NCT01018966

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Apr 2004

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2004

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2005

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2005

Completed
4.7 years until next milestone

First Submitted

Initial submission to the registry

November 24, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 25, 2009

Completed
Last Updated

January 30, 2017

Status Verified

January 1, 2017

Enrollment Period

11 months

First QC Date

November 24, 2009

Last Update Submit

January 27, 2017

Conditions

Solid Tumors

Outcome Measures

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)

    3-week treatment cycles until unacceptable toxicity

Secondary Outcomes (3)

  • 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

    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

    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)

    3-week treatment cycles until unacceptable toxicity

Study Arms (1)

Ixabepilone

EXPERIMENTAL
Drug: Ixabepilone

Interventions

IxabepiloneDRUG

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

Also known as: Ixempra, BMS-247550
Ixabepilone

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Interventions

ixabepilone

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 24, 2009

First Posted

November 25, 2009

Study Start

April 1, 2004

Primary Completion

March 1, 2005

Study Completion

April 1, 2005

Last Updated

January 30, 2017

Record last verified: 2017-01