An Open-Label, Multicenter, Expanded Access Study of Oral AMN107 in Adult Patients With Imatinib (Glivec®/Gleevec®) - Resistant or - Intolerant Chronic Myeloid Leukemia in Blast Crisis, Accelerated Phase or Chronic Phase

This study is currently recruiting participants.

Verified by King Faisal Specialist Hospital & Research Center, September 2007

Sponsors and Collaborators:	King Faisal Specialist Hospital & Research Center Novartis
Information provided by:	King Faisal Specialist Hospital & Research Center
ClinicalTrials.gov Identifier:	NCT00532649

Purpose

An Open-Label, Multicenter, Expanded Access Study of Oral AMN 107 in Adult Patients with Imatinib (Glivec®/Gleevec®_ - Resistant or Intolerant Chronic Myeloid Leukemia in Blast Crisis, Accelerated Phase or Chronic Phase

Condition	Intervention
Chronic Myeloid Leukemia	Drug: AMN 107 (Nilotinib)

MedlinePlus related topics: Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood

Drug Information available for: Imatinib Imatinib mesylate 4-Methyl-N-(3-(4-methylimidazol-1-yl)-5-(trifluoromethyl)phenyl)-3-((4-pyridin-3-ylpyrimidin-2-yl)amino)benzamide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment

Further study details as provided by King Faisal Specialist Hospital & Research Center:

Study Start Date:

May 2007

Eligibility

Genders Eligible for Study:

Both

Criteria

Inclusion Criteria:

Patients with Imatinib resistant CML in blast crisis

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00532649

Contacts

Contact: Naeem A Chaudhri, MD

966-1-4647272 ext 32019

chaudhri@kfshrc.edu.sa

Locations

Saudi Arabia
KFSH&RC	Recruiting
Riyadh, Saudi Arabia, 1211
Contact: Naeem A Chaudhri, MD 966-1-4647272 ext 32019 chaudhri@kfshrc.edu.sa

Sponsors and Collaborators

King Faisal Specialist Hospital & Research Center

Novartis

Investigators

Principal Investigator:	Naeem Chaudhri, MD	King Faisal Specialist Hospital & Research Center, Riyadh
Principal Investigator:	Naeem A Chaudhri, MD	KFSH&RC

More Information

Study ID Numbers:	CAMN107A2109
Study First Received:	September 17, 2007
Last Updated:	September 19, 2007
ClinicalTrials.gov Identifier:	NCT00532649
Health Authority:	United States: Food and Drug Administration

Keywords provided by King Faisal Specialist Hospital & Research Center:

CML

Study placed in the following topic categories:

Imatinib
Blast Crisis
Leukemia
Chronic myelogenous leukemia
Hematologic Diseases

Myeloproliferative Disorders
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid
Bone Marrow Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on January 16, 2009