Clinical trial NCT01286974: A Pharmacokinetic Study to Access How the Body Absorbs and Removes Linifanib in Male Patients With Advanced Solid Tumors.
Official title: Disposition of [14C]ABT-869 in Patients With Solid Tumors Following a Single Oral Dose Administration
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Advanced Solid Tumors
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2011-02-01
Enrollment: 3
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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

Detailed description: This study is designed to assess the mass balance of \[14C\]linifanib and the metabolic profiles of linifanib in 4 subjects with advanced solid tumors following a single oral dose. Subjects may continue on linifanib after completion of the metabolism study. The results of this study will determine the exposure of major metabolites and excretion pathway(s) of the parent drug and metabolites of linifanib in humans.

Eligibility 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) \</= 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.

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.

Primary outcomes:
measure: Pharmacokinetic Profile
timeFrame: Various timepoints from Day 1 through approximately Day 9
measure: Total radioactivity
timeFrame: Various timepoints from Day 1 through approximately Day 9
Secondary outcomes:
measure: Safety (Number of subjects with adverse events and/or dose-limiting toxicities)
timeFrame: At each treatment visit (daily for first 9 days and then approximately every 4 weeks through end of treatment)
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Site Reference ID/Investigator# 40942
state: Ohio
city: Cleveland
country: United States
facility: Site Reference ID/Investigator# 53663
state: Ohio
Study officials:
affiliation: Abbott
name: Mark D. McKee, MD
role: STUDY_DIRECTOR
References: