|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Collaborator: |
Novartis Pharmaceuticals |
| Information provided by: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00449748 |
Purpose
The goal of this clinical research study is to see if RAD001 can help to control the disease in patients with systemic mastocytosis (SM). The safety of this treatment will also be studied.
| Condition | Intervention | Phase |
|---|---|---|
|
Systemic Mastocytosis |
Drug: RAD001 (Everolimus) |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Evaluation of RAD001 as Therapy for Patients With Systemic Mastocytosis |
| Enrollment: | 10 |
| Study Start Date: | April 2007 |
| Study Completion Date: | October 2009 |
| Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: RAD001
Oral 10 mg daily for 30 days
|
Drug: RAD001 (Everolimus)
Oral RAD001 10 mg daily for 30 days
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Texas | |
| The University of Texas M.D. Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | Srdan Verstovsek, MD | M.D. Anderson Cancer Center |
More Information
| Responsible Party: | Srdan Verstovsek, M.D./Associate Professor, The University of Texas M. D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00449748 History of Changes |
| Other Study ID Numbers: | 2006-0759 |
| Study First Received: | March 19, 2007 |
| Results First Received: | April 4, 2011 |
| Last Updated: | April 4, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
Systemic Mastocytosis RAD001 |
|
Mastocytosis Urticaria Pigmentosa Mastocytoma Mastocytosis, Systemic Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms Skin Diseases Mastocytosis, Cutaneous Pigmentation Disorders Everolimus |
Sirolimus Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Antifungal Agents Anti-Infective Agents Anti-Bacterial Agents |