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

Phase 1
18 Years
Not Enrolling
Advanced Solid Tumors

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Trial Information

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

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.

Inclusion Criteria

Inclusion Criteria

- Subject must be >/= 18 years of age.

- Subject must have a histologically or cytologically confirmed non-hematologic

- 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) (ULN) and International Normalized Ratio (INR)
- 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

- 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.

Type of Study:


Study Design:

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

Outcome Measure:

Pharmacokinetic Profile

Outcome Description:

Blood samples for the pharmacokinetics (PK) of linifanib will be collected at designated time points.

Outcome Time Frame:

Various timepoints from Day 1 through approximately Day 9

Safety Issue:


Principal Investigator

Mark D. McKee, MD

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

August 2011

Completion Date:

September 2012

Related Keywords:

  • Advanced Solid Tumors
  • Neoplasms



Site Reference ID/Investigator# 40942 Cleveland, Ohio  44195
Site Reference ID/Investigator# 53663 Cleveland, Ohio  44195