Trial Outcomes & Findings for Selinexor in Patients With Advanced Thymic Epithelial Tumor Progressing After Primary Chemotherapy (NCT NCT03193437)
NCT ID: NCT03193437
Last Updated: 2023-02-16
Results Overview
To determine the overall response rate per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT: Complete Response (CR), Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm.; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR+ PR.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
8 participants
Primary outcome timeframe
24 months
Results posted on
2023-02-16
Participant Flow
Participant milestones
| Measure |
Selinexor
Open Label Selinexor 40 mg
Open Label Selinexor: Selinexor 40 mg oral tablets will be administered twice weekly, either on Monday/Wednesday, Tuesday/Thursday, Wednesday/Friday, Thursday/Saturday, or Friday/Sunday in a 3-weeks-on and 1-week-off schedule.
|
|---|---|
|
Overall Study
STARTED
|
8
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
8
|
Reasons for withdrawal
| Measure |
Selinexor
Open Label Selinexor 40 mg
Open Label Selinexor: Selinexor 40 mg oral tablets will be administered twice weekly, either on Monday/Wednesday, Tuesday/Thursday, Wednesday/Friday, Thursday/Saturday, or Friday/Sunday in a 3-weeks-on and 1-week-off schedule.
|
|---|---|
|
Overall Study
Adverse Event
|
4
|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Disease Progression
|
2
|
Baseline Characteristics
Selinexor in Patients With Advanced Thymic Epithelial Tumor Progressing After Primary Chemotherapy
Baseline characteristics by cohort
| Measure |
Selinexor
n=8 Participants
Open Label Selinexor 40 mg
Open Label Selinexor: Selinexor 40 mg oral tablets will be administered twice weekly, either on Monday/Wednesday, Tuesday/Thursday, Wednesday/Friday, Thursday/Saturday, or Friday/Sunday in a 3-weeks-on and 1-week-off schedule.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 monthsTo determine the overall response rate per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT: Complete Response (CR), Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm.; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR+ PR.
Outcome measures
| Measure |
Selinexor
n=8 Participants
Open Label Selinexor 40 mg
Open Label Selinexor: Selinexor 40 mg oral tablets will be administered twice weekly, either on Monday/Wednesday, Tuesday/Thursday, Wednesday/Friday, Thursday/Saturday, or Friday/Sunday in a 3-weeks-on and 1-week-off schedule.
|
|---|---|
|
Overall Response Rate
|
0 percentage of patients
|
SECONDARY outcome
Timeframe: 24 monthsTo determine the overall response rate to according to modified ITMIG response criteria. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT and MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
Selinexor
n=8 Participants
Open Label Selinexor 40 mg
Open Label Selinexor: Selinexor 40 mg oral tablets will be administered twice weekly, either on Monday/Wednesday, Tuesday/Thursday, Wednesday/Friday, Thursday/Saturday, or Friday/Sunday in a 3-weeks-on and 1-week-off schedule.
|
|---|---|
|
Overall Response Rate
|
0 percent of participants
|
SECONDARY outcome
Timeframe: 6 monthsTo determine six months progression free survival of patients with TET treated with selinexor
Outcome measures
| Measure |
Selinexor
n=8 Participants
Open Label Selinexor 40 mg
Open Label Selinexor: Selinexor 40 mg oral tablets will be administered twice weekly, either on Monday/Wednesday, Tuesday/Thursday, Wednesday/Friday, Thursday/Saturday, or Friday/Sunday in a 3-weeks-on and 1-week-off schedule.
|
|---|---|
|
6 Month Progression Free Survival Rate
|
55.6 percent
|
SECONDARY outcome
Timeframe: 24 monthsTo determine overall survival of patients with TET treated with selinexor
Outcome measures
| Measure |
Selinexor
n=8 Participants
Open Label Selinexor 40 mg
Open Label Selinexor: Selinexor 40 mg oral tablets will be administered twice weekly, either on Monday/Wednesday, Tuesday/Thursday, Wednesday/Friday, Thursday/Saturday, or Friday/Sunday in a 3-weeks-on and 1-week-off schedule.
|
|---|---|
|
24 Month Overall Survival Rate
|
57.1 percent
|
SECONDARY outcome
Timeframe: 24 monthsThe number of adverse events as determined by Common Terminology Criteria for Adverse Events (CTCAEs) version 4.03
Outcome measures
| Measure |
Selinexor
n=8 Participants
Open Label Selinexor 40 mg
Open Label Selinexor: Selinexor 40 mg oral tablets will be administered twice weekly, either on Monday/Wednesday, Tuesday/Thursday, Wednesday/Friday, Thursday/Saturday, or Friday/Sunday in a 3-weeks-on and 1-week-off schedule.
|
|---|---|
|
Adverse Events
|
93 Adverse events
|
Adverse Events
Selinexor
Serious events: 5 serious events
Other events: 8 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Selinexor
n=8 participants at risk
Open Label Selinexor 40 mg
Open Label Selinexor: Selinexor 40 mg oral tablets will be administered twice weekly, either on Monday/Wednesday, Tuesday/Thursday, Wednesday/Friday, Thursday/Saturday, or Friday/Sunday in a 3-weeks-on and 1-week-off schedule.
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
25.0%
2/8 • Number of events 2 • From the time of consent to 30 days following the last dose of study treatment (max 24 months).
|
|
Infections and infestations
Pneumonia
|
25.0%
2/8 • Number of events 4 • From the time of consent to 30 days following the last dose of study treatment (max 24 months).
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
12.5%
1/8 • Number of events 1 • From the time of consent to 30 days following the last dose of study treatment (max 24 months).
|
Other adverse events
| Measure |
Selinexor
n=8 participants at risk
Open Label Selinexor 40 mg
Open Label Selinexor: Selinexor 40 mg oral tablets will be administered twice weekly, either on Monday/Wednesday, Tuesday/Thursday, Wednesday/Friday, Thursday/Saturday, or Friday/Sunday in a 3-weeks-on and 1-week-off schedule.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
50.0%
4/8 • Number of events 10 • From the time of consent to 30 days following the last dose of study treatment (max 24 months).
|
|
Cardiac disorders
Cardiac Disorders other, specify
|
12.5%
1/8 • Number of events 1 • From the time of consent to 30 days following the last dose of study treatment (max 24 months).
|
|
Eye disorders
Cataract
|
12.5%
1/8 • Number of events 1 • From the time of consent to 30 days following the last dose of study treatment (max 24 months).
|
|
Eye disorders
Dry eye
|
12.5%
1/8 • Number of events 1 • From the time of consent to 30 days following the last dose of study treatment (max 24 months).
|
|
Eye disorders
Eye disorders - Other, specify
|
12.5%
1/8 • Number of events 1 • From the time of consent to 30 days following the last dose of study treatment (max 24 months).
|
|
Gastrointestinal disorders
Abdominal pain
|
12.5%
1/8 • Number of events 1 • From the time of consent to 30 days following the last dose of study treatment (max 24 months).
|
|
Gastrointestinal disorders
Constipation
|
25.0%
2/8 • Number of events 2 • From the time of consent to 30 days following the last dose of study treatment (max 24 months).
|
|
Gastrointestinal disorders
Diarrhea
|
25.0%
2/8 • Number of events 2 • From the time of consent to 30 days following the last dose of study treatment (max 24 months).
|
|
Gastrointestinal disorders
Mucositis oral
|
25.0%
2/8 • Number of events 3 • From the time of consent to 30 days following the last dose of study treatment (max 24 months).
|
|
Gastrointestinal disorders
Nausea
|
87.5%
7/8 • Number of events 10 • From the time of consent to 30 days following the last dose of study treatment (max 24 months).
|
|
Gastrointestinal disorders
Vomiting
|
37.5%
3/8 • Number of events 3 • From the time of consent to 30 days following the last dose of study treatment (max 24 months).
|
|
General disorders
asthenia
|
12.5%
1/8 • Number of events 2 • From the time of consent to 30 days following the last dose of study treatment (max 24 months).
|
|
General disorders
lightheadedness
|
12.5%
1/8 • Number of events 1 • From the time of consent to 30 days following the last dose of study treatment (max 24 months).
|
|
General disorders
Edema limbs
|
12.5%
1/8 • Number of events 1 • From the time of consent to 30 days following the last dose of study treatment (max 24 months).
|
|
General disorders
Fatigue
|
25.0%
2/8 • Number of events 2 • From the time of consent to 30 days following the last dose of study treatment (max 24 months).
|
|
General disorders
Fever
|
12.5%
1/8 • Number of events 1 • From the time of consent to 30 days following the last dose of study treatment (max 24 months).
|
|
Infections and infestations
Infections and infestations - Other, specify
|
12.5%
1/8 • Number of events 1 • From the time of consent to 30 days following the last dose of study treatment (max 24 months).
|
|
Infections and infestations
Mucosal infection
|
12.5%
1/8 • Number of events 1 • From the time of consent to 30 days following the last dose of study treatment (max 24 months).
|
|
Infections and infestations
Skin infection
|
12.5%
1/8 • Number of events 1 • From the time of consent to 30 days following the last dose of study treatment (max 24 months).
|
|
Infections and infestations
Upper respiratory infection
|
12.5%
1/8 • Number of events 1 • From the time of consent to 30 days following the last dose of study treatment (max 24 months).
|
|
Investigations
Alanine aminotransferase increased
|
25.0%
2/8 • Number of events 2 • From the time of consent to 30 days following the last dose of study treatment (max 24 months).
|
|
Investigations
Aspartate aminotransferase increased
|
25.0%
2/8 • Number of events 3 • From the time of consent to 30 days following the last dose of study treatment (max 24 months).
|
|
Investigations
Electrocardiogram QT corrected interval prolonged
|
25.0%
2/8 • Number of events 3 • From the time of consent to 30 days following the last dose of study treatment (max 24 months).
|
|
Investigations
Platelet count decreased
|
37.5%
3/8 • Number of events 3 • From the time of consent to 30 days following the last dose of study treatment (max 24 months).
|
|
Investigations
Weight loss
|
12.5%
1/8 • Number of events 1 • From the time of consent to 30 days following the last dose of study treatment (max 24 months).
|
|
Metabolism and nutrition disorders
Anorexia
|
62.5%
5/8 • Number of events 6 • From the time of consent to 30 days following the last dose of study treatment (max 24 months).
|
|
Metabolism and nutrition disorders
Dehydration
|
12.5%
1/8 • Number of events 1 • From the time of consent to 30 days following the last dose of study treatment (max 24 months).
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
12.5%
1/8 • Number of events 1 • From the time of consent to 30 days following the last dose of study treatment (max 24 months).
|
|
Nervous system disorders
Dysgeusia
|
37.5%
3/8 • Number of events 3 • From the time of consent to 30 days following the last dose of study treatment (max 24 months).
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
12.5%
1/8 • Number of events 1 • From the time of consent to 30 days following the last dose of study treatment (max 24 months).
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
12.5%
1/8 • Number of events 2 • From the time of consent to 30 days following the last dose of study treatment (max 24 months).
|
|
Psychiatric disorders
Agitation
|
12.5%
1/8 • Number of events 1 • From the time of consent to 30 days following the last dose of study treatment (max 24 months).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.5%
1/8 • Number of events 2 • From the time of consent to 30 days following the last dose of study treatment (max 24 months).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
37.5%
3/8 • Number of events 4 • From the time of consent to 30 days following the last dose of study treatment (max 24 months).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
12.5%
1/8 • Number of events 1 • From the time of consent to 30 days following the last dose of study treatment (max 24 months).
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
12.5%
1/8 • Number of events 1 • From the time of consent to 30 days following the last dose of study treatment (max 24 months).
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
12.5%
1/8 • Number of events 1 • From the time of consent to 30 days following the last dose of study treatment (max 24 months).
|
|
Skin and subcutaneous tissue disorders
Rash
|
12.5%
1/8 • Number of events 1 • From the time of consent to 30 days following the last dose of study treatment (max 24 months).
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
12.5%
1/8 • Number of events 2 • From the time of consent to 30 days following the last dose of study treatment (max 24 months).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place