To Compare Relative Bioavailability of Two Clinical Formulations of Linifanib.

NCT01381341 | Completed Phase 1

• 1 other identifier: M11-817
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

A pharmacokinetic study to compare 2 clinical formulations of linifanib.

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (1)

• To determine the pharmacokinetic profile of linifanib in subjects with advanced or metastatic solid tumors.

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

  At various time points from Day 1 through Day 5 of Periods 1 and 2

Secondary Outcomes (3)

• Safety: Adverse Events - The number of participants with adverse events will be reported as a measure of Safety.

  Throughout 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.

  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.

• Safety: Clinical Lab Tests will be performed for each participant as a safety measure.

  Screening, Day 1, Periods 1 and 2, Day 5, Period2/Final Visit and 30 day safety follow-up.

Study Arms (1)

linifanib

EXPERIMENTAL

Drug: linifanib

Interventions

linifanib DRUG

QD on Day 1 of Periods 1 and 2

Also known as: ABT-869

linifanib

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Abbott: lead

Study Sites (1)

Site Reference ID/Investigator# 51403

Tacoma, Washington, 98405, 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: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2011
• First Posted: June 27, 2011
• Study Start: May 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: March 23, 2012

Record last verified: 2012-01

Locations

US (1)