NCT00362830

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_1 cancer

Timeline
Completed

Started Aug 2006

Shorter than P25 for phase_1 cancer

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

August 7, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 10, 2006

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
Last Updated

September 19, 2016

Status Verified

September 1, 2016

Enrollment Period

1.1 years

First QC Date

August 7, 2006

Last Update Submit

September 16, 2016

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

  • Determine the maximum tolerated dose and describe any dose limiting toxicities of ixabepilone and vinflunine in an alternating regimen.

    upon occurrence

Secondary Outcomes (1)

  • 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

Study Arms (1)

1

EXPERIMENTAL
Drug: vinflunine + ixabepilone

Interventions

vinflunine + ixabepiloneDRUG

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

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ECOG status of 0-1

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University Of Miami Miller School Of Medicine

Miami, Florida, 33136, United States

Location

The Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

vinflunineixabepilone

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 7, 2006

First Posted

August 10, 2006

Study Start

August 1, 2006

Primary Completion

September 1, 2007

Study Completion

September 1, 2007

Last Updated

September 19, 2016

Record last verified: 2016-09

Locations

US(2)