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Sequoia: A randomized phase III 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

Description

This is an open-label, multi-center, randomized, phase III study designed to compare the efficacy and safety of AM0010 in combination with FOLFOX versus FOLFOX alone in patients with metastatic adenocarcinoma of the pancreas who have progressed on one prior gemcitabine containing regimen.

Status

Accepting new patients

Primary Study Objective(s)

The primary objective of this study is to compare the efficacy of AM0010 in combination with FOLFOX versus FOLFOX alone in patients with metastatic pancreatic cancer as measured by overall survival.

Core eligibility

Note: This is only a partial list of eligibility criteria.

Including patients who have:

  • The presence of metastatic pancreatic adenocarcinoma
  • Measurable disease per RECIST v.1.1
  • Documented tumor progression during or following a gemcitabine containing regimen to treat metastatic disease as established by CT or MRI scan
  • Eastern Cooperative Oncology Group Performance Status of 0 - 1
  • Completed prior chemotherapy at least two weeks (washout period) prior to randomization and recovered from toxicity to grade I or baseline
  • Not received previous radiation therapy or investigational therapy for the treatment of advanced metastatic disease
  • Not received cytotoxic doses of gemcitabine or any other chemotherapy in the adjuvant setting
  • No peripheral neuropathy
  • No known history of dihydropyrimidine dehydrogenase deficiency

Excluding patients who:

  • Are diagnosed with pancreatic islet neoplasm, acinar cell carcinoma, non-adenocarcinoma (i.e., lymphoma, sarcoma), adenocarcinoma originating from the biliary tree, or cystadenocarcinoma
  • Are on Coumadin and not willing to change to LMWH or oral Factor II or Xa inhibitor with half-life of less than 24 hours
  • Have received prior treatment with AM0010 or fluoropyrimidine/platinum containing regimen
  • Were intolerant of a gemcitabine containing regimen
  • Have a history of positivity for human immunodeficiency virus
  • Have chronic active or active viral hepatitis A, B or C infection
  • Have experienced clinically significant bleeding within two weeks prior to randomization (e.g., gastrointestinal (GI) bleeding, intracranial hemorrhage)
  • Are pregnant or lactating
  • Have a history of immune-mediated neurological disorders such as multiple sclerosis, Guillain-Barré or inflammatory CNS/PNS disorders
  • Have experienced clinically significant ascites defined as requiring ≥ 1 paracentesis every 2- weeks
  • Have had major surgery, defined as any surgical procedure that involves general anesthesia and a significant incision (i.e., larger than what is required for placement of central venous access, percutaneous feeding tube, or biopsy), within 28 days prior to randomization or anticipated surgery during the study period
  • Have a prior history of receiving immune modulators including, but not limited to, anti-CTLA4, anti-PD1, anti-PD-L1