Safety and Efficacy of ABT-510 in Subjects With Advanced Renal Cell Carcinoma
NCT ID: NCT00073125
Last Updated: 2007-08-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
103 participants
INTERVENTIONAL
2003-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
ABT-510/Thrombospondin-1 mimetic
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Abbott
INDUSTRY
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Rod Humerickhouse, MD
Role: STUDY_DIRECTOR
Abbott
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Virginia G. Piper Cancer Center
Scottsdale, Arizona, United States
Arizona Cancer Center
Tucson, Arizona, United States
UCLA School of Medicine
Los Angeles, California, United States
Clinical Trials and Research Associates
Montebello, California, United States
The Center for Hematology-Oncology
Boca Raton, Florida, United States
University of Chicago Medical Center
Chicago, Illinois, United States
Central indiana Cancer Center
Indianapolis, Indiana, United States
Kansas City Cancer Centers Southwest
Overland Park, Kansas, United States
University of Michigan
Ann Arbor, Michigan, United States
Kansas City Oncology and Hematology Group
Kansas City, Missouri, United States
Albany Regional Cancer Center
Albany, New York, United States
Raleigh Hematology Oncology Clinic
Cary, North Carolina, United States
US Oncology, P.A.
Dallas, Texas, United States
Texas Cancer Center
Fort Worth, Texas, United States
Texas Cancer Center
Fort Worth, Texas, United States
MD Anderson Cancer Center
Houston, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
Academic Hospital Groningen
Groningen, , Netherlands
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
M02-428
Identifier Type: -
Identifier Source: org_study_id
NCT00080704
Identifier Type: -
Identifier Source: nct_alias