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.|
|ClinicalTrials.gov Identifier: NCT01580397|
Recruitment Status : Completed
First Posted : April 19, 2012
Last Update Posted : June 28, 2013
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Ductal Adenocarcinoma||Drug: INNO-206||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||14 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||May 2012|
|Actual Primary Completion Date :||March 2013|
|Actual Study Completion Date :||June 2013|
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.
- Objective Response Rate [ Time Frame: Approximately 15 months from randomization. ]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. ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01580397
|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|
|Study Director:||Daniel Levitt, M.D., Ph.D.||CytRx|