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Status:

COMPLETED

Phase I/II Trial of Sorafenib Plus Ixabepilone in HER2-Negative Metastatic Breast Cancer

Lead Sponsor:

SCRI Development Innovations, LLC

Collaborating Sponsors:

Bayer

Bristol-Myers Squibb

Conditions:

Metastatic Breast Cancer

Eligibility:

All Genders

18+ years

Phase:

PHASE1

PHASE2

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...

Eligibility Criteria

Inclusion

  • 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.
  • 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,
  • are at least 1 month post-treatment,
  • have no neurologic symptoms,
  • are not on steroids,
  • have a follow-up magnetic resonance imaging (MRI) scan that
  • demonstrates no residual active lesions, and
  • have no new untreated lesions.
  • 5 The following prior therapies are allowed:
  • No prior chemotherapy in the metastatic setting. However,
  • patients must have received prior adjuvant or neo-adjuvant
  • chemotherapy.
  • Prior radiation therapy in either the metastatic or early-stage
  • 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.
  • Any number of hormonal therapies in the neo-adjuvant,
  • 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:
  • Immunohistochemical (IHC) 0 or IHC 1+ OR
  • Fluorescence in situ hybridization (FISH) negative (defined by
  • FISH ratio \<2.2) OR
  • Silver in-situ hybridization (SISH) negative (defined by SISH
  • 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:
  • absolute neutrophil count (ANC) \>1,500/μL;
  • platelets \>100,000/μL;
  • hemoglobin \>9 g/dL.
  • 9 Normal hepatic function as defined by:
  • total bilirubin within normal institutional limits;
  • aspartate aminotransferase (AST) and alanine
  • 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
  • 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
  • ixabepilone, or radiation treatments while on study as well as
  • treatment with other investigational agents while on study.
  • Cardiac disease:
  • •Congestive heart failure (CHF) greater than New York Heart Association
  • (NYHA) Class II (see Appendix B).
  • Unstable angina (anginal symptoms at rest) or new onset angina
  • (i.e., began within the last 3 months).
  • Myocardial infarction within the past 6 months.
  • Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy.
  • Uncontrolled hypertension (systolic blood pressure \>150 mmHg
  • or diastolic pressure \>100 mmHg despite optimal medical
  • management).
  • Thrombolic or embolic events such as cerebrovascular accident,
  • including transient ischemic attacks, within the past 6 months.
  • Pulmonary hemorrhage or bleeding event ≥ grade 2 within
  • 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

    Key Trial Info

    Start Date :

    March 1 2009

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    August 1 2014

    Estimated Enrollment :

    83 Patients enrolled

    Trial Details

    Trial ID

    NCT00825734

    Start Date

    March 1 2009

    End Date

    August 1 2014

    Last Update

    December 22 2014

    Active Locations (15)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 4 (15 locations)

    1

    Florida Cancer Specialists

    Fort Myers, Florida, United States, 33916

    2

    Providence Medical Group

    Terre Haute, Indiana, United States, 47802

    3

    RHHP/ Hope Cancer Center

    Terre Haute, Indiana, United States, 47802

    4

    Baptist Hospital East

    Louisville, Kentucky, United States, 40207