Trial · NCT01607892
Safety Study of the Selective Inhibitor of Nuclear Export (SINE) KPT-330 in Patients With Advanced Hematological Cancer
NCT01607892, Phase 1, Completed, Karyopharm Therapeutics Inc; results first posted 2021-04-01
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety Study of the Selective Inhibitor of Nuclear Export (SINE) KPT-330 in Patients With Advanced Hematological Cancer. Trials, record NCT01607892. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01607892
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety Study of the Selective Inhibitor of Nuclear Export (SINE) KPT-330 in Patients With Advanced Hematological Cancer
- NCT number
- NCT01607892
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 286 participants, actual
- Lead sponsor
- Karyopharm Therapeutics Inc
- Conditions
- Hematological Malignancies
- Interventions
- KPT-330
- First posted
- 2012-05-30
- Last updated
- 2023-01-26
- Results first posted
- 2021-04-01
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | From first dose of study drug administration to end of treatment (up to 27 months) | An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product during the course of a study and which does not necessarily have to have a causal relationship with this treatment. An Serious adverse event (SAE) was an AE resulting in any of the following outcomes: death; life-threatening event; required or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. TEAEs are any untoward medical incidence in a participant during administered study treatment, whether or not these events were related to study treatment. |
| Primary | Recommended Phase 2 Dose (RP2D) of Selinexor | From first dose of study drug administration to end of treatment (up to 27 months) | Recommended Phase 2 dose was determined by maximum tolerated dose (MTD). MTD was defined as the next lower dose level below the one in which \> 1 of 3 participants or ≥ 2 of 6 participants experienced dose-limiting toxicity (DLT), provided that that dose level is ≤25% lower than the highest dose tested. If the projected MTD was \>25% lower than the highest dose tested, then an additional cohort of ≥3 participants were added at a dose that was intermediate between the intolerable dose and the next lower dose. |
| Secondary | Maximum Observed Plasma Concentration (Cmax) of Selinexor | 0 (pre-dose), 0.5, 1, 2, 4, 8, 24 and 48 hours post-dose on Day 1, 8 of Cycle 1 and Days 15, 16 or 17 of Cycle 2 | Cmax was defined as the maximum observed concentration, taken directly from the plasma concentration. |
| Secondary | Time to Maximum Observed Concentration (Tmax) of Selinexor | 0 (pre-dose), 0.5, 1, 2, 4, 8, 24 and 48 hours post-dose on Day 1, 8 of Cycle 1 and Days 15, 16 or 17 of Cycle 2 | Tmax was defined as time of first observation of Cmax, taken directly from the plasma concentration data. |
| Secondary | Average Concentration From Time 0 to 24 Hours (Cavg0-24h) of Selinexor | 0 (pre-dose), 0.5, 1, 2, 4, 8, 24 and 48 hours post-dose on Day 1, 8 of Cycle 1 and Days 15, 16 or 17 of Cycle 2 | Cavg0-24h was defined as average concentration from time 0 to 24 hours. |
| Secondary | Area Under the Concentration-Time Curve From Time 0 to t (AUC0-t) of Selinexor | 0 (pre-dose), 0.5, 1, 2, 4, 8, 24 and 48 hours post-dose on Day 1, 8 of Cycle 1 and Days 15, 16 or 17 of Cycle 2 | AUC0-t was defined as area under the concentration-time curve from time zero to the last non-zero concentration. |
| Secondary | Area Under the Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUC0-inf) of Selinexor | 0 (pre-dose), 0.5, 1, 2, 4, 8, 24 and 48 hours post-dose on Day 1, 8 of Cycle 1 and Days 15, 16 or 17 of Cycle 2 | AUC0-inf was defined as the area under the concentration-time curve from time zero to infinity (extrapolated). |
| Secondary | Apparent Volume of Distribution Uncorrected for Fraction Absorbed (Vd/F) of Selinexor | 0 (pre-dose), 0.5, 1, 2, 4, 8, 24 and 48 hours post-dose on Day 1, 8 of Cycle 1 and Days 15, 16 or 17 of Cycle 2 | Apparent volume of distribution was calculated as Dose/ (kel \*AUC0-inf), uncorrected for fraction absorbed, reported normalized by participant body weight (kilogram \[kg\]). |
| Secondary | Apparent Total Body Clearance, Uncorrected for Fraction Absorbed (Cl/F) of Selinexor | 0 (pre-dose), 0.5, 1, 2, 4, 8, 24 and 48 hours post-dose on Day 1, 8 of Cycle 1 and Days 15, 16 or 17 of Cycle 2 | Cl/F was calculated as Dose/AUC0-inf, uncorrected for fraction absorbed, reported normalized by participant body weight (kg). |
| Secondary | Terminal Half-Life (t½) of Selinexor | 0 (pre-dose), 0.5, 1, 2, 4, 8, 24 and 48 hours post-dose on Day 1, 8 of Cycle 1 and Days 15, 16 or 17 of Cycle 2 | t½ was, calculated as ln(2)/kel, where kel is elimination rate constant, calculated using linear regression on the terminal portion of the log-linear concentration versus time curve. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | From first dose of study drug administration to end of treatment (up to 27 months) | Safety population consisted of all participants who received at least 1 dose of selinexor. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Recommended Phase 2 Dose (RP2D) of Selinexor | From first dose of study drug administration to end of treatment (up to 27 months) | Efficacy analysis set included all participants who had either completed 1 cycle of treatment or discontinued treatment prior to completing the first cycle due to documented progressive disease (PD), death related to disease, or treatment-related toxicity. Here, data was not planned and analyzed based on individual specific disease, hence overall data was analyzed for this outcome measure. | milligram per square meter (mg/m^2) | NUMBER |
| SECONDARY | Maximum Observed Plasma Concentration (Cmax) of Selinexor | 0 (pre-dose), 0.5, 1, 2, 4, 8, 24 and 48 hours post-dose on Day 1, 8 of Cycle 1 and Days 15, 16 or 17 of Cycle 2 | Pharmacokinetic (PK) analysis was defined as all participants who received active drug, selinexor, without the co-administration of another chemotherapeutic (i.e., rituximab), and for whom the PK profile for cycle 1 day1 (C1D1) could be adequately characterized. Here 'Overall Number of Participants Analyzed' signifies number of participants analyzed for this outcome measure. | nanogram per milliliter (ng/mL) | GEOMETRIC_MEAN |
| SECONDARY | Time to Maximum Observed Concentration (Tmax) of Selinexor | 0 (pre-dose), 0.5, 1, 2, 4, 8, 24 and 48 hours post-dose on Day 1, 8 of Cycle 1 and Days 15, 16 or 17 of Cycle 2 | PK analysis was defined as all participants who received active drug, selinexor, without the co-administration of another chemotherapeutic (i.e., rituximab), and for whom the PK profile for C1D1 could be adequately characterized. Here 'Overall Number of Participants Analyzed' signifies number of participants analyzed for this outcome measure. | hour | MEDIAN |
| SECONDARY | Average Concentration From Time 0 to 24 Hours (Cavg0-24h) of Selinexor | 0 (pre-dose), 0.5, 1, 2, 4, 8, 24 and 48 hours post-dose on Day 1, 8 of Cycle 1 and Days 15, 16 or 17 of Cycle 2 | PK analysis was defined as all participants who received active drug, selinexor, without the co-administration of another chemotherapeutic (i.e., rituximab), and for whom the PK profile for C1D1 could be adequately characterized. Here 'Overall Number of Participants Analyzed' signifies number of participants analyzed for this outcome measure. | ng/mL | GEOMETRIC_MEAN |
| SECONDARY | Area Under the Concentration-Time Curve From Time 0 to t (AUC0-t) of Selinexor | 0 (pre-dose), 0.5, 1, 2, 4, 8, 24 and 48 hours post-dose on Day 1, 8 of Cycle 1 and Days 15, 16 or 17 of Cycle 2 | PK analysis was defined as all participants who received active drug, selinexor, without the co-administration of another chemotherapeutic (i.e., rituximab), and for whom the PK profile for C1D1 could be adequately characterized. Here 'Overall Number of Participants Analyzed' signifies number of participants analyzed for this outcome measure. | nanogram* hours per milliliter | GEOMETRIC_MEAN |
| SECONDARY | Area Under the Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUC0-inf) of Selinexor | 0 (pre-dose), 0.5, 1, 2, 4, 8, 24 and 48 hours post-dose on Day 1, 8 of Cycle 1 and Days 15, 16 or 17 of Cycle 2 | PK analysis was defined as all participants who received active drug, selinexor, without the co-administration of another chemotherapeutic (i.e., rituximab), and for whom the PK profile for C1D1 could be adequately characterized. Here 'Overall Number of Participants Analyzed' signifies number of participants analyzed for this outcome measure. | ng*h/mL | GEOMETRIC_MEAN |
| SECONDARY | Apparent Volume of Distribution Uncorrected for Fraction Absorbed (Vd/F) of Selinexor | 0 (pre-dose), 0.5, 1, 2, 4, 8, 24 and 48 hours post-dose on Day 1, 8 of Cycle 1 and Days 15, 16 or 17 of Cycle 2 | PK analysis was defined as all participants who received active drug, selinexor, without the co-administration of another chemotherapeutic (i.e., rituximab), and for whom the PK profile for C1D1 could be adequately characterized. Here 'Overall Number of Participants Analyzed' signifies number of participants analyzed for this outcome measure. | Liter per kilogram (L/kg) | GEOMETRIC_MEAN |
| SECONDARY | Apparent Total Body Clearance, Uncorrected for Fraction Absorbed (Cl/F) of Selinexor | 0 (pre-dose), 0.5, 1, 2, 4, 8, 24 and 48 hours post-dose on Day 1, 8 of Cycle 1 and Days 15, 16 or 17 of Cycle 2 | PK analysis was defined as all participants who received active drug, selinexor, without the co-administration of another chemotherapeutic (i.e., rituximab), and for whom the PK profile for C1D1 could be adequately characterized. Here 'Overall Number of Participants Analyzed' signifies number of participants analyzed for this outcome measure. | Liter per hour per kilogram (L/h/kg) | GEOMETRIC_MEAN |
| SECONDARY | Terminal Half-Life (t½) of Selinexor | 0 (pre-dose), 0.5, 1, 2, 4, 8, 24 and 48 hours post-dose on Day 1, 8 of Cycle 1 and Days 15, 16 or 17 of Cycle 2 | PK analysis was defined as all participants who received active drug, selinexor, without the co-administration of another chemotherapeutic (i.e., rituximab), and for whom the PK profile for C1D1 could be adequately characterized. Here 'Overall Number of Participants Analyzed' signifies number of participants analyzed for this outcome measure. | hour | MEDIAN |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group165
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | Diffuse Large B-cell Lymphoma (DLBCL) | At Least One TEAE | 58 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | Non-Hodgkin Lymphoma (NHL) Excluding DLBCL | At Least One TEAE | 27 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | Multiple Myeloma (MM) | At Least One TEAE | 81 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | Acute Myeloid Leukemia (AML) | At Least One TEAE | 95 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | Other Hematological Malignancies (ALL, CML and CLL) | At Least One TEAE | 24 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | Diffuse Large B-cell Lymphoma (DLBCL) | At Least One Serious TEAE | 33 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | Non-Hodgkin Lymphoma (NHL) Excluding DLBCL | At Least One Serious TEAE | 7 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | Multiple Myeloma (MM) | At Least One Serious TEAE | 52 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | Acute Myeloid Leukemia (AML) | At Least One Serious TEAE | 73 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | Other Hematological Malignancies (ALL, CML and CLL) | At Least One Serious TEAE | 13 | Participants |
1 to 10 of 165Source ClinicalTrials.gov
See all 165 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Diffuse Large B-cell Lymphoma (DLBCL) | 58 | |
| Overall Study | STARTED | Non-Hodgkin Lymphoma (NHL) Excluding DLBCL | 27 | |
| Overall Study | STARTED | Multiple Myeloma (MM) | 81 | |
| Overall Study | STARTED | Acute Myeloid Leukemia (AML) | 95 | |
| Overall Study | STARTED | Other Hematological Malignancies (ALL, CML and CLL) | 24 | |
| Overall Study | COMPLETED | Diffuse Large B-cell Lymphoma (DLBCL) | 0 | |
| Overall Study | COMPLETED | Non-Hodgkin Lymphoma (NHL) Excluding DLBCL | 0 | |
| Overall Study | COMPLETED | Multiple Myeloma (MM) | 0 | |
| Overall Study | COMPLETED | Acute Myeloid Leukemia (AML) | 0 | |
| Overall Study | COMPLETED | Other Hematological Malignancies (ALL, CML and CLL) | 0 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events1,305
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 | Hypotension | Vascular disorders | Diffuse Large B-cell Lymphoma (DLBCL) | 7 | 58 | |
| other | Hypotension | Vascular disorders | Non-Hodgkin Lymphoma (NHL) Excluding DLBCL | 5 | 27 | |
| other | Hypotension | Vascular disorders | Multiple Myeloma (MM) | 9 | 81 | |
| other | Hypotension | Vascular disorders | Acute Myeloid Leukemia (AML) | 19 | 95 | |
| other | Hypotension | Vascular disorders | Other Hematological Malignancies (ALL, CML and CLL) | 2 | 24 | |
| other | Hypertension | Vascular disorders | Diffuse Large B-cell Lymphoma (DLBCL) | 5 | 58 | |
| other | Hypertension | Vascular disorders | Non-Hodgkin Lymphoma (NHL) Excluding DLBCL | 2 | 27 | |
| other | Hypertension | Vascular disorders | Multiple Myeloma (MM) | 1 | 81 | |
| other | Hypertension | Vascular disorders | Acute Myeloid Leukemia (AML) | 9 | 95 | |
| other | Hypertension | Vascular disorders | Other Hematological Malignancies (ALL, CML and CLL) | 3 | 24 |
1 to 10 of 1,305Source ClinicalTrials.gov
See all 1,305 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Diffuse Large B-cell Lymphoma (DLBCL) | ||
| Total, all-cause mortality | Non-Hodgkin Lymphoma (NHL) Excluding DLBCL | ||
| Total, all-cause mortality | Multiple Myeloma (MM) | ||
| Total, all-cause mortality | Acute Myeloid Leukemia (AML) | ||
| Total, all-cause mortality | Other Hematological Malignancies (ALL, CML and CLL) | ||
| Total, other adverse events | Diffuse Large B-cell Lymphoma (DLBCL) | 58 | 58 |
| Total, other adverse events | Non-Hodgkin Lymphoma (NHL) Excluding DLBCL | 27 | 27 |
| Total, other adverse events | Multiple Myeloma (MM) | 80 | 81 |
| Total, other adverse events | Acute Myeloid Leukemia (AML) | 94 | 95 |
| Total, other adverse events | Other Hematological Malignancies (ALL, CML and CLL) | 24 | 24 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers4
The papers the trial lists on ClinicalTrials.gov.
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.
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