Trial Outcomes & Findings for Phase II Study of Ixabepilone in Metastatic Breast Cancer and Its Effects on the Ultrastructure of Neurons (NCT NCT00627978)

Last Updated: 2018-06-26

Results Overview

Digital photographs for morphometry were captured at a magnification of 8000-16,000x and the photos were uploaded onto an imaging platform of transmission electron microscope (iTEM) (Olympus, Mu¨nster, Germany). The figures were enlarged by 50%, and an individual linear array was used to measure the axonal diameter (cross-sectional area) and the number of unmyelinated axons per Remak Schwann cell was enumerated according to the established methodology.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

15 participants

Primary outcome timeframe

Baseline and Over 7 cycles of treatment, approximately 21 weeks

Results posted on

2018-06-26

Participant Flow

Participant milestones

Participant milestones
Measure	Ixabepilone Participants are treated with Ixabepilone. ixabepilone: ixabepilone 40 mg/m2 Q3w over 3 hours	Control No treatment with Ixabepilone
Overall Study STARTED	10	5
Overall Study COMPLETED	10	5
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Phase II Study of Ixabepilone in Metastatic Breast Cancer and Its Effects on the Ultrastructure of Neurons

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ixabepilone n=10 Participants Participants are treated with Ixabepilone. ixabepilone: ixabepilone 40 mg/m2 Q3w over 3 hours	Control n=5 Participants Participants receive no intervention.	Total n=15 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants	5 Participants n=7 Participants	13 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Age, Continuous	55.8 years n=5 Participants	51 years n=7 Participants	54.4 years n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	5 Participants n=7 Participants	15 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants	5 participants n=7 Participants	15 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and Over 7 cycles of treatment, approximately 21 weeks

Outcome measures

Outcome measures
Measure	Ixabepilone n=10 Participants Participants are treated with Ixabepilone. ixabepilone: ixabepilone 40 mg/m2 Q3w over 3 hours	Control n=5 Participants No treatment with Ixabepilone
Axons With Abnormal Morphology Axons grade 0 (normal) or 1 morphology baseline	52 percentage of axons	82 percentage of axons
Axons With Abnormal Morphology Axons grade 0 (normal) or 1 morphology Cycle 7	2 percentage of axons	NA percentage of axons Treatment was not given to the control arm so no value is available for post-7 cycles of treatment
Axons With Abnormal Morphology Axons grade 3 or 4 morphology baseline	24 percentage of axons	15.5 percentage of axons
Axons With Abnormal Morphology Axons grade 3 or 4 morphology Cycle 7	79 percentage of axons	NA percentage of axons Treatment was not given to the control arm so no value is available for post-7 cycles of treatment

Adverse Events

Ixabepilone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Linda Vahdat, MD

Weill Cornell Medicine

Phone: 646-962-9888

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place