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Safety and Efficacy of ABT-510 in Subjects With Advanced Renal Cell Carcinoma
This study has been completed.
First Received: November 17, 2003   Last Updated: August 13, 2007   History of Changes
Sponsor: Abbott
Information provided by: Abbott
ClinicalTrials.gov Identifier: NCT00073125
  Purpose

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


Condition Intervention Phase
Carcinoma, Renal Cell
Drug: ABT-510/Thrombospondin-1 mimetic
Phase II

Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Official Title: A Phase II Randomized Study Evaluating the Safety and Efficacy of ABT-510 in Subjects With Advanced Renal Cell Carcinoma

Resource links provided by NLM:


Further study details as provided by Abbott:

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

Secondary Outcome Measures:
  • Response rate [ Time Frame: One year ]
  • Overall survival [ Time Frame: One year ]
  • Performance status [ Time Frame: One year ]

Enrollment: 103
Study Start Date: May 2003
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00073125

Locations
United States, Arizona
Arizona Cancer Center
Tucson, Arizona, United States, 85724
Virginia G. Piper Cancer Center
Scottsdale, Arizona, United States, 85258
United States, California
Clinical Trials and Research Associates
Montebello, California, United States, 90640
UCLA School of Medicine
Los Angeles, California, United States, 90024
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
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
Texas Cancer Center
Fort Worth, Texas, United States, 66210
Baylor College of Medicine
Houston, Texas, United States
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Texas Cancer Center
Fort Worth, Texas, United States, 76104
US Oncology, P.A.
Dallas, Texas, United States, 75246
Netherlands
Academic Hospital Groningen
Groningen, Netherlands
Academic Hospital Groningen
Groningen, Netherlands
Sponsors and Collaborators
Abbott
Investigators
Study Director: Rod Humerickhouse, MD Abbott
  More Information

No publications provided

Study ID Numbers: M02-428
Study First Received: November 17, 2003
Last Updated: August 13, 2007
ClinicalTrials.gov Identifier: NCT00073125     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Abbott:
Advanced histologically documented renal cell carcinoma

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

ClinicalTrials.gov processed this record on November 27, 2009