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

Completed · Phase 2

Conditions studied: Carcinoma, Renal Cell

In brief

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

Key facts

Study ID

NCT00073125

Run by

Abbott

People needed

103

Starts

2003-05-01

Last updated by the study team

2007-08-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• 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

Full record on ClinicalTrials.gov

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