NCT02985125

LEE011 Plus Everolimus in Patients With Metastatic Pancreatic Adenocarcinoma Refractory to Chemotherapy

A Phase I/II Study of LEE011 Plus Everolimus in Patients With Metastatic Pancreatic Adenocarcinoma Refractory to Chemotherapy

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Georgetown University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a single-arm, open-label, multi-institutional Phase I/II trial of the combination of LEE011 and everolimus in refractory mPAC.

Detailed description

This is a single arm, open label Phase I/II study to evaluate the progression free survival at 8 weeks (PFS8week) of the combination of LEE-011 plus everolimus, in patients with metastatic pancreatic cancer refractory to 5-fluorouracil (5-FU) and gemcitabine-based chemotherapy. Previous studies of third-line therapy in mPAC are limited but reveal stable disease in 25-31% of patients with no partial or complete responses (31% of patients in the GVAX/CRS-207 combination vaccine study had stable disease but only 52% of these patients were treated in the third-line setting). It is hoped that the combination of LEE-011 plus everolimus can increase the PFS8weeks to at least 50%, though early stopping rules are in place for lack of efficacy.

Conditions

• Metastatic Pancreatic Adenocarcinoma

Interventions

Type	Name	Description
DRUG	LEE011	Treatment cycles are 28 days long. It is taken orally. The dosage varies depending on the study arm.
DRUG	Everolimus	Treatment cycles are 28 days long. It is taken orally. On all arms, the dosage will be 2.5mg.

Timeline

• Start date: 2017-05-04
• Primary completion: 2019-07-24
• Completion: 2020-09-28
• First posted: 2016-12-07
• Last updated: 2026-04-07
• Results posted: 2026-04-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study