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NCT00895960 · ClinicalTrials.gov registry record · Phase 1
Dasatinib Plus Radiation Therapy/Temozolomide in Newly-Diagnosed Glioblastoma
A Phase 1 study, sponsored by M.D. Anderson Cancer Center.
- Terminated
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
NCT00895960: Clinical Trial Phase 1 study, sponsored by M.D. Anderson Cancer Center.
NCT00895960 is a Phase 1 study that was terminated before completion, run by M.D. Anderson Cancer Center. The registered enrollment target is 16 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00895960, a Phase 1 study, was terminated before completion, sponsored by M.D. Anderson Cancer Center.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
Study Summary
Phase I: Primary Objectives: -To define the maximum tolerated dose (MTD) of dasatinib (Sprycel) with radiotherapy (RT) and 6 weeks of concomitant temozolomide (TMZ) administered at 75 mg/m\^2/day in patients with newly-diagnosed glioblastoma (GBM). Secondary Objectives: * To characterize the safety profile of dasatinib (Sprycel) in combination with radiotherapy (RT) and concomitant TMZ in patients with newly-diagnosed GBM. * To characterize the safety profile of dasatinib (Sprycel) in combination with adjuvant TMZ in patients with glioblastoma after RT. STUDY DID NOT PROGRESS TO PHASE II PORTION. Phase II: Primary Objectives: -To determine the effectiveness of dasatinib (Sprycel) with radiotherapy (RT) and 6 weeks of concomitant temozolomide (TMZ) administered at 75 mg/m\^2/day followed by adjuvant temozolomide with concurrent dasatinib in patients with newly-diagnosed glioblastoma (GBM) as measured by overall survival. Secondary Objectives: * To determine the efficacy of this treatment as measured by radiographic response (RR), progression-free survival (PFS) and time to progression (TTP). * To characterize the safety profile of dasatinib (Sprycel) in combination with RT and concomitant TMZ in patients with newly-diagnosed GBM. * To characterize the safety profile of dasatinib (Sprycel) in combination with adjuvant TMZ in patients with GBM after RT. Exploratory Objectives: -To correlate tumor genotype, tumor expression of dasatinib target proteins (e.g. Src, EphA2, c-kit and PDGFR), and PTEN levels with response to therapy with dasatinib and temozolomide.
Interventions
- DRUG Dasatinib
- RADIATION RT (Radiotherapy)
- DRUG TMZ (Temozolomide)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2009-05-07 |
| Est. Completion | 2013-08 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00895960
The ClinicalTrials.gov registry entry for NCT00895960 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is M.D. Anderson Cancer Center, which has 2,692 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Dasatinib is the first listed.
NCT00895960 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00895960 about?
NCT00895960 is a clinical study titled "Dasatinib Plus Radiation Therapy/Temozolomide in Newly-Diagnosed Glioblastoma". Phase I: Primary Objectives: -To define the maximum tolerated dose (MTD) of dasatinib (Sprycel) with radiotherapy (RT) and 6 weeks of concomitant temozolomide (TMZ) administered at 75 mg/m\^2/day in patients with newly-diagnosed glioblastoma (GBM). Secondary Objectives: * To characterize the saf...
What is the current status of trial NCT00895960?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2009-05-07. Estimated completion is 2013-08.
What interventions are being tested in trial NCT00895960?
The interventions under investigation include: Dasatinib (DRUG), RT (Radiotherapy) (RADIATION), TMZ (Temozolomide) (DRUG).
Who is sponsoring clinical trial NCT00895960?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
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