Ignite Creation Date:
2024-05-05 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00109707
Status:
COMPLETED
Last Update Posted:
2021-06-29
First Post:
2005-05-02
Brief Title:
A Study of Oral AMN107 in Adults With Chronic Myelogenous Leukemia CML or Other Hematologic Malignancies
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
A Phase IAII Multicenter Dose-escalation Study of Oral AMN107 on a Continuous Daily Dosing Schedule in Adult Patients With Imatinib-resistantIntolerant CML in Chronic or Accelerated Phase or Blast Crisis RelapsedRefractory Ph ALL and Other Hematologic Malignancies
Status:
COMPLETED
Status Verified Date:
2021-06
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:
The purpose of this trial is to assess the efficacy safety tolerability biologic activity and pharmacokinetics of AMN107 in six groups of patients with one of the following conditions
Relapsedrefractory Ph Acute lymphoblastic leukemia ALL arm 1
Group A - Imatinib failure only arms 2 3 and 4
imatinib-resistant or intolerant CML - Chronic Phase CP
imatinib-resistant or intolerant CML - Accelerated Phase AP
imatinib-resistant or intolerant CML - Blast Crisis BC
Group B - Imatinib and other TKI failure arms 2 3 and 4
imatinib-resistant or intolerant CML - Chronic Phase CP
imatinib-resistant or intolerant CML - Accelerated Phase AP
imatinib-resistant or intolerant CML - Blast Crisis BC
Hypereosinophilic syndromechronic eosinophilic leukemia HESCEL arm 5
Systemic mastocytosis Sm arm 6
Relapsedrefractory Ph Acute lymphoblastic leukemia ALL arm 1
Group A - Imatinib failure only arms 2 3 and 4
imatinib-resistant or intolerant CML - Chronic Phase CP
imatinib-resistant or intolerant CML - Accelerated Phase AP
imatinib-resistant or intolerant CML - Blast Crisis BC
Group B - Imatinib and other TKI failure arms 2 3 and 4
imatinib-resistant or intolerant CML - Chronic Phase CP
imatinib-resistant or intolerant CML - Accelerated Phase AP
imatinib-resistant or intolerant CML - Blast Crisis BC
Hypereosinophilic syndromechronic eosinophilic leukemia HESCEL arm 5
Systemic mastocytosis Sm arm 6
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