Trial · NCT02228525
Selective Inhibitor of Nuclear Export (SINE) Selinexor (KPT-330) in Patients With Myelodysplastic Syndromes
NCT02228525, Phase 2, Completed, Memorial Sloan Kettering Cancer Center; results first posted 2022-03-09
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Selective Inhibitor of Nuclear Export (SINE) Selinexor (KPT-330) in Patients With Myelodysplastic Syndromes. Trials, record NCT02228525. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02228525
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Selective Inhibitor of Nuclear Export (SINE) Selinexor (KPT-330) in Patients With Myelodysplastic Syndromes
- NCT number
- NCT02228525
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 25 participants, actual
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Conditions
- Myelodysplastic Syndromes
- Interventions
- selinexor (KPT-330)
- First posted
- 2014-08-29
- Last updated
- 2022-03-09
- Results first posted
- 2022-03-09
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Best Overall Response Rate | 2 years | Using a Simon's two-stage minimax design, this trial will accrue a maximum of 20 patients. Early termination may occur if no responses are observed in the first 13 patients. If at least one response is observed, the trial will continue to the maximum sample size. At the end of the trial, the treatment strategy will be considered promising in this patient population if at least 3 patients achieve a response. The type I and type II errors are set at 0.10. |
| Secondary | Response Duration | 2 years | Response duration will be calculated among patients who achieve a response of HI, mCR, PR or CR using Kaplan-Meier methodology. Median duration of response and the corresponding 95% confidence interval will be estimated. |
| Secondary | Overall Survival | 2 years | Overall survival from the time of study enrollment will be calculated using Kaplan-Meier methodology. Overall survival curves will be displayed for the study population along with selected quantiles and corresponding 95% confidence intervals of survival. |
| Secondary | Participants Evaluated for Adverse Events | 2 years | The safety and tolerability of Selinexor and ST will be evaluated by means of drug related AE reports, physical examinations, and laboratory safety evaluations. Common Terminology Criteria for Adverse Events (CTCAE) V4.03 will be used for grading of AEs. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Best Overall Response Rate | 2 years | Percentage of participants with response | NUMBER | |
| SECONDARY | Response Duration | 2 years | months | MEDIAN | |
| SECONDARY | Overall Survival | 2 years | months | MEDIAN | |
| SECONDARY | Participants Evaluated for Adverse Events | 2 years | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Best Overall Response Rate | Selinexor (KPT-330) | 26 | 95% Confidence Interval 10 to 48 | Percentage of participants with response | |
| Response Duration | Selinexor (KPT-330) | 6.3 | Full Range 2.1 to 7.8 | months | |
| Overall Survival | Selinexor (KPT-330) | 8.5 | Full Range 6.7 to 12.2 | months | |
| Participants Evaluated for Adverse Events | Selinexor (KPT-330) | 25 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Selinexor (KPT-330) | 25 | |
| Overall Study | COMPLETED | Selinexor (KPT-330) | 25 | |
| Overall Study | NOT COMPLETED | Selinexor (KPT-330) | 0 |
Source ClinicalTrials.gov
Adverse events17
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anorexia or weight loss | Metabolism and nutrition disorders | Selinexor (KPT-330) | 10 | 25 | |
| other | Fatigue | General disorders | Selinexor (KPT-330) | 14 | 25 | |
| other | Malaise | General disorders | Selinexor (KPT-330) | 2 | 25 | |
| other | Diarrhea | Gastrointestinal disorders | Selinexor (KPT-330) | 5 | 25 | |
| other | Dysgeusia | Nervous system disorders | Selinexor (KPT-330) | 4 | 25 | |
| other | Increased alanine aminotransferase | Investigations | Selinexor (KPT-330) | 2 | 25 | |
| other | Hyperglycaemia | Metabolism and nutrition disorders | Selinexor (KPT-330) | 9 | 25 | |
| other | Hyperkalaemia | Metabolism and nutrition disorders | Selinexor (KPT-330) | 2 | 25 | |
| other | Hypoalbuminaemia | Metabolism and nutrition disorders | Selinexor (KPT-330) | 6 | 25 | |
| other | Hypocalcaemia | Metabolism and nutrition disorders | Selinexor (KPT-330) | 3 | 25 |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Selinexor (KPT-330) | 7 | 25 |
| Total, other adverse events | Selinexor (KPT-330) | 25 | 25 |
| Total, serious adverse events | Selinexor (KPT-330) | 0 | 25 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 32735836 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02228525
GET https://conductscience.org/api/trials/v1/NCT02228525/registered