Safety and Efficacy of RAD001 in Participants With Mantle Cell Lymphoma Who Are Refractory or Intolerant to Velcade® Therapy

NCT ID: NCT00702052

Last Updated: 2021-05-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-08-22
• Study Completion Date: 2012-04-20

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®.

Conditions

Lymphoma, Mantle- Cell

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Everolimus

Participants 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.

Group Type: EXPERIMENTAL

Everolimus

Intervention Type: DRUG

Everolimus tablets

Interventions

Everolimus

Everolimus tablets

Intervention Type: DRUG

Other Intervention Names

RAD001

Eligibility Criteria

Inclusion Criteria

• 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).

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

Mayo Clinic - Arizona Mayo Clinic - Scottsdale

Multiple Locations, Arizona, United States

Highlands Oncology Group DeptofHighlandsOncologyGrp(2)

Fayetteville, Arkansas, United States

Bay Area Cancer Research Dept.ofBayAreaCancerResearch

Concord, California, United States

City of Hope National Medical Center Dept.ofCityofHopeMedicalCtr(1)

Duarte, California, United States

UCLA/ University of California Los Angeles Dept.of Hem/Oncology

Los Angeles, California, United States

University of California Davis Cancer Center Dept. of UC Davis Cancer (4)

Sacramento, California, United States

Rocky Mountain Cancer Centers RMCC - Denver-Midtown

Greenwood Village, Colorado, United States

Advanced Medical Specialties Medical Onc Hem

Miami, Florida, United States

Georgia Health Sciences University Dept. of MCG

Augusta, Georgia, United States

Northwestern University

Chicago, Illinois, United States

St. Francis Cancer Research Foundation Dept.ofSt.FrancisCancerRes.(2)

Beech Grove, Indiana, United States

Central Indiana Cancer Centers CICC - East (2)

Indianapolis, Indiana, United States

University of Michigan Comprehensive Cancer Center Dept of Michigan Cancer Center

Ann Arbor, Michigan, United States

Mayo Clinic - Rochester Hematology

Rochester, Minnesota, United States

Washington University School Of Medicine-Siteman Cancer Ctr Medical Oncology

St Louis, Missouri, United States

Hackensack University Medical Center Dept ofHackensackUniversityMC

Hackensack, New Jersey, United States

New York University Medical Center NYU Cancer Institute

New York, New York, United States

East Carolina University BrodySchool of Medicine

Greenville, North Carolina, United States

Northwest Cancer Specialists Vancouver Cancer Center (2)

Portland, Oregon, United States

Kaiser Permanente Northwest Dept of Kaiser Northwest (3)

Portland, Oregon, United States

Fox Chase Cancer Center Regulatory Contact

Philadelphia, Pennsylvania, United States

Western Pennsylvania Cancer Institute /Western Penn Hospital Western Pann. Cancer Inst.

Pittsburgh, Pennsylvania, United States

University of Pittsburgh Medical Center Hillman Cancer Center (4)

Pittsburgh, Pennsylvania, United States

Cancer Centers of the Carolinas CC of C -Eastside

Greenville, South Carolina, United States

Vanderbilt University Medical Center, Clinical Trials Center Dept. of VUMC

Nashville, Tennessee, United States

Baylor College of Medicine Dept. of Sammons Cancer (2)

Dallas, Texas, United States

University of Texas Southwestern Medical Center DeptofSimmons Cancer Center(2)

Dallas, Texas, United States

MD Anderson Cancer Center/University of Texas Dept. of MD Anderson (10)

Houston, Texas, United States

Tyler Cancer Center Dept.ofTylerCancerCtr.

Tyler, Texas, United States

Cancer Care Northwest CC Northwest- Spokane South(3)

Spokane, Washington, United States

West Virginia University/ Mary Babb Randolph Cancer Center

Morgantown, West Virginia, United States

Countries

United States

Other Identifiers

2007-005700-40

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CRAD001N2201

Identifier Type: -

Identifier Source: org_study_id