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Farnesyltransferase Inhibitor
Lonafarnib for Gliosarcoma
Phase 1
Waitlist Available
Led By John de Groot
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 11 years
Awards & highlights
Study Summary
This trial is testing the side effects and best dose of lonafarnib when given with temozolomide to see if it can help treat patients with glioblastoma multiforme.
Eligible Conditions
- Gliosarcoma
- Neoplasms
- Glioblastoma
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 11 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 11 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Temozolomide
Tolerability of regimen in patients with disease progression or recurrence during or after recent completion of treatment with temozolomide
Secondary outcome measures
Objective response
Overall survival
Progression free survival (PFS)
+1 moreSide effects data
From 2009 Phase 2 trial • 29 Patients • NCT0042560711%
Stroke
7%
Vomiting
4%
Bacterial infection
4%
Subdural hematoma
4%
Extremity-lower (gait/walking)
4%
Neuropathy: Sensory
4%
Hypokalemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Lonafarnib
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (temozolomide and lonafarnib)Experimental Treatment2 Interventions
Patients receive temozolomide PO QD on days 1-7 and 15-21 and lonafarnib PO BID on days 8-14 and 22-28. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Temozolomide
2010
Completed Phase 3
~1930
Lonafarnib
2003
Completed Phase 3
~720
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,658 Previous Clinical Trials
40,924,454 Total Patients Enrolled
142 Trials studying Gliosarcoma
10,790 Patients Enrolled for Gliosarcoma
M.D. Anderson Cancer CenterLead Sponsor
2,971 Previous Clinical Trials
1,787,181 Total Patients Enrolled
13 Trials studying Gliosarcoma
666 Patients Enrolled for Gliosarcoma
John de GrootPrincipal InvestigatorM.D. Anderson Cancer Center
Frequently Asked Questions
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