A Multicenter, Open-Label Pilot Phase 2 Study to Investigate the Preliminary Efficacy and Safety of INNO-206 (Doxorubicin-EMCH) in Subjects With Advanced or Unresectable Pancreatic Ductal Carcinoma Whose Tumors Have Progressed Following Prior Treatment With Gemcitabine and Fluoropyrimidine-Based Chemotherapy
- 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.
- 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
- 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
- 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