Ignite Creation Date:
2024-05-05 @ 9:07 PM
Last Modification Date:
2024-10-26 @ 9:59 AM
Study NCT ID:
NCT00811070
Status:
COMPLETED
Last Update Posted:
2016-06-28
First Post:
2008-12-17
Brief Title:
Study Evaluating SKI-606 Bosutinib In Japanese Subjects With Philadelphia Chromosome Positive Leukemias
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
Official Title:
A Phase 12 Study Of SKI-606 Administered As A Single Agent In Japanese Subjects With Philadelphia Chromosome Positive Leukemias
Status:
COMPLETED
Status Verified Date:
2016-05
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:
This is a two-part safety and efficacy study of SKI-606 in subjects who have Philadelphia chromosome positive leukemias CML Part 1 will be a dose-escalation study in which an escalating dose of SKI-606 Bosutinib up to 600 mg will be studied in subjects with imatinib resistantrefractory or imatinib intolerant chronic phase CML Part 2 will evaluate the safety and efficacy of the maximum tolerated dose MTD of SKI-606 Bosutinibidentified in Part 1 of the study
Detailed Description:
None
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 |
|---|---|---|---|
| B1871007 | OTHER | Alias Study Number | None |