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Microtubule Inhibitor

Ixabepilone + Bevacizumab for Ovarian, Fallopian Tube, and Peritoneal Cancer

Phase 2
Waitlist Available
Led By Alessandro D. Santin, MD
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights

Study Summary

This trial is testing whether adding the drug bevacizumab to ixabepilone improves progression-free survival in patients with recurrent or persistent platinum-resistant/refractory epithelial ovarian, fallopian tube, or primary peritoneal cancer.

Eligible Conditions
  • Ovarian Cancer
  • Peritoneal Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression-free survival (PFS) differences between Ixabepilone alone and Ixabepilone + Bevacizumab
Secondary outcome measures
Differences in response to the combination of Ixabepilone and Bevacizumab in relationship to previous treatment with Bevacizumab and taxanes
Objective response rate (ORR) and durable disease control rate (DDCR) differences between Ixabepilone alone and Ixabepilone + Bevacizumab
Overall survival (OS) differences between Ixabepilone alone and Ixabepilone + Bevacizumab
+1 more

Side effects data

From 2015 Phase 4 trial • 45 Patients • NCT02036424
22%
vitreous hemorrhage
17%
worsening of cataract
9%
posterior capsule opacification
9%
vitreous syneresis
4%
cranial nerve VI palsy
4%
bradycardia
4%
pneumonia
4%
pyelonephritis
4%
colon cancer
100%
80%
60%
40%
20%
0%
Study treatment Arm
Bevacizumab
Ozurdex

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Ixabepilone + BevacizumabExperimental Treatment2 Interventions
Ixabepilone 20 mg/m2 days 1, 8, 15 + Bevacizumab 10 mg/kg days 1, 15 Q 28 days
Group II: IxabepiloneActive Control1 Intervention
Ixabepilone 20 mg/m2 days 1, 8, 15 Q 28 days
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ixabepilone
2006
Completed Phase 3
~2270
Bevacizumab
2013
Completed Phase 4
~5280

Find a Location

Who is running the clinical trial?

Yale UniversityLead Sponsor
1,847 Previous Clinical Trials
2,737,590 Total Patients Enrolled
3 Trials studying Ovarian Cancer
375 Patients Enrolled for Ovarian Cancer
R-Pharm-US, LLCUNKNOWN
Alessandro D. Santin, MDPrincipal InvestigatorYale University
1 Previous Clinical Trials
20 Total Patients Enrolled

Media Library

Ixabepilone (Microtubule Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03093155 — Phase 2
Ovarian Cancer Research Study Groups: Ixabepilone + Bevacizumab, Ixabepilone
Ovarian Cancer Clinical Trial 2023: Ixabepilone Highlights & Side Effects. Trial Name: NCT03093155 — Phase 2
Ixabepilone (Microtubule Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03093155 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are enrolled in this investigation?

"This trial is currently not accepting applicants. It was posted on April 3, 2017 and last updated on the 13th of April 2022. Alternatively, there are 482 clinical trials for fallopian tubes cancer and 358 studies with Bevacizumab seeking enrolment right now."

Answered by AI

Are any participants being accepted for this research experiment currently?

"This trial is no longer open to new participants. It was initially announced on April 3rd 2017 and was last modified on April 13th 2022. However, there are currently 482 studies recruiting patients with fallopian tubes cancer and 358 trials seeking Bevacizumab users."

Answered by AI

What are the standard uses for Bevacizumab?

"Bevacizumab is a commonly used treatment for malignant neoplasms and can help manage recurrent platinum sensitive primary peritoneal cancer, stage iv epithelial ovarian cancer following initial surgical resection, as well as locally advanced nonsquamous non-small cell lung cancer."

Answered by AI

Has the United States Food and Drug Administration sanctioned the use of Bevacizumab?

"Taking the evidence into account, our team at Power rated Bevacizumab's safety a 2. This is due to Phase 2 trial data which suggests that it is relatively safe but there has yet to be any clinical proof of its efficacy."

Answered by AI

Does this research protocol allow for individuals aged 18 or older to participate?

"The admission requirements for this experimental trial are ages 18 and above, up to a cap of 100 years."

Answered by AI

Have there been previous investigations with Bevacizumab as the primary focus?

"Initially tested in 2004 at Memoral Sloan Kettering Basking Ridge, bevacizumab's clinical trials have since grown to 1077 completed studies. In the present day, a notable proportion of these 358 active trials are being conducted out of New Haven, Connecticut."

Answered by AI

What characteristics make someone an ideal participant for this research?

"Eligible participants for this study must have a diagnosis of fallopian tubes cancer, be between the ages 18 and 100 years old, with an overall recruitment goal of 78 individuals."

Answered by AI
~10 spots leftby Apr 2025