BVD-523 Plus Nab-paclitaxel and Gemcitabine in Patients With Metastatic Pancreatic Cancer

Inclusion Criteria

• •Histologically or cytologically confirmed newly diagnosed treatment-naïve metastatic adenocarcinoma of the pancreas with metastatic disease diagnosed no more than 6 weeks prior to enrollment. Patients with advanced pancreatic cancer progressed on 5-FU (or capecitabine) based regimen will be allowed in the expansion cohort.
• •Measurable disease defined as lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 10 mm with CT scan or MRI, as ≥ 20 mm by chest x-ray, or ≥ 10 mm with calipers by clinical exam.
• •At least 18 years of age.
• •Life expectancy \> 3 months.
• •ECOG performance status ≤ 1
• •Normal bone marrow and organ function as defined below:
• •* Absolute neutrophil count ≥ 1,500/mcL
• •* Platelets ≥ 100,000/mcL
• •* Hemoglobin ≥ 9.0 g/dL
• •* Total bilirubin ≤ IULN
• •* AST(SGOT)/ALT(SGPT) ≤ 2.5 x IULN, unless there are liver metastases in which case AST and ALT ≤ 5.0 x IULN
• •* Creatinine ≤ 1.5 x IULN OR GFR of ≥ 50 mL/min
• •* Cardiac function ≥ ILLN, e.g., LVEF of \> 50% as assessed by MUGA or ECHO, QTc \< 470 ms
• •Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry, for the duration of study participation, and for three months following study discontinuation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.
• •Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).