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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00519090




Registration number
NCT00519090
Ethics application status
Date submitted
17/08/2007
Date registered
21/08/2007
Date last updated
6/11/2011

Titles & IDs
Public title
Nilotinib vs Imatinib in Adult Patients With Philadelphia (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)
Scientific title
A Phase III Randomized, Open- Label Multi-center Study of Nilotinib Versus Imatinib in Adult Patients With Ph+ Chronic Myelogenous Leukemia in Chronic Phase (CML-CP) Who Have a Suboptimal Cytogenetic Response (CyR) on Imatinib
Secondary ID [1] 0 0
CAMN107A2302
Universal Trial Number (UTN)
Trial acronym
ENEST
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Myelogenous Leukemia 0 0
Condition category
Condition code
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia
Cancer 0 0 0 0
Children's - Leukaemia & Lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Imatinib
Treatment: Drugs - Nilotinib (AMN107)

Experimental: Nilotinib (AMN107) -

Active comparator: Imatinib -


Treatment: Drugs: Imatinib
Administered orally as a single agent on a continuous daily schedule given 400 mg bid (twice daily) with food. One cycle comprised of 28 days.

Treatment: Drugs: Nilotinib (AMN107)
Administered orally as a single agent on a continuous daily schedule of 400 mg bid (2 x 200 mg twice daily) without food. Once cycle comprised of 28 days.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Complete Cytogenetic Response Rate(CCyR) in Patients Who Had a Suboptimal Cytogenetic Response on Imatinib
Timepoint [1] 0 0
12 months
Secondary outcome [1] 0 0
Durable Complete Cytogenetic Response Rate
Timepoint [1] 0 0
24 months

Eligibility
Key inclusion criteria
Inclusion criteria:

Diagnosis of Philadelphia chromosome positive chronic myelogenous leukemia in the chronic phase.

Patients with suboptimal cytogenetic response to a dose of 400 mg imatinib (first line therapy) defined as:

* 6 to < 12 months of treatment and -have 36 - 95% Ph+ metaphases, or
* 12 to <18 months of treatment and have 1 - 35% Ph+ metaphases (Standard cytogenetics, no FISH [fluorescence in situ hybridization] analysis was allowed).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

* Patient who have received more than 18 months of imatinib therapy
* Patients who have achieved partial or complete cytogenetic response and lost that response prior to entering the study.
* Prior treatment with greater than 400 mg/day imatinib.
* Uncontrolled or significant cardiovascular disease.
* Severe or uncontrolled medical conditions (i.e. uncontrolled diabetes, active or uncontrolled infection).
* Use of therapeutic coumarin derivatives (i.e., warfarin, acenocoumarol, phenprocoumon)
* Currently taking certain medications that could affect the rhythm of your heart.

Other protocol-defined inclusion/exclusion criteria may apply

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2008
Sample size
Target
Accrual to date
Final
6
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Novartis Investigative Site - Darlinghurst
Recruitment hospital [2] 0 0
Novartis Investigative Site - Herston
Recruitment hospital [3] 0 0
Novartis Investigative Site - Liverpool
Recruitment hospital [4] 0 0
Novartis Investigative Site - Perth
Recruitment hospital [5] 0 0
Novartis Investigative Site - Prahran
Recruitment hospital [6] 0 0
Novartis Investigative Site - South Brisbane
Recruitment hospital [7] 0 0
Novartis Investigative Site - St. Leonards
Recruitment postcode(s) [1] 0 0
- Darlinghurst
Recruitment postcode(s) [2] 0 0
- Herston
Recruitment postcode(s) [3] 0 0
- Liverpool
Recruitment postcode(s) [4] 0 0
- Perth
Recruitment postcode(s) [5] 0 0
- Prahran
Recruitment postcode(s) [6] 0 0
- South Brisbane
Recruitment postcode(s) [7] 0 0
- St. Leonards
Recruitment outside Australia
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United States of America
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Arizona
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United States of America
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California
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Colorado
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Illinois
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Indiana
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Iowa
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Maryland
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Michigan
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Nebraska
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New Jersey
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North Carolina
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Oregon
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Pennsylvania
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Tennessee
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Texas
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United States of America
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Washington
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Belgium
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Brugge
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Belgium
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Gent
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Belgium
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Leuven
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Brazil
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Mannheim
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Brazil
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Porto Alegre
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Brazil
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Sao Paulo
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Czech Republic
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Olomouc
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Czech Republic
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Praha
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Germany
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Berlin
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Germany
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Duesseldorf
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Germany
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Eisensach
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Germany
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Firenze
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Germany
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Griefswald
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Germany
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Hamburg
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Germany
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Jena
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Germany
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Kiel
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Germany
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Leipzeg
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Germany
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Postsdam
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Germany
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Rostock
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Germany
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Stuttgart
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Germany
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Weiden
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Italy
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Bologna
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Italy
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Milano
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Italy
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Napoli
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Italy
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Orbassano
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Italy
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Reggio Calabra
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Italy
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Roma
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Japan
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Nagoya
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Japan
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Oaska
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Japan
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Tokyo
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Korea, Republic of
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Hwasun-Gun
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Korea, Republic of
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Seoul
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Barcelona
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Salamanca
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Santiago de Compostela
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Spain
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Valencia

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00519090