Clinical Trials

Title   Ipsen MM-398-07-02-03
Principal Investigator/ Physician   Moh’d Khushman, MD
Protocol No.   MM-398-07-02-03
Open Date   07/31/2018
Gender   Both
Cancer Site   Pancreatic
Status   Open
Contact Email   MCI Clinical Trials

Protocol: A Randomized, Open-label Phase 2 Study of Nanoliposomal Irinotecan (Nal-IRI)-Containing Regimens Versus Nab-Paclitaxel Plus Gemcitabine in Patients With Previously Untreated, Metastatic Pancreatic Adenocarcinoma

Inclusion Criteria:  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)

Exclusion Criteria:  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 CYP2C8 inhibitors 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


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