Phase I/II Trial of Sorafenib Plus Ixabepilone in HER2-Negative Metastatic Breast Cancer
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00825734 |
Recruitment Status
:
Completed
First Posted
: January 21, 2009
Results First Posted
: December 22, 2014
Last Update Posted
: December 22, 2014
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Tracking Information | ||||
---|---|---|---|---|
First Submitted Date ICMJE | January 19, 2009 | |||
First Posted Date ICMJE | January 21, 2009 | |||
Results First Submitted Date | November 21, 2014 | |||
Results First Posted Date | December 22, 2014 | |||
Last Update Posted Date | December 22, 2014 | |||
Study Start Date ICMJE | March 2009 | |||
Actual Primary Completion Date | June 2013 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Progression-Free Survival (PFS) [ Time Frame: every 9 weeks until treatment discontinuation or death on study ] 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
|
|||
Original Primary Outcome Measures ICMJE |
To assess progression-free survival (PFS) of patients with HER2-negative MBC following treatment with sorafenib/ixabepilone [ Time Frame: 18 months ] | |||
Change History | Complete list of historical versions of study NCT00825734 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
|
|||
Original Secondary Outcome Measures ICMJE |
|
|||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Phase I/II Trial of Sorafenib Plus Ixabepilone in HER2-Negative Metastatic Breast Cancer | |||
Official Title ICMJE | Phase I/II Trial of Sorafenib Plus Ixabepilone in HER2-Negative Metastatic Breast Cancer (MBC) | |||
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. |
|||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase | Phase 1 Phase 2 |
|||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
|||
Condition ICMJE | Metastatic Breast Cancer | |||
Intervention ICMJE |
|
|||
Study Arms |
|
|||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
83 | |||
Original Estimated Enrollment ICMJE |
85 | |||
Actual Study Completion Date | August 2014 | |||
Actual Primary Completion Date | June 2013 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
with metastatic disease. Patients without pathologic or cytologic confirmation of metastatic disease should have unequivocal evidence of metastasis. 3. Measurable disease, as per RECIST criteria (Therasse et al. 2000). 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. 4. Patients with brain metastasis may participate if they: • have undergone appropriate treatment,
demonstrates no residual active lesions, and
patients must have received prior adjuvant or neo-adjuvant chemotherapy.
setting, as long as <25% of the bone marrow has been treated. Radiation therapy must be completed at least 14 days prior to study registration, and all radiation-related toxicities must be resolved to ≤ grade 1 before the patient is eligible for study inclusion.
adjuvant, or metastatic setting is allowed. Patients must discontinue hormonal therapy at least 1 week prior to starting study treatment. •Prior bevacizumab administered >4 weeks before initiation of study treatment is allowed. 6 HER2-negative status. Documentation of HER2 results must be available at the time of study enrollment. HER2-negative is defined as:
FISH ratio <2.2) OR
ratio <2.2). Patients with an IHC 2+ will need to be validated as HER2-negative by FISH. 7 An Eastern Cooperative Oncology Group (ECOG) performance status of < or = to 2. 8. Normal bone marrow function as defined by:
aminotransferase (ALT) <2.5 × the institutional upper limit of normal (ULN) for patients without liver metastasis; <5.0 × ULN for patients with liver metastasis. 10. Normal renal function as defined by creatinine <1.5 × ULN. 11. Left ventricular ejection fraction (LVEF) within institutional limits of normal. 12. International normalized ratio (INR) <1.5 or a prothrombin time/partial thromboplastin time (PT/PTT) within normal limits. Patients receiving anti-coagulation treatment with an agent such as warfarin or heparin may be allowed to participate. The INR should be measured prior to initiation of sorafenib, and for patients on warfarin, INR should be monitored at least weekly following initiation of protocol treatment, until the INR is stable and therapeutic. 13. Life expectancy of >6 months. 14. For women of childbearing potential, negative serum pregnancy test within 7 days prior to starting treatment. 15. For women of childbearing potential and men, agreement to use a method of contraception that is acceptable to their physician from time of first signing the informed consent and for the study duration. Men should use adequate birth control for at least three months after the last administration of sorafenib. If a woman becomes pregnant or suspects she is pregnant while participating in this study, she must agree to inform her treating physician immediately. As applicable, patients must agree to discontinue breast-feeding until at least 3 weeks after their last dose of study drug. 16. Recovery to < grade 1 toxicity due to prior therapy. 17. Ability to understand and willingness to sign a written informed consent document. Exclusion Criteria
4 weeks of the first dose of study treatment, or any other hemorrhage or bleeding event ≥ grade 3 within 4 weeks of the first dose of study treatment. 14. Serious non-healing wound, ulcer, or bone fracture. 15. Evidence or history of bleeding diathesis or coagulopathy. 16. Major surgery, open biopsy or significant traumatic injury within 4 weeks of the first dose of study drugs or anticipation of the need for major surgical procedure. 17. Chronic use of CYP3A4 inducers and use of the following strong CYP3A4 inhibitors: ketoconazole, itraconazole, clarithromycin, atazanavir, nefazodone, saquinavir, telithromycin, ritonavir, amprenavir, indinavir, nelfinavir, delavirdine, and voriconazole. Use of these agents should be discontinued at least 72 hours prior to initiation of study treatment. 18. Use of St. John's Wort or rifampin (rifampicin). 19. Any condition that impairs patient's ability to swallow whole pills or gastrointestinal (GI) tract disease that involves an inability to take oral medication, malabsorption syndrome, a requirement for intravenous (IV) alimentation, prior surgical procedures affecting absorption, or uncontrolled inflammatory GI disease (e.g., Crohn's disease or ulcerative colitis). 20. Psychiatric illness/social situations that would limit compliance with study requirements. 21. Known or suspected allergy to sorafenib, Cremophor EL (polyoxyethylated castor oil) or a drug formulated in Cremophor EL such as paclitaxel or any other agent given in the course of this trial. Exclusion Criteria: |
|||
Sex/Gender |
|
|||
Ages | 18 Years and older (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00825734 | |||
Other Study ID Numbers ICMJE | SCRI BRE 138 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | SCRI Development Innovations, LLC | |||
Study Sponsor ICMJE | SCRI Development Innovations, LLC | |||
Collaborators ICMJE |
|
|||
Investigators ICMJE |
|
|||
PRS Account | SCRI Development Innovations, LLC | |||
Verification Date | December 2014 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |