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

This study has been terminated.

(Terminated early, Sponsor Decision)

Sponsor:

Information provided by (Responsible Party):

Abbott

ClinicalTrials.gov Identifier:

NCT01286974

First received: January 28, 2011

Last updated: September 19, 2012

Last verified: September 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

January 28, 2011

Last Updated Date

September 19, 2012

Start Date ^ICMJE

August 2011

Primary Completion Date

August 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Pharmacokinetics 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.

Change History

Complete list of historical versions of study NCT01286974 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

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 evaluted throughout the study.

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Disposition of [14C]ABT-869 in Patients With Solid Tumors Following a Single Oral Dose Administration

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science

Condition ^ICMJE

Advanced Solid Tumors

Intervention ^ICMJE

Drug: [14C]linifanib
[14C]linifanib, single administration, oral liquid

Other Name: [14C]linifanib
Drug: ABT-869, linifanib
linifanib once a day (QD), oral tablet

Other Name: ABT-869, linifanib

Study Arm (s)

Experimental: ADME
[14C]linifanib

Intervention: Drug: [14C]linifanib
Experimental: Extension
linifanib

Intervention: Drug: ABT-869, linifanib

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

September 2012

Primary Completion Date

August 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Male

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01286974

Other Study ID Numbers ^ICMJE

M10-966

Has Data Monitoring Committee

Responsible Party

Abbott

Study Sponsor ^ICMJE

Abbott

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Mark D. McKee, MD

Abbott

Information Provided By

Abbott

Verification Date

September 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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