Everolimus (RAD001) as Therapy for Patients With Systemic Mastocytosis

Amendment history

1. Jun 16, 2026

   Minor

   5 amendments

   5 re-verifications since 2012-08-01, no change to tracked fields

   v9-v13

2. Apr 4, 2011

   Notable

   Results first posted: Apr 29, 2011

   Primary endpoint revised; Interventions: RAD001 (Drug) to RAD001 (Everolimus) (Drug); Eligibility criteria expanded, about 17 words; and 1 more

   Show all 5 changes in this update

   • Notable Results first posted: Apr 29, 2011
   • Notable Primary endpoint revised
     Show what changed

     PatientsNumber withof ImprovementParticipants inWith Objective Response over 30%
   • Minor Interventions: RAD001 (Drug) to RAD001 (Everolimus) (Drug)
   • Minor Eligibility criteria expanded, about 17 words
     Show what changed

     [...] o weeks since any major surgery or completion of radiation. Eastern Cooperative Oncology Group (ECOG) performance status </= 2 Adequate liver function as shown b [...] bilirubin </= 1.5 x upper limit of normal (ULN), and serum Alanine transaminase (ALT) </= 3 x ULN Prothrombin Time (PT)/Partial thromboplastin time (PTT)/International normalized ratio (INR) within normal institutional limits Signed informed consent [...] sease, active upper GI tract ulceration) A known history of Human immunodeficiency virus (HIV) seropositivity Impairment of gastrointestinal function or g [...]
   • Minor Study description expanded, about 2 words
     Show what changed

     [...] the screening tests, you will have an electrocardiogram (ECG -- )a test that measures the electrical activity of the heart). [...] off study. This is an investigational study. RAD001 is not Food and Drug Administration (FDA) approved or commercially available. It has been authorized [...]

   Study Status, Study Description, Arms and Interventions, Outcome Measures, Eligibility, Participant Flow, Baseline Characteristics, Outcome Measures (Results), Adverse Events, More Information · v8

3. Oct 23, 2009

   Notable

   Primary endpoint revised

   Trial status: Active, Not Recruiting to Completed; Enrollment target: estimated 25 to confirmed 10; Primary and study completion dates changed from estimate of Apr 2010 to Oct 2009; and 1 more

   Show all 5 changes in this update

   • Notable Primary endpoint revised
     Show what changed

     ToPatients studywith ifImprovement RAD001in canObjective helpResponse controlover Systemic Mastocytosis (SM).30%
   • Minor Trial status: Active, Not Recruiting to Completed
   • Minor Enrollment target: estimated 25 to confirmed 10
   • Minor Primary and study completion dates changed from estimate of Apr 2010 to Oct 2009
   • Minor Secondary endpoints shortened, about 9 words
     Show what changed

     To study the safety of RAD001 in SM patients.

   Study Status, Study Design, Arms and Interventions, Outcome Measures · v7

4. May 1, 2009

   Notable

   Primary and study completion dates: Apr 2009 to Apr 2010

   Trial status: Recruiting to Active, Not Recruiting; Eligibility criteria expanded, about 2 words; Site details revised

   Show what changed: Eligibility criteria

   Inclusion Criteria: Patients with SM; including mast cell leukemia. Age >/= 18 [...] ormal institutional limits Signed informed consent Exclusion Criteria: Treatment with any conventional (specifically, interferon [...]

   Study Status, Eligibility, Contacts/Locations · v6

5. Nov 21, 2008

   Notable

   Primary endpoint revised

   Primary completion date: Apr 2009; Eligibility criteria shortened, about 2 words; Secondary endpoint revised; and 3 more

   Show all 7 changes in this update

   • Notable Primary endpoint revised
     Show what changed

     To assessstudy the response rate ofif RAD001 incan patientshelp withcontrol Systemic Mastocytosis (SM).
   • Minor Primary completion date: Apr 2009
   • Minor Eligibility criteria shortened, about 2 words
     Show what changed

     Inclusion Criteria: Patients with SM; including mast cell leukemia. Age >/= 18 years Minimum of two weeks since any major surge [...] ormal institutional limits Signed informed consent Exclusion Criteria: Treatment with any conventional (specifically, interferon [...] d unwilling to practice an effective method of birth control. Women (women of childbearing potential must have a negative urine or ser [...] nancy test within 48 hours prior to administration of RAD001. Protocol; protocol definition of post-menopausal women is: 12 months of natura [...] amenorrhea with serum FSH levels > 40 mIU/m or 6 weeks post-surgical [...] [...]
   • Minor Secondary endpoint revised
     Show what changed

     To assessstudy the safety of RAD001 in SM patients.
   • Minor Study description shortened, about 19 words
     Show what changed

     [...] available. It has been authorized for use in research only. While you are on study, the study sponsor will supply the RAD001 at no cost to you. Up to 25 patients will take part in this study. All will be enrolled at M.D. Anderson.
   • Minor Collaborator revised
     Show what changed

     Novartis Pharmaceuticals
   • Minor Study title expanded, about 1 word
     Show what changed

     Everolimus (RAD001) as Therapy for Patients With Systemic Mastocytosis

   Study Identification, Study Status, Sponsor/Collaborators, Study Description, Arms and Interventions, Outcome Measures, Eligibility · v5

9. Mar 20, 2007

   Minor

   Study First Submitted

• Stopped: an ongoing trial was terminated, suspended or withdrawn.
• Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
• Minor: routine progress and housekeeping, such as sites added or enrollment closed.