Pilot Phase 2 Study to Investigate the Preliminary Efficacy and Safety of INNO-206 in Advanced Pancreatic Cancer
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.
|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|
- 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.
- 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.
|Study Start Date:||May 2012|
|Estimated Study Completion Date:||January 2014|
|Estimated Primary Completion Date:||June 2013 (Final data collection date for primary outcome measure)|
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.
|United States, Arizona|
|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|
|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|