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

NCT01506934 | Terminated Phase 1

• 1 other identifier: M12-468
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Advanced or Metastatic Solid Tumors

Outcome Measures

Primary Outcomes (1)

• Calculate the Cmax and Tmax of participating subjects

  PK parameters will be measured: predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, and 96 hours post-dose in each study period.

Secondary Outcomes (3)

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

  All adverse events occuring from Day 1 of Period 1 through the Final Visit will be reported.

• 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, 2 and 3 and Day 5, Period 2 (FE portion), Day 5, Period 3 (BA Portion)/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, Period 2 (FE portion), Day 5, Period 3 (BA portion)/Final Visit and 30 day safety follow-up.

Study Arms (1)

linifanib

EXPERIMENTAL

Single Doses

Drug: linifanib

Interventions

linifanib 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)

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/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)
• 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 (4)

Site Reference ID/Investigator# 51465

Baltimore, Maryland, 21231, United States

Location

Site Reference ID/Investigator# 61282

Detroit, Michigan, 48201, United States

Location

Site Reference ID/Investigator# 51463

Lebanon, New Hampshire, 03756-0001, United States

Location

Site Reference ID/Investigator# 52122

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Interventions

linifanib

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: October 11, 2011
• First Posted: January 10, 2012
• Study Start: October 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: January 1, 2012
• Last Updated: August 28, 2012

Record last verified: 2012-08

Locations

US (4)