Ignite Creation Date:
2024-05-05 @ 9:46 PM
Last Modification Date:
2024-10-26 @ 10:09 AM
Study NCT ID:
NCT00962091
Status:
COMPLETED
Last Update Posted:
2019-03-12
First Post:
2009-08-18
Brief Title:
Study of MLN8237 in Participants With Advanced Solid Tumors
Sponsor:
Millennium Pharmaceuticals Inc
Organization:
Takeda
Study Overview
Official Title:
An Open-label Phase 1 Study of the Relative Bioavailability Food Effect Safety and Tolerability of MLN8237 in Patients With Advanced Solid Tumors
Status:
COMPLETED
Status Verified Date:
2019-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed 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 n19 pts OS in the fed or fasted state in Part B n6 pts ECT in the fed or fasted state in Part C n24 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
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 n19 pts OS in the fed or fasted state in Part B n6 pts ECT in the fed or fasted state in Part C n24 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U1111-1187-6657 | REGISTRY | WHO | None |