Trial Outcomes & Findings for Phase 2 Trial of Selinexor (KPT-330) for Metastatic Triple Negative Breast Cancer (TNBC) (NCT NCT02402764)
NCT ID: NCT02402764
Last Updated: 2020-09-11
Results Overview
Complete Response (CR) + Partial Response (PR) + Stable Disease (SD) ≥ 12 weeks of selinexor in patients with triple negative breast cancer (TNBC), according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. CR: Disappearance of all target lesions; PR: At least a 30% decrease in the sum of the diameter (LD) of target lesions, taking as reference the baseline sum LD; Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.
COMPLETED
PHASE2
10 participants
Up to 10 months
2020-09-11
Participant Flow
Participants were enrolled at Moffitt Cancer Center between July 2015 and January 2016.
Participant milestones
| Measure |
Selinexor Treatment
Ten patients were treated with oral selinexor 60 mg twice per week (on days 1 and 3) on a schedule of 3 weeks on and 1 week off, each four-week cycle.
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase 2 Trial of Selinexor (KPT-330) for Metastatic Triple Negative Breast Cancer (TNBC)
Baseline characteristics by cohort
| Measure |
Selinexor Treatment
n=10 Participants
Ten patients were treated with oral selinexor 60 mg twice per week (on days 1 and 3) on a schedule of 3 weeks on and 1 week off, each four-week cycle.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
|
Age, Continuous
|
60 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 10 monthsPopulation: All participants
Complete Response (CR) + Partial Response (PR) + Stable Disease (SD) ≥ 12 weeks of selinexor in patients with triple negative breast cancer (TNBC), according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. CR: Disappearance of all target lesions; PR: At least a 30% decrease in the sum of the diameter (LD) of target lesions, taking as reference the baseline sum LD; Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.
Outcome measures
| Measure |
Selinexor Treatment
n=10 Participants
Ten patients were treated with oral selinexor 60 mg twice per week (on days 1 and 3) on a schedule of 3 weeks on and 1 week off, each four-week cycle.
|
|---|---|
|
Clinical Benefit Rate
Stable Disease
|
3 Participants
|
|
Clinical Benefit Rate
Complete Response
|
0 Participants
|
|
Clinical Benefit Rate
Partial Response
|
0 Participants
|
|
Clinical Benefit Rate
Progressive Disease
|
7 Participants
|
SECONDARY outcome
Timeframe: Up to 10 monthsPopulation: Participants with Complete Response or Partial Response
The best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started). The patient's best response assignment will depend on the achievement of both measurement and confirmation criteria.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 10 monthsPopulation: Participants with Complete Response or Partial Response
The duration of overall response is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started) or death. The duration of overall CR is measured from the time measurement criteria are first met for CR until the first date that recurrent disease is objectively documented or death.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 10 monthsPopulation: All participants
Median time to progression. Progression-free survival is defined as time elapsed from the beginning of study treatment to the first documentation of radiologic progression as defined by standard RECIST criteria or death.
Outcome measures
| Measure |
Selinexor Treatment
n=10 Participants
Ten patients were treated with oral selinexor 60 mg twice per week (on days 1 and 3) on a schedule of 3 weeks on and 1 week off, each four-week cycle.
|
|---|---|
|
Progression-Free Survival (PFS)
|
1.0 months
Interval 0.5 to 4.0
|
SECONDARY outcome
Timeframe: End of post-treatment 12 month follow-up, up to 24 months per participantPopulation: All participants
Overall survival, defined as the time from randomization to death from any cause.
Outcome measures
| Measure |
Selinexor Treatment
n=10 Participants
Ten patients were treated with oral selinexor 60 mg twice per week (on days 1 and 3) on a schedule of 3 weeks on and 1 week off, each four-week cycle.
|
|---|---|
|
Overall Survival (OS)
|
6.0 months
Interval 1.7 to 10.4
|
Adverse Events
Selinexor Treatment
Serious adverse events
| Measure |
Selinexor Treatment
n=10 participants at risk
Ten patients were treated with oral selinexor 60 mg twice per week (on days 1 and 3) on a schedule of 3 weeks on and 1 week off, each four-week cycle.
|
|---|---|
|
Cardiac disorders
Sinus tachycardia
|
10.0%
1/10 • Number of events 1 • 10 months
|
|
Nervous system disorders
Memory impairment
|
10.0%
1/10 • Number of events 1 • 10 months
|
|
Eye disorders
Blurred vision
|
10.0%
1/10 • Number of events 1 • 10 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
20.0%
2/10 • Number of events 2 • 10 months
|
Other adverse events
| Measure |
Selinexor Treatment
n=10 participants at risk
Ten patients were treated with oral selinexor 60 mg twice per week (on days 1 and 3) on a schedule of 3 weeks on and 1 week off, each four-week cycle.
|
|---|---|
|
Gastrointestinal disorders
Constipation
|
50.0%
5/10 • Number of events 5 • 10 months
|
|
Gastrointestinal disorders
Vomiting
|
50.0%
5/10 • Number of events 5 • 10 months
|
|
Gastrointestinal disorders
Nausea
|
30.0%
3/10 • Number of events 3 • 10 months
|
|
Gastrointestinal disorders
Diarrhea
|
20.0%
2/10 • Number of events 2 • 10 months
|
|
Gastrointestinal disorders
Abdominal pain
|
10.0%
1/10 • Number of events 1 • 10 months
|
|
Gastrointestinal disorders
Bloating
|
10.0%
1/10 • Number of events 1 • 10 months
|
|
Metabolism and nutrition disorders
Anorexia
|
40.0%
4/10 • Number of events 4 • 10 months
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
20.0%
2/10 • Number of events 2 • 10 months
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
20.0%
2/10 • Number of events 3 • 10 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
10.0%
1/10 • Number of events 1 • 10 months
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
10.0%
1/10 • Number of events 1 • 10 months
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
10.0%
1/10 • Number of events 1 • 10 months
|
|
Investigations
Platelet count decreased
|
30.0%
3/10 • Number of events 6 • 10 months
|
|
Investigations
Alanine aminotransferase increased
|
10.0%
1/10 • Number of events 1 • 10 months
|
|
Investigations
Blood bilirubin increased
|
10.0%
1/10 • Number of events 2 • 10 months
|
|
Investigations
Investigations - Other, specify
|
10.0%
1/10 • Number of events 1 • 10 months
|
|
Nervous system disorders
Dysgeusia
|
20.0%
2/10 • Number of events 2 • 10 months
|
|
Nervous system disorders
Dizziness
|
10.0%
1/10 • Number of events 1 • 10 months
|
|
Nervous system disorders
Encephalopathy
|
10.0%
1/10 • Number of events 1 • 10 months
|
|
Nervous system disorders
Headache
|
10.0%
1/10 • Number of events 1 • 10 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
20.0%
2/10 • Number of events 2 • 10 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.0%
2/10 • Number of events 2 • 10 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
10.0%
1/10 • Number of events 1 • 10 months
|
|
Eye disorders
Blurred vision
|
40.0%
4/10 • Number of events 4 • 10 months
|
|
General disorders
Fatigue
|
30.0%
3/10 • Number of events 5 • 10 months
|
|
General disorders
Fever
|
10.0%
1/10 • Number of events 1 • 10 months
|
|
General disorders
Gait disturbance
|
10.0%
1/10 • Number of events 1 • 10 months
|
|
General disorders
Irritability
|
10.0%
1/10 • Number of events 1 • 10 months
|
|
General disorders
Non-cardiac chest pain
|
10.0%
1/10 • Number of events 1 • 10 months
|
|
Vascular disorders
Hot flashes
|
20.0%
2/10 • Number of events 2 • 10 months
|
|
Vascular disorders
Hypertension
|
10.0%
1/10 • Number of events 1 • 10 months
|
|
Vascular disorders
Hypotension
|
10.0%
1/10 • Number of events 1 • 10 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
20.0%
2/10 • Number of events 2 • 10 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.0%
1/10 • Number of events 1 • 10 months
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
10.0%
1/10 • Number of events 1 • 10 months
|
|
Blood and lymphatic system disorders
Anemia
|
10.0%
1/10 • Number of events 1 • 10 months
|
|
Infections and infestations
Sinusitis
|
10.0%
1/10 • Number of events 2 • 10 months
|
|
Injury, poisoning and procedural complications
Fall
|
10.0%
1/10 • Number of events 1 • 10 months
|
|
Renal and urinary disorders
Urinary incontinence
|
10.0%
1/10 • Number of events 1 • 10 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
10.0%
1/10 • Number of events 1 • 10 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
10.0%
1/10 • Number of events 1 • 10 months
|
Additional Information
Dr. Hyo Sook Han
H. Lee Moffitt Cancer Center and Research Institute
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place