Clinical Trial: Safety and Efficacy of RAD001 in Patients With Mantle Cell Lymphoma Who Are Refractory or Intolerant to Velcade® Therapy.

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: An Open-label, Single-arm Phase II Study of RAD001 in Patients With Mantle Cell Lymphoma Who Are Refractory or Intolerant to Velcade® (Bortezomib).

Brief Summary: This study is to evaluate the safety and efficacy of a daily, oral dose of 10 mg RAD001 in patients with Mantle Cell Lymphoma who are refractory or intolerant to Velcade® therapy and who have received at least one prior antineoplastic agent other than Velcade®, either separately or in combination with Velcade® (see inclusion criteria). Intolerance to Velcade® therapy is determined by the study investigator based on clinical evaluations. Patients are 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®.

Detailed Summary:
Sponsor: Novartis Pharmaceuticals

Current Primary Outcome:

  • Overall response rate [ Time Frame: at the end of the study ]
  • Overall response rate to single-agent treatment with RAD001 in patients with mantle cell lymphoma who are refractory or intolerant to Velcade® therapy. [ Time Frame: at the end of the study ]


Original Primary Outcome: Objective response rate to single-agent treatment with RAD001 in patients with refractory mantle cell lymphoma.

Current Secondary Outcome:

  • Duration of Response [ Time Frame: at the end of the study ]
  • Progression Free Survival [ Time Frame: at the end of the study ]
  • Overall Survival [ Time Frame: at the end of the study ]
  • Safety and tolerability of 10 mg daily RAD001 single-agent therapy [ Time Frame: at the end of the study ]
  • Duration of Response • Progression Free Survival • Overall Survival • Safety and tolerability of 10 mg daily RAD001 single-agent therapy [ Time Frame: at the end of the study ]


Original Secondary Outcome: Duration of Response • Progression Free Survival • Overall Survival • Safety and tolerability of 10 mg daily RAD001 single-agent therapy

Information By: Novartis

Dates:
Date Received: June 19, 2008
Date Started: August 2008
Date Completion:
Last Updated: May 10, 2013
Last Verified: May 2013