A Pharmacokinetic Study to Access How the Body Absorbs and Removes Linifanib in Male Patients With Advanced Solid Tumors.

• Status: Terminated
• Trial end date: 2012-09-01
• Target enrollment: 0
• Participant gender: Male

Summary

A pharmacokinetic study to access how the body absorbs and removes linifanib in male patients with advanced solid tumors.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Abbott

Criteria

Inclusion Criteria

• Subject must be >/= 18 years of age.

• Subject must have a histologically or cytologically confirmed non-hematologic malignancy.

• 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)(ULN) and International Normalized Ratio (INR)
• Subject must be capable of understanding and complying with parameters as outlined in the protocol and able to sign the informed consent.

Exclusion Criteria

• 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 histology.

• 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 virus (HIV).

• Clinically significant uncontrolled conditions/medical symptoms.

• Subject has a documented left ventricular (LV) ejection fraction < 50%.

• Subject has previously received linifanib.