Phase 1
Completed N=54
A Phase I Trial to Assess the Effects of Food and Formulation on PK of KPT-330 in Patients With Sarcoma
Source: ClinicalTrials.gov NCT01896505 ↗Enrolled (actual)
54
Serious AEs
40.7%
Results posted
Jan 2024
Primary outcomePrimary: Area Under the Concentration-time Curve From the Time Zero to the Last Non-zero Concentration (AUC0-t) of Selinexor — 2752; 3175; 3280; 3342 Nanograms*hour per milliliter (ng*h/mL)
Summary
The purpose of this research study is to find out more information such as: to determine the effects of high and low fat foods on the pharmacokinetics (PK) of oral KPT-330 tablets and to compare PK of capsules and tablets in Arms 1 and 2; to evaluate tumor response in sarcoma participants in Arm 3; to compare the PK of 60 milligrams (mg) of the new, 2nd generation tablet formulation and 60 mg of the selinexor suspension formula to the current, 1st generation tablets.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Concentration-time Curve From the Time Zero to the Last Non-zero Concentration (AUC0-t) of Selinexor |
2752; 3175; 3280; 3342; 4086; 4220 | — |
| PRIMARY Area Under the Concentration Time Curve From the Time Zero to Extrapolated to Infinity (AUC0-inf) of Selinexor |
2969; 3412; 3483; 3561; 4117; 4250 | — |
| PRIMARY Maximum Observed Plasma Concentration (Cmax) of Selinexor |
355; 404; 436; 429; 519; 527 | — |
| PRIMARY Time of First Maximum Observed Concentration (Tmax) of Selinexor |
1.5; 3.4; 3.4; 3.8; 2.1; 3.0 | — |
| PRIMARY Terminal Phase Half-Life (t1/2) of Selinexor |
6.2; 5.9; 5.6; 5.7; 6.7; 6.6 | — |
| PRIMARY Apparent Total Body Clearance (CL/F) of Selinexor |
0.3; 0.22; 0.22; 0.21; 0.21; 0.20 | — |
| PRIMARY Apparent Volume of Distribution (Vd/F) of Selinexor |
2.2; 1.8; 1.7; 1.7; 2.0; 1.9 | — |
| SECONDARY Percentage of Participants With Best Overall Response According to Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 Criteria |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Duration of Stable Disease as Per RECIST v1.1 Criteria |
7.49; 3.94; 8.34 | — |
| SECONDARY Progression Free Survival (PFS) as Per RECIST v1.1 Criteria |
4.44; 3.52; 1.84 | — |
| SECONDARY Overall Survival (OS) |
9.00; 7.03; NA | — |
| SECONDARY Time to Progression (TTP) |
4.44; 3.52; 1.74 | — |
| SECONDARY Number of Participants With Growth Modulation Index (GMI) Less Than or Equal to (<=) 1.33 and Greater Than (>) 1.33 |
11; 8; 17; 7; 4; 3 | — |
| SECONDARY Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs |
10; 9; 17; 7; 5; 6 | — |
| SECONDARY Number of Participants With Treatment-Emergent Adverse Events (TEAEs) by Severity |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Clinically Significant Laboratory Abnormalities |
1; 2; 7; 1; 2; 1 | — |
| SECONDARY Number of Participants With Clinically Significant Changes in Vital Signs |
2; 5; 8; 4; 3; 3 | — |
| SECONDARY Number of Participants With Clinically Significant Changes in Electrocardiogram (ECGs) |
2; 0; 1; 0; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- 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.
- Patients must have received at least one prior anticancer regimen for metastatic disease unless there is no other therapy available and evidence of progressive disease on study entry. Patients with stable disease will be included if there has been failure to respond to another drug(s) within the previous 3 months
Exclusion Criteria
- Patients with known liver metastases
- Radiation, chemotherapy, immunotherapy, any other systemic anticancer therapy or participation in an investigational anti-cancer study ≤ 3 weeks prior to initiation of therapy
- Patients with known brain metastasis
- Patients with any gastrointestinal dysfunctions that could interfere with the interpretation of the food effect data
- Patients with known intolerance to low or high fat meals
- In the opinion of the investigator, patients who are significantly below their ideal body weight
Data sourced from ClinicalTrials.gov (NCT01896505). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.