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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00872300 |
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Date of registration:
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30/03/2009 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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PHA-739358 for the Treatment of Multiple Myeloma
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Scientific title:
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An Exploratory Phase II Study of PHA-739358 in Patients With Multiple Myeloma Harbouring the t(4;14) Translocation With or Without FGFR3 Expression |
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Date of first enrolment:
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October 2008 |
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Target sample size:
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7 |
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Recruitment status: |
Terminated |
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URL:
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http://clinicaltrials.gov/show/NCT00872300 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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Phase:
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Phase 2
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Countries of recruitment
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France
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United States
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- active multiple myeloma progressing after at least 2 prior lines of treatment
- measurable disease
- t(4;14) translocation
- life expectancy of at least 3 months
Exclusion Criteria:
- uncontrolled hypertension
- myocardial infarction, unstable angina, symptomatic congestive heart failure,
cerebrovascular accident in the past 6 months.
- pregnancy or breast feeding
- active infections, including HIV
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Multiple Myeloma
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Intervention(s)
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Drug: PHA-739358
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Primary Outcome(s)
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Response Rate according to International Myeloma Working Group uniform response criteria for multiple myeloma.
[Time Frame: At end of each cycle]
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Secondary Outcome(s)
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Overall safety profile
[Time Frame: All cycles]
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Secondary ID(s)
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AURA-6202-011
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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