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Safety and Efficacy of ABT-510 in Subjects With Advanced Renal Cell Carcinoma

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.
ClinicalTrials.gov Identifier: NCT00073125
Recruitment Status : Completed
First Posted : November 18, 2003
Last Update Posted : August 15, 2007
Sponsor:
Information provided by:
Abbott

Brief Summary:
The primary objective of this study is to assess the safety and efficacy of ABT-510 in subjects with advanced renal cell carcinoma.

Condition or disease Intervention/treatment Phase
Carcinoma, Renal Cell Drug: ABT-510/Thrombospondin-1 mimetic Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 103 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: A Phase II Randomized Study Evaluating the Safety and Efficacy of ABT-510 in Subjects With Advanced Renal Cell Carcinoma
Study Start Date : May 2003

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Primary Outcome Measures :
  1. Progression free survival [ Time Frame: One year ]

Secondary Outcome Measures :
  1. Response rate [ Time Frame: One year ]
  2. Overall survival [ Time Frame: One year ]
  3. Performance status [ Time Frame: One 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
Criteria

Inclusion Criteria:

A subject will be eligible for study participation if all of the following criteria are met:

  • The subject is at least 18 years of age.
  • The subject has advanced histologically documented renal cell carcinoma. Advanced disease is defined as locally recurrent disease or metastatic disease that is not amendable to curative resection.
  • The subject has not received prior therapy (anti-tumor radiotherapy, immunotherapy, chemotherapy, or investigational therapy) for metastatic renal cell carcinoma other than excision of primary tumor where appropriate. Local radiation for supportive reasons will be allowed; however, not within 28 days from Study Day 1.
  • The subject has an Eastern Cooperative Oncology Group (ECOG) Performance Score of 0-1
  • The subject is able to self-administer or has a caregiver who can reliably administer subcutaneous injections.
  • The subject must have adequate bone marrow, renal, and hepatic function as follows:

    • Bone Marrow: White blood cell count (WBC) ≥ 3,000/mm3 (3.0 X 109/L); Platelets ≥ 100,000/mm3 (100 X 109/L); Hemoglobin ≥ 9.0 g/dL (1.4 mmol/L)
    • Renal function: serum creatinine ≤ 2.0 mg/dL (0.81 mmol/L)
    • Hepatic function: AST and ALT ≤ 1.5 X ULN unless liver metastases are present, then AST and ALT ≤ 5.0 X ULN; LDH ≤ 1.5 X ULN; bilirubin ≤ 1.5 mg/dL (0.026 mmol/L) Corrected calculated calcium ≤ 10 mg/dL (2.5 mmol/L) Calculation = total calcium - 0.707 (albumin -3.4)Albumin ≥ 3.0 g/dL (0.45 mmol/L)
  • The subject must not be pregnant or lactating and all subjects (male and female) must use a contraceptive method deemed acceptable by the investigator while in the study and for up to two months following completion of therapy.
  • The subject has voluntarily signed and dated an Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved consent prior to any study specific procedures.

Exclusion Criteria:

A subject will be ineligible for study participation if any of the following criteria are met:

  • The subject has a history of or currently exhibits Central Nervous System (CNS) metastasis. Brain MRI within 28 days of enrollment is required to confirm absence of CNS metastases.
  • The subject is receiving therapeutic anticoagulation therapy. Low dose anticoagulation (e.g., low dose Coumadin) for catheter prophylaxis will be permitted; PT/PTT must be within normal limits.
  • The subject has a history of or currently exhibits clinically significant cancer related events of bleeding (e.g., hemoptysis). The subject has a recent history of (within 4 weeks of Study Day 1) or currently exhibits other clinically significant signs of bleeding.
  • The subject exhibits evidence of clinically significant uncontrolled conditions(s) and/or is considered by the investigator to be unable to tolerate the proposed treatment or procedures.
  • The subject has history of other previous malignancies within 5 years, with the exception of: Adequately treated in situ carcinoma of the cervix uteri or Basal or squamous cell carcinoma of the skin

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 ClinicalTrials.gov identifier (NCT number): NCT00073125


Locations
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United States, Arizona
Virginia G. Piper Cancer Center
Scottsdale, Arizona, United States, 85258
Arizona Cancer Center
Tucson, Arizona, United States, 85724
United States, California
UCLA School of Medicine
Los Angeles, California, United States, 90024
Clinical Trials and Research Associates
Montebello, California, United States, 90640
United States, Florida
The Center for Hematology-Oncology
Boca Raton, Florida, United States, 33486
United States, Illinois
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
United States, Indiana
Central indiana Cancer Center
Indianapolis, Indiana, United States, 46227
United States, Kansas
Kansas City Cancer Centers Southwest
Overland Park, Kansas, United States, 66210
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
United States, Missouri
Kansas City Oncology and Hematology Group
Kansas City, Missouri, United States, 64111
United States, New York
Albany Regional Cancer Center
Albany, New York, United States, 12208
United States, North Carolina
Raleigh Hematology Oncology Clinic
Cary, North Carolina, United States, 27511
United States, Texas
US Oncology, P.A.
Dallas, Texas, United States, 75246
Texas Cancer Center
Fort Worth, Texas, United States, 66210
Texas Cancer Center
Fort Worth, Texas, United States, 76104
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Baylor College of Medicine
Houston, Texas, United States
Netherlands
Academic Hospital Groningen
Groningen, Netherlands
Sponsors and Collaborators
Abbott
Investigators
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Study Director: Rod Humerickhouse, MD Abbott

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ClinicalTrials.gov Identifier: NCT00073125     History of Changes
Obsolete Identifiers: NCT00080704
Other Study ID Numbers: M02-428
First Posted: November 18, 2003    Key Record Dates
Last Update Posted: August 15, 2007
Last Verified: August 2007

Keywords provided by Abbott:
Advanced histologically documented renal cell carcinoma

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