A clinical trial to determine the most suitable dose of a combination of eribulin and capecitabine for use in late stage breast cancer patients

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 76

Inclusion Criteria

Subjects in Dose-escalation cohorts (Phase 1b):
1) Histologically or cytologically confirmed cancer that is advanced and/or metastatic
2) Resistant/refractory to approved therapies (defined as progressive
disease during or within 6 months after the last anti-cancer therapy) or
for whom single agent capecitabine at this dose level and schedule
would be a reasonable treatment option in the opinion of the investigator
3) Eastern Cooperative Oncology Group (ECOG) performance status (PS) = 2
4) For subjects that previously received capecitabine all capecitabine
related toxicities must have completely resolved.

Subjects in Dose-confirmation cohorts (Phase 2):
1) Histologically or cytologically confirmed carcinoma of the breast that is advanced and/or metastatic
2) Received up to three prior chemotherapy regimens in any setting
(sequential neo-adjuvant/adjuvant treatment counting as one regimen)
3) Chemotherapy regimens must have included an anthracycline (unless
anthracycline containing chemotherapy is inappropriate) and a taxane,
either in combination or in separate regimens
4) No prior treatment with capecitabine in any setting
5) At least one lesion of = 1.5cm in longest diameter for non-lymph nodes and =1.5cm in shortest diameter for lymph nodes which is serially measurable according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
6) ECOG-PS 0 or 1

General inclusion criteria:
1) Adequate bone marrow function:
absolute neutrophil count (ANC) = 1.5 x 10 9/L, hemoglobin = 10.0 g/dL (this may have been corrected by growth factor or transfusion), and platelet count = 100 x 109/L
2) Adequate liver function as evidenced by bilirubin = 1.5 times the upper limits of normal (ULN) and alkaline phosphatase, alanine
aminotransferase (ALT), and aspartate aminotransferase (AST)
= 3 x ULN (in the case of liver metastases = 5 x ULN)
3) Adequate renal function as evidenced by calculated creatinine clearance = 50 mL/min as per the Cockcroft-Gault formula or radioisotope measurement
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1) Suspected dihydropyrimidine dehydrogenase (DPD) deficiency
2) Prior participation in an eribulin clinical study, even if not assigned to
eribulin treatment
3) Pre-existing neuropathy > Grade 2
4) Subjects with brain or subdural metastases are not eligible, unless they have completed local therapy and have discontinued the use of
corticosteroids for this indication for at least 4 weeks before starting
study treatment. Any symptoms attributed to brain metastases must be stable for at least 4 weeks before starting study treatment; radiographic stability should be determined by comparing contrast-enhanced computed tomography (CT) or magnetic resonance imaging (MRI) brain scan performed during screening to a prior scan performed at least 4 weeks earlier.
5) Electrocardiogram (ECG) with QTc interval > 470 msec

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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