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Due to enrollment challenges
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This is a single-arm, multi-center, open-label phase 2 study of the SINEâ„¢ compound selinexor given orally to patients with relapsed or refractory PTCL or CTCL.
Approximately 60 patients with relapsed or refractory PTCL or CTCL who meet the eligibility criteria and have none of the exclusion criteria will be enrolled to receive selinexor until either disease progression or intolerance has occurred.
This is a single-arm, multi-center, open-label phase 2 study of the SINEâ„¢ compound selinexor given orally to patients with relapsed or refractory PTCL or CTCL.
Approximately 60 patients with relapsed or refractory PTCL or CTCL who meet the eligibility criteria and have none of the exclusion criteria will be enrolled to receive selinexor until either disease progression or intolerance has occurred.
Enrolled patients will be given selinexor as an oral fixed 60 mg dose (equivalent to ~35 mg/m²) on Days 1 and 3 of Weeks 1-4 of each 4-week cycle (total 8 doses per cycle).
There is no maximum treatment duration. Patients will receive supportive therapy to mitigate selinexor side effects, as well as best supportive care (BSC).
Patients enrolled under Protocol Versions <3.0 were to receive selinexor orally, at a fixed dose of 60 mg (equivalent to ~35 mg/m²) on Days 1 and 3 of Weeks 1-3 of each 4-week cycle (total of 6 doses per cycle). Selinexor was not taken during Week 4.
For all patients enrolled in this study (regardless of the protocol version) who continued onto Cycle 3 and forward, the dose was to be increased by 20 mg to 80 mg (administered on Days 1 and 3 of Weeks 1-4), only after consultation with the Sponsor's Medical Monitor.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Selinexor | Experimental | 60 mg dose (equivalent to ~35 mg/m²) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Selinexor | Drug | 20 mg oral tablets: 60 mg dose on Days 1 and 3 of Weeks 1-4 of each 4-week cycle (Protocol V.3.0). 20 mg oral tablets: 60 mg dose on Days 1 and 3 of Weeks 1-3 of each 4-week cycle (Protocol V.<3.0). Number of Cycles: up to 12 but there is no maximal duration for treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) | Overall Response (OR) = Complete Response (CR) + Partial Response (PR). Objective disease response assessment in PTCL patients was made according to the revised response criteria based on the International Working Group (IWG) guidelines for malignant lymphoma (Cheson, 2007). Objective disease response assessment in CTCL patients was assessed according to the revised CTCL Consensus Response Criteria (Olsen, 2011) using physical examination, including the Modified Severity Weighted Assessment Tool (mSWAT) for skin assessment. CTCL Global Response Score was used as a secondary efficacy assessment. Progression was defined as the first occurrence of progressive disease (PD) per the revised response criteria. Clinical disease progression in the absence of formal criteria for PD must be documented by a physician. | Disease response was assessed at screening and every 8 weeks (patients with PTCL); or at Cycle 1 Day 1 and every 4 weeks (patients with CTCL), until disease progression. |
| Best Overall Response: Complete Response (CR) | Patients who achieved CR (disappearance of all detectable evidence of disease). Objective disease response assessment in PTCL patients was made according to the revised response criteria based on the International Working Group (IWG) guidelines for malignant lymphoma (Cheson, 2007). Objective disease response assessment in CTCL patients was assessed according to the revised CTCL Consensus Response Criteria (Olsen, 2011) using physical examination, including the Modified Severity Weighted Assessment Tool (mSWAT) for skin assessment. CTCL Global Response Score was used as a secondary efficacy assessment. | Disease response was assessed at screening and every 8 weeks (patients with PTCL); or at Cycle 1 Day 1 and every 4 weeks (patients with CTCL), until disease progression. |
| Best Overall Response: Partial Response (PR) | Patients whose best overall response to study treatment was PR (regression of measurable disease and no new sites). Objective disease response assessment in PTCL patients was made according to the revised response criteria based on the International Working Group (IWG) guidelines for malignant lymphoma (Cheson, 2007). Objective disease response assessment in CTCL patients was assessed according to the revised CTCL Consensus Response Criteria (Olsen, 2011) using physical examination, including the Modified Severity Weighted Assessment Tool (mSWAT) for skin assessment. CTCL Global Response Score was used as a secondary efficacy assessment. |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Stable Disease, Including Patients With Partial Response | Duration of time from the date of start of study treatment to the date of disease progression. Objective disease response assessment in PTCL patients was made according to the revised response criteria based on the International Working Group (IWG) guidelines for malignant lymphoma (Cheson, 2007). Objective disease response assessment in CTCL patients was assessed according to the revised CTCL Consensus Response Criteria (Olsen, 2011) using physical examination, including the Modified Severity Weighted Assessment Tool (mSWAT) for skin assessment. CTCL Global Response Score was used as a secondary efficacy assessment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Concord Repatriation General Hospital (CRGH) | Concord | New South Wales | 2139 | Australia | ||
| Royal North Shore Hospital |
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| ID | Title | Description |
|---|---|---|
| FG000 | Selinexor (PTCL) | Assigned to 60 mg dose twice weekly |
| FG001 | Selinexor (CTCL) | Assigned to 60 mg dose twice weekly |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Disease response was assessed at screening and every 8 weeks (patients with PTCL); or at Cycle 1 Day 1 and every 4 weeks (patients with CTCL), until disease progression. |
| Best Overall Response: Stable Disease (SD) | Patients whose best overall response to study treatment was SD (failure to attain criteria needed for CR or PR, or to meet criteria for PD). Objective disease response assessment in PTCL patients was made according to the revised response criteria based on the International Working Group (IWG) guidelines for malignant lymphoma (Cheson, 2007). Objective disease response assessment in CTCL patients was assessed according to the revised CTCL Consensus Response Criteria (Olsen, 2011) using physical examination, including the Modified Severity Weighted Assessment Tool (mSWAT) for skin assessment. CTCL Global Response Score was used as a secondary efficacy assessment. | Disease response was assessed at screening and every 8 weeks (patients with PTCL); or at Cycle 1 Day 1 and every 4 weeks (patients with CTCL), until disease progression. |
| Best Overall Response: Progressive Disease (PD) | Patients whose best overall response to study treatment was PD. Progression was defined as the first occurrence of progressive disease (PD). Objective disease response assessment in PTCL patients was made according to the revised response criteria based on the International Working Group (IWG) guidelines for malignant lymphoma (Cheson, 2007). Objective disease response assessment in CTCL patients was assessed according to the revised CTCL Consensus Response Criteria (Olsen, 2011) using physical examination, including the Modified Severity Weighted Assessment Tool (mSWAT) for skin assessment. CTCL Global Response Score was used as a secondary efficacy assessment. Clinical disease progression in the absence of formal criteria for PD must be documented by a physician. | Disease response was assessed at screening and every 8 weeks (patients with PTCL); or at Cycle 1 Day 1 and every 4 weeks (patients with CTCL), until disease progression. |
| Best Overall Response: Not Evaluable (NE) | Patients who could not be assessed quantitatively for disease response for any reason. | Disease response was assessed at screening and every 8 weeks (patients with PTCL); or at Cycle 1 Day 1 and every 4 weeks (patients with CTCL), until disease progression. |
| Date of start of study treatment to date of progression. Patients without documented PD are censored on date of last radiologic assessment. |
| Disease Control Rate (DCR) | Percentage of patients who have CR, PR, or SD lasting ≥ 8 weeks. Objective disease response assessment in PTCL patients was made according to the revised response criteria based on the International Working Group (IWG) guidelines for malignant lymphoma (Cheson, 2007). Objective disease response assessment in CTCL patients was assessed according to the revised CTCL Consensus Response Criteria (Olsen, 2011) using physical examination, including the Modified Severity Weighted Assessment Tool (mSWAT) for skin assessment. CTCL Global Response Score was used as a secondary efficacy assessment. | Disease response was assessed at screening and every 8 weeks (patients with PTCL); or at Cycle 1 Day 1 and every 4 weeks (patients with CTCL), until disease progression. |
| Progression Free Survival (PFS) | Duration of time from start of study treatment to date of disease progression or death from any cause. | Study treatment start date to date of disease progression or date of death. Patients without documented PD are censored on date of last radiologic assessment. |
| St Leonards |
| New South Wales |
| 2139 |
| Australia |
| Westmead Hospital | Westmead | New South Wales | 2145 | Australia |
| Cabrini Hospital | Malvern | Victoria | Australia |
| National Cancer Centre | Singapore | 169610 | Singapore |
| FG002 | Selinexor (CTCL) 8 Doses/Cycle | Assigned to 60 mg dose twice weekly for weeks 1-4 |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Selinexor (PTCL) | Assigned to 60 mg dose, 6 doses/cycle |
| BG001 | Selinexor (CTCL) | Assigned to 60 mg dose, 6 doses/cycle (6 patients); Assigned to 60 mg dose, 8 doses/cycle (1 patient) |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Overall Response Rate (ORR) | Overall Response (OR) = Complete Response (CR) + Partial Response (PR). Objective disease response assessment in PTCL patients was made according to the revised response criteria based on the International Working Group (IWG) guidelines for malignant lymphoma (Cheson, 2007). Objective disease response assessment in CTCL patients was assessed according to the revised CTCL Consensus Response Criteria (Olsen, 2011) using physical examination, including the Modified Severity Weighted Assessment Tool (mSWAT) for skin assessment. CTCL Global Response Score was used as a secondary efficacy assessment. Progression was defined as the first occurrence of progressive disease (PD) per the revised response criteria. Clinical disease progression in the absence of formal criteria for PD must be documented by a physician. | Due to the limited enrollment in this study, only the Intent to Treat (ITT) Population, consisting of all patients who received at least 1 dose of study treatment (which is identical to the Safety Population), was evaluated for efficacy. | Posted | Number | 80% Confidence Interval | Percentage of participants | Disease response was assessed at screening and every 8 weeks (patients with PTCL); or at Cycle 1 Day 1 and every 4 weeks (patients with CTCL), until disease progression. |
|
|
| ||||||||||||||||||||||||||||
| Primary | Best Overall Response: Complete Response (CR) | Patients who achieved CR (disappearance of all detectable evidence of disease). Objective disease response assessment in PTCL patients was made according to the revised response criteria based on the International Working Group (IWG) guidelines for malignant lymphoma (Cheson, 2007). Objective disease response assessment in CTCL patients was assessed according to the revised CTCL Consensus Response Criteria (Olsen, 2011) using physical examination, including the Modified Severity Weighted Assessment Tool (mSWAT) for skin assessment. CTCL Global Response Score was used as a secondary efficacy assessment. | Intent to Treat population | Posted | Count of Participants | Participants | Disease response was assessed at screening and every 8 weeks (patients with PTCL); or at Cycle 1 Day 1 and every 4 weeks (patients with CTCL), until disease progression. |
|
| ||||||||||||||||||||||||||||||
| Primary | Best Overall Response: Partial Response (PR) | Patients whose best overall response to study treatment was PR (regression of measurable disease and no new sites). Objective disease response assessment in PTCL patients was made according to the revised response criteria based on the International Working Group (IWG) guidelines for malignant lymphoma (Cheson, 2007). Objective disease response assessment in CTCL patients was assessed according to the revised CTCL Consensus Response Criteria (Olsen, 2011) using physical examination, including the Modified Severity Weighted Assessment Tool (mSWAT) for skin assessment. CTCL Global Response Score was used as a secondary efficacy assessment. | Intent to Treat (ITT) population | Posted | Count of Participants | Participants | Disease response was assessed at screening and every 8 weeks (patients with PTCL); or at Cycle 1 Day 1 and every 4 weeks (patients with CTCL), until disease progression. |
|
| ||||||||||||||||||||||||||||||
| Primary | Best Overall Response: Stable Disease (SD) | Patients whose best overall response to study treatment was SD (failure to attain criteria needed for CR or PR, or to meet criteria for PD). Objective disease response assessment in PTCL patients was made according to the revised response criteria based on the International Working Group (IWG) guidelines for malignant lymphoma (Cheson, 2007). Objective disease response assessment in CTCL patients was assessed according to the revised CTCL Consensus Response Criteria (Olsen, 2011) using physical examination, including the Modified Severity Weighted Assessment Tool (mSWAT) for skin assessment. CTCL Global Response Score was used as a secondary efficacy assessment. | Intent to Treat population | Posted | Count of Participants | Participants | Disease response was assessed at screening and every 8 weeks (patients with PTCL); or at Cycle 1 Day 1 and every 4 weeks (patients with CTCL), until disease progression. |
|
| ||||||||||||||||||||||||||||||
| Primary | Best Overall Response: Progressive Disease (PD) | Patients whose best overall response to study treatment was PD. Progression was defined as the first occurrence of progressive disease (PD). Objective disease response assessment in PTCL patients was made according to the revised response criteria based on the International Working Group (IWG) guidelines for malignant lymphoma (Cheson, 2007). Objective disease response assessment in CTCL patients was assessed according to the revised CTCL Consensus Response Criteria (Olsen, 2011) using physical examination, including the Modified Severity Weighted Assessment Tool (mSWAT) for skin assessment. CTCL Global Response Score was used as a secondary efficacy assessment. Clinical disease progression in the absence of formal criteria for PD must be documented by a physician. | Intent to Treat population | Posted | Count of Participants | Participants | Disease response was assessed at screening and every 8 weeks (patients with PTCL); or at Cycle 1 Day 1 and every 4 weeks (patients with CTCL), until disease progression. |
| |||||||||||||||||||||||||||||||
| Primary | Best Overall Response: Not Evaluable (NE) | Patients who could not be assessed quantitatively for disease response for any reason. | Intent to Treat population | Posted | Count of Participants | Participants | Disease response was assessed at screening and every 8 weeks (patients with PTCL); or at Cycle 1 Day 1 and every 4 weeks (patients with CTCL), until disease progression. |
|
| ||||||||||||||||||||||||||||||
| Secondary | Duration of Stable Disease, Including Patients With Partial Response | Duration of time from the date of start of study treatment to the date of disease progression. Objective disease response assessment in PTCL patients was made according to the revised response criteria based on the International Working Group (IWG) guidelines for malignant lymphoma (Cheson, 2007). Objective disease response assessment in CTCL patients was assessed according to the revised CTCL Consensus Response Criteria (Olsen, 2011) using physical examination, including the Modified Severity Weighted Assessment Tool (mSWAT) for skin assessment. CTCL Global Response Score was used as a secondary efficacy assessment. | Those participants with stable disease, including those with partial response, as a subset of the Intent to Treat (ITT) population | Posted | Median | 95% Confidence Interval | Days | Date of start of study treatment to date of progression. Patients without documented PD are censored on date of last radiologic assessment. |
|
| |||||||||||||||||||||||||||||
| Secondary | Disease Control Rate (DCR) | Percentage of patients who have CR, PR, or SD lasting ≥ 8 weeks. Objective disease response assessment in PTCL patients was made according to the revised response criteria based on the International Working Group (IWG) guidelines for malignant lymphoma (Cheson, 2007). Objective disease response assessment in CTCL patients was assessed according to the revised CTCL Consensus Response Criteria (Olsen, 2011) using physical examination, including the Modified Severity Weighted Assessment Tool (mSWAT) for skin assessment. CTCL Global Response Score was used as a secondary efficacy assessment. | Intent to Treat (ITT) Population | Posted | Number | 80% Confidence Interval | Percentage of participants | Disease response was assessed at screening and every 8 weeks (patients with PTCL); or at Cycle 1 Day 1 and every 4 weeks (patients with CTCL), until disease progression. |
|
| |||||||||||||||||||||||||||||
| Secondary | Progression Free Survival (PFS) | Duration of time from start of study treatment to date of disease progression or death from any cause. | Intent to Treat population. | Posted | Median | 95% Confidence Interval | Days | Study treatment start date to date of disease progression or date of death. Patients without documented PD are censored on date of last radiologic assessment. |
|
|
Day of onset after the first dose of study treatment through 30 days following the last dose of study treatment.
All patients who received at least 1 dose of study treatment were included in the Safety Population.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Selinexor (PTCL) | Assigned to 60 mg; 6 doses/cycle | 3 | 9 | 8 | 9 | 9 | 9 |
| EG001 | Selinexor (CTCL) | Assigned to 60 mg; 6 doses/cycle (6 patients) Assigned to 60 mg; 8 doses/cycle (1 patient) | 1 | 7 | 1 | 7 | 7 | 7 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Anemia | Blood and lymphatic system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Febrile Neutropenia | Blood and lymphatic system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Wound Infection Staphylococcal | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Aphasia | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Rectal Haemorrhage | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Muscular Weakness | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Psychotic Disorder | Psychiatric disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Renal Impairment | Renal and urinary disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Deep Vein Thrombosis | Vascular disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (20.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Dry Mouth | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Gastroesophageal Reflux Disease | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Abnormal Loss of Weight | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Neutrophilia | Blood and lymphatic system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Fungal Skin Infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Skin Infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Night Sweats | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Swelling Face | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Vision Blurred | Eye disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Blood Lactate Dehydrogenase Increased | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Mean Cell Haemoglobin Concentration Increased | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Orthostatic Hypotension | Vascular disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Ear Pain | Ear and labyrinth disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Muscular Weakness | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Feeling Cold | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Influenza Like Illness | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Pain | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Peripheral Swelling | General disorders | MedDRA (20.1) | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Amnesia | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
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| Neuropathy Peripheral | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
|
Due to unexpectedly slow recruitment, the Sponsor decided to terminate the study after 16 patients had been enrolled. The small study population limits the evaluation of both efficacy and safety of selinexor in patients with PTCL or CTCL.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jatin Shah, MD | Karyopharm Therapeutics Inc. | (617) 658-0600 | jshah@karyopharm.com |
| ID | Term |
|---|---|
| D016411 | Lymphoma, T-Cell, Peripheral |
| D016410 | Lymphoma, T-Cell, Cutaneous |
| ID | Term |
|---|---|
| D016399 | Lymphoma, T-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C585161 | selinexor |
Not provided
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Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Participants |
|
|
| Participants |
|
|
| Participants |
|
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| Units | Counts |
|---|
| Participants |
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| Participants |
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| Participants |
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