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

NCT02985125 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2026-04-07

Study results available
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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.

Conditions

  • Metastatic Pancreatic Adenocarcinoma

Interventions

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.

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY

  • University of Texas Southwestern Medical Center

    collaborator OTHER

  • Cedars-Sinai Medical Center

    collaborator OTHER

  • Virginia Mason Hospital/Medical Center

    collaborator OTHER

  • Georgetown University

    lead OTHER

Principal Investigators

  • Benjamin Weinberg, MD · Lombardi Comprehensive Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-04
Primary Completion
2019-07-24
Completion
2020-09-28
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT02985125 on ClinicalTrials.gov