A Phase II Randomized Study Evaluating the Safety and Efficacy of ABT-510 in Subjects With Advanced Renal Cell Carcinoma
A subject will be eligible for study participation if all of the following criteria are
- 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
- 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
A subject will be ineligible for study participation if any of the following criteria are
- 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
- 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