Clinical trial NCT01580397 (phase 2, status: completed)
Conditions: pancreatic ductal adenocarcinoma
ICD codes: C22.0, C22.1, C4A.9, C7B.1, D09.9, C4A.0, C4A.31
Drugs: inno-206
SMILES: COC1=C2C(=O)C3=C(O)C4=C(C[C@](O)(C[C@@H]4O[C@H]4C[C@H](N)[C@H](O)[C@H](C)O4)C(\CO)=N\NC(=O)CCCCCN4C(=O)C=CC4=O)C(O)=C3C(=O)C2=CC=C1
Eligibility criteria:

        Inclusion Criteria:

          -  Age ≥ 18 years of age; male or female.

          -  Histologically or cytologically confirmed, locally advanced, unresectable, and/or
             metastatic pancreatic ductal adenocarcinoma.

          -  Cancer progression after treatment with one gemcitabine and one
             fluoropyrimidine-containing chemotherapy regimen.

          -  Capable of providing informed consent and complying with trial procedures.

          -  ECOG performance status 0-1.

          -  Life expectancy ≥ 8 weeks.

          -  Measurable tumor lesions according to RECIST 1.1 criteria.

          -  Women must not be able to become pregnant (eg post-menopausal for at least 1 year,
             surgically sterile, or practicing adequate birth control methods) for the duration of
             the study. (Adequate contraception includes: oral contraception, implanted
             contraception, intrauterine device implanted for at least 3 months, or barrier method
             in conjunction with spermicide.)

          -  Women of child bearing potential must have a negative serum or urine pregnancy test at
             the Screening Visit and be non-lactating.

          -  Geographic accessibility to the site.

        Exclusion Criteria:

          -  Prior exposure to > 3 cycles or 225 mg/m2 of doxorubicin or Doxil®.

          -  Palliative surgery and/or radiation treatment less than 4 weeks prior to
             Randomization.

          -  Exposure to any investigational agent within 30 days of Randomization.

          -  Evidence of central nervous system (CNS) metastasis (negative imaging study, if
             clinically indicated, within 4 weeks of Screening Visit).

          -  History of other malignancies (except cured basal cell carcinoma, superficial bladder
             cancer or carcinoma in situ of the cervix) unless documented free of cancer for ≥ 5
             years.

          -  Laboratory values: Screening serum creatinine > 1.5x upper limit of normal (ULN),
             alanine aminotransferase (ALT) > 3×ULN or > 5×ULN if liver metastases are present,
             total bilirubin > 3×ULN, absolute neutrophil count < 1,500/mm3, platelet concentration
             < 100,000/mm3, absolute lymphocyte count < 1000/mm3, hematocrit level < 27% for
             females or < 30% for males, or coagulation tests (prothrombin time [PT], partial
             thromboplastin time [PTT], International Normalized Ratio [INR]) > 1.5×ULN, serum
             albumin ≤ 2.8 g/dL.

          -  Clinically evident congestive heart failure > class II of the New York Heart
             Association (NYHA) guidelines.

          -  Current, serious, clinically significant cardiac arrhythmias, defined as the existence
             of an absolute arrhythmia or ventricular arrhythmias classified as Lown III, IV or V.

          -  History or signs of active coronary artery disease with or without angina pectoris.

          -  Serious myocardial dysfunction ultrasound-determined, with absolute left ventricular
             ejection fraction (LVEF) < 45% of predicted.

          -  History of HIV infection.

          -  Active, clinically significant serious infection requiring treatment with antibiotics,
             anti-virals or anti-fungals.

          -  Major surgery within 4 weeks prior to Randomization.

          -  Substance abuse or any condition that might interfere with the subject's participation
             in the study or in the evaluation of the study results.

          -  Any condition that is unstable and could jeopardize the subject's participation in the
             study.