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Completed

NCT Number: NCT01018966

Study of Ixabepilone (BMS-247550) in Patients With Solid Tumors

The purpose of this study is to determine the DLT, MTD and recommended Phase II dose of ixabepilone in Japanese patients with solid tumors.

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Key information

Conditions

Solid Tumors

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 20 years or older
  • Histologically or cytologically confirmed diagnosis of adenocarcinoma Solid tumors

Exclusion criteria

  • Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of ≥2

Treatment and study plan

ixabepilone

Drug

Lyophilized and solvent, IV, 10-50 mg/m2, Q3W, At least 1 cycle, (21 days)

Other names: Ixempra, BMS-247550

Primary outcomes

  1. To establish the maximum tolerated dose (MTD), and a recommended Phase II dose of Ixabepilone when administered every three weeks by assessing status of treatment, dose intensity, and dose-limiting toxicities (DLT)

    Time frame: 3-week treatment cycles until unacceptable toxicity

Secondary outcomes

  1. To evaluate safety by assessing adverse events. Toxicity will be evaluated according to the Common Toxicity Criteria Version 3.0 (CTC). Response will be evaluated according to the RECIST (Response Evaluation Criteria in Solid Tumors) criteria

    Time frame: 3-week treatment cycles

  2. To evaluate the plasma pharmacokinetics of Ixabepilone according to the following parameters: Cmax, AUC(INF), Tmax, t1/2, MRT(INF), Vss, Cltot

    Time frame: Cycle 1 (first 3 weeks of study therapy)

  3. To describe any preliminary evidence of anti-tumor activity (response), assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST)

    Time frame: 3-week treatment cycles until unacceptable toxicity

Sponsors and collaborators

Lead sponsor

R-Pharm

Industry

Registry information

Official study title

Phase I Study of Ixabepilone (BMS-247550) in Patients With Solid Tumors

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
Nov 25, 2009
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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