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


Phase 1
18 Years
N/A
Not Enrolling
Both
Advanced Solid Tumors

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Trial Information

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


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.

Inclusion 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) ULN) and International Normalized Ratio (INR)
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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Outcome Measure:

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

Outcome Description:

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

Outcome Time Frame:

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

Safety Issue:

No

Principal Investigator

Mark D. McKee, MD

Investigator Role:

Study Director

Investigator Affiliation:

Abbott

Authority:

United States: Food and Drug Administration

Study ID:

M11-817

NCT ID:

NCT01381341

Start Date:

May 2011

Completion Date:

December 2011

Related Keywords:

  • Advanced Solid Tumors

Name

Location

Site Reference ID/Investigator# 51403Tacoma, Washington  98405