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A Phase 1, Open Label, Randomized, Adaptive, Cross-Over Study Evaluating the Bioavailability of Two Formulations of Linifanib and Food Effect on Pharmacokinetics of Linifanib in Subjects With Advanced or Metastatic Solid Tumors


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

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Trial Information

A Phase 1, Open Label, Randomized, Adaptive, Cross-Over Study Evaluating the Bioavailability of Two Formulations of Linifanib and Food Effect on Pharmacokinetics of Linifanib in Subjects With Advanced or Metastatic Solid Tumors


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.

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/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) 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:

Calculate the Cmax and Tmax of participating subjects

Outcome Time Frame:

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.

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

M12-468

NCT ID:

NCT01506934

Start Date:

October 2011

Completion Date:

January 2012

Related Keywords:

  • Advanced or Metastatic Solid Tumors
  • Neoplasms

Name

Location

Site Reference ID/Investigator# 51465Baltimore, Maryland  21231
Site Reference ID/Investigator# 61282Detroit, Michigan  48201
Site Reference ID/Investigator# 51463Lebanon, New Hampshire  03756-0001
Site Reference ID/Investigator# 52122San Antonio, Texas  78229