A Phase I Dose Escalation Study of RAD001 Administered in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma

Phase 1

Completed

• Conditions: Non-Hodgkin's Lymphoma
• Interventions: Drug: Everolmus

• Registration Number: NCT00622258
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

This study assesses the tolerability, safety, efficacy and pharmacokinetics of everolimus in Japanese patients. Everolimus is administered orally everyday to adult patients with relapsed or refractory non-Hodgkin's lymphoma who have progressed despite standard therapy or for whom standard systemic therapy dose not exist.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-02-12
• Study First Submitted QC: 2008-02-12
• Study First Posted: 2008-02-22
• Study Start: 2008-03
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Status Verified: 2014-09
• Last Update Submitted: 2020-12-17
• Last Update Posted: 2020-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Everolimus	Everolmus	-

Primary Outcome Measures

Name	Time	Method
To assess the pharmacokinetics in Japanese patients	1st sycle
To assess the safety and tolerability of RAD001 in Japanese patients with relapsed or refractory non-Hodgkin's lymphoma	whole study period

Secondary Outcome Measures

Name	Time	Method
To seek preliminary evidence of efficacy in this population	Every 2 cycles

Trial Locations

Locations (1)

Novartis Investigative Site; 🇯🇵 Kyoto, Japan