A Phase 1, Multi-center, Non-randomized, Open Label, Dose Escalation Design Study of Sorafenib (BAY43-9006) in Combination With Eribulin in Subjects With Advanced, Metastatic or Refractory Solid Tumors
Inclusion Criteria:
- Study population:
- For dose escalation cohorts: Subjects with advanced, metastatic or refractory
solid malignancy who are not candidates for standard therapy
- For expansion cohort only: Histologically or cytologically proven metastatic
breast cancer that is refractory to standard therapy and not amenable to surgery
with curative intent. Prior therapy should have included an anthracycline and a
taxane in either the adjuvant or metastatic setting.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Male or female at least 18 years of age
- Predicted life expectancy of at least 12 weeks
- Able to swallow and retain oral medication
Exclusion Criteria:
- Prolonged corrected QT (QTc), defined as QTcF (QT interval corrected for heart rate
according to Fridericia) interval > 450 msec at screening by central reader
- Cardiac disease: Congestive heart failure > NYHA Class II; subjects must not have
unstable angina (angina symptoms at rest) or new-onset angina (began within the last
3 months) or myocardial infarction within the past 6 months; cardiac ventricular
arrhythmias requiring anti-arrhythmic therapy
- Arterial or venous thrombi, including cerebrovascular accident and myocardial
infarction in the past 6 months
- Pulmonary hemorrhage event ≥ CTCAE (common toxicity criteria for adverse events)
Grade 2 within 4 weeks
- Any other hemorrhage/bleeding event ≥ CTCAE Grade 3 within 4 weeks
- Chemotherapy, hormonal therapy, investigational drugs, or radiotherapy within the
last 28 days and/or not recovered (< Grade 1) from prior therapy. Start of study
treatment is allowed within less than 28 days of the prior therapy provided that 5
half-lives of the prior treatment drug(s) have elapsed.
- Use of medication that may prolong QTc