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Main
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Note: This record shows only the 20 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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17 October 2012 |
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Main ID: |
NCT00309049 |
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Date of registration:
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29/03/2006 |
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Primary sponsor: |
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Public title:
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Ixabepilone Administered as an Enteric Coated Formulation.
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Scientific title:
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An Exploratory Study of Ixabepilone Administered as an Enteric Coated Formulation in Patients With Advanced Cancer. |
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Date of first enrolment:
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April 2006 |
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Target sample size:
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30 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00309049 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Bristol-Myers Squibb |
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Address:
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Telephone:
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Email:
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Affiliation:
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Bristol-Myers Squibb |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- ECOG status of 0-2.
Exclusion Criteria:
- Unable to swallow pills.
- Current or recent GI disease or GI surgery.
- Brain mets.
- Severe nerve damage.
- ANC <1,500/mm3
- Platelets <125K.
- Bilirubin >=1.5 times the IULN.
- ALT/AST >=1.5 times the IULN.
- Creatine >1.5 times the IULN.
- Prior treatment with Ixabepilone.
- Strong use of CYPP450 drugs.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Cancer
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Intervention(s)
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Drug: Ixabepilone
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Primary Outcome(s)
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Determine the action of Ixabepilone in the body over a period of time including the process of absorption, distribution, metabolism and elimination.
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Secondary Outcome(s)
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Determine the rate and extent to which Ixabepilone is absorbed or otherwise available to the treatment site in the body.
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Secondary ID(s)
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CA163-088
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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