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To Assess the Effect of Rifampicin on the Pharmacokinetics of Eribulin Mesylate in Participants With Advanced Solid Tumors

NCT03002493 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2017-03-15

No results posted yet for this study

Summary

The primary objective of this study was to assess the effect of cytochrome P450 3A4 enzyme (CYP3A4) induction by rifampicin on the pharmacokinetics (PK) of eribulin mesylate following intravenous (IV) administration in participants with advanced solid tumors. The secondary objectives of this study were to assess the safety of eribulin mesylate when co-administered with rifampicin and assess the safety and activity of eribulin mesylate as a single agent.

Conditions

  • Tumor

Interventions

DRUG

Eribulin mesylate

Treatment phase: During Cycle 1, eribulin mesylate was administered as a 2 to 5 minute (min) intravenous (IV) infusion at 1.4 mg/m2 on Day 1 and Day 15 of 21-day cycle. During subsequent cycles, eribulin mesylate administration as a 2 to 5 min IV infusion at 1.4 mg/m2 on Day 1 and Day 8 of a 21-day cycle. Extension phase: Eribulin mesylate was administered continuously as a 2 to 5 min IV infusion at 1.4 mg/m2 on Day 1 and Day 8 of 21-day cycles, as long as the Investigator considered eribulin mesylate therapy to be clinically appropriate.

DRUG

Eribulin mesylate

DRUG

Rifampicin

Treatment phase: Rifampicin 600 mg was administered orally once a day, from Day 9 to Day 20 of 28-day cycle of Cycle 1.

Sponsors & Collaborators

  • Eisai Limited

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2011-02-28
Completion
2011-06-30

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03002493 on ClinicalTrials.gov