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NCT02101905 · ClinicalTrials.gov registry record · Phase 1
Lapatinib Ditosylate Before Surgery in Treating Patients With Recurrent High-Grade Glioma
A Phase 1 study of Recurrent Glioblastoma and Gliosarcoma, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 29
- Enrollment target
- 12
- Study locations
NCT02101905: Completed Phase 1 study of Recurrent Glioblastoma and Gliosarcoma, sponsored by National Cancer Institute (NCI).
NCT02101905 is a Phase 1 study of Recurrent Glioblastoma and Gliosarcoma that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 29 participants, below the 68-participant average among 62 other Recurrent Glioblastoma trials with a reported enrollment target (57% lower). The trial reports 12 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02101905, a Phase 1 study of Recurrent Glioblastoma and Gliosarcoma, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 29 participants
- Enrollment target
- 12
- Study locations
Study Summary
This pilot phase I clinical trial studies how well lapatinib ditosylate before surgery works in treating patients with high-grade glioma that has come back after a period of time during which the tumor could not be detected. Lapatinib ditosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Primary Outcome
4 pk samples obtained: pretreatment, pre-surgery, post-surgery and interpolated pre-surgery each subject received 2500mg twice a day for two days.
Conditions Studied
Interventions
- OTHER Laboratory Biomarker Analysis
- PROCEDURE Therapeutic Conventional Surgery
- DRUG Lapatinib
- OTHER Pharmacological Study
- DRUG Lapatinib Ditosylate
Study Locations (12)
New York
- Memorial Sloan Kettering Commack - Commack
- Memorial Sloan Kettering Westchester - Harrison
- Memorial Sloan Kettering Cancer Center - New York
New Jersey
- Memorial Sloan Kettering Basking Ridge - Basking Ridge
- Memorial Sloan Kettering Monmouth - Middletown
California
- UCLA / Jonsson Comprehensive Cancer Center - Los Angeles
Maryland
- Johns Hopkins University/Sidney Kimmel Cancer Center - Baltimore
Massachusetts
- Dana-Farber Cancer Institute - Boston
Michigan
- Henry Ford Hospital - Detroit
North Carolina
- Wake Forest University Health Sciences - Winston-Salem
Ohio
- Cleveland Clinic Foundation - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2016-11-07 |
| Est. Completion | 2024-10-30 |
| Phase | Phase 1 |
What the finished NCT02101905 record still lists
NCT02101905 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 participants, a relatively small participant target, below the 68-participant average among 62 other Recurrent Glioblastoma trials with a reported enrollment target (57% lower).
The record links to 7 conditions, with Recurrent Glioblastoma appearing as the primary indexed condition, and to 5 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT02101905 lists 12 locations in 9 states (New York, New Jersey, California).
Frequently Asked Questions
What is clinical trial NCT02101905 about?
NCT02101905 is a clinical study titled "Lapatinib Ditosylate Before Surgery in Treating Patients With Recurrent High-Grade Glioma". This pilot phase I clinical trial studies how well lapatinib ditosylate before surgery works in treating patients with high-grade glioma that has come back after a period of time during which the tumor could not be detected. Lapatinib ditosylate may stop the growth of tumor cells by blocking some of...
What is the current status of trial NCT02101905?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 29 participants. The study started on 2016-11-07. Estimated completion is 2024-10-30.
What conditions does trial NCT02101905 study?
This clinical trial studies the following conditions: Recurrent Glioblastoma, Gliosarcoma, Anaplastic Astrocytoma, Anaplastic Oligodendroglioma, Anaplastic Ependymoma.
What interventions are being tested in trial NCT02101905?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Therapeutic Conventional Surgery (PROCEDURE), Lapatinib (DRUG), Pharmacological Study (OTHER), Lapatinib Ditosylate (DRUG).
Who is sponsoring clinical trial NCT02101905?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02101905 being conducted?
This trial has 12 study locations across California, Maryland, Massachusetts, Michigan, New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Recurrent Glioblastoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02101905's enrollment target sits among peer trials
29 36th of 62 higher than 27 of 62 other Recurrent Glioblastoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Recurrent Glioblastoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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