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

PHASE1TerminatedINTERVENTIONAL
Enrollment

16

Participants

Timeline

Start Date

July 30, 2015

Primary Completion Date

April 27, 2016

Study Completion Date

April 27, 2016

Conditions
Previously Untreated Pancreatic Ductal AdenocarcinomaRelapsed/Refractory Pancreatic Ductal Adenocarcinoma
Interventions
DRUG

Idelalisib

Tablets administered orally twice daily

DRUG

Nab-paclitaxel

125 mg/m\^2 administered intravenously on Days 1, 8 and 15 of each 28 day cycle

DRUG

mFOLFOX6

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.

Trial Locations (9)

14642

University of Rochester, Rochester

20007

Georgetown University, Washington D.C.

29605

Greenville Hospital System, Greenville

46506

Indiana University Goshen Center for Cancer Care, Goshen

75230

Mary Crowley Medical Research Center, Dallas

80045

University of Colorado Cancer Center, Aurora

85258

Scottsdale Healthcare Clinical Research Institute, Scottsdale

90048

Cedars Sinai Medical Center, Los Angeles

02215

Dana Farber/ Harvard Cancer Institute, Boston

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Gilead Sciences

INDUSTRY