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

NCT01286974 | Terminated Phase 1

• 1 other identifier: M10-966
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (1)

• Safety (Number of subjects with adverse events and/or dose-limiting toxicities)

  At each treatment visit (daily for first 9 days and then approximately every 4 weeks through end of treatment)

Study Arms (2)

ADME

EXPERIMENTAL

\[14C\]linifanib

Drug: [14C]linifanib

Extension

EXPERIMENTAL

linifanib

Drug: ABT-869, linifanib

Interventions

[14C]linifanib DRUG

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

ADME

ABT-869, linifanib DRUG

linifanib once a day (QD), oral tablet

Extension

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Abbott: lead

Study Sites (2)

Site Reference ID/Investigator# 40942

Cleveland, Ohio, 44195, United States

Location

Site Reference ID/Investigator# 53663

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Interventions

linifanib

Study Officials

• Mark D. McKee, MD

  Abbott

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2011
• First Posted: February 1, 2011
• Study Start: August 1, 2011
• Primary Completion: August 1, 2012
• Study Completion: September 1, 2012
• Last Updated: September 21, 2012

Record last verified: 2012-09

Locations

US (2)