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

NCT02468557 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2021-04-02

Study results available
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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

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.

Sponsors & Collaborators

Principal Investigators

  • Gilead Study Director · Gilead Sciences

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-30
Primary Completion
2016-04-27
Completion
2016-04-27
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02468557 on ClinicalTrials.gov