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mTOR Inhibitor

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

Phase 1 & 2
Waitlist Available
Research Sponsored by Georgetown University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
All Individual Drugs Already Approved
Approved for 10 Other Conditions
No Placebo-Only Group

Summary

This trial is testing a combination of two drugs, LEE011 and everolimus, to see if they are effective in treating patients with refractory mPAC.

Eligible Conditions
  • Pancreatic Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Progression-free survival (PFS) rate at 8 weeks
Secondary study objectives
Best response in a patient using RECIST v1.1 criteria
Number of adverse events as accessed by NCI CTCAE v4.03
Overall survival (OS)
+1 more

Side effects data

From 2023 Phase 3 trial • 668 Patients • NCT01958021
61%
NEUTROPENIA
51%
NAUSEA
37%
FATIGUE
35%
DIARRHOEA
33%
ALOPECIA
28%
VOMITING
27%
ARTHRALGIA
24%
CONSTIPATION
22%
HEADACHE
21%
HOT FLUSH
20%
BACK PAIN
19%
NEUTROPHIL COUNT DECREASED
19%
WHITE BLOOD CELL COUNT DECREASED
19%
COUGH
18%
ANAEMIA
18%
DECREASED APPETITE
17%
RASH
15%
LEUKOPENIA
15%
ALANINE AMINOTRANSFERASE INCREASED
15%
ASPARTATE AMINOTRANSFERASE INCREASED
14%
HYPERTENSION
13%
ASTHENIA
13%
PRURITUS
12%
STOMATITIS
12%
OEDEMA PERIPHERAL
12%
PYREXIA
12%
DIZZINESS
12%
INSOMNIA
11%
DYSPNOEA
10%
DRY MOUTH
10%
UPPER RESPIRATORY TRACT INFECTION
10%
URINARY TRACT INFECTION
10%
PAIN IN EXTREMITY
9%
ABDOMINAL PAIN
9%
DYSGEUSIA
8%
MUSCULOSKELETAL PAIN
8%
ANXIETY
8%
DRY SKIN
7%
DYSPEPSIA
7%
LACRIMATION INCREASED
7%
NASOPHARYNGITIS
7%
BLOOD CREATININE INCREASED
7%
BONE PAIN
7%
MYALGIA
7%
DEPRESSION
6%
ABDOMINAL PAIN UPPER
6%
THROMBOCYTOPENIA
6%
DRY EYE
6%
LYMPHOCYTE COUNT DECREASED
6%
WEIGHT DECREASED
6%
OROPHARYNGEAL PAIN
5%
VERTIGO
5%
INFLUENZA LIKE ILLNESS
5%
INFLUENZA
5%
HYPERGLYCAEMIA
5%
HYPOCALCAEMIA
5%
MUSCULOSKELETAL CHEST PAIN
4%
NON-CARDIAC CHEST PAIN
4%
BLOOD ALKALINE PHOSPHATASE INCREASED
4%
BREAST PAIN
3%
MUSCLE SPASMS
1%
GENERAL PHYSICAL HEALTH DETERIORATION
1%
CHOLECYSTITIS
1%
HEPATIC FAILURE
1%
HEPATOTOXICITY
1%
SEPSIS
1%
FEMUR FRACTURE
1%
DEHYDRATION
1%
SYNCOPE
1%
MENTAL STATUS CHANGES
1%
PLEURAL EFFUSION
1%
PULMONARY EMBOLISM
1%
HYPOTENSION
1%
FEBRILE NEUTROPENIA
1%
ASCITES
1%
PNEUMONIA
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ribociclib 600mg + Letrozole 2.5mg
Placebo + Letrozole 2.5mg

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

5Treatment groups
Experimental Treatment
Group I: Phase II - DoseExperimental Treatment2 Interventions
Treatment cycles are 28 days long. LEE011 (taken orally) - the recommended phase II dose Once daily on days 1-21 Everolimus (taken orally) - 2.5mg Once daily on days 1-28
Group II: Phase I - Dose Level 2Experimental Treatment2 Interventions
Treatment cycles are 28 days long. LEE011 (taken orally) - 300mg Once daily on days 1-21 Everolimus (taken orally) - 2.5mg Once daily on days 1-28
Group III: Phase I - Dose Level 1Experimental Treatment2 Interventions
Treatment cycles are 28 days long. LEE011 (taken orally) - 250mg Once daily on days 1-21 Everolimus (taken orally) - 2.5mg Once daily on days 1-28
Group IV: Phase I - Dose Level -2Experimental Treatment2 Interventions
Treatment cycles are 28 days long. LEE011 (taken orally) - 150mg Once daily on days 1-21 Everolimus (taken orally) - 2.5mg Once daily on days 1-28
Group V: Phase I - Dose Level -1Experimental Treatment2 Interventions
Treatment cycles are 28 days long. LEE011 (taken orally) - 200mg Once daily on days 1-21 Everolimus (taken orally) - 2.5mg Once daily on days 1-28
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ribociclib
FDA approved
Everolimus
FDA approved

Find a Location

Who is running the clinical trial?

Georgetown UniversityLead Sponsor
350 Previous Clinical Trials
139,121 Total Patients Enrolled
NovartisIndustry Sponsor
1,639 Previous Clinical Trials
2,774,259 Total Patients Enrolled
University of Texas Southwestern Medical CenterOTHER
1,089 Previous Clinical Trials
1,059,639 Total Patients Enrolled
Cedars-Sinai Medical CenterOTHER
513 Previous Clinical Trials
163,345 Total Patients Enrolled
Virginia Mason Hospital/Medical CenterOTHER
22 Previous Clinical Trials
8,479 Total Patients Enrolled
Benjamin Weinberg, MDStudy ChairLombardi Comprehensive Cancer Center
5 Previous Clinical Trials
150 Total Patients Enrolled
~5 spots leftby Dec 2025
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