Know Cancer

or
forgot password

A Phase 1 Study of Ixabepilone Administered as 3 Oral Doses Each Separated by 6 Hours Every 21 Days in Subjects With Advanced Cancer


Phase 1
18 Years
N/A
Not Enrolling
Both
Advanced Solid Tumors

Thank you

Trial Information

A Phase 1 Study of Ixabepilone Administered as 3 Oral Doses Each Separated by 6 Hours Every 21 Days in Subjects With Advanced Cancer


Inclusion Criteria:



- Males and females, 18 or older

- Histologically or cytologically confirmed diagnosis of solid tumor malignancy

- Measurable or non-measurable disease as defined by Response Evaluation Criteria
In Solid Tumors (RECIST) criteria

- Karnofsky Performance Status (KPS) of 70-100

- Recovered from toxicities resulting from previous therapies

Exclusion Criteria:

- More than 3 prior cytotoxic regimens in the metastatic setting

- Current or recent gastrointestinal (GI) disease that would impact the absorption of
study drug

- Inability to swallow whole capsules

- Inadequate hepatic and renal function

- Function exposure to any epothilone

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Number of Participants With a Dose-Limiting Toxicity (DLT)

Outcome Description:

DLT: any of the following, considered related to ixabepilone, occurring in Cycle 1: Absolute neutrophil count (ANC) <500 cells/mm^3 for ≥5 consecutive days or febrile neutropenia of any duration; Grade(Gr)4 thrombocytopenia <25,000 cells/mm^3 or Gr3 with bleeding requiring platelet transfusion; Gr3/4 nausea, vomiting, or diarrhea despite use of adequate intervention, fatigue, any other clinically significant drug-related ≥Gr 3 non-hematologic toxicity, delayed recovery (to Gr ≤1 or baseline, except alopecia) from toxicity which delays initiation of Cycle 2 by ≥3 weeks.

Outcome Time Frame:

During Cycle 1 (Day 0 through Day 21)

Safety Issue:

Yes

Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb

Authority:

United States: Food and Drug Administration

Study ID:

CA163-149

NCT ID:

NCT00632424

Start Date:

May 2008

Completion Date:

June 2009

Related Keywords:

  • Advanced Solid Tumors

Name

Location

Stanford UniversityStanford, California  94305
Georgetown University Medical CenterWashington, District of Columbia  20007