Phase 2
Completed N=10
Everolimus (RAD001) as Therapy for Patients With Systemic Mastocytosis
Systemic Mastocytosis
Source: ClinicalTrials.gov NCT00449748 ↗
Enrolled (actual)
10
Serious AEs
20.0%
Results posted
Apr 2011
Primary outcomePrimary: Number of Participants With Objective Response — 0 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Objective Response |
— | — |
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
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. Informational only — not medical advice.