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NCT01591577 · ClinicalTrials.gov registry record · Phase 2
Lapatinib With Temozolomide and Regional Radiation Therapy for Patients With Newly-Diagnosed Glioblastoma Multiforme
A Phase 2 study of Newly Diagnosed Glioblastoma Multiforme, sponsored by Jonsson Comprehensive Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 50
- Enrollment target
- 1
- Study location
NCT01591577: Completed Phase 2 study of Newly Diagnosed Glioblastoma Multiforme, sponsored by Jonsson Comprehensive Cancer Center.
NCT01591577 is a Phase 2 study of Newly Diagnosed Glioblastoma Multiforme that has completed, run by Jonsson Comprehensive Cancer Center. The registered enrollment target is 50 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01591577, a Phase 2 study of Newly Diagnosed Glioblastoma Multiforme, has completed, sponsored by Jonsson Comprehensive Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 50 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to test the safety and effects of a combination of a study drug, Lapatinib, plus the administration of standard radiation therapy and an FDA approved drug Temozolomide (chemotherapy agent) in patients with newly diagnozed glioblastoma Multiforme.Currently, only radiation therapy and Temozolomide chemotherapy are standard treatment for brain cancer.Lapatinib has not been FDA approved for use in brain tumors treatment. It has been approved to be used as a daily treatment with other chemotherapies by the FDA for the treatment of advanced breast cancer. The purpose of this study is to find the answers to the following research questions: 1. Is Lapatinib given twice a week at higher dosages, with radiation therapy and Temozolomide, safe when given to patients with brain tumor? 2. What are the side effects of Lapatinib given twice a week at higher dosages when given with radiation therapy and Temozolomide and how often do they occur? 3. Can Lapatinib, radiation, and Temozolomide be effective in shrinking tumors when given to patients with brain tumors? 4. To determine whether the presence of genetic alterations specific proteins in the tumor samples can predict whether this study drug is effective on the tumor.
Primary Outcome
The primary objective is to estimate the overall survival in subjects with newly-diagnosed glioblastoma treated with lapatinib/temozolomide/radiation followed by lapatinib/temozolomide for 2 years or until progression is detected. If no progression is seen at 2 years, then single-agent lapatinib will be continued until progression.
Conditions Studied
Interventions
- OTHER Lapatinib/Temozolomide/radiation
Study Locations (1)
California
- UCLA - Los Angeles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2012-12-07 |
| Est. Completion | 2024-05-07 |
| Phase | Phase 2 |
What the finished NCT01591577 record still lists
NCT01591577 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% lower).
The record links to 1 condition, with Newly Diagnosed Glioblastoma Multiforme appearing as the primary indexed condition, and to 1 intervention - of which Lapatinib/Temozolomide/radiation is the first listed.
NCT01591577 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT01591577 about?
NCT01591577 is a clinical study titled "Lapatinib With Temozolomide and Regional Radiation Therapy for Patients With Newly-Diagnosed Glioblastoma Multiforme". The purpose of this study is to test the safety and effects of a combination of a study drug, Lapatinib, plus the administration of standard radiation therapy and an FDA approved drug Temozolomide (chemotherapy agent) in patients with newly diagnozed glioblastoma Multiforme.Currently, only radiation...
What is the current status of trial NCT01591577?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 50 participants. The study started on 2012-12-07. Estimated completion is 2024-05-07.
What conditions does trial NCT01591577 study?
This clinical trial studies the following conditions: Newly Diagnosed Glioblastoma Multiforme.
What interventions are being tested in trial NCT01591577?
The interventions under investigation include: Lapatinib/Temozolomide/radiation (OTHER).
Who is sponsoring clinical trial NCT01591577?
This trial is sponsored by Jonsson Comprehensive Cancer Center, which has 321 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01591577 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01591577's enrollment target sits among peer trials
50 1195th of 2000 higher than 740 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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