ASTELLAS 3082-CL-0301:A Phase 3, Double-blind, Placebo-controlled, Randomized Study to Assess the Efficacy and Safety of ASP3082 in Combination with mFOLFIRINOX or NALIRIFOX as First-line Treatment in Participants with KRAS G12D-mutated Metastatic Pancreatic Adenocarcinoma
Study Sponsor: Astellas Pharma Global Development, Inc.
Location: HealthPartners Cancer Center at Regions Hospital, HealthPartners Frauenshuh Cancer Center
Phase of Study: Phase III
Purpose of study: The purpose of the study is to see if the study drug ASP3082 is a safe and effective treatment for patients with metastatic pancreatic ductal adenocarcinoma cancer (PDAC) with KRASG12D mutation. This is a randomized study, meaning you have a chance to receive either the study drug in combination with chemotherapy, OR placebo in combination with chemotherapy. The combination of chemotherapy is FDA approved to treat your cancer type, so regardless of whether you receive the study drug or the placebo drug, you will still be receiving at least the current standard of treatment.
Inclusion Criteria:
– Must have documented pancreatic ductal adenocarcinoma with confirmed KRAS G12D mutation based on genetic testing.
– Has no option for surgery or radiotherapy with curative intent.
– Must consent to, and provide a baseline tissue specimen during the screening period. Archival tissue is allowed
– Must have an ECOG of 0-1.
– Must have adequate organ function as determined by local lab tests within 7 days prior to being randomized.
– Patient must agree not to take part in any other research study using an investigational drug at the same time.
*Additional inclusion criteria may apply, and will be discussed with the physician and research team.
Exclusion Criteria:
– Patient has neuroendocrine, acinar pancreatic carcinoma, or pancreatic cancer with squamous/adenosquamous features.
– Has another active cancer at the same time (requiring hormonal, or other interventional therapies – some exceptions may apply and can be discussed in further detail with the treating physician).
– Has chronic inflammatory bowel disease, bowel obstruction, or severe/uncontrolled diarrhea.
– Has sensory neuropathy with impairment.
– Has ascites or pleural effusion which required intervention, within 30 days prior to starting study.
– Has pulmonary embolism, history of, or active lung disease, or pulmonary fibrosis, or uncontrolled seizures.
– Has significant cardiac history (to be discussed in greater detail with the provider).
– Has received prior treatment for PDAC (up to 2 doses of chemo [mFOLFIRINOX, or NALFIRINOX] are allowed during the screening period for the study).
– Has had prior treatment with a drug that specifically targets KRAS G12D.
*Additional exclusion criteria may apply, and will be discussed with the physician and research team.
Study Contact:
Alissa Gavenda
(952) 993-6705
alissa.gavenda@healthpartners.com
