Trial Outcomes & Findings for LEE011 Plus Everolimus in Patients With Metastatic Pancreatic Adenocarcinoma Refractory to Chemotherapy (NCT NCT02985125)

Last Updated: 2026-04-07

Results Overview

Determine the Recommended Phase II dose (RP2D) of LEE011 (ribociclib) in the combination with everolimus in patients with mPAC refractory to 5-FU- and GEM-based chemotherapy based on DLTs within the first 4 weeks of treatment.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

12 participants

Primary outcome timeframe

First 4 weeks of treatment

Results posted on

2026-04-07

Participant Flow

Participant milestones

Participant milestones
Measure	Phase I - Dose Level 1 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 LEE011: Treatment cycles are 28 days long. It is taken orally. The dosage varies depending on the study arm. Everolimus: Treatment cycles are 28 days long. It is taken orally. On all arms, the dosage will be 2.5mg.	Phase I - Dose Level 2 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 LEE011: Treatment cycles are 28 days long. It is taken orally. The dosage varies depending on the study arm. Everolimus: Treatment cycles are 28 days long. It is taken orally. On all arms, the dosage will be 2.5mg.
Overall Study STARTED	6	6
Overall Study COMPLETED	6	6
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: First 4 weeks of treatment

Population: All dose levels used to determin the recommended dose

Outcome measures

Outcome measures
Measure	Phase I -All Dose Levels (1 and 2) n=12 Participants Dose Level 1 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 LEE011: Treatment cycles are 28 days long. It is taken orally. The dosage varies depending on the study arm. Everolimus: Treatment cycles are 28 days long. It is taken orally. On all arms, the dosage will be 2.5mg. Dose Level 2 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 LEE011: Treatment cycles are 28 days long. It is taken orally. The dosage varies depending on the study arm. Everolimus: Treatment cycles are 28 days long. It is taken orally. On all arms, the dosage will be 2.5mg.
Phase I: Determine the Recommended Phase II Dose (RP2D)	300 mg

PRIMARY outcome

Timeframe: 8 weeks

Population: Study met stopping criteria due to lack of response in phase 1. No patients enrolled into phase II. Endpoint Not applicable.

PFS at 8 weeks in a patient with refractory mPAC treated with LEE011 and everolimus, defined as positive if a patient does not have evidence of progressive disease at 8 weeks as measured by expert radiologists using RECIST v1.1 criteria

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 years

Population: Study met stopping criteria due to lack of response in phase 1. No patients enrolled into phase II. Endpoing Not applicable.

PFS in a patient with refractory mPAC treated with LEE011 and everolimus, defined as the time from Cycle 1, Day 1 to progressive disease (as measured by expert radiologists using RECIST v1.1 criteria), death from any cause, or last follow-up, as determined by the investigator of LEE011 and everolimus in patients with mPAC refractory to chemotherapy

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 years

Population: Study met stopping criteria due to lack of response in phase 1. No patients enrolled into phase II. Endpoint Not applicable.

Overall survival (OS) in a patient with refractory mPAC treated with LEE011 and everolimus, defined as the time from Cycle 1, Day 1 to death from any cause or last follow-up

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 years

Population: Study met stopping criteria due to lack of response in phase 1. No patients enrolled into phase II. Endpoint Not applicable.

Best response in a patient, defined as the largest percent decrease in tumor size from baseline and categorized as a complete response, partial response, or stable disease by imaging studies, measured by expert radiologists using RECIST v1.1 criteria

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 years

Population: Study met stopping criteria due to lack of response in phase 1. No patients enrolled into phase II. Endpoint Not applicable.

Adverse events in a patient with refractory mPAC treated with LEE011 and everolimus, defined as the number of grade 3 and 4 toxicities according to National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE v4.03) that occur after Cycle 1, Day 1

Outcome measures

Outcome data not reported

Adverse Events

Phase I - Dose Level 1

Serious events: 2 serious events

Other events: 6 other events

Deaths: 2 deaths

Phase I - Dose Level 2

Serious events: 1 serious events

Other events: 6 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Phase I - Dose Level 1 n=6 participants at risk 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 LEE011: Treatment cycles are 28 days long. It is taken orally. The dosage varies depending on the study arm. Everolimus: Treatment cycles are 28 days long. It is taken orally. On all arms, the dosage will be 2.5mg.	Phase I - Dose Level 2 n=6 participants at risk 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 LEE011: Treatment cycles are 28 days long. It is taken orally. The dosage varies depending on the study arm. Everolimus: Treatment cycles are 28 days long. It is taken orally. On all arms, the dosage will be 2.5mg.
Skin and subcutaneous tissue disorders Rash maculo-papular	16.7% 1/6 • Number of events 1 • From the time of study drug administration until 30 days following discontinuation. (Max 143 days)	0.00% 0/6 • From the time of study drug administration until 30 days following discontinuation. (Max 143 days)
Respiratory, thoracic and mediastinal disorders Dyspnea	16.7% 1/6 • Number of events 1 • From the time of study drug administration until 30 days following discontinuation. (Max 143 days)	0.00% 0/6 • From the time of study drug administration until 30 days following discontinuation. (Max 143 days)
Gastrointestinal disorders Abdominal Pain	16.7% 1/6 • Number of events 1 • From the time of study drug administration until 30 days following discontinuation. (Max 143 days)	16.7% 1/6 • Number of events 1 • From the time of study drug administration until 30 days following discontinuation. (Max 143 days)
Gastrointestinal disorders Diarrhea	16.7% 1/6 • Number of events 1 • From the time of study drug administration until 30 days following discontinuation. (Max 143 days)	0.00% 0/6 • From the time of study drug administration until 30 days following discontinuation. (Max 143 days)
Gastrointestinal disorders Vomiting	16.7% 1/6 • Number of events 1 • From the time of study drug administration until 30 days following discontinuation. (Max 143 days)	0.00% 0/6 • From the time of study drug administration until 30 days following discontinuation. (Max 143 days)
General disorders Fever	0.00% 0/6 • From the time of study drug administration until 30 days following discontinuation. (Max 143 days)	16.7% 1/6 • Number of events 1 • From the time of study drug administration until 30 days following discontinuation. (Max 143 days)

Other adverse events

Additional Information

Benjamin Weinber, MD

Georgetown University

Phone: 202-444-2223

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Phase I - Dose Level 1 n=6 Participants 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 LEE011: Treatment cycles are 28 days long. It is taken orally. The dosage varies depending on the study arm. Everolimus: Treatment cycles are 28 days long. It is taken orally. On all arms, the dosage will be 2.5mg.	Phase I - Dose Level 2 n=6 Participants 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 LEE011: Treatment cycles are 28 days long. It is taken orally. The dosage varies depending on the study arm. Everolimus: Treatment cycles are 28 days long. It is taken orally. On all arms, the dosage will be 2.5mg.	Total n=12 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=527 Participants	0 Participants n=527 Participants	0 Participants n=1054 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=527 Participants	1 Participants n=527 Participants	5 Participants n=1054 Participants
Age, Categorical >=65 years	2 Participants n=527 Participants	5 Participants n=527 Participants	7 Participants n=1054 Participants
Sex: Female, Male Female	5 Participants n=527 Participants	5 Participants n=527 Participants	10 Participants n=1054 Participants
Sex: Female, Male Male	1 Participants n=527 Participants	1 Participants n=527 Participants	2 Participants n=1054 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=527 Participants	0 Participants n=527 Participants	0 Participants n=1054 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=527 Participants	6 Participants n=527 Participants	12 Participants n=1054 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=527 Participants	0 Participants n=527 Participants	0 Participants n=1054 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=527 Participants	0 Participants n=527 Participants	0 Participants n=1054 Participants
Race (NIH/OMB) Asian	0 Participants n=527 Participants	0 Participants n=527 Participants	0 Participants n=1054 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=527 Participants	0 Participants n=527 Participants	0 Participants n=1054 Participants
Race (NIH/OMB) Black or African American	2 Participants n=527 Participants	2 Participants n=527 Participants	4 Participants n=1054 Participants
Race (NIH/OMB) White	4 Participants n=527 Participants	4 Participants n=527 Participants	8 Participants n=1054 Participants
Race (NIH/OMB) More than one race	0 Participants n=527 Participants	0 Participants n=527 Participants	0 Participants n=1054 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=527 Participants	0 Participants n=527 Participants	0 Participants n=1054 Participants

Measure	Phase I - Dose Level 1 n=6 participants at risk 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 LEE011: Treatment cycles are 28 days long. It is taken orally. The dosage varies depending on the study arm. Everolimus: Treatment cycles are 28 days long. It is taken orally. On all arms, the dosage will be 2.5mg.	Phase I - Dose Level 2 n=6 participants at risk 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 LEE011: Treatment cycles are 28 days long. It is taken orally. The dosage varies depending on the study arm. Everolimus: Treatment cycles are 28 days long. It is taken orally. On all arms, the dosage will be 2.5mg.
Infections and infestations Sepsis	0.00% 0/6 • From the time of study drug administration until 30 days following discontinuation. (Max 143 days)	16.7% 1/6 • Number of events 1 • From the time of study drug administration until 30 days following discontinuation. (Max 143 days)
Metabolism and nutrition disorders Anorexia	16.7% 1/6 • Number of events 1 • From the time of study drug administration until 30 days following discontinuation. (Max 143 days)	0.00% 0/6 • From the time of study drug administration until 30 days following discontinuation. (Max 143 days)
Gastrointestinal disorders Diarrhea	33.3% 2/6 • Number of events 2 • From the time of study drug administration until 30 days following discontinuation. (Max 143 days)	16.7% 1/6 • Number of events 1 • From the time of study drug administration until 30 days following discontinuation. (Max 143 days)
Nervous system disorders Dysgeusia	16.7% 1/6 • Number of events 1 • From the time of study drug administration until 30 days following discontinuation. (Max 143 days)	0.00% 0/6 • From the time of study drug administration until 30 days following discontinuation. (Max 143 days)
General disorders Fatigue	16.7% 1/6 • Number of events 1 • From the time of study drug administration until 30 days following discontinuation. (Max 143 days)	33.3% 2/6 • Number of events 2 • From the time of study drug administration until 30 days following discontinuation. (Max 143 days)
Investigations Neutrophil count decreased	50.0% 3/6 • Number of events 3 • From the time of study drug administration until 30 days following discontinuation. (Max 143 days)	66.7% 4/6 • Number of events 4 • From the time of study drug administration until 30 days following discontinuation. (Max 143 days)
Investigations Lymphocyte Count Decreased	0.00% 0/6 • From the time of study drug administration until 30 days following discontinuation. (Max 143 days)	16.7% 1/6 • Number of events 1 • From the time of study drug administration until 30 days following discontinuation. (Max 143 days)
Blood and lymphatic system disorders Anemia	16.7% 1/6 • Number of events 1 • From the time of study drug administration until 30 days following discontinuation. (Max 143 days)	33.3% 2/6 • Number of events 2 • From the time of study drug administration until 30 days following discontinuation. (Max 143 days)
Investigations Platelet Count Decreased	16.7% 1/6 • Number of events 1 • From the time of study drug administration until 30 days following discontinuation. (Max 143 days)	66.7% 4/6 • Number of events 4 • From the time of study drug administration until 30 days following discontinuation. (Max 143 days)
Gastrointestinal disorders Abdominal Pain	33.3% 2/6 • Number of events 2 • From the time of study drug administration until 30 days following discontinuation. (Max 143 days)	16.7% 1/6 • Number of events 1 • From the time of study drug administration until 30 days following discontinuation. (Max 143 days)
General disorders Edema limbs	16.7% 1/6 • Number of events 1 • From the time of study drug administration until 30 days following discontinuation. (Max 143 days)	16.7% 1/6 • Number of events 1 • From the time of study drug administration until 30 days following discontinuation. (Max 143 days)
Injury, poisoning and procedural complications Fracture	16.7% 1/6 • Number of events 1 • From the time of study drug administration until 30 days following discontinuation. (Max 143 days)	0.00% 0/6 • From the time of study drug administration until 30 days following discontinuation. (Max 143 days)
Gastrointestinal disorders Nausea	33.3% 2/6 • Number of events 2 • From the time of study drug administration until 30 days following discontinuation. (Max 143 days)	16.7% 1/6 • Number of events 1 • From the time of study drug administration until 30 days following discontinuation. (Max 143 days)
Gastrointestinal disorders Vomiting	33.3% 2/6 • Number of events 2 • From the time of study drug administration until 30 days following discontinuation. (Max 143 days)	0.00% 0/6 • From the time of study drug administration until 30 days following discontinuation. (Max 143 days)
Skin and subcutaneous tissue disorders Pruritis	16.7% 1/6 • Number of events 1 • From the time of study drug administration until 30 days following discontinuation. (Max 143 days)	0.00% 0/6 • From the time of study drug administration until 30 days following discontinuation. (Max 143 days)
Skin and subcutaneous tissue disorders Rash maculo-papular	33.3% 2/6 • Number of events 2 • From the time of study drug administration until 30 days following discontinuation. (Max 143 days)	0.00% 0/6 • From the time of study drug administration until 30 days following discontinuation. (Max 143 days)
Gastrointestinal disorders Mucositis oral	16.7% 1/6 • Number of events 1 • From the time of study drug administration until 30 days following discontinuation. (Max 143 days)	33.3% 2/6 • Number of events 2 • From the time of study drug administration until 30 days following discontinuation. (Max 143 days)
Respiratory, thoracic and mediastinal disorders Epistaxis	16.7% 1/6 • Number of events 1 • From the time of study drug administration until 30 days following discontinuation. (Max 143 days)	0.00% 0/6 • From the time of study drug administration until 30 days following discontinuation. (Max 143 days)
Investigations Weight Loss	16.7% 1/6 • Number of events 1 • From the time of study drug administration until 30 days following discontinuation. (Max 143 days)	16.7% 1/6 • Number of events 1 • From the time of study drug administration until 30 days following discontinuation. (Max 143 days)
Gastrointestinal disorders Anal Hemorrhage	16.7% 1/6 • Number of events 1 • From the time of study drug administration until 30 days following discontinuation. (Max 143 days)	0.00% 0/6 • From the time of study drug administration until 30 days following discontinuation. (Max 143 days)
Renal and urinary disorders Urinary Frequency	16.7% 1/6 • Number of events 1 • From the time of study drug administration until 30 days following discontinuation. (Max 143 days)	0.00% 0/6 • From the time of study drug administration until 30 days following discontinuation. (Max 143 days)
Renal and urinary disorders Acute Kidney Injury	16.7% 1/6 • Number of events 1 • From the time of study drug administration until 30 days following discontinuation. (Max 143 days)	33.3% 2/6 • Number of events 2 • From the time of study drug administration until 30 days following discontinuation. (Max 143 days)
Respiratory, thoracic and mediastinal disorders Allergic Rhinitis	0.00% 0/6 • From the time of study drug administration until 30 days following discontinuation. (Max 143 days)	16.7% 1/6 • Number of events 1 • From the time of study drug administration until 30 days following discontinuation. (Max 143 days)
Metabolism and nutrition disorders Hypophosphatemia	0.00% 0/6 • From the time of study drug administration until 30 days following discontinuation. (Max 143 days)	16.7% 1/6 • Number of events 1 • From the time of study drug administration until 30 days following discontinuation. (Max 143 days)
Investigations Aspartate aminotransferase increased	0.00% 0/6 • From the time of study drug administration until 30 days following discontinuation. (Max 143 days)	16.7% 1/6 • Number of events 1 • From the time of study drug administration until 30 days following discontinuation. (Max 143 days)
Musculoskeletal and connective tissue disorders Chest wall pain	0.00% 0/6 • From the time of study drug administration until 30 days following discontinuation. (Max 143 days)	16.7% 1/6 • Number of events 1 • From the time of study drug administration until 30 days following discontinuation. (Max 143 days)
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/6 • From the time of study drug administration until 30 days following discontinuation. (Max 143 days)	16.7% 1/6 • Number of events 1 • From the time of study drug administration until 30 days following discontinuation. (Max 143 days)
General disorders Fever	0.00% 0/6 • From the time of study drug administration until 30 days following discontinuation. (Max 143 days)	33.3% 2/6 • Number of events 2 • From the time of study drug administration until 30 days following discontinuation. (Max 143 days)
Metabolism and nutrition disorders Dehydration	0.00% 0/6 • From the time of study drug administration until 30 days following discontinuation. (Max 143 days)	16.7% 1/6 • Number of events 1 • From the time of study drug administration until 30 days following discontinuation. (Max 143 days)
Metabolism and nutrition disorders Hyperglycemia	0.00% 0/6 • From the time of study drug administration until 30 days following discontinuation. (Max 143 days)	16.7% 1/6 • Number of events 1 • From the time of study drug administration until 30 days following discontinuation. (Max 143 days)
Metabolism and nutrition disorders Hyperkalemia	0.00% 0/6 • From the time of study drug administration until 30 days following discontinuation. (Max 143 days)	16.7% 1/6 • Number of events 1 • From the time of study drug administration until 30 days following discontinuation. (Max 143 days)
Infections and infestations Infections and infestations - Other, specify	0.00% 0/6 • From the time of study drug administration until 30 days following discontinuation. (Max 143 days)	16.7% 1/6 • Number of events 1 • From the time of study drug administration until 30 days following discontinuation. (Max 143 days)
Cardiac disorders Sinus tachycardia	0.00% 0/6 • From the time of study drug administration until 30 days following discontinuation. (Max 143 days)	16.7% 1/6 • Number of events 1 • From the time of study drug administration until 30 days following discontinuation. (Max 143 days)