Study of Single Agent Idelalisib Followed by Idelalisib in Combination With Chemotherapy in Adults With Metastatic Pancreatic Ductal Adenocarcinoma

Inclusion Criteria:

- The presence of metastatic pancreatic adenocarcinoma plus 1 of the following:

- Histological diagnosis of pancreatic adenocarcinoma confirmed pathologically, OR

- Pathologist confirmed histological/cytological diagnosis of adenocarcinoma
consistent with pancreas origin

- Measurable disease per RECIST v1.1

- Prior systemic chemotherapy treatment for metastatic pancreatic ductal adenocarcinoma
(Arm: idelalisib single agent only)

- Received one prior line of chemotherapy for metastatic pancreatic ductal
adenocarcinoma (Arm: idelalisib + mFOLFOX6 only)

- Adequate organ function defined as follows:

- Hepatic: Total bilirubin ≤ 1.25 x upper limit of normal (ULN) (Arm: idelalisib +
nab-paclitaxel ); total bilirubin ≤1.5 x ULN (Arm: single agent idelalisib and
Arm: idelalisib + mFOLFOX6); aspartate transaminase (AST) (SGOT), alanine
transaminase (ALT) (SGPT) < 2.5 x ULN, and albumin > 3.0 g/dL

- Hematological: absolute neutrophil count (ANC) > 1,500 cells/mm^3, platelet >
100,000 cells/mm^3, hemoglobin > 9.0 g/dL

- Renal: Serum creatinine ≤ 1.5 x ULN OR calculated creatinine clearance (CrCl) >
30 ml/min as calculated by the Cockcroft-Gault method

- Able to comprehend and willing to sign the written informed consent form

Exclusion Criteria:

- Currently or previously treated with biologic, or immunotherapy

- Currently or previously treated with conventional chemotherapy, or other agents for
metastatic pancreatic ductal adenocarcinoma (Arm: idelalisib + nab-paclitaxel only)

- Evidence of ongoing systemic bacterial, fungal, or viral infection at the time of
enrollment

- Known HIV infection

- History of a concurrent or second malignancy except for adequately treated local
basal cell or squamous cell carcinoma of the skin, cervical carcinoma in situ,
superficial bladder cancer, asymptomatic prostate cancer without known metastatic
disease and with no requirement for therapy or requiring only hormonal therapy and
with normal prostate-specific antigen for ≥ 1 year prior to enrollment, adequately
treated Stage 1 or 2 non-pancreatic cancer currently in complete remission, or any
other non-pancreatic cancer that has been in complete remission for ≥ 5 years

- Diagnosis of pancreatic islet neoplasm, acinar cell carcinoma, non-adenocarcinoma
(eg, lymphoma, sarcoma), adenocarcinoma originating from the biliary tree or
cystadenocarcinoma

- History of serious allergic reaction, including anaphylaxis and toxic epidermal
necrolysis

- Presence of peripheral neuropathy ≥ Grade 2 (Arm: idelalisib + nab-paclitaxel and
Arm: idelalisib + mFOLFOX6)

- Documented myocardial infarction or unstable/uncontrolled cardiac disease (eg,
unstable angina, congestive heart failure [New York Heart Association > Class III])
within 6 months or enrollment

- Known hypersensitivity to idelalisib, its metabolites, or formulation excipients

- Known hypersensitivity to nab-paclitaxel (Arm: idelalisib + nab-paclitaxel), their
metabolites, or formulation excipients

- Known hypersensitivity to 5-fluorouracil, leucovorin, or oxaliplatin (Arm: idelalisib
+ mFOLFOX6), their metabolites, or formulation excipients