Phase I/II Trial of Sorafenib Plus Ixabepilone in HER2-Negative Metastatic Breast Cancer
1 other identifier
interventional
83
1 country
15
Brief Summary
In this study, patients with metastatic HER2-negative breast cancer will receive treatment with ixabepilone and sorafenib until disease progression or unacceptable toxicity occurs. The Phase I portion of this study will determine the maximum tolerated doses (MTDs) of sorafenib and ixabepilone that may be used in combination for first- or second-line treatment of MBC. The MTDs identified in the Phase I portion of the study will be used in the Phase II portion which will evaluate the efficacy and safety of the combination of sorafenib and ixabepilone in patients who have received at least one prior chemotherapy treatment in either the adjuvant or neoadjuvant setting or following one prior MBC chemotherapy in MBC patients who had not received prior adjuvant or neoadjuvant breast cancer chemotherapy. This will be one of the initial trials investigating the use of this treatment combination for MBC. This trial will be conducted under the leadership of the Sarah Cannon Research Institute (SCRI) Oncology Research Consortium, a community-based, multi-center, clinical trial organization.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Mar 2009
Longer than P75 for phase_1
15 active sites
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
First Submitted
Initial submission to the registry
January 19, 2009
CompletedFirst Posted
Study publicly available on registry
January 21, 2009
CompletedStudy Start
First participant enrolled
March 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2014
CompletedResults Posted
Study results publicly available
December 22, 2014
CompletedDecember 22, 2014
December 1, 2014
4.3 years
January 19, 2009
November 21, 2014
December 16, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-Free Survival (PFS)
Measured from Day 1 of study drug administration to disease progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST) - progression is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
every 9 weeks until treatment discontinuation or death on study
Secondary Outcomes (4)
6-month Progression-Free Survival
every 9 weeks, up to 6 months
Objective Response Rate
every 9 weeks until discontinuation of treatment
Overall Survival (OS)
every 9 weeks until treatment discontinuation or death on study
Number of Patients With Adverse Events as a Measure of of Safety and Tolerability
every 9 weeks until treatment discontinuation or unacceptable toxicity
Study Arms (3)
Dose Level 1
EXPERIMENTALSorafenib PO BID (200mg), Ixabepilone IV every 21 days (40mg/m\^2)
Dose Level -1
EXPERIMENTALSorafenib PO BID (200mg), Ixabepilone IV every 21 days (32mg/m\^2)
Dose Level 1a
EXPERIMENTALSorafenib PO BID (400mg), Ixabepilone IV every 21 days (32mg/m\^2)
Interventions
Dose Level 1 - Sorafenib PO BID (200mg) Dose Level -1 - Sorafenib PO BID (200mg) Dose Level 1a - Sorafenib PO BID (400mg)
Dose Level 1 - Ixabepilone IV every 21 days (40mg/m\^2) Dose Level -1 - Ixabepilone IV every 21 days (32mg/m\^2) Dose Level 1a - Ixabepilone IV every 21 days (32mg/m\^2)
Eligibility Criteria
You may qualify if:
- Age ≥ 18 years.
- Histologically or cytologically confirmed breast cancer diagnosis
- with metastatic disease. Patients without pathologic or cytologic
- confirmation of metastatic disease should have unequivocal
- evidence of metastasis.
- \. Measurable disease, as per RECIST criteria (Therasse et al.
- ). Measurable disease cannot be previously irradiated
- unless progression was documented. Measurable disease is
- defined as: at least one lesion that can be accurately measured in
- at least one dimension \[longest diameter to be recorded\] as
- \>20 mm with conventional techniques, or as \>10 mm with spiral
- computed tomography (CT) scan. Disease must be measurable,
- i.e., bone-only disease or evaluable-only disease is not eligible.
- \. Patients with brain metastasis may participate if they:
- have undergone appropriate treatment,
- +70 more criteria
You may not qualify if:
- More than one (\>1) prior chemotherapy regimen.
- Treatment with chemotherapy, biologic agents, or targeted agents
- within the previous 4 weeks.
- Previous treatment with sorafenib or ixabepilone.
- Women who are pregnant or breastfeeding.
- Neuropathy (motor or sensory) greater than grade 1.
- Uncontrolled intercurrent illness including (but not limited to)
- ongoing or active infection \>grade 2.
- Known history of human immunodeficiency virus (HIV), Hepatitis
- B, or Hepatitis C infection.
- History of other non-breast cancer malignancy treated with
- curative intent within the 5 years preceding study enrollment with
- the exception of carcinoma in situ of the cervix, non-melanoma
- skin cancer, or follicular thyroid cancer.
- Concurrent hormonal therapy, chemotherapy other than
- +42 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- SCRI Development Innovations, LLClead
- Bayercollaborator
- Bristol-Myers Squibbcollaborator
Study Sites (15)
Florida Cancer Specialists
Fort Myers, Florida, 33916, United States
Providence Medical Group
Terre Haute, Indiana, 47802, United States
RHHP/ Hope Cancer Center
Terre Haute, Indiana, 47802, United States
Baptist Hospital East
Louisville, Kentucky, 40207, United States
Hematology Oncology Clinic, LLP
Baton Rouge, Louisiana, 70806, United States
Mercy Hospital
Portland, Maine, 04101, United States
Center for Cancer and Blood Disorders
Bethesda, Maryland, 20817, United States
National Capital Clinical Research Consortium
Bethesda, Maryland, 20817, United States
St. Louis Cancer Care
Chesterfield, Missouri, 63044, United States
Portsmouth Regional Hospital
Portsmouth, New Hampshire, 03801, United States
Hematology-Oncology Associates of Northern NJ
Morristown, New Jersey, 07962, United States
Oncology Hematology Care
Cincinnati, Ohio, 45242, United States
South Carolina Oncology Associates
Columbia, South Carolina, 29210, United States
Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States
Tennessee Oncology, PLLC
Nashville, Tennessee, 37023, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- John D. Hainsworth, MD
- Organization
- Sarah Cannon Research Institute
Study Officials
- STUDY CHAIR
Denise A. Yardley, M.D.
SCRI Development Innovations, LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 19, 2009
First Posted
January 21, 2009
Study Start
March 1, 2009
Primary Completion
June 1, 2013
Study Completion
August 1, 2014
Last Updated
December 22, 2014
Results First Posted
December 22, 2014
Record last verified: 2014-12