18 and older, any sex, with Solid Tumor. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)Primary· From start of study drug administration to 30 days after last dose of study treatment (maximum duration of 45 months)
An Adverse Event (AE) was defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. TEAE was defined as an adverse event with an onset that occurs after receiving study drug. A serious adverse event (SAE) was defined as an AE that meets one or more of the mentioned criteria; is fatal, life threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly/birth def
Participants with TEAEs
Group
Value
95% CI
Arm A (Colorectal Cancer)
59
Arm B (Gynecological Cancer)
20
Arm C (Squamous Cell Cancer)
21
Arm D (Castrate-resistant Prostate Cancer)
21
Arm E (Glioblastoma Multiforme)
6
Arm F (Melanoma)
15
Arm G (Other Solid Tumors)
46
Participants with TESAEs
Group
Value
95% CI
Arm A (Colorectal Cancer)
30
Arm B (Gynecological Cancer)
13
Arm C (Squamous Cell Cancer)
9
Arm D (Castrate-resistant Prostate Cancer)
8
Arm E (Glioblastoma Multiforme)
2
Arm F (Melanoma)
5
Arm G (Other Solid Tumors)
24
Number of Participants With Treatment-related Treatment-emergent Adverse EventsPrimary· From start of study drug administration to 30 days after last dose of study treatment (maximum duration of 45 months)
An AE was defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. TEAE was defined as an adverse event with an onset that occurs after receiving study drug. A treatment-related AE was any untoward medical occurrence in a clinical investigation participant administered a medicinal product; the event had a causal relationship with the treatment or usage.
Participants with Treatment-related TEAEs
Group
Value
95% CI
Arm A (Colorectal Cancer)
59
Arm B (Gynecological Cancer)
19
Arm C (Squamous Cell Cancer)
20
Arm D (Castrate-resistant Prostate Cancer)
21
Arm E (Glioblastoma Multiforme)
6
Arm F (Melanoma)
14
Arm G (Other Solid Tumors)
45
Participants with Treatment-related TESAEs
Group
Value
95% CI
Arm A (Colorectal Cancer)
6
Arm B (Gynecological Cancer)
2
Arm C (Squamous Cell Cancer)
1
Arm D (Castrate-resistant Prostate Cancer)
4
Arm E (Glioblastoma Multiforme)
1
Arm F (Melanoma)
1
Arm G (Other Solid Tumors)
9
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Greater Than or Equal to Grade 3, Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE), Version 4.03Primary· From start of study drug administration to 30 days after last dose of study treatment (maximum duration of 45 months)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. As per NCI-CTCAE version 4.03, Grade 1: asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2: moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental activities of daily life (ADL); Grade 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of existing hospitalization indicated, disabling, limiting self-care
Group
Value
95% CI
Arm A (Colorectal Cancer)
50
Arm B (Gynecological Cancer)
17
Arm C (Squamous Cell Cancer)
16
Arm D (Castrate-resistant Prostate Cancer)
17
Arm E (Glioblastoma Multiforme)
4
Arm F (Melanoma)
11
Arm G (Other Solid Tumors)
35
Number of Participants Who Experienced Dose Limiting Toxicity (DLT)Primary· Cycle 1 only (28-day cycle)
Evaluation of DLTs was only conducted in participants who participated in the Dose-escalation Phase. A DLT was defined as any of the following, considered possibly related to drug administration, occurring in the first 28 days (or 21 days for participants on Schedule 8) at the target dose (ie, for Schedule 2 this meant the first 4 weeks after the 12 mg/m2 run-in week): Missed selinexor doses due to drug-related toxicities, discontinuation of a participant due to a toxicity that was at least possibly related to study drug before completing Cycle 1.
Group
Value
95% CI
Arm A (Colorectal Cancer)
1
Arm B (Gynecological Cancer)
0
Arm C (Squamous Cell Cancer)
0
Arm D (Castrate-resistant Prostate Cancer)
0
Arm E (Glioblastoma Multiforme)
0
Arm F (Melanoma)
1
Arm G (Other Solid Tumors)
2
Recommended Phase 2 Dose (RP2D)Primary· From start of study drug administration to 30 days after last dose of study treatment (maximum duration of 45 months)
The RP2D was the maximum tolerated dose (MTD) or less. MTD was defined as the next lower dose level below the one in which \>1 of 3 participants or ≥2 of 6 participants experienced DLT, provided that dose level was ≤25 percent (%) lower than the highest (intolerable) dose tested. If the projected MTD was \>25% lower than the highest dose tested, then an additional cohort of ≥3 participants was added at a dose that was intermediate between the intolerable dose and the next lower dose.
Group
Value
95% CI
Arms A to G: Overall Solid Tumor Malignancies
35
Maximum Observed Plasma Concentration (Cmax) of SelinexorSecondary· Cycle1, Day1: Pre-dose, 30, 60, 120, 240, 480 minutes
Cmax was defined as maximum observed concentration, taken directly from the plasma concentration data.
Group
Value
95% CI
Selinexor Dose: 3 mg/m^2
30
Selinexor Dose: 6 mg/m^2
75
± 38.2
Selinexor Dose: 12 mg/m^2
149
± 32
Selinexor Dose: 16.8 mg/m^2
168
Selinexor Dose: 20 mg/m^2
220
± 44.5
Selinexor Dose: 23 mg/m^2
308
± 12.1
Selinexor Dose: 28 mg/m^2
293
± 58.3
Selinexor Dose: 30 mg/m^2
413
± 46.7
Selinexor Dose: 35 mg/m^2
349
± 25.4
Selinexor Dose: 39 mg/m^2
528
± 12.5
Selinexor Dose: 40 mg/m^2
442
± 63.6
Selinexor Dose: 45 mg/m^2
390
± 25.3
Time of Maximum Observed Concentration in Plasma (Tmax) of SelinexorSecondary· Cycle1, Day1: Pre-dose, 30, 60, 120, 240, 480 minutes
Tmax was defined as time of first observation of Cmax, taken directly from the plasma concentration data.
Group
Value
95% CI
Selinexor Dose: 3 mg/m^2
1
Selinexor Dose: 6 mg/m^2
2.1
0.9 – 7.5
Selinexor Dose: 12 mg/m^2
2.0
1.0 – 7.7
Selinexor Dose: 16.8 mg/m^2
2.1
Selinexor Dose: 20 mg/m^2
2.3
2.0 – 7.5
Selinexor Dose: 23 mg/m^2
2.1
1.1 – 8.0
Selinexor Dose: 28 mg/m^2
3.1
0.5 – 7.6
Selinexor Dose: 30 mg/m^2
2.9
0.5 – 7.7
Selinexor Dose: 35 mg/m^2
3.8
2.0 – 7.8
Selinexor Dose: 39 mg/m^2
3.1
1.0 – 4.3
Selinexor Dose: 40 mg/m^2
3.9
2.1 – 4.2
Selinexor Dose: 45 mg/m^2
4.2
2.1 – 8.0
Area Under the Concentration Time Curve From the Time of Dosing to Time in Plasma (AUC0-t) of SelinexorSecondary· Cycle1, Day1: Pre-dose, 30, 60, 120, 240, 480 minutes
AUC0-t was defined as area under the concentration-time curve from time zero to the last non-zero concentration.
Group
Value
95% CI
Selinexor Dose: 3 mg/m^2
333
Selinexor Dose: 6 mg/m^2
707
± 13.6
Selinexor Dose: 12 mg/m^2
1578
± 21.0
Selinexor Dose: 16.8 mg/m^2
1369
Selinexor Dose: 20 mg/m^2
2446
± 23.3
Selinexor Dose: 23 mg/m^2
3387
± 17.7
Selinexor Dose: 28 mg/m^2
3106
± 31
Selinexor Dose: 30 mg/m^2
3861
± 16.6
Selinexor Dose: 35 mg/m^2
3691
± 25.0
Selinexor Dose: 39 mg/m^2
4885
± 15.3
Selinexor Dose: 40 mg/m^2
5255
± 24.4
Selinexor Dose: 45 mg/m^2
4390
± 24.9
Area Under the Concentration Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of SelinexorSecondary· Cycle1, Day1: Pre-dose, 30, 60, 120, 240, 480 minutes
AUC0-inf was defined as area under the concentration-time curve from time zero to infinity (extrapolated). It was calculated as AUC0-t + Ct/kel, where: Ct = the last observed non-zero concentration and Kel = elimination rate constant.
t1/2 was defined as elimination half-life, it was calculated as ln(2)/kel, where In = natural logarithm and kel = elimination rate constant.
Group
Value
95% CI
Selinexor Dose: 3 mg/m^2
6.2
Selinexor Dose: 6 mg/m^2
5.6
4.8 – 6.4
Selinexor Dose: 12 mg/m^2
5.0
4.1 – 7.8
Selinexor Dose: 16.8 mg/m^2
5.7
Selinexor Dose: 20 mg/m^2
5.6
4.2 – 7.5
Selinexor Dose: 23 mg/m^2
5.8
5.7 – 6.4
Selinexor Dose: 28 mg/m^2
5.7
Selinexor Dose: 30 mg/m^2
6.5
4.1 – 7.9
Selinexor Dose: 35 mg/m^2
6.0
4.0 – 7.0
Selinexor Dose: 39 mg/m^2
5.9
3.5 – 6.2
Selinexor Dose: 40 mg/m^2
6.9
5.4 – 7.2
Selinexor Dose: 45 mg/m^2
7.3
Apparent Total Body Clearance (CL/F) of SelinexorSecondary· Cycle1, Day1: Pre-dose, 30, 60, 120, 240, 480 minutes
CL/F was calculated as Dose/AUC0-inf, uncorrected for fraction absorbed; reported normalized by participant body weight (kilogram).
Group
Value
95% CI
Selinexor Dose: 3 mg/m^2
0.20
Selinexor Dose: 6 mg/m^2
0.18
± 7.9
Selinexor Dose: 12 mg/m^2
0.19
± 16
Selinexor Dose: 16.8 mg/m^2
0.20
Selinexor Dose: 20 mg/m^2
0.19
± 27
Selinexor Dose: 23 mg/m^2
0.19
± 26.1
Selinexor Dose: 28 mg/m^2
0.18
Selinexor Dose: 30 mg/m^2
0.17
± 16.8
Selinexor Dose: 35 mg/m^2
0.20
± 26.7
Selinexor Dose: 39 mg/m^2
0.20
± 12.5
Selinexor Dose: 40 mg/m^2
0.19
± 24.4
Selinexor Dose: 45 mg/m^2
0.27
Apparent Volume of Distribution of Selinexor (Vd/F)Secondary· Cycle1, Day1: Pre-dose, 30, 60, 120, 240, 480 minutes
Vd/F was calculated as Dose/(kel \* AUC0-inf), uncorrected for fraction absorbed; reported normalized by participant body weight (kilogram).
Group
Value
95% CI
Selinexor Dose: 3 Milligram Per Square Meter (mg/m2)
1.8
Selinexor Dose: 6 mg/m2
1.4
± 12.5
Selinexor Dose: 12 mg/m2
1.4
± 22.5
Selinexor Dose: 16.8 mg/m2
1.6
Selinexor Dose: 20 mg/m2
1.6
± 20.9
Selinexor Dose: 23 mg/m2
1.6
± 21.2
Selinexor Dose: 28 mg/m2
1.5
Selinexor Dose: 30 mg/m2
1.6
± 6.6
Selinexor Dose: 35 mg/m2
1.6
± 26.6
Selinexor Dose: 39 mg/m2
1.5
± 26.1
Selinexor Dose: 40 mg/m2
1.9
± 31.1
Selinexor Dose: 45 mg/m2
2.8
Adverse events — posted to ClinicalTrials.gov
Time frame: From start of study drug administration to 30 days after last dose of study treatment (maximum duration of 45 months).
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Arm A (Colorectal Cancer)
Serious: 30/59 (51%)
Deaths: —
Arm B (Gynecological Cancer)
Serious: 13/20 (65%)
Deaths: —
Arm C (Squamous Cell Cancer)
Serious: 9/21 (43%)
Deaths: —
Arm D (Castrate-resistant Prostate Cancer)
Serious: 8/21 (38%)
Deaths: —
Arm E (Glioblastoma Multiforme)
Serious: 2/6 (33%)
Deaths: —
Arm F (Melanoma)
Serious: 5/15 (33%)
Deaths: —
Arm G (Other Solid Tumors)
Serious: 24/47 (51%)
Deaths: —
Serious adverse events (78 terms)
Reaction
System
Arm A (Colorectal Cancer)
Arm B (Gynecological Cancer)
Arm C (Squamous Cell Cancer)
Arm D (Castrate-resistant …
Arm E (Glioblastoma Multif…
Arm F (Melanoma)
Arm G (Other Solid Tumors)
Sepsis
Infections and infestations
—
—
—
—
—
—
—
Nausea
Gastrointestinal disorders
—
—
—
—
—
—
—
Small intestinal obstruction
Gastrointestinal disorders
—
—
—
—
—
—
—
Back pain
Musculoskeletal and connective tissue disorders
—
—
—
—
—
—
—
Hypotension
Vascular disorders
—
—
—
—
—
—
—
Thrombocytopenia
Blood and lymphatic system disorders
—
—
—
—
—
—
—
Large intestinal obstruction
Gastrointestinal disorders
—
—
—
—
—
—
—
Vomiting
Gastrointestinal disorders
—
—
—
—
—
—
—
Fatigue
General disorders
—
—
—
—
—
—
—
Lung infection
Infections and infestations
—
—
—
—
—
—
—
Syncope
Nervous system disorders
—
—
—
—
—
—
—
Dyspnoea
Respiratory, thoracic and mediastinal disorders
—
—
—
—
—
—
—
Cataract
Eye disorders
—
—
—
—
—
—
—
Abdominal pain
Gastrointestinal disorders
—
—
—
—
—
—
—
Blood bilirubin increased
Investigations
—
—
—
—
—
—
—
Dehydration
Metabolism and nutrition disorders
—
—
—
—
—
—
—
Spinal cord compression
Nervous system disorders
—
—
—
—
—
—
—
Anaemia
Blood and lymphatic system disorders
—
—
—
—
—
—
—
Cardiac failure
Cardiac disorders
—
—
—
—
—
—
—
Large intestinal stenosis
Gastrointestinal disorders
—
—
—
—
—
—
—
Upper gastrointestinal haemorrhage
Gastrointestinal disorders
—
—
—
—
—
—
—
Asthenia
General disorders
—
—
—
—
—
—
—
Death
General disorders
—
—
—
—
—
—
—
Hyperglycaemia
Metabolism and nutrition disorders
—
—
—
—
—
—
—
Pain in extremity
Musculoskeletal and connective tissue disorders
—
—
—
—
—
—
—
Other adverse events (198 terms — click to expand)
Phase 1 study to evaluate the safety and tolerability of selinexor and determine the Recommended Phase 2 Dose (RP2D) of selinexor for advanced or metastatic solid tumor malignancies.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07447817 — Selinexor and Pacritinib in JAK Inhibitor-naïve MF Patients With Cytopenias
· Phase 2
· not yet recruiting
NCT07200102 — Selinexor Maintenance Post CAR-T Cell Therapy for Multiple Myeloma
· Phase 1
· recruiting
NCT07204041 — Efficacy and Safety of XTD Regimen (Selinexor, Thalidomide and Dexamethasone) in Adult Patients With Relapsed/Refractory
· Phase 2
· active not recruiting
NCT06966154 — A Phase Ib/II Clinical Study Evaluating the Safety and Efficacy of Tislelizumab in Combination With Golidocitinib and Se
· Phase 1, PHASE2
· recruiting
NCT06900088 — Selinexor Combined With Azacitidine Therapy in High-Risk Myeloid Neoplasms Patients
· Phase 2
· not yet recruiting
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Other Karyopharm Therapeutics Inc trials
Trials by the same sponsor.
NCT04854434 — A Study to Evaluate the Safety and Efficacy of Selinexor With or Without Pembrolizumab Versus Standard of Care in Previo
· Phase 2
· terminated
NCT04768881 — Safety and Efficacy of Selinexor in Combination With Pembrolizumab in Recurrent Advanced Melanoma
· Phase 2
· terminated
NCT04421378 — A Study of Selinexor in Combination With Standard of Care Therapy for Newly Diagnosed or Recurrent Glioblastoma
· Phase 1, PHASE2
· terminated
NCT04355676 — Evaluation of Activity and Safety of Two Regimens of Low Dose Oral Selinexor in Participants With Moderate or Severe COV
· Phase 2
· withdrawn
NCT04349098 — Evaluation of Activity and Safety of Oral Selinexor in Participants With Severe COVID-19 Infection
· Phase 2
· completed
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Karyopharm Therapeutics Inc
Last refreshed: 26 January 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01607905.