A Study of the Alternative Administration of Ixabepilone and Vinflunine

A Study of the Alternating Administration of Ixabepilone and Vinflunine Every Three Weeks in Patients With Advanced Cancer

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00362830

Enrollment

Registered

2006-08-10

Start date

2006-08-31

Completion date

2007-09-30

Last updated

2016-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer

Brief summary

The purpose of the study is to test how vinflunine interacts with ixabepilone in the human body.

Interventions

DRUGvinflunine + ixabepilone

solution for injection, IV, vinflunine: 250 to 320 mg/m2 + ixabepilone: 30 to 40 mg/m2, every 3 wks, variable duration

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* ECOG status of 0-1

Exclusion criteria

* Inability to tolerate venous access * Brain mets * Severe nerve damage * ANC \<2,000/mm3 * Platelets \<100K * Bilirubin \>= 1.5 times the IULN * ALT/AST \>= 2.5 times the IULN * Creatinine \<50 mL/min * Prior treatment with vinflunine and/or ixabepilone * Strong use of CYPP450 drugs

Design outcomes

Primary

Measure	Time frame
Determine the maximum tolerated dose and describe any dose limiting toxicities of ixabepilone and vinflunine in an alternating regimen.	upon occurrence

Secondary

Measure	Time frame
Determine the overall safety profile, efficacy and rate and extent to which ixabepilone and vinflunine are absorbed or otherwise available to the treatment site in the body.	upon occurrence

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026