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
  Purpose

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.


Condition Intervention Phase
Pancreatic Ductal Adenocarcinoma
Drug: INNO-206
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by CytRx:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 14
Study Start Date: May 2012
Study Completion Date: June 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: INNO-206 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01580397

Locations
United States, Arizona
Scottsdale Healthcare
Scottsdale, Arizona, United States, 85258
United States, California
Samuel Oschin Comprehensive Cancer Institute
Los Angeles, California, United States, 90048
Sarcoma Oncology Center
Santa Monica, California, United States, 90403
United States, Minnesota
Virginia Piper Cancer Institute
Minneapolis, Minnesota, United States, 55407-3799
United States, New Jersey
Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08901
United States, Wisconsin
Medical College of Wisconsin - Division of Neoplastic Diseases and Related Disorders
Milwaukee, Wisconsin, United States, 53266
Sponsors and Collaborators
CytRx
Investigators
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
  More Information

No publications provided

Responsible Party: CytRx
ClinicalTrials.gov Identifier: NCT01580397     History of Changes
Other Study ID Numbers: INNO-206-P2-PDA-01
Study First Received: April 13, 2012
Last Updated: June 27, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by CytRx:
Pancreatic cancer
INNO-206
Doxorubicin-EMCH

Additional relevant MeSH terms:
Adenocarcinoma
Pancreatic Neoplasms
Carcinoma, Pancreatic Ductal
Carcinoma, Ductal, Breast
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Carcinoma, Ductal
Neoplasms, Ductal, Lobular, and Medullary
Breast Neoplasms
Breast Diseases
Skin Diseases
Doxorubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 20, 2014