Phase 2 N=10 Treatment

Everolimus (RAD001) as Therapy for Patients With Systemic Mastocytosis

Systemic Mastocytosis

Bottom Line

View on ClinicalTrials.gov: NCT00449748 ↗

Enrolled (actual)

Serious AEs

20.0%

Results posted

Apr 2011

Primary outcome: Primary: Number of Participants With Objective Response — 0 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: RAD001 (Everolimus) (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: M.D. Anderson Cancer Center
Primary completion: Oct 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Objective Response	—	—

Summary

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.

Eligibility Criteria

Inclusion Criteria

Patients with SM; including mast cell leukemia.
Age >/= 18 years
Minimum of two weeks since any major surgery or completion of radiation.
Eastern Cooperative Oncology Group (ECOG) performance status 40 mIU/m or 6 weeks post-surgical bilateral oophorectomy with or without hysterectomy)
Patients who have received prior treatment with an mTOR inhibitor (e.g., sirolimus, temsirolimus)
Patients with a known hypersensitivity to RAD001 (everolimus) or other rapamycins (sirolimus, temsirolimus) or to its excipients
Patients unwilling to or unable to comply with the protocol

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00449748). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.