Effect of Rifampin on the Pharmacokinetics of Linifanib in Subjects With Advanced or Metastatic Solid Tumors

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01401933
• Date of registration: 29/04/2011
• Primary sponsor: Abbott
• Public title: Effect of Rifampin on the Pharmacokinetics of Linifanib in Subjects With Advanced or Metastatic Solid Tumors
• Scientific title: A Phase 1 Study To Assess the Effect of Rifampin on the Pharmacokinetics of Linifanib in Subjects With Advanced or Metastatic Solid Tumors
• Date of first enrolment: May 2011
• Target sample size: 14
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01401933
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Countries of recruitment

United States

Contacts

• Name: Mark D. McKee, MD
• Affiliation: Abbott

Key inclusion & 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 HCC.

3. Eastern Cooperative Oncology Group (ECOG) Performance Score of 0-2.

4. Subject must have adequate bone marrow, renal and hepatic function.

- 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 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).

4. Subject has received potential inhibitors of the metabolism of linifanib within 21
days prior to initial study drug administration. Such drugs include CYP3A
inhibitors, CYP1A2 inhibitors, CYP2C19 inhibitors, CYP2C8 substrates and CYP3A
inducers.

5. Current enrollment in another clinical trial..



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Advanced Solid Tumors

Intervention(s)

Drug: Linifanib

Drug: Rifampin

Primary Outcome(s)

To investigate the effect of rifampin on the pharmacokinetic of linifanib in subjects with advanced or metastatic solid tumors. [Time Frame: Blood samples for the PK of linifanib will be collected at various time points from Day 1 through Day 17.]

Secondary Outcome(s)

Safety: Adverse Events - The number of participants with adverse events will be reported as a measure of Safety. [Time Frame: Through out the study]

Safety: Clinical Lab Tests will be performed for each participant as a safety measure. [Time Frame: Screening, Day 1, Day 13, Day 17/Final Visit and 30 day safety follow up visit.]

Safety: Physical Examination and Vital Signs - Physical examination will be performed and vital signs will be assessed for participants as a measure of safety. [Time Frame: Physical exam will be done at Screening, Day1, Day 13, Day 17/Final Visit and 30 day safety follow-up. Vital Signs (blood pressure, heart rate, body temperature) will be done at all visits.]

Secondary ID(s)

M11-307

Source(s) of Monetary Support

Please refer to primary and secondary sponsors