Safety and Efficacy of RAD001 in Participants With Mantle Cell Lymphoma Who Are Refractory or Intolerant to Velcade® Therapy
PILLAR-1
An Open-Label, Single-Arm, Phase II Study of RAD001 in Patients With Mantle Cell Lymphoma Who Are Refractory or Intolerant to Velcade® (Bortezomib)
2 other identifiers
interventional
58
1 country
31
Brief Summary
This study was to evaluate the safety and efficacy of a daily, oral dose of 10 mg RAD001 in participants with Mantle Cell Lymphoma who were refractory or intolerant to Velcade® therapy and who had received at least one prior antineoplastic agent other than Velcade®, either separately or in combination with Velcade® (see inclusion criteria). Intolerance to Velcade® therapy was determined by the study investigator based on clinical evaluations. Participants were considered refractory to Velcade® if they have documented radiological progression on or within 12 months of the last dose of Velcade® when given alone or, on or within 12 months of the last dose of the last component of a combination therapy which included Velcade®.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Aug 2008
Typical duration for phase_2
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 19, 2008
CompletedFirst Posted
Study publicly available on registry
June 20, 2008
CompletedStudy Start
First participant enrolled
August 22, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 20, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
April 20, 2012
CompletedResults Posted
Study results publicly available
May 25, 2021
CompletedMay 25, 2021
April 1, 2021
3.7 years
June 19, 2008
April 30, 2021
April 30, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Response Rate (ORR)
Overall response rate was defined as the percentage of participants with a best overall disease response of complete response (CR) or partial response (PR). CR was defined as complete disappearance of all extranodal lesions. PR was defined as at least a 50% decrease in the sum of the product of diameter (SPD) of all index nodal and extranodal lesions.
From date of enrollment up to disease progression or death (approximately 3.8 years)
Secondary Outcomes (5)
Disease Control Rate (DCR)
From date of start of treatment up to disease progression or death (approximately up to 3.8 years)
Duration of Response
From date of start of treatment up to disease progression or death (approximately up to 3.8 years)
Progression Free Survival (PFS)
From date of start of treatment up to disease progression or death (approximately up to 3.8 years)
Overall Survival
From date of start of treatment up to disease progression or death (approximately up to 3.8 years)
Number of Participants With At Least One Adverse Event (AE) and Serious Adverse Event (SAE)
From the start of the study and 28 days after study drug discontinuation (approximately up to 18 months)
Study Arms (1)
Everolimus
EXPERIMENTALParticipants received everolimus tablets, 10 mg, orally, once daily during each 28 day cycle until determination of objective tumor progression or unacceptable toxicity, or death, or consent withdrawal, or discontinuation from the study for any other reason.
Interventions
Eligibility Criteria
You may qualify if:
- Adult participants (≥18 years old) with Mantle Cell Lymphoma that has been confirmed by central pathology review (archival diagnostic tumor specimen required).
- Participants with mantle cell lymphoma who have documented refractory disease to Velcade® (bortezomib) or who have documented intolerance to Velcade® therapy. Intolerance to Velcade® is determined by the study investigator based on clinical evaluations. Participants are considered refractory to Velcade® if they have documented radiological progression on or within 12 months of last dose of Velcade® when given alone or, on or within 12 months from the last dose of the last component of a combination therapy which included Velcade®. Participants are considered refractory to Velcade®, if Velcade® is part of a combination treatment for the disease.
- Participants must have received at least one prior antineoplastic agent, other than Velcade® either separately or in combination with Velcade® (bortezomib).
- At least one site of measurable nodal disease at baseline \>2.0 cm in the longest transverse diameter and clearly measurable in at least two perpendicular dimensions, as determined by computer tomography (CT) scan (or magnetic resonance imaging (MRI), only if CT scan can not be performed).
- Eastern Cooperative Oncology Group (ECOG) performance status = 0, 1 or 2.
- Life expectancy ≥3 months.
- Adequate bone marrow, liver and renal function.
- Platelets ≥75 x 10\^9/L (untransfused platelets).
You may not qualify if:
- Participants who are currently receiving anticancer therapies or have received anticancer therapies within 4 weeks of the start of study drug (including chemotherapy, radiation, antibodies, targeted therapy etc.) are not eligible.
- Previous treatment with mammalian target of rapamycin (mTOR) inhibitors (e.g. everolimus, sirolimus, temsirolimus, etc).
- Participants with prior allogeneic stem cell transplant.
- Grade 3 or 4 unresolved toxicity from prior antineoplastic therapies.
- Currently taking other investigational agents or received other investigational drugs within 4 weeks of the start of study drug.
- Participants with central nervous system (CNS) lymphoma are not eligible; head magnetic resonance imaging (MRI) (or computer tomography (CT) if MRI is not available) is required prior to study entry.
- Use of chronic, systemic corticosteroids or another immunosuppressive agent, except prednisone ≤20 mg daily (or equivalent) for adrenal insufficiency (must have been on a stable dosage regimen for ≥4 weeks prior to the first treatment with RAD001).
- HIV positive participants are not eligible; (human immunodeficiency virus (HIV) testing is not required for study entry; review of previous medical records is required).
- Uncontrolled hyperlipidemia (≥Grade 3 hyperlipidemia despite optimal supportive medical therapy).
- Active, bleeding disorders or major surgery within 4 weeks of starting study drug.
- Severe and/or uncontrolled medical conditions such as symptomatic congestive heart failure (New York Heart Association Class III or IV), unstable angina, myocardial infarction within 6 months or study start, severely impaired lung function, cirrhosis, chronic active/persistent hepatitis.
- History of another primary malignancy ≤3 years prior to study entry.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (31)
Mayo Clinic - Arizona Mayo Clinic - Scottsdale
Multiple Locations, Arizona, 85259, United States
Highlands Oncology Group DeptofHighlandsOncologyGrp(2)
Fayetteville, Arkansas, 72703, United States
Bay Area Cancer Research Dept.ofBayAreaCancerResearch
Concord, California, 94520, United States
City of Hope National Medical Center Dept.ofCityofHopeMedicalCtr(1)
Duarte, California, 91010-3000, United States
UCLA/ University of California Los Angeles Dept.of Hem/Oncology
Los Angeles, California, 90095, United States
University of California Davis Cancer Center Dept. of UC Davis Cancer (4)
Sacramento, California, 95817, United States
Rocky Mountain Cancer Centers RMCC - Denver-Midtown
Greenwood Village, Colorado, 80121, United States
Advanced Medical Specialties Medical Onc Hem
Miami, Florida, 33176, United States
Georgia Health Sciences University Dept. of MCG
Augusta, Georgia, 30912, United States
Northwestern University
Chicago, Illinois, 60611, United States
St. Francis Cancer Research Foundation Dept.ofSt.FrancisCancerRes.(2)
Beech Grove, Indiana, 46107, United States
Central Indiana Cancer Centers CICC - East (2)
Indianapolis, Indiana, 46227, United States
University of Michigan Comprehensive Cancer Center Dept of Michigan Cancer Center
Ann Arbor, Michigan, 48109-0944, United States
Mayo Clinic - Rochester Hematology
Rochester, Minnesota, 55905, United States
Washington University School Of Medicine-Siteman Cancer Ctr Medical Oncology
St Louis, Missouri, 63110, United States
Hackensack University Medical Center Dept ofHackensackUniversityMC
Hackensack, New Jersey, 07601, United States
New York University Medical Center NYU Cancer Institute
New York, New York, 10016, United States
East Carolina University BrodySchool of Medicine
Greenville, North Carolina, 27858, United States
Northwest Cancer Specialists Vancouver Cancer Center (2)
Portland, Oregon, 97210, United States
Kaiser Permanente Northwest Dept of Kaiser Northwest (3)
Portland, Oregon, 97227, United States
Fox Chase Cancer Center Regulatory Contact
Philadelphia, Pennsylvania, 19111-2497, United States
Western Pennsylvania Cancer Institute /Western Penn Hospital Western Pann. Cancer Inst.
Pittsburgh, Pennsylvania, 15224, United States
University of Pittsburgh Medical Center Hillman Cancer Center (4)
Pittsburgh, Pennsylvania, 15232, United States
Cancer Centers of the Carolinas CC of C -Eastside
Greenville, South Carolina, 29605, United States
Vanderbilt University Medical Center, Clinical Trials Center Dept. of VUMC
Nashville, Tennessee, 37212, United States
Baylor College of Medicine Dept. of Sammons Cancer (2)
Dallas, Texas, 75246, United States
University of Texas Southwestern Medical Center DeptofSimmons Cancer Center(2)
Dallas, Texas, 75390-8527, United States
MD Anderson Cancer Center/University of Texas Dept. of MD Anderson (10)
Houston, Texas, 77030-4009, United States
Tyler Cancer Center Dept.ofTylerCancerCtr.
Tyler, Texas, 75702, United States
Cancer Care Northwest CC Northwest- Spokane South(3)
Spokane, Washington, 99202, United States
West Virginia University/ Mary Babb Randolph Cancer Center
Morgantown, West Virginia, 26506, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Novartis Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 19, 2008
First Posted
June 20, 2008
Study Start
August 22, 2008
Primary Completion
April 20, 2012
Study Completion
April 20, 2012
Last Updated
May 25, 2021
Results First Posted
May 25, 2021
Record last verified: 2021-04