Randomized Study of AM0010 in Combination With FOLFOX Compared to FOLFOX Alone as Second-line Tx in Pts With Metastatic Pancreatic Cancer That Has Progressed During or Following a First-Line Gemcitabine Containing Regimen
Description
Brief Summary
To compare the efficacy of pegilodecakin in combination with FOLFOX versus FOLFOX alone in
participants with metastatic pancreatic cancer as measured by overall survival.
Detailed Description
This is an open-label, multi-center, randomized, Phase 3 study designed to compare the
efficacy and safety of pegilodecakin in combination with FOLFOX versus FOLFOX alone in
participants with metastatic adenocarcinoma of the pancreas who have progressed on one prior
gemcitabine containing regimen.
Phase
N/AInclusion and Exclusion Criteria
- The presence of metastatic pancreatic adenocarcinoma
- Measurable disease per RECIST v.1.1
- Participant must have 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
- Participant must have completed prior chemotherapy at least 2 weeks (washout period) prior to randomization and recovered from toxicity to Grade 1 or baseline
- Participants must not have received previous radiation therapy or investigational therapy for the treatment of advanced metastatic disease.
- Participants having received cytotoxic doses of gemcitabine or any other chemotherapy in the adjuvant setting are not eligible for this study
- No peripheral neuropathy
- No known history of dihydropyrimidine dehydrogenase deficiency
- Diagnosis of pancreatic islet neoplasm, acinar cell carcinoma, non- adenocarcinoma (i.e., lymphoma, sarcoma), adenocarcinoma originating from the biliary tree, or cystadenocarcinoma
- Participant on Coumadin and not willing to change to LMWH or oral Factor II or Xa inhibitor with half-life of less than 24 hours.
- Participant has received prior treatment with pegilodecakin or fluoropyrimidine/platinum containing regimen
- Participants who were intolerant of a gemcitabine containing regimen.
- History of positivity for human immunodeficiency virus
- Chronic active or active viral hepatitis A, B, or C infection
- Clinically significant bleeding within two weeks prior to randomization (e.g., gastrointestinal (GI) bleeding, intracranial hemorrhage)
- Pregnant or lactating women
- Participants with a history of immune-mediated neurological disorders such as multiple sclerosis, Guillain-Barr
Sites
Please contact the trial administrator to learn more about where you can participate in this trial. Please use the contact form on the right side.
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