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

August 13, 2007 updated by: Abbott

A Phase II Randomized Study Evaluating the Safety and Efficacy of ABT-510 in Subjects With Advanced Renal Cell Carcinoma

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

103

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression free survival
Time Frame: One year
One year

Secondary Outcome Measures

Outcome Measure
Time Frame
Response rate
Time Frame: One year
One year
Overall survival
Time Frame: One year
One year
Performance status
Time Frame: One year
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott

Investigators

  • Study Director: Rod Humerickhouse, MD, Abbott

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2003

Study Registration Dates

First Submitted

November 17, 2003

First Submitted That Met QC Criteria

November 17, 2003

First Posted (Estimate)

November 18, 2003

Study Record Updates

Last Update Posted (Estimate)

August 15, 2007

Last Update Submitted That Met QC Criteria

August 13, 2007

Last Verified

August 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M02-428

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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