NCT02468557

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

A Phase 1b Study of Single Agent Idelalisib Followed by Idelalisib in Combination With Chemotherapy in Subjects With Metastatic Pancreatic Ductal Adenocarcinoma

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Previously Untreated Pancreatic Ductal Adenocarcinoma
• Relapsed/Refractory Pancreatic Ductal Adenocarcinoma

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2015-07-30
• Primary completion: 2016-04-27
• Completion: 2016-04-27
• First posted: 2015-06-11
• Last updated: 2021-04-02
• Results posted: 2021-03-22

Locations

9 sites across 1 country: United States

Regulatory

• FDA-regulated drug study