An Open-Label Phase I Study to Assess the Effect of Rifampicin in the Pharmacokinetics of Eribulin Mesylate (E7389) in Subjects with Advanced Solid Tumours

Completed

• Conditions: drug metabolism / cancer; 10027656

• Registration Number: NL-OMON32968
• Lead Sponsor: Eisai

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 12 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 14

Inclusion Criteria

• Histologically or cytologically confirmed advanced solid tumors
that have progressed following standard therapy or for which no
standard therapy exists (including surgery or radiation therapy)
• Adequate renal function as evidenced by serum creatinine
<= 2.0 mg/dL (<= 176 µmol/L) or calculated creatinine clearance
>= 40 mL/minute per the Cockcroft and Gault formula
• Adequate liver function as evidenced by bilirubin <= 1.5 times the
upper limit of normal (ULN) and alkaline phosphatase (ALP),
alanine transaminase (ALT), and aspartate transaminase (AST)
<= 3 times the ULN (in the case of liver metastasis <= 5 times
ULN). In case ALP > 3 times the ULN (in the absence of liver
metastasis) or > 5 times the ULN (in the presence of liver
metastasis), and the subject is also known to have bone
metastasis, the liver specific ALP must be separated from the total
and used to assess the liver function instead of the total ALP.
- Age >=18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2

Exclusion Criteria

• Subjects with a hypersensitivity to halichondrin B and/or
halichondrin B chemical derivative or a hypersensitivity to
rifampicin
• Subjects with prior participation in an eribulin clinical study, even
if not previously assigned to eribulin treatment
• Subjects with pre-existing neuropathy > Grade 2
• Subjects receiving any medication, dietary supplements or other
compounds or substances known to inhibit or induce CYP3A4 at
the time the study starts

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Pharmacokinetic - Primary Endpoint:<br /><br>PK parameters AUC0-* and Cmax for eribulin will be estimated in the<br /><br>presence and absence of rifampicin. PK parameters will be calculated<br /><br>by non-compartmental analysis of the plasma concentration-time data.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Adverse Events both by means of laboratory reserach and by means of physical<br /><br>research and information of the patient.</p><br>