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Completed

NCT Number: NCT01381341

To Compare Relative Bioavailability of Two Clinical Formulations of Linifanib.

A pharmacokinetic study to compare 2 clinical formulations of linifanib.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Site Reference ID/Investigator# 51403

Tacoma, Washington, 98405, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age is greater than or equal to 18 years.
  • Subject must have a histologically or cytologically confirmed non-hematologic malignancy other than Hepatocellular Carcinoma (HCC).
  • Eastern Cooperative Oncology Group (ECOG) Performance Score of 0-2.
  • 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)
  • Subject must have Partial Thromboplastin Time (PTT) </= 1.5 x Upper Limit of Normal ( ULN) and International Normalized Ratio (INR) </= 1.5.

Exclusion criteria

  • 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.
  • Subject has undergone major surgery within 21 days of Period 1, Study Day 1.
  • 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).
  • Current enrollment in another clinical trial.

Treatment and study plan

Linifanib

Drug

QD on Day 1 of Periods 1 and 2

Other names: ABT-869

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Abbott

Industry

Registry information

Official study title

A Phase 1 Pharmacokinetic Study To Compare the Relative Bioavailability of Two Clinical Formulations of Linifanib in Subjects With Solid Tumors

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Jun 27, 2011
Registry last updated
Mar 23, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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