Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Study of Treatment With Nilotinib in Adult Patients With Imatinib - Resistant or - Intolerant Chronic Myeloid Leukemia in Blast Crisis, Accelerated Phase or Chronic Phase (MACS0439)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00786812
First received: November 5, 2008
Last updated: April 1, 2014
Last verified: April 2014
  Purpose

Maintain and monitor long-term hematological and cytogenetic responses previously obtained by patients participating in the [CAMN107A2109] study


Condition Intervention Phase
Chronic Myeloid Leukemia
Drug: Nilotinib
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label, Multicenter Study of Treatment With Nilotinib in Adult Patients With Imatinib - Resistant or - Intolerant Chronic Myeloid Leukemia in Blast Crisis, Accelerated Phase or Chronic Phase

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Disease response (complete hematologic response, cytogenetic response) and progression at or until 24 months, depending of the case every 3 months [ Time Frame: 3 - 24 months ] [ Designated as safety issue: Yes ]

Enrollment: 89
Study Start Date: August 2008
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
CAMN107A2109 Extension Patients Drug: Nilotinib
AMN107 Naive Drug: Nilotinib

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. patients currrently participating in Novartis study CAMN107A2109
  2. imatinib - resistant or intolerant - Philadelphia chromosome-positive CML in chronic (CML-CP)accelerated phase (CML-AP) or in blast crisis (CML-BC)
  3. males or females ≥18 years of age
  4. WHO Performance Status of ≤ 2
  5. patients must have the following laboratory values: ALT and AST ≤ 2.5 x ULN or ≤ 5.0 x ULN if considered due to tumor

Exclusion Criteria:

  1. Impaired cardiac function; use of therapeutic coumarin derivatives
  2. patients who have undergone a major surgery and have not recovered from side effects of such therapy within 15 days
  3. patients who are pregnant or breast feeding, or adults of reproductive potential not employing an effective method of birth control
  4. patients who have received chemotherapy ≤ 1 week or who are within 5 half-lives of their last dose of chemotherapy
  5. ,.patients who have received imatinib or dasatinib at least 3 days prior to beginning of study drug or who have not recovered from side effects of such therapy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00786812

Locations
Brazil
Novartis Investigative Site
Belo Horizonte, MG, Brazil, 30130-100
Novartis Investigative Site
Curitiba, PR, Brazil, 80060-900
Novartis Investigative Site
Rio de Janeiro, RJ, Brazil, 20230-130
Novartis Investigative Site
Porto Alegre, RS, Brazil, 90035-903
Novartis Investigative Site
Campinas, SP, Brazil, 13083-970
Novartis Investigative Site
Jaú, SP, Brazil, 17210-080
Novartis Investigative Site
Ribeirao Preto, SP, Brazil, 14048-900
Novartis Investigative Site
São Paulo, SP, Brazil, 01401-901
Novartis Investigative Site
São Paulo, SP, Brazil, 05403-000
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00786812     History of Changes
Other Study ID Numbers: CAMN107ABR03
Study First Received: November 5, 2008
Last Updated: April 1, 2014
Health Authority: United States: Food and Drug Administration
Brazil: National Health Surveillance Agency

Keywords provided by Novartis:
Leukemia
adult chronic myeloid leukemia
imatinib
nilotinib

Additional relevant MeSH terms:
Blast Crisis
Leukemia
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid
Bone Marrow Diseases
Carcinogenesis
Cell Transformation, Neoplastic
Hematologic Diseases
Myeloproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Neoplastic Processes
Pathologic Processes
Imatinib
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014