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


Phase 1
20 Years
75 Years
Not Enrolling
Both
Solid Tumors

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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)

Outcome Time Frame:

3-week treatment cycles until unacceptable toxicity

Safety Issue:

Yes

Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb

Authority:

Japan: Pharmaceuticals and Medical Devices Agency

Study ID:

CA163-029

NCT ID:

NCT01018966

Start Date:

April 2004

Completion Date:

April 2005

Related Keywords:

  • Solid Tumors
  • Neoplasms

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