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Clinical Trials

Topic   Pancreatic Cancer
Title   A Randomized Phase 3 Study of AM0010 in Combination with FOLFOX Compared with FOLFOX Alone as Second-line Therapy in Patients with Metastatic Pancreatic Cancer that has Progressed During or Following a First-Line Gemcitabine Containing Regimen
Summary   The purpose of this study is to determine if an investigational drug, AM0010, in combination with a chemotherapy regimen, FOLFOX (Oxaliplatin plus 5-Fluorouracil (5-FU) plus Leucovorin), is safe and effective in the treatment of patients with metastatic pancreatic cancer that has progressed during or following a first-line Gemcitabine containing regimen, compared with FOLFOX alone. An “investigational drug” is a drug that is being tested and is not approved in the United States by the Food and Drug Administration (FDA). Both AM0010 and FOLFOX are investigational as used in this study. AM0010 has been tested previously in approximately 330 humans. It is expected that approximately 566 patients will be enrolled in this study. For more information, please visit www.clinicaltrials.gov
Description   Patients will be randomly assigned a treatment arm and will receive study treatment until confirmed disease progression, unacceptable toxicity or withdrawl of consent.
IRB Number   20162918
Inclusion/Notes   To be eligible for this study, patients must meet several criteria, including but not limited to the following:
  • This study is for patients age 18 and older.
  • Histologically confirmed pancreatic adenocarcinoma.
  • Patients must have metastatic pancreatic cancer that has come back or continued to grow despite receiving a first-line Gemcitabine containing regimen. Patient must not have received previous radiation therapy, surgery, or investigational therapy for the treatment of advanced metastatic disease.
  • At least 2 weeks must pass between the completion of prior therapy and entry into the study.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. For example, patients must be well enough that they would be able to carry out office work or light housework.
Status   Open
Start Date   02/28/2017
Principal Name   Alexander Hindenburg, MD
Contact Name   Lisa Chen, Research Nurse Coordinator
Email   lchen2@nyuwinthrop.org
Fax   516-663-1871
Current Trial Type   Interventional
Phone   516-663-9500
Alternate Phone   516-663-1081