Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
KCP-330 · 1 trial · 1 indication
AUC0-t was defined as area under the concentration-time curve from time zero to the last non-zero concentration.
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.
Cmax was defined as maximum observed concentration, taken directly from the plasma concentration data.
Tmax was defined as time of first observation of Cmax, taken directly from the plasma concentration data.
t1/2 was the terminal phase half-life, it was calculated as ln(2)/kel.
Apparent total body clearance was calculated as Dose/AUC0-inf, uncorrected for fraction absorbed; reported normalized by participant body weight (kilogram \[kg\]).
Vd/F was calculated as Dose/ (kel \*AUC0-inf), uncorrected for fraction absorbed; reported normalized by participant body weight (kg).
| Arm | Type | Description |
|---|---|---|
| Arm 1 | EXPERIMENTAL | Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received Selinexor 30 milligrams per meter square (mg/m\^2) orally twice weekly in treatment sequence ABCD (Treatment A: fasted, tablet formulation on Day 1 of Week 1; Treatment B: high-fat meal, tablet formulation on Day 1 of Week 2; Treatment C: low-fat meal, tablet formulation on Day 1 of Week 3; Treatment D: low-fat meal, capsule formulation on Day 1 of Week 4 in Cycle 1 (Weeks 1 to 4). |
| Arm 2 | EXPERIMENTAL | Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 30 mg/m\^2 orally twice weekly in treatment sequence BADC (Treatment B: high-fat meal, tablet formulation on Day 1 of Week 1; Treatment A: fasted, tablet formulation on Day 1 of Week 2; Treatment D: low fat meal, capsule formulation on Day 1 of Week 3; Treatment C: low-fat meal, tablet formulation on Day 1 of Week 4 in Cycle 1 (Weeks 1 to 4).All participants received the current (1st generation) tablet formula at a dose of 60 mg on Day 3 of Weeks 1-3 of Cycle 1. |
| Arm 3 | EXPERIMENTAL | Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received Selinexor 50 mg/m\^2 first generation tablets twice weekly on Days 1 and 3 of each week within 30 minutes of solid food consumption. |
| Arm 4 | EXPERIMENTAL | Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received Selinexor 60 mg/m\^2 orally in treatment sequence ABC (Treatment A: current \[1st generation\] tablets on Day 1 of Week 1; Treatment B: new \[2nd generation\] tablets on Day 1 of Week 2; Treatment C: suspension dose of current \[1st generation\] tablets on Day 1 of Week 3 in Cycle 1 (Weeks 1 to 3). All participants received the current (1st generation) tablet formula at a dose of 60 mg on Day 3 of Weeks 1-3 of Cycle 1. |
| Arm 5 | EXPERIMENTAL | Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received Selinexor 60 mg/m\^2 orally in treatment sequence CAB (Treatment C: suspension dose of current \[1st generation\] tablets on Day 1 of Week 1; Treatment A: current \[1st generation\] tablets on Day 1 of Week 2; Treatment B: new \[2nd generation\] tablets on Day 1 of Week 3 in Cycle 1 (Weeks 1 to 3). All participants received the current (1st generation) tablet formula at a dose of 60 mg on Day 3 of Weeks 1-3 of Cycle 1. |
| Arm 6 | EXPERIMENTAL | Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received Selinexor 60 mg/m\^2 orally in treatment sequence BCA (Treatment B: new \[2nd generation\] tablets on Day 1 of Week 1; Treatment C: suspension dose of current \[1st generation\] tablets on Day 1 of Week 2; Treatment A: current \[1st generation\] tablets on Day 1 of Week 3 in Cycle 1 (Weeks 1 to 3). All participants received the current (1st generation) tablet formula at a dose of 60 mg on Day 3 of Weeks 1-3 of Cycle 1. |
| Name | Type | Description |
|---|---|---|
| KCP-330 | DRUG | - |
Inclusion Criteria: 1. Patients must have histologically confirmed soft tissue or bone/cartilage sarcoma. Patients with sarcoma of small round blue cell tumor types are allowed. Gastrointestinal stromal tumors (GIST) are excluded. 2. Patients must have received at least one prior anticancer regimen...
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KCP-330 is an investigational small molecule being studied for the treatment of sarcoma. It is in Phase 1 clinical development and is being evaluated in patients with sarcoma to assess the effects of food and formulation on the drug's pharmacokinetics.
KCP-330 is being developed by Karyopharm Therapeutics Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol KPTI. The company is conducting clinical trials to evaluate the drug in patients with sarcoma.
KCP-330 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 1 trial has been completed to study its pharmacokinetics in patients with sarcoma.
KCP-330 has one completed clinical trial, identified as NCT01896505. This Phase 1 trial assessed the effects of food and formulation on the pharmacokinetics of KPT-330 in patients with sarcoma. The trial enrolled 54 participants and was conducted in the United States and Canada.
Yes, KCP-330 is also known as KPT-330. The clinical trial NCT01896505 uses the name KPT-330 in its title, referring to the same investigational drug being developed by Karyopharm Therapeutics for sarcoma.