Clinical Trials Logo

Clinical Trial Summary

The purposes of this study were to estimate the relative (Rel) bioavailability (BA) of an oral solution (OS) formulation of alisertib in reference to a powder-in-capsule (PIC) formulation, to characterize the effect of food on the single-dose pharmacokinetics (PK) of alisertib OS and enteric-coated tablets (ECT), to characterize the multiple-dose safety, tolerability, and steady-state PK of alisertib administered as an OS, and to characterize the multiple-dose safety and tolerability of alisertib administered as an ECT.


Clinical Trial Description

The drug being tested in this study is called alisertib (MLN8237). Alisertib is being tested to treat people who have advanced solid tumors. This study will look at the relative bioavailability (BA) (Part A), food effect and multiple-dose PK and safety of the oral solution (OS) (Part B) and food effect and safety of the enteric-coated tablet (ECT) formulation (Part C).

The study enrolled 53 patients (pts). Prior to initiation of Part A, 4 participants were enrolled in a dose escalation cohort. Participants in the study received:

• Alisertib 15 mg to 50 mg orally In the first 2 cycles of all 3 parts of the study, a single dose of alisertib was administered on Day 1 (PIC or OS in Part A [n=19 pts]; OS, in the fed or fasted state, in Part B [n=6 pts]; ECT, in the fed or fasted state, in Part C [n=24 pts]), In Part A, participants then continued on the PIC formulation at 40 mg BID for 7 days (Days 3 - 9). In Part B, participants continued on the OS formulation at a calculated dose administered BID for 7 days (Days 3 - 9). In Part C, the ECT formulation was continued at 40 mg BID for 7 days (Days 3 - 9); however, dose escalation to 50 mg BID was permitted after Cycle 1 based on tolerability and safety findings in the prior cycles. All participants took doses at a gap of 12 hours each day for 7 days followed by a 14-day rest period in a 21-days cycle for the remaining cycles.

This multi-center trial was conducted in the United States. The overall time to participate in this study was 30 months. Participants made multiple visits to the clinic, and final assessments were performed approximately 30 days after last dose of study drug. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT00962091
Study type Interventional
Source Takeda
Contact
Status Completed
Phase Phase 1
Start date September 25, 2009
Completion date July 1, 2014

See also
  Status Clinical Trial Phase
Active, not recruiting NCT04972981 - A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of ADCT-901 in Participants With Selected Advanced Solid Tumors Phase 1
Completed NCT05086822 - A Study of Irinotecan Hydrochloride Liposome in Advanced Solid Tumors Phase 1
Completed NCT03260322 - A Multiple-dose Study of ASP8374, an Immune Checkpoint Inhibitor, as a Single Agent and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors Phase 1
Completed NCT02526017 - Study of Cabiralizumab in Combination With Nivolumab in Patients With Selected Advanced Cancers Phase 1
Recruiting NCT06040541 - Study of RMC-9805 in Participants With KRASG12D-Mutant Solid Tumors Phase 1
Recruiting NCT05862831 - Clinical Study of PM1003 in Phase I/IIa Treatment of Advanced Malignant Solid Tumors Phase 1/Phase 2
Recruiting NCT03641794 - Indoleamine 2,3-Dioxygenase (IDO) Inhibitor in Healthy Volunteers Phase 1
Terminated NCT03665129 - IPH5401 (Anti-C5aR) in Combination With Durvalumab in Patients With Advanced Solid Tumors Phase 1
Recruiting NCT05914116 - A Study of DB-1311 in Advanced/Metastatic Solid Tumors Phase 1/Phase 2
Completed NCT01693562 - A Phase 1/2 Study to Evaluate MEDI4736 Phase 1/Phase 2
Recruiting NCT04387916 - A Study of KC1036 in Patients With Advanced Solid Tumors Phase 1
Completed NCT04095273 - Study to Test How Well Patients With Advanced Solid Tumors Respond to Treatment With the Elimusertib in Combination With Pembrolizumab, to Find the Optimal Dose for Patients, How the Drug is Tolerated and the Way the Body Absorbs, Distributes and Discharges the Drug Phase 1
Not yet recruiting NCT03692520 - Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of SCT200 in Patients With Advanced Solid Tumors Phase 1
Completed NCT02997176 - An Open-Label Pharmacokinetics and Safety Study of Talazoparib (MDV3800) Phase 1
Recruiting NCT04446260 - A Study of SHR-A1811 in Subjects With Advanced Malignant Solid Tumors Phase 1
Recruiting NCT06239155 - A Phase I/II Study of AST-3424 in Subjects With Advanced Solid Tumors Phase 1/Phase 2
Terminated NCT02253992 - An Investigational Immuno-therapy Study to Determine the Safety of Urelumab Given in Combination With Nivolumab in Solid Tumors and B-cell Non-Hodgkin's Lymphoma Phase 1/Phase 2
Recruiting NCT06076291 - An Open-label Study of SG1827 in Subjects With Advanced Solid Tumors Phase 1
Completed NCT03545971 - A Study of IBI310 for the Treatment of Patients With Advanced Solid Tumors. Phase 1
Recruiting NCT05457517 - A Phase 1b/2 Study of YL-13027 Combined With Sintilimab in Patients With Advanced Solid Tumors Phase 1/Phase 2