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mTOR Inhibitor

LEE011 for Pancreatic Cancer

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

Study 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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Progression-free survival (PFS) rate at 8 weeks

Secondary outcome measures

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%

COUGH

19%

NEUTROPHIL COUNT DECREASED

19%

WHITE BLOOD CELL COUNT DECREASED

18%

ANAEMIA

18%

DECREASED APPETITE

17%

RASH

15%

ALANINE AMINOTRANSFERASE INCREASED

15%

ASPARTATE AMINOTRANSFERASE INCREASED

15%

LEUKOPENIA

14%

HYPERTENSION

13%

PRURITUS

13%

ASTHENIA

12%

DIZZINESS

12%

PYREXIA

12%

INSOMNIA

12%

OEDEMA PERIPHERAL

12%

STOMATITIS

11%

DYSPNOEA

10%

DRY MOUTH

10%

PAIN IN EXTREMITY

10%

UPPER RESPIRATORY TRACT INFECTION

10%

URINARY TRACT INFECTION

ABDOMINAL PAIN

DYSGEUSIA

MUSCULOSKELETAL PAIN

DRY SKIN

ANXIETY

DEPRESSION

NASOPHARYNGITIS

MYALGIA

BLOOD CREATININE INCREASED

DYSPEPSIA

LACRIMATION INCREASED

BONE PAIN

THROMBOCYTOPENIA

WEIGHT DECREASED

OROPHARYNGEAL PAIN

ABDOMINAL PAIN UPPER

LYMPHOCYTE COUNT DECREASED

DRY EYE

INFLUENZA

MUSCULOSKELETAL CHEST PAIN

INFLUENZA LIKE ILLNESS

VERTIGO

HYPERGLYCAEMIA

HYPOCALCAEMIA

BREAST PAIN

NON-CARDIAC CHEST PAIN

BLOOD ALKALINE PHOSPHATASE INCREASED

MUSCLE SPASMS

ASCITES

HYPOTENSION

DEHYDRATION

HEPATIC FAILURE

FEBRILE NEUTROPENIA

SYNCOPE

MENTAL STATUS CHANGES

FEMUR FRACTURE

CHOLECYSTITIS

GENERAL PHYSICAL HEALTH DETERIORATION

HEPATOTOXICITY

SEPSIS

PLEURAL EFFUSION

PULMONARY EMBOLISM

PNEUMONIA

100%

80%

60%

40%

20%

Study treatment Arm

Ribociclib 600mg + Letrozole 2.5mg

Placebo + Letrozole 2.5mg

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Georgetown UniversityLead Sponsor

343 Previous Clinical Trials

136,458 Total Patients Enrolled

NovartisIndustry Sponsor

1,611 Previous Clinical Trials

2,720,991 Total Patients Enrolled

University of Texas Southwestern Medical CenterOTHER

1,048 Previous Clinical Trials

1,053,731 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is LEE011 a novel medication or has it been studied before?

"As of now, there are a total of 146 studies ongoing that are researching LEE011. 26 of those investigations are classified as Phase 3 trials. Although the majority of the research for LEE011 is based in Portland, Oregon, there are 6078 locations worldwide where related trials are taking place."

Answered by AI

Are there any available slots for new patients in this clinical trial?

"This study, which was active from May 4th, 2017 to May 20th, 2019 is no longer recruiting patients according to the clinicaltrials.gov website. Although this research is not being conducted anymore, there are 944 other trials that are still looking for participants."

Answered by AI

For what purpose is LEE011 most often prescribed?

"LEE011 is used to treat organ transplant rejection, usually in kidney patients. It can also sometimes be helpful for those suffering from waldenstrom macroglobulinemia, lung issues, and advanced carcinoid tumor."

Answered by AI

How many people are chosen to participate in this research project?

"This study is not enrolling patients at the moment, but it was updated as recently as May 20th, 2019. If you are looking for other clinical trials, there are 798 trials actively enrolling participants with neoplasm metastasis and 146 trials for LEE011 that are currently recruiting."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2017. "LEE011 Plus Everolimus in Patients With Metastatic Pancreatic Adenocarcinoma Refractory to Chemotherapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02985125.

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