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

NCT ID: NCT01286974

Last Updated: 2012-09-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-08-31
• Study Completion Date: 2012-09-30

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.

Conditions

Advanced Solid Tumors

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

ADME

\[14C\]linifanib

Group Type: EXPERIMENTAL

[14C]linifanib

Intervention Type: DRUG

\[14C\]linifanib, single administration, oral liquid

Extension

linifanib

Group Type: EXPERIMENTAL

ABT-869, linifanib

Intervention Type: DRUG

linifanib once a day (QD), oral tablet

Interventions

[14C]linifanib

\[14C\]linifanib, single administration, oral liquid

Intervention Type: DRUG

ABT-869, linifanib

linifanib once a day (QD), oral tablet

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Abbott

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mark D. McKee, MD

Role: STUDY_DIRECTOR

Abbott

Locations

Site Reference ID/Investigator# 40942

Cleveland, Ohio, United States

Site Reference ID/Investigator# 53663

Cleveland, Ohio, United States

Countries

United States

Other Identifiers

M10-966

Identifier Type: -

Identifier Source: org_study_id