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

January 27, 2017 updated by: R-Pharm

Phase I 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

25

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ixabepilone
Drug: Ixabepilone
Lyophilized and solvent, IV, 10-50 mg/m2, Q3W, At least 1 cycle, (21 days)
Other Names:
  • BMS-247550
  • Ixempra

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
3-week treatment cycles until unacceptable toxicity

Secondary Outcome Measures

Outcome Measure
Time Frame
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
3-week treatment cycles
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)
Cycle 1 (first 3 weeks of study therapy)
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
3-week treatment cycles until unacceptable toxicity

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

R-Pharm

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2004

Primary Completion (Actual)

March 1, 2005

Study Completion (Actual)

April 1, 2005

Study Registration Dates

First Submitted

November 24, 2009

First Submitted That Met QC Criteria

November 24, 2009

First Posted (Estimate)

November 25, 2009

Study Record Updates

Last Update Posted (Estimate)

January 30, 2017

Last Update Submitted That Met QC Criteria

January 27, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA163-029

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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