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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
CytRx
ClinicalTrials.gov Identifier:
NCT01580397
First received: April 13, 2012
Last updated: June 27, 2013
Last verified: June 2013

April 13, 2012
June 27, 2013
May 2012
March 2013   (final data collection date for primary outcome measure)
Objective Response Rate [ Time Frame: Approximately 15 months from randomization. ] [ Designated as safety issue: No ]
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. ] [ Designated as safety issue: No ]
Objective response rate is defined as Complete Responders + Partial Responders per RECIST 1.1.
Complete list of historical versions of study NCT01580397 on ClinicalTrials.gov Archive Site
  • Disease Control Rate [ Time Frame: After all subjects have been on study for 4 months. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: Yes ]
    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
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
14
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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01580397
INNO-206-P2-PDA-01
No
CytRx
CytRx
Not Provided
Principal Investigator: Daniel Von Hoff, M.D., F.A.C.P. Translational Genomics Research Institute, Phoenix, Arizona.
Study Director: Daniel Levitt, M.D., Ph.D. CytRx
CytRx
June 2013

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