Trial · NCT01986348
Study Evaluating the Efficacy and Safety of Selinexor (KPT-330) in Participants With Recurrent Gliomas
NCT01986348, Phase 2, Terminated, Karyopharm Therapeutics Inc; results first posted 2021-08-02
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study Evaluating the Efficacy and Safety of Selinexor (KPT-330) in Participants With Recurrent Gliomas. Trials, record NCT01986348. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01986348
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study Evaluating the Efficacy and Safety of Selinexor (KPT-330) in Participants With Recurrent Gliomas
- NCT number
- NCT01986348
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 76 participants, actual
- Lead sponsor
- Karyopharm Therapeutics Inc
- Conditions
- Glioblastoma, Glioma
- Interventions
- Selinexor
- First posted
- 2013-11-18
- Last updated
- 2023-01-26
- Results first posted
- 2021-08-02
- Limitations and caveats
- Study was terminated due to Sponsor decision (all except 1 patient were off-treatment and 2 patients were in survival follow-up).
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 6-Month Progression-Free Survival (PFS) Rate | From start of study treatment up to disease progression or death, whichever occurred first (assessed up to Month 6) | The analysis of 6mPFS was performed by calculating the estimated survival probability of having PFS ≥ 6 months based on Kaplan-Meier method, where PFS was defined as the time from the start of study treatment until first documented progression based on Response Assessment in Neuro-Oncology (RANO) criteria, or death from any cause. Progressive disease occurs when either of the criteria was present: greater than or equal to (≥) 25 percentage (%) increase in T1 gadolinium enhancing disease, increase in T2/ Fluid-attenuated inversion recovery (FLAIR), detection of new lesions, or decreased clinical status. |
| Secondary | Overall Response Rate (ORR) | Up to 71 months | The ORR was determined as percentage of participants who had either complete response (CR) or partial response (PR) using the RANO criteria. CR: No T1 gadolinium enhancing disease, stable or decreasing T2/FLAIR, no new lesions, no corticosteroid use and stable, or increasing clinical status. PR: ≥50% decrease in T1 gadolinium enhancing disease, stable or decreasing T2/FLAIR, no new lesions, stable or decreased use of corticosteroids, and stable or increased clinical status. |
| Secondary | Overall Survival (OS) | From date of study treatment up to date of death (assessed up to 71 months) | The OS was calculated from the date of start of study treatment to the date of death. Participants who were still alive prior to the data cut-off for final efficacy analysis, or who dropout prior to study end, were censored on the day they were last known to be alive. The OS was estimated using Kaplan-Meier method. |
| Secondary | Progression-free Survival (PFS) | From start of study treatment up to disease progression (assessed up to 71 months) | The PFS was calculated from the date of start of study treatment to the date of disease progression based on RANO criteria, or date of death should progression not have occurred. Progressive disease occurs when either of the criteria was present: ≥25% increase in T1 gadolinium enhancing disease, increased T2/FLAIR, detection of new lesions, or decreased clinical status. |
| Secondary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | From start of study treatment administration up to 71 months | An adverse event (AE) was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. A serious adverse event (SAE) was defined as an AE that was fatal; life threatening (places the participant at immediate risk of death); requires in-patient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; was a congenital anomaly/birth defect; and other important medical events. TEAE was defined as any AE with onset or worsening of a pre-existing condition on or after the first administration of study medication through 30 days following last dose or any event considered drug-related by the Investigator through the end of the study. TEAEs included both serious and non-serious TEAEs. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 6-Month Progression-Free Survival (PFS) Rate | From start of study treatment up to disease progression or death, whichever occurred first (assessed up to Month 6) | Modified intent-to-treat (mITT) population consisted of all enrolled participants in Arms B, C and D who had received at least 1 dose of study medication and have at least 1 post-baseline efficacy follow-up assessment, unless the participant discontinued treatment prior to the first post baseline assessment due to death, toxicity, or PD. Data for this outcome measure was not planned to be collected and analyzed for Arm A: Selinexor 60 mg and Surgery. | percentage of participants | NUMBER |
| SECONDARY | Overall Response Rate (ORR) | Up to 71 months | mITT population consisted of all enrolled participants in Arms B, C and D who had received at least 1 dose of study medication and have at least 1 post-baseline efficacy follow-up assessment, unless the participant discontinued treatment prior to the first post baseline assessment due to death, toxicity, or disease progression. Data for this outcome measure was not planned to be collected and analyzed for Arm A: Selinexor 60 mg and Surgery. | percentage of participants | NUMBER |
| SECONDARY | Overall Survival (OS) | From date of study treatment up to date of death (assessed up to 71 months) | mITT population consisted of all enrolled participants in Arms B, C and D who had received at least 1 dose of study medication and have at least 1 post-baseline efficacy follow-up assessment, unless the participant discontinued treatment prior to the first post baseline assessment due to death, toxicity, or disease progression. Data for this outcome measure was not planned to be collected and analyzed for Arm A: Selinexor 60 mg and Surgery. | months | MEDIAN |
| SECONDARY | Progression-free Survival (PFS) | From start of study treatment up to disease progression (assessed up to 71 months) | mITT population consisted of all enrolled participants in Arms B, C and D who had received at least 1 dose of study medication and have at least 1 post-baseline efficacy follow-up assessment, unless the participant discontinued treatment prior to the first post baseline assessment due to death, toxicity, or disease progression. Data for this outcome measure was not planned to be collected and analyzed for Arm A: Selinexor 60 mg and Surgery. | months | MEDIAN |
| SECONDARY | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | From start of study treatment administration up to 71 months | Safety population consisted of all participants who had received any amount of study treatment. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 6-Month Progression-Free Survival (PFS) Rate | Arm B: Selinexor 50 mg/m^2 | 9.72 | 95% Confidence Interval 2.67 to 35.39 | percentage of participants | |
| 6-Month Progression-Free Survival (PFS) Rate | Arm C: Selinexor 60 mg | 7.69 | 95% Confidence Interval 1.17 to 50.57 | percentage of participants | |
| 6-Month Progression-Free Survival (PFS) Rate | Arm D: Selinexor 80 mg | 17.24 | 95% Confidence Interval 7.77 to 38.27 | percentage of participants | |
| Overall Response Rate (ORR) | Arm B: Selinexor 50 mg/m^2 | 8.3 | 95% Confidence Interval 1.0 to 27.0 | percentage of participants | |
| Overall Response Rate (ORR) | Arm C: Selinexor 60 mg | 7.7 | 95% Confidence Interval 0.2 to 36.0 | percentage of participants | |
| Overall Response Rate (ORR) | Arm D: Selinexor 80 mg | 10.0 | 95% Confidence Interval 2.1 to 26.5 | percentage of participants | |
| Overall Survival (OS) | Arm B: Selinexor 50 mg/m^2 | 10.51 | 95% Confidence Interval 4.93 to 16.95 | months | |
| Overall Survival (OS) | Arm C: Selinexor 60 mg | 8.48 | 95% Confidence Interval 7.29 to NA | months | |
| Overall Survival (OS) | Arm D: Selinexor 80 mg | 10.15 | 95% Confidence Interval 7.03 to 15.38 | months | |
| Progression-free Survival (PFS) | Arm B: Selinexor 50 mg/m^2 | 1.64 | 95% Confidence Interval 1.18 to 3.15 | months |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm A: Selinexor 60 mg and Surgery | 8 | |
| Overall Study | STARTED | Arm B: Selinexor 50 mg/m^2 | 24 | |
| Overall Study | STARTED | Arm C: Selinexor 60 mg | 14 | |
| Overall Study | STARTED | Arm D: Selinexor 80 mg | 30 | |
| Overall Study | COMPLETED | Arm A: Selinexor 60 mg and Surgery | 0 | |
| Overall Study | COMPLETED | Arm B: Selinexor 50 mg/m^2 | 0 | |
| Overall Study | COMPLETED | Arm C: Selinexor 60 mg | 0 | |
| Overall Study | COMPLETED | Arm D: Selinexor 80 mg | 0 | |
| Overall Study | NOT COMPLETED | Arm A: Selinexor 60 mg and Surgery | 8 | |
| Overall Study | NOT COMPLETED | Arm B: Selinexor 50 mg/m^2 | 24 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events600
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 | Thrombocytopenia | Blood and lymphatic system disorders | Arm A: Selinexor 60 mg and Surgery | 6 | 8 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Arm B: Selinexor 50 mg/m^2 | 16 | 24 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Arm C: Selinexor 60 mg | 6 | 14 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Arm D: Selinexor 80 mg | 11 | 30 | |
| other | Leukopenia | Blood and lymphatic system disorders | Arm A: Selinexor 60 mg and Surgery | 0 | 8 | |
| other | Leukopenia | Blood and lymphatic system disorders | Arm B: Selinexor 50 mg/m^2 | 7 | 24 | |
| other | Leukopenia | Blood and lymphatic system disorders | Arm C: Selinexor 60 mg | 1 | 14 | |
| other | Leukopenia | Blood and lymphatic system disorders | Arm D: Selinexor 80 mg | 14 | 30 | |
| other | Neutropenia | Blood and lymphatic system disorders | Arm A: Selinexor 60 mg and Surgery | 1 | 8 | |
| other | Neutropenia | Blood and lymphatic system disorders | Arm B: Selinexor 50 mg/m^2 | 7 | 24 |
1 to 10 of 600Source ClinicalTrials.gov
See all 600 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm A: Selinexor 60 mg and Surgery | 8 | 8 |
| Total, all-cause mortality | Arm B: Selinexor 50 mg/m^2 | 22 | 24 |
| Total, all-cause mortality | Arm C: Selinexor 60 mg | 10 | 14 |
| Total, all-cause mortality | Arm D: Selinexor 80 mg | 21 | 30 |
| Total, other adverse events | Arm A: Selinexor 60 mg and Surgery | 8 | 8 |
| Total, other adverse events | Arm B: Selinexor 50 mg/m^2 | 24 | 24 |
| Total, other adverse events | Arm C: Selinexor 60 mg | 14 | 14 |
| Total, other adverse events | Arm D: Selinexor 80 mg | 30 | 30 |
| Total, serious adverse events | Arm A: Selinexor 60 mg and Surgery | 5 | 8 |
| Total, serious adverse events | Arm B: Selinexor 50 mg/m^2 | 7 | 24 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT01986348
GET https://conductscience.org/api/trials/v1/NCT01986348/events?page=2