To Compare Relative Bioavailability of Two Clinical Formulations of Linifanib.

Abbott

Status and phase: Completed; Phase 1

Conditions: Advanced Solid Tumors

Treatments: Drug: linifanib

Study type: Interventional

Funder types: Industry

Identifiers

NCT01381341

M11-817

Details and patient eligibility

About

A pharmacokinetic study to compare 2 clinical formulations of linifanib.

Full description

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.

Enrollment: 13 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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) </= 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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

13 participants in 1 patient group

linifanib

Experimental group

Treatment:

Drug: linifanib