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NCT01849146 · ClinicalTrials.gov registry record · Phase 1
Adavosertib, Radiation Therapy, and Temozolomide in Treating Patients With Newly Diagnosed or Recurrent Glioblastoma
A Phase 1 study of Glioblastoma and Recurrent Glioblastoma, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 74
- Enrollment target
- 12
- Study locations
NCT01849146: Completed Phase 1 study of Glioblastoma and Recurrent Glioblastoma, sponsored by National Cancer Institute (NCI).
NCT01849146 is a Phase 1 study of Glioblastoma and Recurrent Glioblastoma that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 74 participants, below the 109-participant average among 199 other Glioblastoma trials with a reported enrollment target (32% lower). The trial reports 12 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01849146, a Phase 1 study of Glioblastoma and Recurrent Glioblastoma, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 74 participants
- Enrollment target
- 12
- Study locations
Study Summary
This phase I trial studies the side effects and best dose of adavosertib when given together with radiation therapy and temozolomide in treating patients with glioblastoma that is newly diagnosed or has come back. Adavosertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving adavosertib, radiation therapy, and temozolomide may work better in treating patients with newly diagnosed or recurrent glioblastoma compared to radiation therapy and temozolomide alone.
Primary Outcome
Will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. Severity and frequency of toxicity will be tabulated by the tested dose or doses using descriptive statistics. The proportion of subjects who experience grade 3 or above toxicities will be estimated, along with 95% confidence intervals by each type of toxicity.
Conditions Studied
Interventions
- RADIATION Radiation Therapy
- DRUG Temozolomide
- DRUG Adavosertib
Study Locations (12)
California
- UCLA / Jonsson Comprehensive Cancer Center - Los Angeles
- UCSF Medical Center-Parnassus - San Francisco
Massachusetts
- Massachusetts General Hospital Cancer Center - Boston
- Dana-Farber Cancer Institute - Boston
Pennsylvania
- University of Pennsylvania/Abramson Cancer Center - Philadelphia
- University of Pittsburgh Cancer Institute (UPCI) - Pittsburgh
Alabama
- University of Alabama at Birmingham Cancer Center - Birmingham
Maryland
- Johns Hopkins University/Sidney Kimmel Cancer Center - Baltimore
Michigan
- Henry Ford Hospital - Detroit
New York
- Memorial Sloan Kettering Cancer Center - New York
North Carolina
- Wake Forest University Health Sciences - Winston-Salem
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 74 participants |
| Start Date | 2013-10-24 |
| Est. Completion | 2024-10-30 |
| Phase | Phase 1 |
What the finished NCT01849146 record still lists
NCT01849146 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 74 participants, a relatively small participant target, below the 109-participant average among 199 other Glioblastoma trials with a reported enrollment target (32% lower).
The record links to 2 conditions, with Glioblastoma appearing as the primary indexed condition, and to 3 interventions - of which Radiation Therapy is the first listed.
NCT01849146 lists 12 locations in 9 states (California, Massachusetts, Pennsylvania).
Frequently Asked Questions
What is clinical trial NCT01849146 about?
NCT01849146 is a clinical study titled "Adavosertib, Radiation Therapy, and Temozolomide in Treating Patients With Newly Diagnosed or Recurrent Glioblastoma". This phase I trial studies the side effects and best dose of adavosertib when given together with radiation therapy and temozolomide in treating patients with glioblastoma that is newly diagnosed or has come back. Adavosertib may stop the growth of tumor cells by blocking some of the enzymes needed ...
What is the current status of trial NCT01849146?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 74 participants. The study started on 2013-10-24. Estimated completion is 2024-10-30.
What conditions does trial NCT01849146 study?
This clinical trial studies the following conditions: Glioblastoma, Recurrent Glioblastoma.
What interventions are being tested in trial NCT01849146?
The interventions under investigation include: Radiation Therapy (RADIATION), Temozolomide (DRUG), Adavosertib (DRUG).
Who is sponsoring clinical trial NCT01849146?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01849146 being conducted?
This trial has 12 study locations across Alabama, California, Maryland, Massachusetts, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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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 NCT01849146's enrollment target sits among peer trials
74 62nd of 199 higher than 136 of 199 other Glioblastoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other 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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