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A Study of ABT-751 in Patients With Renal Cell Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00073112
Recruitment Status : Completed
First Posted : November 18, 2003
Last Update Posted : November 29, 2007
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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.

Condition or disease Intervention/treatment Phase
Renal Cell Cancer Drug: ABT-751 Phase 2

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Study Type : Interventional  (Clinical Trial)
Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Study of ABT-751 in Subjects With Refractory Colorectal Carcinoma
Study Start Date : August 2003
Actual Study Completion Date : September 2006

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Objective Response Rate in subjects with RCC [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Time to Tumor Progression (TTP) [ Time Frame: 1 year ]
  2. Survival [ Time Frame: 2 years ]
  3. Toxicities associated with treatment administration [ Time Frame: 1 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00073112

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Sponsors and Collaborators
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Study Director: Helen Eliopoulos, M.D. Abbott

Layout table for additonal information Identifier: NCT00073112     History of Changes
Obsolete Identifiers: NCT00080717
Other Study ID Numbers: M02-416
First Posted: November 18, 2003    Key Record Dates
Last Update Posted: November 29, 2007
Last Verified: November 2007

Additional relevant MeSH terms:
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Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases