Pilot Phase 2 Study to Investigate the Preliminary Efficacy and Safety of INNO-206 in Advanced Pancreatic Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01580397
Recruitment Status : Completed
First Posted : April 19, 2012
Last Update Posted : June 28, 2013
Information provided by (Responsible Party):

April 13, 2012
April 19, 2012
June 28, 2013
May 2012
March 2013   (Final data collection date for primary outcome measure)
Objective Response Rate [ Time Frame: Approximately 15 months from randomization. ]
Objective response rate is defined as Complete Responders + Partial Responders per RECIST 1.1.
Objective Response Rate [ Time Frame: At the end of study, or approximately 15 months from study start. ]
Objective response rate is defined as Complete Responders + Partial Responders per RECIST 1.1.
Complete list of historical versions of study NCT01580397 on Archive Site
  • Disease Control Rate [ Time Frame: After all subjects have been on study for 4 months. ]
    Disease control rate is Complete Responders + Partial Responders + Stable Disease
  • Progression-free Survival [ Time Frame: From the date of randomization until the date of first documented progression assessed up to 20 months. ]
    A >=20% increase in the sum of the LD of target lesions from the smallest sum of the LD recorded since the treatment started.
  • Safety Assessments [ Time Frame: From randomization upto 15 months. ]
    Adverse events, serious adverse events, vital signs, physical examinations, ECG, safety labs will be evaluated for overall toxicity of INNO-206 in this population.
Same as current
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Pilot Phase 2 Study to Investigate the Preliminary Efficacy and Safety of INNO-206 in Advanced Pancreatic Cancer
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
Patients with metastatic, locally advanced, or unresectable pancreatic ductal carcinomas (PDA) who have failed prior chemotherapy with gemcitabine regimens have an extremely poor prognosis with progression-free survival of around 13 weeks and median overall survival of approximately 20 weeks after second line chemotherapy. Recent studies suggest that albumin may be preferentially concentrated in pancreatic cancers that appear to be starved for this protein. Thus, any molecule attached to albumin would also collect inside the tumor. Based on its postulated mechanism of action, INNO-206 may improve the activity of doxorubicin without increasing its toxicity, as has been demonstrated in animal studies, and induce enhanced anti-tumor efficacy.
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Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Pancreatic Ductal Adenocarcinoma
Drug: INNO-206
INNO-206 at a total dose of 350 mg/m2 (260 mg/m2 doxorubicin equivalent) will be administered as a 30 minute IV infusion every 21 days.
Experimental: INNO-206
Intervention: Drug: INNO-206
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
June 2013
March 2013   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
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Principal Investigator: Daniel Von Hoff, M.D., F.A.C.P. Translational Genomics Research Institute
Study Director: Daniel Levitt, M.D., Ph.D. CytRx
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP