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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


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Breast Neoplasms

Thank you

Trial Information

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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of participants with Adverse Events as a Measure of Safety and Tolerability

Outcome Time Frame:

Up to 30 months

Safety Issue:

Yes

Principal Investigator

Bayer Study Director

Investigator Role:

Study Director

Investigator Affiliation:

Bayer

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

15977

NCT ID:

NCT01585870

Start Date:

July 2012

Completion Date:

July 2014

Related Keywords:

  • Breast Neoplasms
  • Safety
  • Tolerability
  • Pharmacokinetics
  • Clinical benefit
  • Sorafenib
  • Eribulin
  • Breast cancer
  • Breast Neoplasms
  • Neoplasms

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