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To Compare Relative Bioavailability of Two Clinical Formulations of Linifanib.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Abbott
ClinicalTrials.gov Identifier:
NCT01381341
First received: June 14, 2011
Last updated: March 21, 2012
Last verified: January 2012
History of Changes
  Purpose

A pharmacokinetic study to compare 2 clinical formulations of linifanib.


Condition Intervention Phase
Advanced Solid Tumors
 Drug: linifanib
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Abbott:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Blood samples for the pharmacokinetics (PK) of linifanib will be collected at designated time points and assayed.


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

  • 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. ] [ Designated as safety issue: Yes ]
    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.

  • 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. ] [ Designated as safety issue: Yes ]
    Chemistry, hematology, urinalysis lab tests


Enrollment: 13
Study Start Date: May 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: linifanib Drug: linifanib
QD on Day 1 of Periods 1 and 2
Other Name: ABT-869

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01381341

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

No publications provided

Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT01381341     History of Changes
Other Study ID Numbers: M11-817
Study First Received: June 14, 2011
Last Updated: March 21, 2012
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on June 17, 2013