Ignite Creation Date:
2024-05-05 @ 4:34 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00261846
Status:
COMPLETED
Last Update Posted:
2017-07-27
First Post:
2005-12-02
Brief Title:
Study Evaluating SKI-606 Bosutinib In Philadelphia Chromosome Positive Leukemias
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
Official Title:
A Phase 12 Study Of Bosutinib Ski-606 In Philadelphia Chromosome Positive Leukemias
Status:
COMPLETED
Status Verified Date:
2017-06
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 an open-label continuous daily dosing two-part safety and efficacy study of SKI-606 bosutinib in Philadelphia chromosome positive leukemias Ph Part 1 is a dose-escalation study in chronic phase Chronic Myelogenous Leukemia CML subjects to establish the maximum tolerated dose MTD in this subject population Part 2 has begun after the completion of Part 1 and after a dose has been established for the compound in chronic phase subjects Part 2 is a study of the the efficacy of 500mg daily oral SKI-606 bosutinib in patients with all phases of Ph CML and Ph Acute Lymphocytic Leukemia ALL The protocol will test the hypotheses that oral daily dosing of bosutinib at 500 mg will attain 1 Major Cytogenetic Response MCyR in chronic phase CML patients and 2 Overall Hematological Response OHR in advanced leukemia patients Each phase of the disease will be evaluated as a separate cohort
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 |
|---|---|---|---|
| B1871006 3160A4-200-WW | None | None | None |
| 2005-004230-40 | EUDRACT_NUMBER | None | None |
| B1871006 | OTHER | Alias Study Number | None |