A Pharmacokinetic Study to Access How the Body Absorbs and Removes Linifanib in Male Patients With Advanced Solid Tumors.
Stopped early · Phase 1
Conditions studied: Advanced Solid Tumors
In brief
A pharmacokinetic study to access how the body absorbs and removes linifanib in male patients with advanced solid tumors.
Key facts
- Study ID
- NCT01286974
- Run by
- Abbott
- People needed
- 3
- Starts
- 2011-08-01
- Expected to finish
- 2012-09-01
- Last updated by the study team
- 2012-09-21
Who can join
Age: 18 and older. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- 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) </= 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.
You may not qualify if…
- 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.
Where it is running
- Site Reference ID/Investigator# 40942 — Cleveland, Ohio, United States
- Site Reference ID/Investigator# 53663 — Cleveland, Ohio, United States
Full record on ClinicalTrials.gov
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