Safety and Efficacy of ABT-510 in Subjects With Advanced Renal Cell Carcinoma
A Phase II Randomized Study Evaluating the Safety and Efficacy of ABT-510 in Subjects With Advanced Renal Cell Carcinoma
1 other identifier
interventional
103
2 countries
18
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2003
CompletedFirst Submitted
Initial submission to the registry
November 17, 2003
CompletedFirst Posted
Study publicly available on registry
November 18, 2003
CompletedAugust 15, 2007
August 1, 2007
November 17, 2003
August 13, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression free survival
One year
Secondary Outcomes (3)
Response rate
One year
Overall survival
One year
Performance status
One year
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Abbottlead
Study Sites (18)
Virginia G. Piper Cancer Center
Scottsdale, Arizona, 85258, United States
Arizona Cancer Center
Tucson, Arizona, 85724, United States
UCLA School of Medicine
Los Angeles, California, 90024, United States
Clinical Trials and Research Associates
Montebello, California, 90640, United States
The Center for Hematology-Oncology
Boca Raton, Florida, 33486, United States
University of Chicago Medical Center
Chicago, Illinois, 60637, United States
Central indiana Cancer Center
Indianapolis, Indiana, 46227, United States
Kansas City Cancer Centers Southwest
Overland Park, Kansas, 66210, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Kansas City Oncology and Hematology Group
Kansas City, Missouri, 64111, United States
Albany Regional Cancer Center
Albany, New York, 12208, United States
Raleigh Hematology Oncology Clinic
Cary, North Carolina, 27511, United States
US Oncology, P.A.
Dallas, Texas, 75246, United States
Texas Cancer Center
Fort Worth, Texas, 66210, United States
Texas Cancer Center
Fort Worth, Texas, 76104, United States
MD Anderson Cancer Center
Houston, Texas, 77030, United States
Baylor College of Medicine
Houston, Texas, United States
Academic Hospital Groningen
Groningen, Netherlands
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Rod Humerickhouse, MD
Abbott
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 17, 2003
First Posted
November 18, 2003
Study Start
May 1, 2003
Last Updated
August 15, 2007
Record last verified: 2007-08