safety and efficacy of abt-510 in subjects with advanced renal cell carcinoma

Conditions: Carcinoma, Renal Cell

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


Eligibility criteria:
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

Keywords: advanced histologically documented renal cell carcinoma