Study of Nanoliposomal Irinotecan (Nal-IRI)-Containing Regimens Versus Nab-paclitaxel Plus Gemcitabine in Patients With Previously Untreated, Metastatic Pancreatic Adenocarcinoma
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Ipsen
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Histologically or cytologically confirmed adenocarcinoma of the pancreas that has not been previously treated in the metastatic setting
Unresectable, locally advanced or metastatic disease; diagnosed within 6 weeks prior to screening
At least one tumor lesion measurable by CT or MRI scan (according to RECIST v1.1)
ECOG performance status of 0 or 1 at screening and within 72 hours prior to first dose if first dose occurs more than 72 hours post-screening
Adequate hematological, hepatic, renal and cardiac function
Recovered from the effects of any prior surgery or radiotherapy
Patient has a Karnofsky performance status (KPS) ≥ 70 at Screening, and within 72 hours prior to date of first dose if first dose occurs more than 72 hours after screening (Part 1B only)
You may not be if
Prior treatment of pancreatic cancer in the metastatic setting (or locally advanced setting) with surgery (placement of stent is allowed), radiotherapy, chemotherapy or investigational therapy
Prior treatment of pancreatic cancer with chemotherapy in adjuvant setting, except those where at least 12 months have elapsed since completion of the last dose and no persistent treatment-related toxicities present
Uncontrolled Central Nervous System (CNS) metastases
Clinically significant gastrointestinal disorder
History of any second malignancy in the last 3 years. Patients with prior history of in-situ cancer or basal or squamous cell skin cancer are eligible
Presence of any contraindications for nal-IRI, irinotecan, 5-FU, leucovorin, oxaliplatin
Use of strong CYP3A4 or inducers or presence of any other contra indications for irinotecan
Pregnant or breast feeding
Neuroendocrine or acinar pancreatic carcinoma
Serum albumin \< 3 g/dL at screening visit and within 72 hours prior to first dose if first dose occurs more than 72 hours post screening
Patients with symptoms and signs of clinically unacceptable deterioration of primary disease at time of screening
Previous treatment with irinotecan-based, nab-paclitaxel-based or gemcitabine-based resulting in disease progression
Clareo Health | Study of Nanoliposomal Irinotecan (Nal-IRI)-Containing Regimens Versus Nab-paclitaxel Plus Gemcitabine in Patients With Previously Untreated, Metastatic Pancreatic Adenocarcinoma
