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

Purpose

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

Condition	Intervention	Phase
Advanced Solid Tumors	Drug: [14C]linifanib Drug: ABT-869, linifanib	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Basic Science
Official Title:	Disposition of [14C]ABT-869 in Patients With Solid Tumors Following a Single Oral Dose Administration

Resource links provided by NLM:

MedlinePlus related topics: Cancer

U.S. FDA Resources

Further study details as provided by Abbott:

Primary Outcome Measures:

Pharmacokinetic Profile [ Time Frame: Various timepoints from Day 1 through approximately Day 9 ] [ Designated as safety issue: No ]
Blood samples for the pharmacokinetics (PK) of linifanib will be collected at designated time points.
Total radioactivity [ Time Frame: Various timepoints from Day 1 through approximately Day 9 ] [ Designated as safety issue: No ]
Blood, urine, and fecal samples for total radioactivity analysis will be collected at designated time points.

Secondary Outcome Measures:

Safety (Number of subjects with adverse events and/or dose-limiting toxicities) [ Time Frame: At each treatment visit (daily for first 9 days and then approximately every 4 weeks through end of treatment) ] [ Designated as safety issue: Yes ]
Adverse event monitoring, lab test assessments, physical exam and vital signs will be evaluated throughout the study.

Enrollment:	3
Study Start Date:	August 2011
Study Completion Date:	September 2012
Primary Completion Date:	August 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: ADME [14C]linifanib	Drug: [14C]linifanib [14C]linifanib, single administration, oral liquid Other Name: [14C]linifanib
Experimental: Extension linifanib	Drug: ABT-869, linifanib linifanib once a day (QD), oral tablet Other Name: ABT-869, linifanib

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01286974

Locations

United States, Ohio
Site Reference ID/Investigator# 40942
Cleveland, Ohio, United States, 44195
Site Reference ID/Investigator# 53663
Cleveland, Ohio, United States, 44195

Sponsors and Collaborators

Abbott

Investigators

Study Director:

Mark D. McKee, MD

Abbott

More Information

No publications provided

Responsible Party:	Abbott
ClinicalTrials.gov Identifier:	NCT01286974 History of Changes
Other Study ID Numbers:	M10-966
Study First Received:	January 28, 2011
Last Updated:	September 19, 2012
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Neoplasms

ClinicalTrials.gov processed this record on May 21, 2013