A Study Evaluating the Bioavailability of Two Formulations of Linifanib and Food Effect on Pharmacokinetics of Linifanib in Subjects With Advanced or Metastatic Solid Tumors

NCT ID: NCT01506934

Last Updated: 2012-08-28

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2012-01-31

Brief Summary

A pharmacokinetic study to compare 2 clinical formulations of linifanib and the effect of food on the pharmacokinetics of linifanib.

Detailed Description

This study is designed to evaluate the bioavailability of linifanib from two formulations and the effect of food on the pharmacokinetics of the linifanib formulation intended for commercialization. Subjects may enroll in a separate extension study to continue receiving linifanib after completion of this study.

Conditions

Advanced or Metastatic Solid Tumors

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

linifanib

Single Doses

Group Type: EXPERIMENTAL

linifanib

Intervention Type: DRUG

Single Dose on Day 1 of Periods 1, 2 and 3 (Bioavailability Portion)

Single Dose on Day 1 of Periods 1 and 2 (Food Effect Portion)

Interventions

linifanib

Single Dose on Day 1 of Periods 1, 2 and 3 (Bioavailability Portion)

Single Dose on Day 1 of Periods 1 and 2 (Food Effect Portion)

Intervention Type: DRUG

Other Intervention Names

ABT-869

Eligibility 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/mm3 (1.5 X 109/L); Platelets >= 75,000/mm3 (75 X 109/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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Site Reference ID/Investigator# 51465

Baltimore, Maryland, United States

Site Reference ID/Investigator# 61282

Detroit, Michigan, United States

Site Reference ID/Investigator# 51463

Lebanon, New Hampshire, United States

Site Reference ID/Investigator# 52122

San Antonio, Texas, United States

Countries

United States

Other Identifiers

M12-468

Identifier Type: -

Identifier Source: org_study_id