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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT00519090
Ethics application status
Date submitted
17/08/2007
Date registered
21/08/2007
Date last updated
7/11/2011

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 - Due to early termination of the trial, the number of patients was too small and imbalanced and therefore analysis was not performed.
Timepoint [1] 0 0
12 months
Secondary outcome [1] 0 0
Durable Complete Cytogenetic Response Rate - Due to early termination of the trial, the number of patients was too small and imbalanced and therefore analysis was not performed.
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
Gender
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
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
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United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Indiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Iowa
Country [7] 0 0
United States of America
State/province [7] 0 0
Maryland
Country [8] 0 0
United States of America
State/province [8] 0 0
Michigan
Country [9] 0 0
United States of America
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Nebraska
Country [10] 0 0
United States of America
State/province [10] 0 0
New Jersey
Country [11] 0 0
United States of America
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North Carolina
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United States of America
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Oregon
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United States of America
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Pennsylvania
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United States of America
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Tennessee
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United States of America
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Texas
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United States of America
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Washington
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Belgium
State/province [17] 0 0
Brugge
Country [18] 0 0
Belgium
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Gent
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Belgium
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Leuven
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Brazil
State/province [20] 0 0
Mannheim
Country [21] 0 0
Brazil
State/province [21] 0 0
Porto Alegre
Country [22] 0 0
Brazil
State/province [22] 0 0
Sao Paulo
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Czech Republic
State/province [23] 0 0
Olomouc
Country [24] 0 0
Czech Republic
State/province [24] 0 0
Praha
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Germany
State/province [25] 0 0
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
State/province [30] 0 0
Hamburg
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Germany
State/province [31] 0 0
Jena
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Germany
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Kiel
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Germany
State/province [33] 0 0
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
State/province [38] 0 0
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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Spain
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Barcelona
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Spain
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Madrid
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Spain
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Salamanca
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Spain
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Santiago de Compostela
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Spain
State/province [53] 0 0
Valencia

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

Ethics approval
Ethics application status

Summary
Brief summary
In this study, the efficacy and safety of nilotinib 400 mg twice daily, will be compared with
imatinib 400 mg twice daily in patients with a suboptimal response to imatinib for their
Philadelphia chromosome-positive (Ph+) Chronic Myelogenous Leukemia in the chronic phase
(CML-CP).
Trial website
https://clinicaltrials.gov/show/NCT00519090
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

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT00519090