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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01286974
Recruitment Status : Terminated (Terminated early, Sponsor Decision)
First Posted : February 1, 2011
Last Update Posted : September 21, 2012
Information provided by (Responsible Party):

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

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

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 : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Disposition of [14C]ABT-869 in Patients With Solid Tumors Following a Single Oral Dose Administration
Study Start Date : August 2011
Actual Primary Completion Date : August 2012
Actual Study Completion Date : September 2012

Arm Intervention/treatment
Experimental: ADME
Drug: [14C]linifanib
[14C]linifanib, single administration, oral liquid
Experimental: Extension
Drug: ABT-869, linifanib
linifanib once a day (QD), oral tablet

Primary Outcome Measures :
  1. Pharmacokinetic Profile [ Time Frame: Various timepoints from Day 1 through approximately Day 9 ]
    Blood samples for the pharmacokinetics (PK) of linifanib will be collected at designated time points.

  2. Total radioactivity [ Time Frame: Various timepoints from Day 1 through approximately Day 9 ]
    Blood, urine, and fecal samples for total radioactivity analysis will be collected at designated time points.

Secondary Outcome Measures :
  1. 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) ]
    Adverse event monitoring, lab test assessments, physical exam and vital signs will be evaluated throughout the study.

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01286974

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
Study Director: Mark D. McKee, MD Abbott

Responsible Party: Abbott Identifier: NCT01286974     History of Changes
Other Study ID Numbers: M10-966
First Posted: February 1, 2011    Key Record Dates
Last Update Posted: September 21, 2012
Last Verified: September 2012