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OpenTrials
Completed

NCT Number: NCT00207129

Effect of Capecitabine on the Pharmacokinetics of BMS-247550 and BMS-247550 on the Pharmacokinetics of Capecitabine and Its Metabolites in Patients With Advanced Malignancies

The purpose of this study is to test how BMS-247550 (ixabepilone) affects the removal of capecitabine from the body and how capecitabine affects the removal of BMS-247550 from the body.

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Key information

Conditions

Advanced Solid Tumors Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Local Institution

San Antonio, Texas, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Recovery from surgery or radiation therapy
  • Measurable or non-measurable disease
  • Available for follow-up

Exclusion criteria

  • Neuropathy
  • Uncontrolled pulmonary or cardiovascular disease
  • Known history of HIV infection

Treatment and study plan

ixabepilone

Drug

Solution, I.V. infusion, 40 mg/m2, Cycles 1-18: once per cycle (Day 1) cycles 2-18 (6-54 weeks) depending on response.

Other names: Ixempra

Capecitabine

Drug

Tablets, Oral, 1000 mg/m2, Cycle 1: Once (Day 1) Cycle 2: Twice daily (Days 1-5) Cycles 3-18: None, 2 cycles (6 weeks).

Primary outcomes

  1. Effect of capecitabine on the pharmacokinetics of BMS-247550 and to assess the effect of BMS-247550 on the pharmacokinetics of capecitabine

Secondary outcomes

  1. Safety/Tumor response

Sponsors and collaborators

Lead sponsor

R-Pharm

Industry

Registry information

Official study title

Effect of Capecitabine on the Pharmacokinetics of BMS-247550 on the Pharmacokinetics of Capecitabine and Its Metabolites in Patients With Advanced Malignancies

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
Sep 21, 2005
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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