Phase 1
Completed N=24
A Study to Evaluate the Effect of Itraconazole on the Pharmacokinetics of Alisertib in Participants With Advanced Solid Tumors or Relapsed/Refractory Lymphoma
Source: ClinicalTrials.gov NCT02259010 ↗Enrolled (actual)
24
Serious AEs
50.0%
Results posted
Sep 2019
Primary outcomePrimary: Cmax: Maximum Observed Concentration of Alisertib in Presence and Absence of Itraconazole in Part A — 1060.3; 1002.8 nmol/L
Summary
This study will assess the effect of multi-dose administration of itraconazole on the single-dose pharmacokinetics (PK) of alisertib.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cmax: Maximum Observed Concentration of Alisertib in Presence and Absence of Itraconazole in Part A |
1060.3; 1002.8 | — |
| PRIMARY AUC(Last): Area Under the Plasma Concentration Curve From Time 0 to the Time of the Last Quantifiable Concentration of Alisertib in Presence and Absence of Itraconazole in Part A |
15541.6; 20219.5 | — |
| PRIMARY AUC∞: Area Under the Plasma Concentration Curve From Time 0 to Infinity of Alisertib in Presence and Absence of Itraconazole in Part A |
16804.6; 23488.7 | — |
| SECONDARY CL/F: Oral Clearance of Alisertib in Presence and Absence of Itraconazole in Part A |
4.416; 3.177 | — |
| SECONDARY Tmax: Time to Reach Maximum Plasma Concentration of Alisertib in Presence and Absence of Itraconazole in Part A |
2.920; 2.920 | — |
| SECONDARY Terminal Phase Elimination Half-Life of Alisertib in Presence and Absence of Itraconazole in Part A |
22.55; 25.37 | — |
| SECONDARY Cmax: Maximum Observed Plasma Concentration for Alisertib Metabolites M1 and M2 in Presence and Absence of Itraconazole in Part A |
409.4; 450.0; 114.0; 103.5 | — |
| SECONDARY Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Alisertib Metabolites M1 and M2 in Presence and Absence of Itraconazole in Part A |
3.090; 3.800; 9.360; 23.600 | — |
| SECONDARY AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Alisertib Metabolites M1 and M2 in Presence and Absence of Itraconazole in Part A |
10550.8; 15776.1; 5880.6; 5081.6 | — |
| SECONDARY Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) |
24; 12 | — |
| SECONDARY Number of Participants With Abnormal Laboratory Values Reported as AEs |
3; 3; 2; 1; 1; 1 | — |
| SECONDARY Number of Participants With Clinically Significant Change in Weight Reported as AEs |
2 | — |
| SECONDARY Number of Participants With Clinically Significant Change in Vital Sign Reported as AEs |
3; 2; 1 | — |
Eligibility Criteria
Inclusion Criteria
- Male and female participants 18 years of age or older.
- Participants with histologic or cytologic diagnosis of advanced or metastatic solid tumors or lymphomas for which no curative or life-prolonging therapies exist.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Exclusion Criteria
- Systemic treatment with moderate or strong CYP3A inhibitors or inducers must be discontinued at least 14 days before the first dose of alisertib, and the use of these agents is not permitted during the study (except for the protocol-specified administration of itraconazole).
- Known gastrointestinal (GI) abnormality (including recurrent nausea or vomiting) or GI procedure that could interfere with or modify the oral absorption or tolerance of alisertib.
- Known hypersensitivity or intolerance to itraconazole or similar class agents.
Data sourced from ClinicalTrials.gov (NCT02259010). 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.