0/3 (0.00%)  2/15 (13.33%)  0/8 (0.00%) 
Aspartate Aminotransferase Increased † 1  1/3 (33.33%)  0/15 (0.00%)  0/8 (0.00%) 
Blood Creatinine Phophokinase Decreased † 1  0/3 (0.00%)  1/15 (6.67%)  0/8 (0.00%) 
Blood Creatinine Phosphokinase Increased † 1  1/3 (33.33%)  0/15 (0.00%)  0/8 (0.00%) 
Hypophonesis † 1  0/3 (0.00%)  1/15 (6.67%)  0/8 (0.00%) 
International Normalised Ratio Increased † 1  0/3 (0.00%)  1/15 (6.67%)  0/8 (0.00%) 
Protein Total Decreased † 1  0/3 (0.00%)  1/15 (6.67%)  0/8 (0.00%) 
Metabolism and nutrition disorders       
Decreased Appetite † 1  2/3 (66.67%)  5/15 (33.33%)  2/8 (25.00%) 
Hyponatraemia † 1  1/3 (33.33%)  4/15 (26.67%)  2/8 (25.00%) 
Hypokalaemia † 1  1/3 (33.33%)  1/15 (6.67%)  3/8 (37.50%) 
Hypocalcaemia † 1  1/3 (33.33%)  1/15 (6.67%)  2/8 (25.00%) 
Hypercalcaemia † 1  1/3 (33.33%)  2/15 (13.33%)  0/8 (0.00%) 
Hyperglycaemia † 1  1/3 (33.33%)  1/15 (6.67%)  1/8 (12.50%) 
Hypoalbuminaemia † 1  0/3 (0.00%)  2/15 (13.33%)  1/8 (12.50%) 
Hypomagnesaemia † 1  0/3 (0.00%)  2/15 (13.33%)  1/8 (12.50%) 
Hypercreatininaemia † 1  0/3 (0.00%)  1/15 (6.67%)  1/8 (12.50%) 
Cachexia † 1  0/3 (0.00%)  1/15 (6.67%)  0/8 (0.00%) 
Dehydration † 1  0/3 (0.00%)  0/15 (0.00%)  1/8 (12.50%) 
Hyperkalaemia † 1  0/3 (0.00%)  1/15 (6.67%)  0/8 (0.00%) 
Hypermagnesaemia † 1  0/3 (0.00%)  0/15 (0.00%)  1/8 (12.50%) 
Hypochloraemia † 1  0/3 (0.00%)  1/15 (6.67%)  0/8 (0.00%) 
Hypophosphataemia † 1  0/3 (0.00%)  1/15 (6.67%)  0/8 (0.00%) 
Musculoskeletal and connective tissue disorders       
Back Pain † 1  1/3 (33.33%)  4/15 (26.67%)  0/8 (0.00%) 
Arthralgia † 1  0/3 (0.00%)  1/15 (6.67%)  1/8 (12.50%) 
Hypercreatinaemia † 1  0/3 (0.00%)  0/15 (0.00%)  2/8 (25.00%) 
Pain In Extremity † 1  0/3 (0.00%)  2/15 (13.33%)  0/8 (0.00%) 
Groin Pain † 1  0/3 (0.00%)  1/15 (6.67%)  0/8 (0.00%) 
Muscular Weakness † 1  0/3 (0.00%)  0/15 (0.00%)  1/8 (12.50%) 
Musculoskeletal Chest Pain † 1  0/3 (0.00%)  1/15 (6.67%)  0/8 (0.00%) 
Myopathy † 1  0/3 (0.00%)  1/15 (6.67%)  0/8 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Tumour Pain † 1  0/3 (0.00%)  0/15 (0.00%)  2/8 (25.00%) 
Tumour Associated Fever † 1  0/3 (0.00%)  1/15 (6.67%)  0/8 (0.00%) 
Nervous system disorders       
Dizziness † 1  0/3 (0.00%)  1/15 (6.67%)  4/8 (50.00%) 
Headache † 1  0/3 (0.00%)  3/15 (20.00%)  0/8 (0.00%) 
Dysgeusia † 1  0/3 (0.00%)  1/15 (6.67%)  1/8 (12.50%) 
Aphasia † 1  0/3 (0.00%)  1/15 (6.67%)  0/8 (0.00%) 
Ataxia † 1  0/3 (0.00%)  1/15 (6.67%)  0/8 (0.00%) 
Horner's Syndrome † 1  0/3 (0.00%)  1/15 (6.67%)  0/8 (0.00%) 
Hypokinesia † 1  0/3 (0.00%)  1/15 (6.67%)  0/8 (0.00%) 
Lethargy † 1  0/3 (0.00%)  1/15 (6.67%)  0/8 (0.00%) 
Migraine With Aura † 1  0/3 (0.00%)  1/15 (6.67%)  0/8 (0.00%) 
Nervous System Disorder † 1  0/3 (0.00%)  1/15 (6.67%)  0/8 (0.00%) 
Paraesthesia † 1  0/3 (0.00%)  1/15 (6.67%)  0/8 (0.00%) 
Visual Field Defect † 1  0/3 (0.00%)  1/15 (6.67%)  0/8 (0.00%) 
Psychiatric disorders       
Confusional State † 1  0/3 (0.00%)  0/15 (0.00%)  1/8 (12.50%) 
Insomnia † 1  0/3 (0.00%)  1/15 (6.67%)  0/8 (0.00%) 
Renal and urinary disorders       
Pollakiuria † 1  0/3 (0.00%)  1/15 (6.67%)  1/8 (12.50%) 
Urinary Incontinence † 1  0/3 (0.00%)  2/15 (13.33%)  0/8 (0.00%) 
Haematuria † 1  0/3 (0.00%)  0/15 (0.00%)  1/8 (12.50%) 
Incontinence † 1  0/3 (0.00%)  1/15 (6.67%)  0/8 (0.00%) 
Renal Failure † 1  0/3 (0.00%)  0/15 (0.00%)  1/8 (12.50%) 
Reproductive system and breast disorders       
Oedema Genital † 1  0/3 (0.00%)  1/15 (6.67%)  0/8 (0.00%) 
Pelvic Pain † 1  0/3 (0.00%)  1/15 (6.67%)  0/8 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Cough † 1  1/3 (33.33%)  1/15 (6.67%)  3/8 (37.50%) 
Dyspnoea † 1  0/3 (0.00%)  2/15 (13.33%)  1/8 (12.50%) 
Haemoptysis † 1  0/3 (0.00%)  1/15 (6.67%)  0/8 (0.00%) 
Nasal Congestion † 1  0/3 (0.00%)  1/15 (6.67%)  0/8 (0.00%) 
Oropharyngeal Pain † 1  0/3 (0.00%)  0/15 (0.00%)  1/8 (12.50%) 
Pleural Effusion † 1  0/3 (0.00%)  0/15 (0.00%)  1/8 (12.50%) 
Pulmonary Embolism † 1  0/3 (0.00%)  1/15 (6.67%)  0/8 (0.00%) 
Rhinorrhoea † 1  0/3 (0.00%)  1/15 (6.67%)  0/8 (0.00%) 
Skin and subcutaneous tissue disorders       
Dry Skin † 1  1/3 (33.33%)  1/15 (6.67%)  0/8 (0.00%) 
Erythema † 1  0/3 (0.00%)  1/15 (6.67%)  0/8 (0.00%) 
Pruritus † 1  0/3 (0.00%)  1/15 (6.67%)  0/8 (0.00%) 
Skin Discolouration † 1  0/3 (0.00%)  1/15 (6.67%)  0/8 (0.00%) 
Skin Lesion † 1  0/3 (0.00%)  1/15 (6.67%)  0/8 (0.00%) 
Vascular disorders       
Hypotension † 1  2/3 (66.67%)  0/15 (0.00%)  2/8 (25.00%) 
Haematoma † 1  1/3 (33.33%)  1/15 (6.67%)  0/8 (0.00%) 
Deep Vein Thrombosis † 1  0/3 (0.00%)  1/15 (6.67%)  0/8 (0.00%) 
Embolism † 1  0/3 (0.00%)  1/15 (6.67%)  0/8 (0.00%) 
Haemorrhage † 1  0/3 (0.00%)  0/15 (0.00%)  1/8 (12.50%) 
Hot Flush † 1  1/3 (33.33%)  0/15 (0.00%)  0/8 (0.00%) 
Hypertension † 1  0/3 (0.00%)  0/15 (0.00%)  1/8 (12.50%) 
Pallor † 1  1/3 (33.33%)  0/15 (0.00%)  0/8 (0.00%) 
Phlebitis † 1  0/3 (0.00%)  1/15 (6.67%)  0/8 (0.00%) 
Post Procedural Contusion † 1  0/3 (0.00%)  1/15 (6.67%)  0/8 (0.00%) 
1
Term from vocabulary, MedDRA 20.1
†
Indicates events were collected by systematic assessment
The low number of formal objective responses (leading to the termination of the study following the first stage), coupled with the high number of censored observations, limited meaningful analyses and the ability to draw conclusions from the data.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Jatin Shah, MD
Organization: Karyopharm Therapeutics Inc.
Phone: (617) 658-0600
EMail: jshah@karyopharm.com
Publications:
Layout table for additonal information
Responsible Party: Karyopharm Therapeutics Inc
ClinicalTrials.gov Identifier: NCT02138786    
Other Study ID Numbers: KCP-330-010
First Submitted: May 13, 2014
First Posted: May 15, 2014
Results First Submitted: December 18, 2019
Results First Posted: February 11, 2020
Last Update Posted: January 26, 2023