Trial Outcomes & Findings for Selinexor in Treating Patients With Relapsed Small Cell Lung Cancer (NCT NCT02351505)
NCT ID: NCT02351505
Last Updated: 2016-05-16
Results Overview
Estimated by the method of Kaplan and Meier for each cohort. Appropriate one-sided 90% confidence boundary will also be calculated for the final test Kaplan-Meyer test statistic at 12 weeks.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
1 participants
Primary outcome timeframe
Time from the date of study registration to the date of disease progression or to the date of last observation when no event (disease progression) has occurred, assessed up to 4 years
Results posted on
2016-05-16
Participant Flow
Participant milestones
| Measure |
Arm A: Selinexor (KPT-330)
Patients receive selinexor PO twice weekly. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Pharmacological Study: Correlative studies
|
|---|---|
|
Overall Study
STARTED
|
1
|
|
Overall Study
COMPLETED
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Selinexor in Treating Patients With Relapsed Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Arm A: Selinexor (KPT-330)
n=1 Participants
Patients receive selinexor PO twice weekly. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=93 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 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
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
1 patients
n=93 Participants
|
PRIMARY outcome
Timeframe: Time from the date of study registration to the date of disease progression or to the date of last observation when no event (disease progression) has occurred, assessed up to 4 yearsPopulation: Unable to analyze data due to only 1 patient being enrolled on the study
Estimated by the method of Kaplan and Meier for each cohort. Appropriate one-sided 90% confidence boundary will also be calculated for the final test Kaplan-Meyer test statistic at 12 weeks.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 4 yearsPopulation: Unable to analyze data due to only 1 patient being enrolled on the study
The overall response rate will be calculated as the number of PRs and CRs divided by the total number of evaluable patients. Estimates will be accompanied by exact binomial confidence intervals as well.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 4 yearsPopulation: Unable to analyze data due to only 1 patient being enrolled on the study
Estimates will be accompanied by exact binomial confidence intervals.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Date of study registration to the date of event (i.e., death) or the date of last follow-up if no event has occurred at their last evaluation assessed up to 4 yearsPopulation: Unable to analyze data due to only 1 patient being enrolled on the study
Kaplan-Meier curves will be used to estimate overall survival. Consider Cox proportional hazards models to explore a limited set of confounding factors.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 4 yearsPopulation: Unable to analyze data due to only 1 patient being enrolled on the study
Summarized by descriptive statistics for each of the disease cohorts. The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns. In addition, review all adverse event data that is graded as 3, 4, or 5 and classified as either "unrelated" or "unlikely to be related" to study treatment in the event of an actual relationship developing.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 4 yearsThe incidence of severe (grade 3+) adverse events or toxicities will be described.
Outcome measures
| Measure |
Arm A: Selinexor (KPT-330)
n=1 Participants
Patients receive selinexor PO twice weekly. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Pharmacological Study: Correlative studies
|
|---|---|
|
Incidence of Severe (Grade 3+) Adverse Events or Toxicities as Per NCI CTCAE v4.0
Hyperglycemia
|
100 percentage of patients
|
|
Incidence of Severe (Grade 3+) Adverse Events or Toxicities as Per NCI CTCAE v4.0
Fatigue
|
100 percentage of patients
|
|
Incidence of Severe (Grade 3+) Adverse Events or Toxicities as Per NCI CTCAE v4.0
Generalized muscle weakness
|
100 percentage of patients
|
|
Incidence of Severe (Grade 3+) Adverse Events or Toxicities as Per NCI CTCAE v4.0
Bilateral Lower Extrem Edema
|
100 percentage of patients
|
|
Incidence of Severe (Grade 3+) Adverse Events or Toxicities as Per NCI CTCAE v4.0
Hyponatremia
|
100 percentage of patients
|
SECONDARY outcome
Timeframe: Up to 4 yearsPopulation: Unable to analyze data due to only 1 patient being enrolled on the study
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 4 yearsPopulation: Unable to analyze data due to only 1 patient being enrolled on the study
Outcome measures
Outcome data not reported
Adverse Events
Arm A: Selinexor (KPT-330)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Arm A: Selinexor (KPT-330)
n=1 participants at risk
Patients receive selinexor PO twice weekly. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Investigations
Activated PTT prolonged
|
100.0%
1/1 • Number of events 1
Frequency and severity of adverse events and tolerability of the regimen were collected and summarized by descriptive statistics for each of the disease cohorts. As per NCI CTCAE v4.0, the term toxicity is defined as adverse events that are classified as either not related, possibly, probably, or definitely related to study treatment.
|
|
Blood and lymphatic system disorders
Anemia
|
100.0%
1/1 • Number of events 1
Frequency and severity of adverse events and tolerability of the regimen were collected and summarized by descriptive statistics for each of the disease cohorts. As per NCI CTCAE v4.0, the term toxicity is defined as adverse events that are classified as either not related, possibly, probably, or definitely related to study treatment.
|
|
Gastrointestinal disorders
Anorexia
|
100.0%
1/1 • Number of events 1
Frequency and severity of adverse events and tolerability of the regimen were collected and summarized by descriptive statistics for each of the disease cohorts. As per NCI CTCAE v4.0, the term toxicity is defined as adverse events that are classified as either not related, possibly, probably, or definitely related to study treatment.
|
|
Nervous system disorders
Concentration impairment
|
100.0%
1/1 • Number of events 1
Frequency and severity of adverse events and tolerability of the regimen were collected and summarized by descriptive statistics for each of the disease cohorts. As per NCI CTCAE v4.0, the term toxicity is defined as adverse events that are classified as either not related, possibly, probably, or definitely related to study treatment.
|
|
Nervous system disorders
Depressed level of conciousness
|
100.0%
1/1 • Number of events 1
Frequency and severity of adverse events and tolerability of the regimen were collected and summarized by descriptive statistics for each of the disease cohorts. As per NCI CTCAE v4.0, the term toxicity is defined as adverse events that are classified as either not related, possibly, probably, or definitely related to study treatment.
|
|
Eye disorders
Eye disorder-decreased visual acuity
|
100.0%
1/1 • Number of events 1
Frequency and severity of adverse events and tolerability of the regimen were collected and summarized by descriptive statistics for each of the disease cohorts. As per NCI CTCAE v4.0, the term toxicity is defined as adverse events that are classified as either not related, possibly, probably, or definitely related to study treatment.
|
|
Eye disorders
Fall
|
100.0%
1/1 • Number of events 1
Frequency and severity of adverse events and tolerability of the regimen were collected and summarized by descriptive statistics for each of the disease cohorts. As per NCI CTCAE v4.0, the term toxicity is defined as adverse events that are classified as either not related, possibly, probably, or definitely related to study treatment.
|
|
General disorders
Fatigue
|
100.0%
1/1 • Number of events 1
Frequency and severity of adverse events and tolerability of the regimen were collected and summarized by descriptive statistics for each of the disease cohorts. As per NCI CTCAE v4.0, the term toxicity is defined as adverse events that are classified as either not related, possibly, probably, or definitely related to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Generalized Muscle Weakness
|
100.0%
1/1 • Number of events 1
Frequency and severity of adverse events and tolerability of the regimen were collected and summarized by descriptive statistics for each of the disease cohorts. As per NCI CTCAE v4.0, the term toxicity is defined as adverse events that are classified as either not related, possibly, probably, or definitely related to study treatment.
|
|
Nervous system disorders
Headache
|
100.0%
1/1 • Number of events 1
Frequency and severity of adverse events and tolerability of the regimen were collected and summarized by descriptive statistics for each of the disease cohorts. As per NCI CTCAE v4.0, the term toxicity is defined as adverse events that are classified as either not related, possibly, probably, or definitely related to study treatment.
|
|
Renal and urinary disorders
Hematuria
|
100.0%
1/1 • Number of events 1
Frequency and severity of adverse events and tolerability of the regimen were collected and summarized by descriptive statistics for each of the disease cohorts. As per NCI CTCAE v4.0, the term toxicity is defined as adverse events that are classified as either not related, possibly, probably, or definitely related to study treatment.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
100.0%
1/1 • Number of events 1
Frequency and severity of adverse events and tolerability of the regimen were collected and summarized by descriptive statistics for each of the disease cohorts. As per NCI CTCAE v4.0, the term toxicity is defined as adverse events that are classified as either not related, possibly, probably, or definitely related to study treatment.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
100.0%
1/1 • Number of events 1
Frequency and severity of adverse events and tolerability of the regimen were collected and summarized by descriptive statistics for each of the disease cohorts. As per NCI CTCAE v4.0, the term toxicity is defined as adverse events that are classified as either not related, possibly, probably, or definitely related to study treatment.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
100.0%
1/1 • Number of events 1
Frequency and severity of adverse events and tolerability of the regimen were collected and summarized by descriptive statistics for each of the disease cohorts. As per NCI CTCAE v4.0, the term toxicity is defined as adverse events that are classified as either not related, possibly, probably, or definitely related to study treatment.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
100.0%
1/1 • Number of events 1
Frequency and severity of adverse events and tolerability of the regimen were collected and summarized by descriptive statistics for each of the disease cohorts. As per NCI CTCAE v4.0, the term toxicity is defined as adverse events that are classified as either not related, possibly, probably, or definitely related to study treatment.
|
|
General disorders
Edema
|
100.0%
1/1 • Number of events 1
Frequency and severity of adverse events and tolerability of the regimen were collected and summarized by descriptive statistics for each of the disease cohorts. As per NCI CTCAE v4.0, the term toxicity is defined as adverse events that are classified as either not related, possibly, probably, or definitely related to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgias
|
100.0%
1/1 • Number of events 1
Frequency and severity of adverse events and tolerability of the regimen were collected and summarized by descriptive statistics for each of the disease cohorts. As per NCI CTCAE v4.0, the term toxicity is defined as adverse events that are classified as either not related, possibly, probably, or definitely related to study treatment.
|
|
Gastrointestinal disorders
Nausea
|
100.0%
1/1 • Number of events 1
Frequency and severity of adverse events and tolerability of the regimen were collected and summarized by descriptive statistics for each of the disease cohorts. As per NCI CTCAE v4.0, the term toxicity is defined as adverse events that are classified as either not related, possibly, probably, or definitely related to study treatment.
|
|
Investigations
Platelet count decreased
|
100.0%
1/1 • Number of events 1
Frequency and severity of adverse events and tolerability of the regimen were collected and summarized by descriptive statistics for each of the disease cohorts. As per NCI CTCAE v4.0, the term toxicity is defined as adverse events that are classified as either not related, possibly, probably, or definitely related to study treatment.
|
|
Infections and infestations
Urinary tract infection
|
100.0%
1/1 • Number of events 1
Frequency and severity of adverse events and tolerability of the regimen were collected and summarized by descriptive statistics for each of the disease cohorts. As per NCI CTCAE v4.0, the term toxicity is defined as adverse events that are classified as either not related, possibly, probably, or definitely related to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
100.0%
1/1 • Number of events 1
Frequency and severity of adverse events and tolerability of the regimen were collected and summarized by descriptive statistics for each of the disease cohorts. As per NCI CTCAE v4.0, the term toxicity is defined as adverse events that are classified as either not related, possibly, probably, or definitely related to study treatment.
|
Additional Information
Erin Bertino, MD
The Ohio State University Comprehensive Cancer Center
Phone: 614-293-8054
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place