Trial · NCT01896505
A Phase I Trial to Assess the Effects of Food and Formulation on PK of KPT-330 in Patients With Sarcoma
NCT01896505, Phase 1, Completed, Karyopharm Therapeutics Inc; results first posted 2024-01-08
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Phase I Trial to Assess the Effects of Food and Formulation on PK of KPT-330 in Patients With Sarcoma. Trials, record NCT01896505. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01896505
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase I Trial to Assess the Effects of Food and Formulation on PK of KPT-330 in Patients With Sarcoma
- NCT number
- NCT01896505
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 54 participants, actual
- Lead sponsor
- Karyopharm Therapeutics Inc
- Conditions
- Sarcoma
- Interventions
- KCP-330
- First posted
- 2013-07-11
- Last updated
- 2024-01-08
- Results first posted
- 2024-01-08
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Area Under the Concentration-time Curve From the Time Zero to the Last Non-zero Concentration (AUC0-t) of Selinexor | Day 1 of weeks 1-3 in Cycle 1: Pre-dose (within 10 minutes before swallowing study drug), 15, 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 10,18, 24, and 48 hours post-dose | AUC0-t was defined as area under the concentration-time curve from time zero to the last non-zero concentration. |
| Primary | Area Under the Concentration Time Curve From the Time Zero to Extrapolated to Infinity (AUC0-inf) of Selinexor | Day 1 of weeks 1-3 in Cycle 1: Pre-dose (within 10 minutes before swallowing study drug), 15, 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 18, 24, and 48 hours post-dose | AUC0-inf was defined as area under the concentration-time curve from time zero to infinity (extrapolated), AUC0-inf was calculated as AUC0-t + Ct/ elimination rate constant (kel), where: Ct = the last observed non- zero concentration. |
| Primary | Maximum Observed Plasma Concentration (Cmax) of Selinexor | Day 1 of weeks 1-3 in Cycle 1: Pre-dose (within 10 minutes before swallowing study drug), 15, 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 18, 24, and 48 hours post-dose | Cmax was defined as maximum observed concentration, taken directly from the plasma concentration data. |
| Primary | Time of First Maximum Observed Concentration (Tmax) of Selinexor | Day 1 of weeks 1-3 in Cycle 1: Pre-dose (within 10 minutes before swallowing study drug), 15, 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 18, 24, and 48 hours post-dose | Tmax was defined as time of first observation of Cmax, taken directly from the plasma concentration data. |
| Primary | Terminal Phase Half-Life (t1/2) of Selinexor | Day 1 of weeks 1-3 in Cycle 1: Pre-dose (within 10 minutes before swallowing study drug), 15, 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 18, 24, and 48 hours post-dose | t1/2 was the terminal phase half-life, it was calculated as ln(2)/kel. |
| Primary | Apparent Total Body Clearance (CL/F) of Selinexor | Day 1 of weeks 1-3 in Cycle 1: Pre-dose (within 10 minutes before swallowing study drug), 15, 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 18, 24, and 48 hours post-dose | Apparent total body clearance was calculated as Dose/AUC0-inf, uncorrected for fraction absorbed; reported normalized by participant body weight (kilogram \[kg\]). |
| Primary | Apparent Volume of Distribution (Vd/F) of Selinexor | Day 1 of weeks 1-3 in Cycle 1: Pre-dose (within 10 minutes before swallowing study drug), 15, 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 18, 24, and 48 hours post-dose | Vd/F was calculated as Dose/ (kel \*AUC0-inf), uncorrected for fraction absorbed; reported normalized by participant body weight (kg). |
| Secondary | Percentage of Participants With Best Overall Response According to Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 Criteria | From the date of first documented response until the date of documented progression or last disease assessment (up to 39 months) | Best overall response rate was defined as the percentage of participants who achieved complete response (CR), and partial response (PR), as assessed by the RECIST v1.1 criteria. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non target) must have reduction in the short axis to less than (\<) 10 millimeter (mm). PR was defined as At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum longest diameter (LD). |
| Secondary | Duration of Stable Disease as Per RECIST v1.1 Criteria | From the date of first dose of study treatment to first documented radiologic evidence of disease recurrence or progression, censored date (up to 39 months) | Duration of at least stable disease was defined as the time from the date of first dose of study treatment to first documented radiologic evidence of disease recurrence or progression as per RECIST v1.1 Criteria. Participants without evidence of progression were censored at time of last disease assessment. Progressive Disease (PD) was defined as at least a 20% increase in the sum of diameters of measured lesions taking as references the smallest sum of diameters recorded since the treatment started. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Appearance of one or more new lesions also constituted progressive disease. |
| Secondary | Progression Free Survival (PFS) as Per RECIST v1.1 Criteria | From first dose of study treatment to time of disease progression or death, censored date (up to 39 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 v1.1, 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. Participants who were last known to be alive and without evidence of progression were censored at time of last disease assessment. If date of progression or death occurred after more than 1 missed disease assessment interval, or 30 days after end of treatment, participants were censored at the time of last evaluable disease assessment prior to the missed assessment. |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 registered outcomesOutcomes18
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Area Under the Concentration-time Curve From the Time Zero to the Last Non-zero Concentration (AUC0-t) of Selinexor | Day 1 of weeks 1-3 in Cycle 1: Pre-dose (within 10 minutes before swallowing study drug), 15, 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 10,18, 24, and 48 hours post-dose | Pharmacokinetic (PK) population included all participants in Arms 1, 2 and Arms 4, 5, and 6 who received selinexor, and for whom the PK profile for all treatments could be adequately characterized. Here 'overall number of participants analyzed' signifies number of participants evaluable for this outcome measure. As pre-specified in SAP and protocol Arm 3 was a non-PK group assessment, so data was not collected and analyzed for this PK outcome. | Nanograms*hour per milliliter (ng*h/mL) | GEOMETRIC_MEAN |
| PRIMARY | Area Under the Concentration Time Curve From the Time Zero to Extrapolated to Infinity (AUC0-inf) of Selinexor | Day 1 of weeks 1-3 in Cycle 1: Pre-dose (within 10 minutes before swallowing study drug), 15, 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 18, 24, and 48 hours post-dose | PK population included all participants in Arms 1, 2 and Arms 4, 5, and 6 who received selinexor, and for whom the PK profile for all treatments could be adequately characterized. Here 'overall number of participants analyzed' signifies participants who are evaluable for this outcome measure. As pre-specified in SAP and protocol Arm 3 was a non-PK group assessment, so data was not collected and analyzed for this PK outcome. | ng*h/mL | GEOMETRIC_MEAN |
| PRIMARY | Maximum Observed Plasma Concentration (Cmax) of Selinexor | Day 1 of weeks 1-3 in Cycle 1: Pre-dose (within 10 minutes before swallowing study drug), 15, 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 18, 24, and 48 hours post-dose | PK population included all participants in Arms 1, 2 and Arms 4, 5, and 6 who received selinexor, and for whom the PK profile for all treatments could be adequately characterized. Here 'overall number of participants analyzed' signifies participants who are evaluable for this outcome measure. As pre-specified in SAP and protocol Arm 3 was a non-PK group assessment, so data was not collected and analyzed for this PK outcome. | Nanogram per milliliter (ng/mL) | GEOMETRIC_MEAN |
| PRIMARY | Time of First Maximum Observed Concentration (Tmax) of Selinexor | Day 1 of weeks 1-3 in Cycle 1: Pre-dose (within 10 minutes before swallowing study drug), 15, 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 18, 24, and 48 hours post-dose | PK population included all participants in Arms 1, 2 and Arms 4, 5, and 6 who received selinexor, and for whom the PK profile for all treatments could be adequately characterized. Here 'overall number of participants analyzed' signifies participants who are evaluable for this outcome measure. As pre-specified in SAP and protocol Arm 3 was a non-PK group assessment, so data was not collected and analyzed for this PK outcome. | Hour | MEDIAN |
| PRIMARY | Terminal Phase Half-Life (t1/2) of Selinexor | Day 1 of weeks 1-3 in Cycle 1: Pre-dose (within 10 minutes before swallowing study drug), 15, 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 18, 24, and 48 hours post-dose | PK population included all participants in Arms 1, 2 and Arms 4, 5, and 6 who received selinexor, and for whom the PK profile for all treatments could be adequately characterized. Here 'overall number of participants analyzed' signifies participants who are evaluable for this outcome measure. As pre-specified in SAP and protocol Arm 3 was a non-PK group assessment, so data was not collected and analyzed for this PK outcome. | Hour | MEAN |
| PRIMARY | Apparent Total Body Clearance (CL/F) of Selinexor | Day 1 of weeks 1-3 in Cycle 1: Pre-dose (within 10 minutes before swallowing study drug), 15, 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 18, 24, and 48 hours post-dose | PK population included all participants in Arms 1, 2 and Arms 4, 5, and 6 who received selinexor, and for whom the PK profile for all treatments could be adequately characterized. Here 'overall number of participants analyzed' signifies participants who are evaluable for this outcome measure. As pre-specified in SAP and protocol Arm 3 was a non-PK group assessment, so data was not collected and analyzed for this PK outcome. | Liter per hour per kilogram (L/h/kg) | GEOMETRIC_MEAN |
| PRIMARY | Apparent Volume of Distribution (Vd/F) of Selinexor | Day 1 of weeks 1-3 in Cycle 1: Pre-dose (within 10 minutes before swallowing study drug), 15, 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 18, 24, and 48 hours post-dose | PK population included all participants in Arms 1, 2 and Arms 4, 5, and 6 who received selinexor, and for whom the PK profile for all treatments could be adequately characterized. Here 'overall number of participants analyzed' signifies participants who are evaluable for this outcome measure. As pre-specified in SAP and protocol Arm 3 was a non-PK group assessment, so data was not collected and analyzed for this PK outcome. | Liter per kilogram (L/kg) | GEOMETRIC_MEAN |
| SECONDARY | Percentage of Participants With Best Overall Response According to Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 Criteria | From the date of first documented response until the date of documented progression or last disease assessment (up to 39 months) | Safety population consisted of all participants who received at least one dose of selinexor. Data for this outcome measure analysis was planned to be analyzed as per disease specific sarcoma. | Percentage of participants | NUMBER |
| SECONDARY | Duration of Stable Disease as Per RECIST v1.1 Criteria | From the date of first dose of study treatment to first documented radiologic evidence of disease recurrence or progression, censored date (up to 39 months) | Safety population consisted of all participants who received at least one dose of selinexor. Data for this outcome measure was planned to be analyzed as per disease specific sarcoma. | Months | MEDIAN |
| SECONDARY | Progression Free Survival (PFS) as Per RECIST v1.1 Criteria | From first dose of study treatment to time of disease progression or death, censored date (up to 39 months) | Safety population consisted of all participants who received at least one dose of selinexor. Data for this outcome measure was planned to be analyzed as per disease specific sarcoma. | Months | MEDIAN |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 outcomesResults by group277
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Area Under the Concentration-time Curve From the Time Zero to the Last Non-zero Concentration (AUC0-t) of Selinexor | Arms 1 and 2: Treatment A: Fasted, Tablet Formulation | 2752 | Geometric Coefficient of Variation 37.5 | Nanograms*hour per milliliter (ng*h/mL) | |
| Area Under the Concentration-time Curve From the Time Zero to the Last Non-zero Concentration (AUC0-t) of Selinexor | Arms 1 and 2: Treatment B: High-Fat Meal, Tablet Formulation | 3175 | Geometric Coefficient of Variation 25.3 | Nanograms*hour per milliliter (ng*h/mL) | |
| Area Under the Concentration-time Curve From the Time Zero to the Last Non-zero Concentration (AUC0-t) of Selinexor | Arms 1 and 2: Treatment C: Low-Fat Meal, Tablet Formulation | 3280 | Geometric Coefficient of Variation 19.3 | Nanograms*hour per milliliter (ng*h/mL) | |
| Area Under the Concentration-time Curve From the Time Zero to the Last Non-zero Concentration (AUC0-t) of Selinexor | Arms 1 and 2: Treatment D: Low-Fat Meal, Capsule Formulation | 3342 | Geometric Coefficient of Variation 21.4 | Nanograms*hour per milliliter (ng*h/mL) | |
| Area Under the Concentration-time Curve From the Time Zero to the Last Non-zero Concentration (AUC0-t) of Selinexor | Arms 4, 5, and 6: Treatment A: First Generation Tablet | 4086 | Geometric Coefficient of Variation 22.3 | Nanograms*hour per milliliter (ng*h/mL) | |
| Area Under the Concentration-time Curve From the Time Zero to the Last Non-zero Concentration (AUC0-t) of Selinexor | Arms 4, 5, and 6: Treatment B: Second Generation Tablet | 4220 | Geometric Coefficient of Variation 22.0 | Nanograms*hour per milliliter (ng*h/mL) | |
| Area Under the Concentration-time Curve From the Time Zero to the Last Non-zero Concentration (AUC0-t) of Selinexor | Arms 4, 5, and 6: Treatment C: Oral Suspension | 3955 | Geometric Coefficient of Variation 21.2 | Nanograms*hour per milliliter (ng*h/mL) | |
| Area Under the Concentration Time Curve From the Time Zero to Extrapolated to Infinity (AUC0-inf) of Selinexor | Arms 1 and 2: Treatment A: Fasted, Tablet Formulation | 2969 | Geometric Coefficient of Variation 34.1 | ng*h/mL | |
| Area Under the Concentration Time Curve From the Time Zero to Extrapolated to Infinity (AUC0-inf) of Selinexor | Arms 1 and 2: Treatment B: High-Fat Meal, Tablet Formulation | 3412 | Geometric Coefficient of Variation 23.8 | ng*h/mL | |
| Area Under the Concentration Time Curve From the Time Zero to Extrapolated to Infinity (AUC0-inf) of Selinexor | Arms 1 and 2: Treatment C: Low-Fat Meal, Tablet Formulation | 3483 | Geometric Coefficient of Variation 18.1 | ng*h/mL |
1 to 10 of 277Source ClinicalTrials.gov
See all 277 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm 1: | 10 | |
| Overall Study | STARTED | Arm 2: | 9 | |
| Overall Study | STARTED | Arm 3: | 17 | |
| Overall Study | STARTED | Arm 4: | 7 | |
| Overall Study | STARTED | Arm 5: | 5 | |
| Overall Study | STARTED | Arm 6: | 6 | |
| Overall Study | COMPLETED | Arm 1: | 0 | |
| Overall Study | COMPLETED | Arm 2: | 0 | |
| Overall Study | COMPLETED | Arm 3: | 0 | |
| Overall Study | COMPLETED | Arm 4: | 0 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events1,440
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 | Arm 1: | 3 | 10 | |
| other | Anaemia | Blood and lymphatic system disorders | Arm 2: | 7 | 9 | |
| other | Anaemia | Blood and lymphatic system disorders | Arm 3: | 12 | 17 | |
| other | Anaemia | Blood and lymphatic system disorders | Arm 4: | 1 | 7 | |
| other | Anaemia | Blood and lymphatic system disorders | Arm 5: | 4 | 5 | |
| other | Anaemia | Blood and lymphatic system disorders | Arm 6: | 5 | 6 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Arm 1: | 2 | 10 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Arm 2: | 8 | 9 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Arm 3: | 9 | 17 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Arm 4: | 1 | 7 |
1 to 10 of 1,440Source ClinicalTrials.gov
See all 1,440 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm 1: | 2 | 10 |
| Total, all-cause mortality | Arm 2: | 2 | 9 |
| Total, all-cause mortality | Arm 3: | 1 | 17 |
| Total, all-cause mortality | Arm 4: | 3 | 7 |
| Total, all-cause mortality | Arm 5: | 3 | 5 |
| Total, all-cause mortality | Arm 6: | 2 | 6 |
| Total, other adverse events | Arm 1: | 10 | 10 |
| Total, other adverse events | Arm 2: | 9 | 9 |
| Total, other adverse events | Arm 3: | 17 | 17 |
| Total, other adverse events | Arm 4: | 7 | 7 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 27458288 | 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
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