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

Advanced Solid Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01286974
• Other study ID #: M10-966
• Status: Terminated
• Phase: Phase 1
• First received: January 28, 2011
• Last updated: September 19, 2012
• Start date: August 2011
• Est. completion date: September 2012

Study information

• Verified date: September 2012
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: September 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Advanced Solid Tumors

Intervention

Drug:
• [14C]linifanib
[14C]linifanib, single administration, oral liquid
• ABT-869, linifanib
linifanib once a day (QD), oral tablet

Locations

Country	Name	City	State
United States	Site Reference ID/Investigator# 40942	Cleveland	Ohio
United States	Site Reference ID/Investigator# 53663	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetic Profile	Blood samples for the pharmacokinetics (PK) of linifanib will be collected at designated time points.	Various timepoints from Day 1 through approximately Day 9	No
Primary	Total radioactivity	Blood, urine, and fecal samples for total radioactivity analysis will be collected at designated time points.	Various timepoints from Day 1 through approximately Day 9	No
Secondary	Safety (Number of subjects with adverse events and/or dose-limiting toxicities)	Adverse event monitoring, lab test assessments, physical exam and vital signs will be evaluated throughout the study.	At each treatment visit (daily for first 9 days and then approximately every 4 weeks through end of treatment)	Yes