Conditions: Previously Untreated Pancreatic Ductal Adenocarcinoma Relapsed/Refractory Pancreatic Ductal Adenocarcinoma
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 16
Healthy volunteers: no

Brief summary:
The primary objective of this study is to evaluate the safety of single agent idelalisib and to evaluate safety and define the maximum tolerated dose (MTD) of idelalisib in combination with chemotherapy in adults with metastatic pancreatic ductal adenocarcinoma.

Detailed description:

Arms:
arm 1: Participants were administered with idelalisib (IDL) 150 mg tablets orally, twice daily (morning and evening) for 8 weeks. arm 2: Participants will receive escalating doses of idelalisib at a dose level of up to 150mg + nab-paclitaxel. arm 3: Participants will receive escalating doses of idelalisib at a dose level of up to 150mg + mFOLFOX6.

Interventions: intervention 1: Idelalisib intervention 2: Nab-paclitaxel intervention 3: mFOLFOX6
Intervention descriptions: intervention 1: Tablets administered orally twice daily intervention 2: 125 mg/m\^2 administered intravenously on Days 1, 8 and 15 of each 28 day cycle intervention 3: mFOLFOX6 will be administered intravenously on Days 1 and 15 of each 28 day cycle. This regimen consists of levoleucovorin 200 milligram/meter per square (mg/m\^2) or racemic leucovorin 400 mg/m\^2, oxaliplatin 85 mg/m\^2, bolus 5-fluorouracil 400 mg/m\^2, and a 46 hour infusion of 5-fluorouracil 2, 400 mg/m\^2.

Protocol document: