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A Phase 2 Study of ABT-751 in Subjects With Refractory Colorectal Carcinoma


Phase 2
18 Years
N/A
Not Enrolling
Both
Colorectal Cancer

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Trial Information

A Phase 2 Study of ABT-751 in Subjects With Refractory Colorectal Carcinoma

Inclusion Criteria


Inclusion Criteria

- Colorectal cancer.

- Recurrent tumor following treatment with irinotecan and/or oxaliplatin.

- Able to tolerate normal activities of daily living.

- Adequate bone marrow, kidney, and liver function.

Exclusion Criteria

- Pregnant or breast feeding.

- Anti-tumor therapy within 4 weeks of the start of ABT-751 administration.

- Prior radiation therapy.

- CNS metastasis.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Objective Response Rate in subjects with Recurrent Colorectal Cancer

Outcome Time Frame:

1 year

Principal Investigator

Helen Eliopoulos, MD

Investigator Role:

Study Director

Investigator Affiliation:

Abbott

Authority:

United States: Food and Drug Administration

Study ID:

M02-446

NCT ID:

NCT00073138

Start Date:

August 2003

Completion Date:

February 2005

Related Keywords:

  • Colorectal Cancer
  • Colorectal Neoplasms

Name

Location

Duke University Medical CenterDurham, North Carolina  27710
Northwestern UniversityChicago, Illinois  60611
University of Chicago Medical CenterChicago, Illinois  60637
Cancer Institute Medical GroupLos Angeles, California  90025
University of Southern CaliforniaLos Angeles, California  90033
University of Wisconsin Medical CenterMadison, Wisconsin  53792