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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Pancreatic Ductal Adenocarcinoma

Thank you

Trial Information

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


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Objective Response Rate

Outcome Description:

Objective response rate is defined as Complete Responders + Partial Responders per RECIST 1.1.

Outcome Time Frame:

Approximately 15 months from randomization.

Safety Issue:

No

Principal Investigator

Daniel Von Hoff, M.D., F.A.C.P.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Translational Genomics Research Institute, Phoenix, Arizona.

Authority:

United States: Food and Drug Administration

Study ID:

INNO-206-P2-PDA-01

NCT ID:

NCT01580397

Start Date:

May 2012

Completion Date:

June 2013

Related Keywords:

  • Pancreatic Ductal Adenocarcinoma
  • Pancreatic cancer
  • INNO-206
  • Doxorubicin-EMCH
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Pancreatic Neoplasms
  • Carcinoma, Pancreatic Ductal
  • Carcinoma, Ductal, Breast

Name

Location

Virginia Piper Cancer InstituteMinneapolis, Minnesota  55407
Cancer Institute of New JerseyNew Brunswick, New Jersey  08901
Scottsdale HealthcareScottsdale, Arizona  85251
Sarcoma Oncology CenterSanta Monica, California  90403
Samuel Oschin Comprehensive Cancer InstituteLos Angeles, California  90048
Medical College of Wisconsin - Division of Neoplastic Diseases and Related DisordersMilwaukee, Wisconsin  53266