Disposition of [14C]ABT-869 in Patients With Solid Tumors Following a Single Oral Dose Administration
- Subject must be >/= 18 years of age.
- Subject must have a histologically or cytologically confirmed non-hematologic
- Eastern cooperative Oncology Group (ECOG) Performance Score of 0 to 2.
- Subject must have adequate bone marrow, renal and hepatic function.
- Subject must have Partial Thromboplastin Time (PTT) = 1.5 x Upper Limit of Normal
(ULN) and International Normalized Ratio (INR) = 1.5.
- Subject must be capable of understanding and complying with parameters as outlined in
the protocol and able to sign the informed consent.
- Subject has received previous administration of a radiolabeled research substance
within 12 months prior to Study Day 1 or exposure to significant radiation (e.g.,
barium meal, etc.) within the past 3 months or within a period defined by 5
half-lives, whichever is shorter, prior to Study Day 1.
- Subject has received anti-cancer therapy including investigational agents, cytotoxic
chemotherapy, radiation, hormonal or biologic therapy within 21 days or within a
period defined by 5 half-lives, whichever is shorter, prior to Study Day 1.
- Subject is currently using a known inhibitor (e.g., ketoconazole) or inducer (e.g.,
rifampin) of cytochrome P450 3A (CYP3A) within 1 month prior to Study Day 1.
- Subject has not recovered to less than or equal to grade 1 clinically significant
adverse effects/toxicities of the previous therapy.
- Subject has undergone major surgery within 21 days of Study Day 1.
- The subject has brain or meningeal metastases.
- The subject has non-small cell lung cancer (NSCLC) with a predominant squamous cell
- Subject is receiving therapeutic anticoagulation therapy.
- Subject has a history of/or currently exhibits clinically significant events of
bleeding (e.g., hemoptysis).
- Subject has proteinuria Common Terminology Criteria (CTC) Grade > 2 at baseline.
- Subject currently exhibits symptomatic or persistent, uncontrolled hypertension.
- Subject has a history of myocardial infarction within 6 months.
- Subject has known autoimmune disease with renal involvement.
- Subject is receiving combination anti-retroviral therapy for human immunodeficiency
- Clinically significant uncontrolled conditions/medical symptoms.
- Subject has a documented left ventricular (LV) ejection fraction < 50%.
- Subject has previously received linifanib.