Trial · NCT02606461
Selinexor in Advanced Liposarcoma
NCT02606461, Phase 2, Phase 3, Completed, Karyopharm Therapeutics Inc; results first posted 2021-12-07
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Selinexor in Advanced Liposarcoma. Trials, record NCT02606461. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02606461
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Selinexor in Advanced Liposarcoma
- NCT number
- NCT02606461
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 342 participants, actual
- Lead sponsor
- Karyopharm Therapeutics Inc
- Conditions
- Dedifferentiated Liposarcoma
- Interventions
- Selinexor, Placebo
- First posted
- 2015-11-17
- Last updated
- 2023-01-23
- Other registries' IDs
- eudract:2015-003594-14
- Results first posted
- 2021-12-07
Source ClinicalTrials.gov
Registered outcomes26
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Phase 3 Double Blind: Progression-free Survival (PFS) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 | From the date of randomization until the first date of disease progression, or death due to any cause whichever occurred first (up to 57 months) | PFS was defined as the time from the date of randomization until the first date of Independent Review Committee (IRC)-confirmed PD per RECIST version 1.1, or death due to any cause. PD was defined as at least a 20% increase in the sum of the longest diameter (SLD), taking as reference the smallest sum of the longest diameter (SLD) recorded from baseline or the appearance of 1 or more new lesions. |
| Primary | Phase 3 Open Label: Progression-free Survival (PFS) as Per RECIST Version 1.1 | From the date of randomization in the Phase 3 open label period until the first date of disease progression, or death due to any cause whichever occurred first (up to 57 months) | PFS was defined as the time from the date of randomization in the Phase 3 open-label period until the first date of IRC-confirmed PD per RECIST version 1.1, or death due to any cause. PD was defined as at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. |
| Primary | Phase 2 Double Blind: Progression-free Survival (PFS) as Per RECIST Version 1.1 | From date of randomization until the first date of PD or death due to any cause, whichever occurred first (up to 57 months) | PFS was defined as the time from date of randomization until the first date of IRC-confirmed PD per RECIST version 1.1, or death due to any cause. PD was defined as at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. |
| Primary | Phase 2 Open Label: Progression-free Survival (PFS) as Per RECIST Version 1.1 | From date of randomization in the Phase 2 open label period until the first date of PD or death due to any cause, whichever occurred first (up to 57 months) | PFS was defined as the time from date of randomization in the Phase 2 open-label period until the first date of IRC-confirmed PD per RECIST version 1.1, or death due to any cause. PD was defined as at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. |
| Secondary | Phase 3 Double Blind: Overall Survival (OS) | From date of randomization until death due to any cause, whichever occurred first (up to 70 months) | OS was defined as the duration (in months) from the date of randomization to death from any cause. Participants last known to be alive were censored at the date of discontinuation from the study, or database cut date, whichever was earlier. |
| Secondary | Phase 3 Open Label: Overall Survival (OS) | From date of randomization in phase 3 open label period until death due to any cause, whichever occurred first (up to 70 months) | OS was defined as the duration (in months) from the date of randomization in the Phase 3 open-label period to death from any cause. Participants last known to be alive were censored at the date of discontinuation from the study, or database cut date, whichever was earlier. |
| Secondary | Phase 2 Double Blind: Overall Survival (OS) | From the date of randomization until death due to any cause, whichever occurred first (up to 70 months) | OS was defined as the duration (in months) from the date of randomization to death from any cause. Participants last known to be alive were censored at the date of discontinuation from the study, or database cut date, whichever was earlier. |
| Secondary | Phase 2 Open Label: Overall Survival (OS) | From date of randomization in the Phase 2 open-label period until death due to any cause, whichever occurred first (up to 70 months) | OS was defined as the duration (in months) from the date of randomization in the Phase 2 open-label period to death from any cause. Participants last known to be alive were censored at the date of discontinuation from the study, or database cut date, whichever was earlier. |
| Secondary | Phase 3 Double Blind: Time-to-Progression (TTP) as Per RECIST Version 1.1 | From date of randomization until the first date of PD or death due to any cause, whichever occurred first (up to 70 months) | TTP was defined as the time from date of randomization until ICR-determined PD per RECIST version 1.1, or death due to disease progression, whichever occurred first. PD was defined as at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. |
| Secondary | Phase 3 Open Label: Time-to-Progression (TTP) as Per RECIST Version 1.1 | From date of randomization in the Phase 3 open label period until the first date of PD or death due to any cause, whichever occurred first (up to 70 months) | TTP was defined as the time from date of randomization in the Phase 3 open-label period until ICR-determined PD per RECIST version 1.1, or death due to disease progression, whichever occurred first. PD was defined as at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 registered outcomesOutcomes26
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Phase 3 Double Blind: Progression-free Survival (PFS) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 | From the date of randomization until the first date of disease progression, or death due to any cause whichever occurred first (up to 57 months) | Phase 3 Intent-to-Treat Population (Ph3-ITT) consisted of all participants randomized to study treatment in Phase 3, regardless of whether or not they received study treatment. | Months | MEDIAN |
| PRIMARY | Phase 3 Open Label: Progression-free Survival (PFS) as Per RECIST Version 1.1 | From the date of randomization in the Phase 3 open label period until the first date of disease progression, or death due to any cause whichever occurred first (up to 57 months) | The Phase 3 Open-Label Population (Ph3-OL) consisted of all participants in Phase 3 who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor. | Months | MEDIAN |
| PRIMARY | Phase 2 Double Blind: Progression-free Survival (PFS) as Per RECIST Version 1.1 | From date of randomization until the first date of PD or death due to any cause, whichever occurred first (up to 57 months) | The Phase 2 Intent-to-Treat Population (Ph2-ITT) consisted of all participants randomized to study treatment in Phase 2, regardless of whether or not they received study treatment. | Months | MEDIAN |
| PRIMARY | Phase 2 Open Label: Progression-free Survival (PFS) as Per RECIST Version 1.1 | From date of randomization in the Phase 2 open label period until the first date of PD or death due to any cause, whichever occurred first (up to 57 months) | The Phase 2 Open-Label Population (Ph2-OL) consisted of all participants in Phase 2 who were randomized to placebo in the blinded phase, entered open-label period, and received at least one dose of open-label selinexor. | Months | MEDIAN |
| SECONDARY | Phase 3 Double Blind: Overall Survival (OS) | From date of randomization until death due to any cause, whichever occurred first (up to 70 months) | The Ph3-ITT consisted of all participants randomized to study treatment in Phase 3, regardless of whether or not they received study treatment. | Months | MEDIAN |
| SECONDARY | Phase 3 Open Label: Overall Survival (OS) | From date of randomization in phase 3 open label period until death due to any cause, whichever occurred first (up to 70 months) | The Ph3-OL consisted of all participants in Phase 3 who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor. | Months | MEDIAN |
| SECONDARY | Phase 2 Double Blind: Overall Survival (OS) | From the date of randomization until death due to any cause, whichever occurred first (up to 70 months) | The Ph2-ITT consisted of all participants randomized to study treatment in Phase 2, regardless of whether or not they received study treatment. | Months | MEDIAN |
| SECONDARY | Phase 2 Open Label: Overall Survival (OS) | From date of randomization in the Phase 2 open-label period until death due to any cause, whichever occurred first (up to 70 months) | The Ph2-OL consisted of all participants in Phase 2 who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor. | Months | MEDIAN |
| SECONDARY | Phase 3 Double Blind: Time-to-Progression (TTP) as Per RECIST Version 1.1 | From date of randomization until the first date of PD or death due to any cause, whichever occurred first (up to 70 months) | The Ph3-ITT consisted of all participants randomized to study treatment in Phase 3, regardless of whether or not they received study treatment. | Months | MEDIAN |
| SECONDARY | Phase 3 Open Label: Time-to-Progression (TTP) as Per RECIST Version 1.1 | From date of randomization in the Phase 3 open label period until the first date of PD or death due to any cause, whichever occurred first (up to 70 months) | The Ph3-OL consisted of all participants in Phase 3 who were randomized to placebo in the blinded phase, entered the open-label period, and received at least one dose of open-label selinexor. | Months | MEDIAN |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 outcomesResults by group74
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Phase 3 Double Blind: Progression-free Survival (PFS) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 | Phase 3 Double-blinded: Selinexor | 2.83 | 95% Confidence Interval 2.73 to 4.11 | Months | |
| Phase 3 Double Blind: Progression-free Survival (PFS) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 | Phase 3 Double-blinded: Placebo | 2.07 | 95% Confidence Interval 1.51 to 3.06 | Months | |
| Phase 3 Open Label: Progression-free Survival (PFS) as Per RECIST Version 1.1 | Phase 3 Open Label: Selinexor | 2.73 | 95% Confidence Interval 1.97 to 4.14 | Months | |
| Phase 2 Double Blind: Progression-free Survival (PFS) as Per RECIST Version 1.1 | Phase 2 Double-blinded: Selinexor | 3.02 | 95% Confidence Interval 1.41 to NA | Months | |
| Phase 2 Double Blind: Progression-free Survival (PFS) as Per RECIST Version 1.1 | Phase 2 Double-blinded: Placebo | 2.76 | 95% Confidence Interval 1.58 to NA | Months | |
| Phase 2 Open Label: Progression-free Survival (PFS) as Per RECIST Version 1.1 | Phase 2 Open Label: Selinexor | 1.38 | 95% Confidence Interval 1.38 to 2.27 | Months | |
| Phase 3 Double Blind: Overall Survival (OS) | Phase 3 Double-blinded: Selinexor | 10.38 | 95% Confidence Interval 8.41 to 13.40 | Months | |
| Phase 3 Double Blind: Overall Survival (OS) | Phase 3 Double-blinded: Placebo | 12.71 | 95% Confidence Interval 8.54 to 15.90 | Months | |
| Phase 3 Open Label: Overall Survival (OS) | Phase 3 Open Label: Selinexor | 10.18 | 95% Confidence Interval 5.78 to 14.69 | Months | |
| Phase 2 Double Blind: Overall Survival (OS) | Phase 2 Double-blinded: Selinexor | 17.31 | 95% Confidence Interval 10.51 to 29.57 | Months |
1 to 10 of 74Source ClinicalTrials.gov
See all 74 results by groupParticipant flow42
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Period 1: Double-blinded Period | STARTED | Phase 2 Double-blinded: Selinexor | 27 | |
| Period 1: Double-blinded Period | STARTED | Phase 2 Double-blinded: Placebo | 30 | |
| Period 1: Double-blinded Period | STARTED | Phase 3 Double-blinded: Selinexor | 188 | |
| Period 1: Double-blinded Period | STARTED | Phase 3 Double-blinded: Placebo | 97 | |
| Period 1: Double-blinded Period | STARTED | Phase 2 Open-label: Selinexor | 0 | |
| Period 1: Double-blinded Period | STARTED | Phase 3 Open-label: Selinexor | 0 | |
| Period 1: Double-blinded Period | Treated | Phase 2 Double-blinded: Selinexor | 27 | |
| Period 1: Double-blinded Period | Treated | Phase 2 Double-blinded: Placebo | 30 | |
| Period 1: Double-blinded Period | Treated | Phase 3 Double-blinded: Selinexor | 187 | |
| Period 1: Double-blinded Period | Treated | Phase 3 Double-blinded: Placebo | 97 |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 participant flowAdverse events1,194
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 | Anaemia | Blood and lymphatic system disorders | Phase 2 Double-blinded: Selinexor | 16 | 27 | |
| other | Anaemia | Blood and lymphatic system disorders | Phase 2 Double-blinded: Placebo | 9 | 30 | |
| other | Anaemia | Blood and lymphatic system disorders | Phase 3 Double-blinded: Selinexor | 91 | 187 | |
| other | Anaemia | Blood and lymphatic system disorders | Phase 3 Double-blinded: Placebo | 22 | 97 | |
| other | Anaemia | Blood and lymphatic system disorders | Phase 2 Open-label: Selinexor | 10 | 24 | |
| other | Anaemia | Blood and lymphatic system disorders | Phase 3 Open-label: Selinexor | 26 | 63 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Phase 2 Double-blinded: Selinexor | 11 | 27 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Phase 2 Double-blinded: Placebo | 2 | 30 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Phase 3 Double-blinded: Selinexor | 72 | 187 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Phase 3 Double-blinded: Placebo | 5 | 97 |
1 to 10 of 1,194Source ClinicalTrials.gov
See all 1,194 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Phase 2 Double-blinded: Selinexor | 18 | 27 |
| Total, all-cause mortality | Phase 2 Double-blinded: Placebo | 25 | 30 |
| Total, all-cause mortality | Phase 3 Double-blinded: Selinexor | 127 | 187 |
| Total, all-cause mortality | Phase 3 Double-blinded: Placebo | 67 | 97 |
| Total, all-cause mortality | Phase 2 Open-label: Selinexor | 20 | 24 |
| Total, all-cause mortality | Phase 3 Open-label: Selinexor | 43 | 63 |
| Total, other adverse events | Phase 2 Double-blinded: Selinexor | 27 | 27 |
| Total, other adverse events | Phase 2 Double-blinded: Placebo | 29 | 30 |
| Total, other adverse events | Phase 3 Double-blinded: Selinexor | 186 | 187 |
| Total, other adverse events | Phase 3 Double-blinded: Placebo | 94 | 97 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 35394800 | 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/NCT02606461
GET https://conductscience.org/api/trials/v1/NCT02606461/registered?page=2