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OpenTrials
Completed

NCT Number: NCT00309049

Ixabepilone Administered as an Enteric Coated Formulation.

The purpose of this study is to determine the pharmacokinetics of oral Ixabepilone.

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Key information

Conditions

Cancer Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Local Institution, Washington D.C., District of Columbia, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ixabepilone

Drug

Capsules / IV formulation, Oral/IV, 15 mg IV and 30 mg Oral (3 capsules) in cycle 1 with a sequence of IV oral and oral dosage and 40 mg IV dose every 3 weeks on cycle 2 onwards, 3 times in cycle 1 (21 days) and every 3 weeks from cycle 2 onwards, 48-96 weeks depending on response.

Other names: Ixempra

Primary outcomes

  1. Determine the action of Ixabepilone in the body over a period of time including the process of absorption, distribution, metabolism and elimination.

Secondary outcomes

  1. Determine the rate and extent to which Ixabepilone is absorbed or otherwise available to the treatment site in the body.

Sponsors and collaborators

Lead sponsor

R-Pharm

Industry

Registry information

Official study title

An Exploratory Study of Ixabepilone Administered as an Enteric Coated Formulation in Patients With Advanced Cancer.

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Mar 31, 2006
Registry last updated
Jan 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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