Ribociclib (LEE011) in Preoperative Glioma and Meningioma Patients

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Nader Sanai
Study ID
NCT02933736
Phase
EARLY_PHASE1
Status
Active Not Recruiting

Conditions

  • Glioblastoma Multiforme
  • Meningioma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

In the proposed trial, patients will be administered ribociclib prior to surgical resection of their tumor. Patients will be enrolled in time-intervals sequentially (non-randomized). All patients will be orally-administered 5 doses of LEE011 (900 mg/d) with the final dose occurring at one of 3 intervals before brain tumor resection.

Key Dates

Start date
Oct 17, 2016
Status verified
Mar 2026
Primary completion
Mar 1, 2023
Completion
Mar 31, 2027

Study Design

Enrollment
48 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Administration of ribociclib
    Subjects will be administered ribociclib prior to surgical resection of their tumor. All patients will be orally-administered 5 doses of LEE011 (900 mg/d) with the final dose occurring at one of 3 following intervals before brain tumor resection: Cohort 1: last ribociclib dose 2-4 hours prior to craniotomy for tumor resection Cohort 2: last ribociclib dose 6-8 hours prior to craniotomy for tumor resection Cohort 3: last ribociclib dose 23-25 hours prior to craniotomy for tumor resection

Primary Outcome Measure

Plasma Exposure [ Time Frame: 0.5, 1, 2, 4, 6, 8, and 24 hours post-last 900 mg dosing ]

Locations (1)

FacilityCityStateZIPSite coordinators
Barrow Brain and SpinePhoenixArizona85013-

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By research site
Barrow Brain and Spine· Phoenix, AZ

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