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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, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower). 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.
Primary Outcome
The MTD of dasatinib will be that dose at which fewer than one-third of participants experience dose limiting toxicity (DLT). Escalations are planned in groups of three patients, with an additional three patients to be added at the first indication of DLT.
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 |
Why NCT00895960 stopped before completion
NCT00895960 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower).
The record links to 0 conditions, and to 3 interventions - of which Dasatinib is the first listed.
NCT00895960 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00895960's enrollment target sits among peer trials
16 1786th of 2000 higher than 203 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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