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Clinical Trials/NCT00073112
NCT00073112CompletedPhase 2

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

Abbott44 sites in 2 countries60 target enrollmentStarted: August 1, 2003Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Completed
Sponsor
Abbott
Enrollment
60
Locations
44
Primary Endpoint
Objective Response Rate in subjects with RCC
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

The purpose of the study is to determine if ABT-751 will decrease tumors, and determine how long the tumor shrinkage can be maintained in patients with renal cell cancer. Patients will receive ABT-751 by mouth daily for 21 days. Patients will be off drug for 7 days before starting the next cycle of drug.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Renal Cell Carcinoma.
  • •Recurrent tumor.
  • •At least 6 weeks post-nephrectomy.
  • •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.
  • •CNS metastasis.

Outcomes

Primary Outcomes

Objective Response Rate in subjects with RCC

Time Frame: 1 year

Secondary Outcomes

  • Time to Tumor Progression (TTP)(1 year)
  • Survival(2 years)
  • Toxicities associated with treatment administration(1 year)

Investigators

Sponsor
Abbott
Sponsor Class
Industry

Study Sites (44)

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