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

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

An Open-Label, Single-Arm, Phase II Study of RAD001 in Patients With Mantle Cell Lymphoma Who Are Refractory or Intolerant to Velcade® (Bortezomib)

NCT00702052•Novartis Pharmaceuticals

View on ClinicalTrials.gov

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®.

Eligibility

Age

18 - 90 years

Sex

ALL

Healthy Volunteers

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

•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.
•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).
•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.

Locations (31)

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

Key Dates

Start Date

August 22, 2008

Primary Completion Date

April 20, 2012

Completion Date

April 20, 2012

Last Updated

May 25, 2021

Enrollment

ACTUAL participants

Conditions

Lymphoma, Mantle- Cell

Interventions

Everolimus

DRUG