18 and older, any sex, with Hematological Malignancies. 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 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 thes
At Least One TEAE
Group
Value
95% CI
Diffuse Large B-cell Lymphoma (DLBCL)
58
Non-Hodgkin Lymphoma (NHL) Excluding DLBCL
27
Multiple Myeloma (MM)
81
Acute Myeloid Leukemia (AML)
95
Other Hematological Malignancies (ALL, CML and CLL)
24
At Least One Serious TEAE
Group
Value
95% CI
Diffuse Large B-cell Lymphoma (DLBCL)
33
Non-Hodgkin Lymphoma (NHL) Excluding DLBCL
7
Multiple Myeloma (MM)
52
Acute Myeloid Leukemia (AML)
73
Other Hematological Malignancies (ALL, CML and CLL)
13
Recommended Phase 2 Dose (RP2D) of SelinexorPrimary· 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.
Group
Value
95% CI
Advanced Hematological Malignancies.
35
Maximum Observed Plasma Concentration (Cmax) of SelinexorSecondary· 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.
Group
Value
95% CI
Selinexor (3 mg/m^2)
49.0
± NA
Selinexor (6 mg/m^2)
50.0
± 61.1
Selinexor (12 mg/m^2)
149
± 37.6
Selinexor (16.8 mg/m^2)
205
± 46.8
Selinexor (23 mg/m^2)
262
± 37.5
Selinexor (30 mg/m^2)
387
± 37.1
Selinexor (35 mg/m^2)
407
± 44.4
Selinexor (40 mg/m^2)
416
± 36.6
Selinexor (46 mg/m^2)
670
± 18.5
Selinexor (55 mg/m^2)
583
± 41.4
Selinexor (60 mg/m^2)
668
± 33.2
Selinexor (70 mg/m^2)
800
± 32.4
Time to Maximum Observed Concentration (Tmax) of SelinexorSecondary· 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.
Group
Value
95% CI
Selinexor (3 mg/m^2)
NA
2.1 – 2.2
Selinexor (6 mg/m^2)
4.0
2.1 – 7.7
Selinexor (12 mg/m^2)
3.0
1.1 – 4.2
Selinexor (16.8 mg/m^2)
2.08
0.92 – 8.5
Selinexor (23 mg/m^2)
2.0
1.0 – 7.8
Selinexor (30 mg/m^2)
2.0
0.72 – 4.4
Selinexor (35 mg/m^2)
2.0
0.92 – 4.1
Selinexor (40 mg/m^2)
4.0
2.0 – 7.5
Selinexor (46 mg/m^2)
2.0
0.50 – 4.2
Selinexor (55 mg/m^2)
2.9
1.0 – 8.0
Selinexor (60 mg/m^2)
1.9
1.8 – 2.0
Selinexor (70 mg/m^2)
2.0
1.0 – 4.0
Average Concentration From Time 0 to 24 Hours (Cavg0-24h) of SelinexorSecondary· 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.
Group
Value
95% CI
Selinexor (3 mg/m^2)
17.0
± NA
Selinexor (6 mg/m^2)
20.3
± 94.8
Selinexor (12 mg/m^2)
61.8
± 39.9
Selinexor (16.8 mg/m^2)
79.0
± 61.8
Selinexor (23 mg/m^2)
108
± 46.8
Selinexor (30 mg/m^2)
160
± 38.0
Selinexor (35 mg/m^2)
168
± 54.0
Selinexor (40 mg/m^2)
163
± 29.2
Selinexor (46 mg/m^2)
297
± 26.3
Selinexor (55 mg/m^2)
208
± 19.1
Selinexor (60 mg/m^2)
337
± 4.2
Selinexor (70 mg/m^2)
353
± 26.2
Area Under the Concentration-Time Curve From Time 0 to t (AUC0-t) of SelinexorSecondary· 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.
Group
Value
95% CI
Selinexor (3 mg/m^2)
331
± NA
Selinexor (6 mg/m^2)
564
± 41.9
Selinexor (12 mg/m^2)
1459
± 20.5
Selinexor (16.8 mg/m^2)
1829
± 23.3
Selinexor (23 mg/m^2)
2774
± 36.7
Selinexor (30 mg/m^2)
3461
± 26.9
Selinexor (35 mg/m^2)
3901
± 29.2
Selinexor (40 mg/m^2)
4481
± 23.8
Selinexor (46 mg/m^2)
5228
± 21.6
Selinexor (55 mg/m^2)
5601
± 36.2
Selinexor (60 mg/m^2)
5282
± 57.9
Selinexor (70 mg/m^2)
5466
± 45.7
Area Under the Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUC0-inf) of SelinexorSecondary· 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).
Group
Value
95% CI
Selinexor (3 mg/m^2)
348
± NA
Selinexor (6 mg/m^2)
733
± NA
Selinexor (12 mg/m^2)
1529
± 18.7
Selinexor (16.8 mg/m^2)
1867
± 23.6
Selinexor (23 mg/m^2)
2645
± 1111
Selinexor (30 mg/m^2)
3513
± 26.0
Selinexor (35 mg/m^2)
3948
± 28.6
Selinexor (40 mg/m^2)
4552
± 23.7
Selinexor (46 mg/m^2)
5284
± 21.0
Selinexor (55 mg/m^2)
6089
± 32.3
Selinexor (60 mg/m^2)
6964
± 12.2
Selinexor (70 mg/m^2)
7803
± 8.5
Apparent Volume of Distribution Uncorrected for Fraction Absorbed (Vd/F) of SelinexorSecondary· 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 \[kg\]).
Group
Value
95% CI
Selinexor (3 mg/m^2)
1.6
± NA
Selinexor (6 mg/m^2)
1.5
± NA
Selinexor (12 mg/m^2)
1.9
± 21.2
Selinexor (16.8 mg/m^2)
1.9
± 29.9
Selinexor (23 mg/m^2)
1.9
± 34.1
Selinexor (30 mg/m^2)
1.7
± 24.1
Selinexor (35 mg/m^2)
2.0
± 30.3
Selinexor (40 mg/m^2)
1.7
± 29.1
Selinexor (46 mg/m^2)
1.8
± 12.9
Selinexor (55 mg/m^2)
1.9
± 27.9
Selinexor (60 mg/m^2)
1.6
± 23.0
Selinexor (70 mg/m^2)
1.7
± 13.4
Apparent Total Body Clearance, Uncorrected for Fraction Absorbed (Cl/F) of SelinexorSecondary· 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).
Group
Value
95% CI
Selinexor (3 mg/m^2)
0.19
± NA
Selinexor (6 mg/m^2)
0.21
± NA
Selinexor (12 mg/m^2)
0.21
± 26.6
Selinexor (16.8 mg/m^2)
0.22
± 22.8
Selinexor (23 mg/m^2)
0.20
± 54.9
Selinexor (30 mg/m^2)
0.21
± 25.3
Selinexor (35 mg/m^2)
0.22
± 25.9
Selinexor (40 mg/m^2)
0.23
± 26.2
Selinexor (46 mg/m^2)
0.22
± 12.9
Selinexor (55 mg/m^2)
0.20
± 24.6
Selinexor (60 mg/m^2)
0.19
± 27.5
Selinexor (70 mg/m^2)
0.22
± 7.8
Terminal Half-Life (t½) of SelinexorSecondary· 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.
Group
Value
95% CI
Selinexor (3 mg/m^2)
NA
5.5 – 6.1
Selinexor (6 mg/m^2)
NA
4.4 – 5.1
Selinexor (12 mg/m^2)
6.2
4.2 – 7.8
Selinexor (16.8 mg/m^2)
6.1
3.1 – 8.7
Selinexor (23 mg/m^2)
6.9
3.5 – 12.0
Selinexor (30 mg/m^2)
5.8
3.9 – 8.4
Selinexor (35 mg/m^2)
6.2
4.6 – 10.4
Selinexor (40 mg/m^2)
4.8
2.7 – 9.8
Selinexor (46 mg/m^2)
5.7
4.1 – 6.8
Selinexor (55 mg/m^2)
6.6
5.4 – 10.1
Selinexor (60 mg/m^2)
5.9
4.3 – 5.9
Selinexor (70 mg/m^2)
5.2
5.0 – 6.0
Number of Participants With Overall Response of SelinexorSecondary· From first dose of study drug administration to end of treatment (up to 27 months)
Objective response for each malignancy was defined using the disease response criteria by malignancy; For NHL (including DLBCL, PTCL, and CTCL), objective response included complete response (CR) and partial response (PR). For MM, objective response included stringent complete response (sCR), CR, very good partial response (VGPR), and PR. For WM, objective response included CR, VGPR, and PR. For CLL, ALL, and AML, objective response included complete remission and Partial remission. For CML, objective response includes complete cytogenic response, and complete hematologic response (CHR).
Complete response
Group
Value
95% CI
Diffuse Large B-cell Lymphoma (DLBCL)
5
Non-Hodgkin Lymphoma (NHL) Excluding DLBCL
1
Multiple Myeloma (MM)
0
Acute Myeloid Leukemia (AML)
0
Other Hematological Malignancies (ALL, CML and CLL)
0
Partial response
Group
Value
95% CI
Diffuse Large B-cell Lymphoma (DLBCL)
7
Non-Hodgkin Lymphoma (NHL) Excluding DLBCL
8
Multiple Myeloma (MM)
6
Acute Myeloid Leukemia (AML)
0
Other Hematological Malignancies (ALL, CML and CLL)
0
Morphologic complete remission
Group
Value
95% CI
Diffuse Large B-cell Lymphoma (DLBCL)
0
Non-Hodgkin Lymphoma (NHL) Excluding DLBCL
0
Multiple Myeloma (MM)
0
Acute Myeloid Leukemia (AML)
4
Other Hematological Malignancies (ALL, CML and CLL)
0
Partial remission
Group
Value
95% CI
Diffuse Large B-cell Lymphoma (DLBCL)
0
Non-Hodgkin Lymphoma (NHL) Excluding DLBCL
0
Multiple Myeloma (MM)
0
Acute Myeloid Leukemia (AML)
3
Other Hematological Malignancies (ALL, CML and CLL)
1
Complete cytogenetic response
Group
Value
95% CI
Diffuse Large B-cell Lymphoma (DLBCL)
0
Non-Hodgkin Lymphoma (NHL) Excluding DLBCL
0
Multiple Myeloma (MM)
0
Acute Myeloid Leukemia (AML)
0
Other Hematological Malignancies (ALL, CML and CLL)
0
Complete hematological response
Group
Value
95% CI
Diffuse Large B-cell Lymphoma (DLBCL)
0
Non-Hodgkin Lymphoma (NHL) Excluding DLBCL
0
Multiple Myeloma (MM)
0
Acute Myeloid Leukemia (AML)
0
Other Hematological Malignancies (ALL, CML and CLL)
0
Duration of ResponseSecondary· From first dose of study drug administration to end of treatment (up to 27 months)
Duration of response was defined as the time from the first occurrence of objective response to first documented evidence of disease recurrence or progression. Participants without evidence of progression were censored at time of last evaluable disease assessment. Objective response was defined as any response of partial response/remission or better for all malignancies; for AML, a response of morphologic leukemia-free state is also included for ORR. Duration of response was calculated by Kaplan-Meier method.
Group
Value
95% CI
Diffuse Large B-cell Lymphoma (DLBCL)
335.5
48 – NA
Non-Hodgkin Lymphoma (NHL) Excluding DLBCL
251
36 – NA
Multiple Myeloma (MM)
180
57 – NA
Acute Myeloid Leukemia (AML)
76
29 – NA
Other Hematological Malignancies (ALL, CML and CLL)
NA
NA – NA
Adverse events — posted to ClinicalTrials.gov
Time frame: From first dose of study drug administration to end of treatment (up to 27 months).
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Diffuse Large B-cell Lymphoma (DLBCL)
Serious: 33/58 (57%)
Deaths: —
Non-Hodgkin Lymphoma (NHL) Excluding DLBCL
Serious: 7/27 (26%)
Deaths: —
Multiple Myeloma (MM)
Serious: 52/81 (64%)
Deaths: —
Acute Myeloid Leukemia (AML)
Serious: 73/95 (77%)
Deaths: —
Other Hematological Malignancies (ALL, CML and CLL)
Serious: 13/24 (54%)
Deaths: —
Serious adverse events (147 terms)
Reaction
System
Diffuse Large B-cell Lymph…
Non-Hodgkin Lymphoma (NHL)…
Multiple Myeloma (MM)
Acute Myeloid Leukemia (AML)
Other Hematological Malign…
Sepsis
Infections and infestations
—
—
—
—
—
Febrile neutropenia
Blood and lymphatic system disorders
—
—
—
—
—
Pneumonia
Infections and infestations
—
—
—
—
—
Fatigue
General disorders
—
—
—
—
—
Pyrexia
General disorders
—
—
—
—
—
Dehydration
Metabolism and nutrition disorders
—
—
—
—
—
Malignant neoplasm progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
—
—
—
—
Thrombocytopenia
Blood and lymphatic system disorders
—
—
—
—
—
Acute kidney injury
Renal and urinary disorders
—
—
—
—
—
Lung infection
Infections and infestations
—
—
—
—
—
Bacteraemia
Infections and infestations
—
—
—
—
—
Death
General disorders
—
—
—
—
—
Confusional state
General disorders
—
—
—
—
—
Respiratory failure
Respiratory, thoracic and mediastinal disorders
—
—
—
—
—
Vomiting
Gastrointestinal disorders
—
—
—
—
—
Staphylococcal infection
Infections and infestations
—
—
—
—
—
Embolism
Vascular disorders
—
—
—
—
—
Hypotension
Vascular disorders
—
—
—
—
—
Asthenia
General disorders
—
—
—
—
—
Disease progression
General disorders
—
—
—
—
—
Multiple organ dysfunction syndrome
General disorders
—
—
—
—
—
Delirium
Psychiatric disorders
—
—
—
—
—
Fall
Injury, poisoning and procedural complications
—
—
—
—
—
Aspartate aminotransferase increased
Investigations
—
—
—
—
—
Tachycardia
Cardiac disorders
—
—
—
—
—
Other adverse events (114 terms — click to expand)
The purpose of this research study is to find out more information relating to the highest dose of KCP-330 that can be given safely and side effects it may cause, to examine how the body affects KCP-330 concentrations in the blood (pharmacokinetics or PK), to examine the effects of KCP-330 on the body (pharmacodynamics or PDn) and to obtain information on its effectiveness in treating cancer.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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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/NCT01607892.