Clinical trial NCT00383760 (phase 2, status: completed)
Conditions: adenocarcinoma of the pancreas, pancreatic cancer, recurrent pancreatic cancer, stage ii pancreatic cancer, stage iii pancreatic cancer, stage iv pancreatic cancer
ICD codes: C22.0, C22.1, C4A.9, C7B.1, D09.9, C4A.0, C4A.31, C25.3, C25.3, C25.3, C25.3, C25.3
Drugs: eribulin mesylate
SMILES: [H][C@@]12O[C@@]3([H])CCC4CC(=O)C[C@H]5[C@H](C[C@H]6O[C@H](C[C@@H](C)C6=C)CC[C@@H]6O[C@H](CC6=C)CC[C@@]67C[C@@H](O[C@H]1[C@@H](O6)[C@@]3([H])O4)[C@@H]2O7)O[C@H](C[C@H](O)CN)[C@@H]5OC
Eligibility criteria:

        Inclusion Criteria:

          -  Histologically/cytologically confirmed pancreatic carcinoma (locally advanced,
             unresectable or metastatic)

          -  measurable disease (at least 1 lesion accurately measured in at least 1 dimension
             (longest diameter as >20mm with conventional techniques or >10mm with spiral CT scan)

          -  >=4 weeks from any major surgery

          -  Up to 1 prior line of gemcitabine based systemic therapy (single agent/combination
             therapy) for locally advanced/metastatic disease with evidence of disease progression.
             Prior therapy with inhibitors of angiogenesis and/or the epidermal growth factor
             receptor permitted. Last chemotherapy dose >=4 weeks prior to randomization.

          -  May have received prior 5FU (+/- folinic acid)/gemcitabine given concurrently with
             radiation as a "radiation sensitizer". Last chemotherapy dose >=4 weeks prior to
             randomization.

          -  Prior radiation treatment >=4 weeks prior to randomization

          -  Age >18 years.

          -  Life expectancy >=3 months

          -  ECOG< 2(Karnofsky-60%)

          -  leukocytes>3,000/mcL

          -  absolute neutrophil count>1,500/mcL

          -  platelets>100,000/mcL

          -  total bilirubin < 1.5 UNL

          -  AST/ALT≤2.5x institutional ULN

          -  creatinine within institution limits OR creatinine clearance>60mL/min/1.73m2 for
             patients with creatinine levels above institution limits

          -  concurrent use of inhibitors/inducers of CYP3A4 are prohibited during the study
             treatment period

          -  effects of E7389 on developing human fetus are unknown. Women of childbearing
             potential and men must agree to use adequate contraception (hormonal or barrier method
             of birth control; abstinence) prior to study entry and for the duration of study
             participation

          -  Ability to understand/willingness to sign written informed consent

        Exclusion Criteria:

          -  chemotherapy/radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C)
             prior to entering study or those who have not recovered from adverse events due to
             agents administered more than 4 weeks earlier

          -  May not be receiving other investigational agents

          -  Known brain metastases

          -  History of allergic reactions attributed to compounds of similar chemical or biologic
             composition to E7389

          -  Uncontrolled intercurrent illness including but not limited to ongoing or active
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
             arrhythmia, or psychiatric illness/social situations that would limit compliance with
             study

          -  Pregnant women excluded because E7389 is an antitubulin agent with the potential for
             teratogenic/abortifacient effects

          -  HIV-positive patients on combination antiretroviral therapy are ineligible because of
             potential for p PK interactions with E7389

          -  Other active malignancies in past 5 years except for cervical carcinoma in situ and
             non-melanomatous skin cancer