A Phase 3, Multicenter, Open-label, Randomized Study of Nab-Paclitaxel Plus Gemcitabine Versus Gemcitabine Alone as Adjuvant Therapy in Subjects With Surgically Resected Pancreatic Adenocarcinoma
A Phase 3, Multicenter, Open-label, Randomized Study of Nab-Paclitaxel Plus Gemcitabine Versus Gemcitabine Alone as Adjuvant Therapy in Subjects With Surgically Resected Pancreatic Adenocarcinoma
The purpose of this study is to compare whether there is a delay or prevention of recurrence or death in participants with surgically removed pancreatic cancer who then take nab-Paclitaxel in combination with gemcitabine compared to those who take gemcitabine alone.
ABI-007-PANC-003 is a Phase 3, international, multicenter, randomized, open-label, controlled study that will compare the efficacy of nab-paclitaxel in combination with gemcitabine to gemcitabine alone as adjuvant treatment for 6 cycles in patients with surgically resected pancreatic adenocarcinoma.
Inclusion Criteria:
Histologically confirmed resected ductal pancreatic adenocarcinoma with macroscopic complete resection (R0 and R1). Subjects with neuroendocrine (and mixed type) tumors are excluded.
Pancreatic cancer surgical staging: Tumor (T) 1-3, Lymph Node (LN) N0-1, Metastasis (M) 0.
Subject should be able to start treatment no later than 12 weeks postsurgery.
≥18 years of age at the time of signing the informed consent form (ICF).
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Acceptable hematology parameters:
Acceptable blood chemistry levels:
Cancer antigen (CA)19-9 <100 U/mL assessed within 14 days of randomization
Acceptable coagulation studies as demonstrated by prothrombin time (PT) and partial thromboplastin time (PTT) within normal limits (±15%)
Exclusion Criteria:
A subject will not be eligible for inclusion in this study if any of the following criteria apply:
Prior neo-adjuvant treatment or radiation therapy for pancreatic adenocarcinoma
Presence of or history of metastatic pancreatic adenocarcinoma
Any other malignancy within 5 years prior to randomization, with the exception of adequately treated in-situ carcinoma of the cervix, uteri, or nonmelanomatous skin cancer (all treatment of which should have been completed 6 months prior to randomization)
Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy, defined as ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics, antiviral therapy, and/or other treatment
Known infection with hepatitis B or C, or history of human immunodeficiency virus (HIV) infection, or subject receiving immunosuppressive or myelosuppressive medications that would in the opinion of the investigator, increase the risk of serious neutropenic complications
History of allergy or hypersensitivity to nab-paclitaxel or gemcitabine or any of their excipients
Serious medical risk factors involving any of the major organ systems, or serious psychiatric disorders, which could compromise the subject's safety or the study data integrity. These include, but are not limited to:
San Francisco, California 9411, United States
Rochester, New York 14642, United States
Sleepy Hollow, New York 10591, United States
Winston-Salem, North Carolina 27157-1082, United States
Cincinnati, Ohio 45267-0501, United States
Oklahoma City, Oklahoma 73104, United States
Toulose, 31059, France
Toulose, 31059, France
Szeged, 6720, Hungary
Lisbon, 1069-639, Portugal
Pamplona/ Navarra, 31008, Spain
Pamplona/ Navarra, 31008, Spain
Tapei, 10002, Taiwan
Tapei, 10002, Taiwan
Sheffield South Yorkshire, S10 2SS, United Kingdom