To Compare Relative Bioavailability of Two Clinical Formulations of Linifanib.

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: NCT01381341
Recruitment Status : Completed
First Posted : June 27, 2011
Last Update Posted : March 23, 2012
Information provided by (Responsible Party):

Brief Summary:
A pharmacokinetic study to compare 2 clinical formulations of linifanib.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumors Drug: linifanib Phase 1

Detailed Description:
This study is designed to evaluate the bioavailability of linifanib from 2 formulations. Subjects may enroll in a separate extension study to continue receiving linifanib after completion of this study.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Phase 1 Pharmacokinetic Study To Compare the Relative Bioavailability of Two Clinical Formulations of Linifanib in Subjects With Solid Tumors
Study Start Date : May 2011
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Arm Intervention/treatment
Experimental: linifanib Drug: linifanib
QD on Day 1 of Periods 1 and 2
Other Name: ABT-869

Primary Outcome Measures :
  1. To determine the pharmacokinetic profile of linifanib in subjects with advanced or metastatic solid tumors. [ Time Frame: At various time points from Day 1 through Day 5 of Periods 1 and 2 ]
    Blood samples for the pharmacokinetics (PK) of linifanib will be collected at designated time points and assayed.

Secondary Outcome Measures :
  1. Safety: Adverse Events - The number of participants with adverse events will be reported as a measure of Safety. [ Time Frame: Throughout the study ]
    The investigators will monitor each subject for clinical and lab evidence of adverse events on a routine basis through out the study.

  2. Safety: Physical Examination and Vital Signs - Physical examination will be performed and vital signs will be assessed for participants as a measure of safety. [ Time Frame: Physical exam at Screening, Day 1 of Periods 1 and 2 and Day 5, Period 2/Final Visit and 30 day safety follow-up; Vital Signs (blood pressure, heart rate, body temperature) will be done at all visits. ]
    Complete physical exam, including body weight, will be done at Screening. A symptom-directed physical exam, including bodyweight, will be done at Day 1, Periods 1 and 2, Day 5, Period 2/Final Visit and 30 day safety follow-up.

  3. Safety: Clinical Lab Tests will be performed for each participant as a safety measure. [ Time Frame: Screening, Day 1, Periods 1 and 2, Day 5, Period2/Final Visit and 30 day safety follow-up. ]
    Chemistry, hematology, urinalysis lab tests

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

Inclusion Criteria

  1. Age is greater than or equal to 18 years.
  2. Subject must have a histologically or cytologically confirmed non-hematologic malignancy other than Hepatocellular Carcinoma (HCC).
  3. Eastern Cooperative Oncology Group (ECOG) Performance Score of 0-2.
  4. Subject must have adequate bone marrow, renal and hepatic function as follows:

    • Bone Marrow: Absolute neutrophil count (ANC) >= 1,500/mm^3 (1.5 X 10^9/L); Platelets >= 75,000/mm^3 (75 X 10^9/L); Hemoglobin >= 9.0 g/dL (1.4 mmol/L)
    • Renal function: serum creatinine <= 2.0 mg/dL (0.81 mmol/L);
    • Hepatic function: AST and ALT <= 1.5 X ULN unless liver metastases are present, then AST and ALT <= 5.0 X ULN; bilirubin <= 1.5 mg/dL (0.026 mmol/L)
  5. Subject must have Partial Thromboplastin Time (PTT) </= 1.5 x Upper Limit of Normal ( ULN) and International Normalized Ratio (INR) </= 1.5.

Exclusion Criteria

  1. Subject has received anti-cancer therapy including investigational agents, cytotoxic chemotherapy, radiation therapy or biologic therapy within 21 days or within a period defined by 5 half lives, whichever is shorter, prior to study drug administration. In addition subject has not recovered to less than or equal to Grade 1 clinically significant adverse effects/toxicities of the previous therapy.
  2. Subject has undergone major surgery within 21 days of Period 1, Study Day 1.
  3. Subject has untreated brain or meningeal metastases. Subjects with treated brain metastases that are radiographically or clinically stable (for at least 4 weeks after therapy) and who have no evidence of cavitation or hemorrhage in the brain lesion, are eligible provided that they are asymptomatic and do not require corticosteroids (must have discontinued steroids at least 1 week prior to Study Day 1, Period 1).
  4. Current enrollment in another clinical trial.

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): NCT01381341

United States, Washington
Site Reference ID/Investigator# 51403
Tacoma, Washington, United States, 98405
Sponsors and Collaborators
Study Director: Mark D. McKee, MD Abbott

Responsible Party: Abbott Identifier: NCT01381341     History of Changes
Other Study ID Numbers: M11-817
First Posted: June 27, 2011    Key Record Dates
Last Update Posted: March 23, 2012
Last Verified: January 2012