Trial · NCT00392171
The Effects of Continuous 28-day (28/28) Temozolomide Chemotherapy in Subjects With Recurrent Malignant Glioma Who Have Failed the Conventional 5-day (5/28) Treatment (P04601)
NCT00392171, Phase 2, Completed, Merck Sharp & Dohme LLC; results first posted 2010-05-17
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. The Effects of Continuous 28-day (28/28) Temozolomide Chemotherapy in Subjects With Recurrent Malignant Glioma Who Have Failed the Conventional 5-day (5/28) Treatment (P04601). Trials, record NCT00392171. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00392171
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- The Effects of Continuous 28-day (28/28) Temozolomide Chemotherapy in Subjects With Recurrent Malignant Glioma Who Have Failed the Conventional 5-day (5/28) Treatment (P04601)
- NCT number
- NCT00392171
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 120 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Glioma, Astrocytoma, Oligodendroglioma, Glioblastoma
- Interventions
- Temozolomide
- First posted
- 2006-10-25
- Last updated
- 2017-06-07
- Results first posted
- 2010-05-17
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Surviving at Six Months of Treatment Without Evidence of Disease Progression. | 6 months | Progression-free survival as determined by Kaplan-Meier method. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Surviving at Six Months of Treatment Without Evidence of Disease Progression. | 6 months | Participants who received allocated intervention.~The percentage of participants reported is based on the number of participants within each category (not total number of all categories combined). | Percentage of Participants | NUMBER |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Surviving at Six Months of Treatment Without Evidence of Disease Progression. | Temozolomide | Anaplastic Glioma (n=28) | 35.7 | Percentage of Participants | |
| Percentage of Participants Surviving at Six Months of Treatment Without Evidence of Disease Progression. | Temozolomide | Early Glioblastoma Multiforme (GBM) (n=33) | 27.3 | Percentage of Participants | |
| Percentage of Participants Surviving at Six Months of Treatment Without Evidence of Disease Progression. | Temozolomide | Extended Glioblastoma Multiforme (GBM) (n=27) | 7.4 | Percentage of Participants | |
| Percentage of Participants Surviving at Six Months of Treatment Without Evidence of Disease Progression. | Temozolomide | Rechallenge Glioblastoma Multiforme (GBM) (n=28) | 35.7 | Percentage of Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Temozolomide | 120 | |
| Overall Study | COMPLETED | Temozolomide | 15 | |
| Overall Study | NOT COMPLETED | Temozolomide | 105 |
Source ClinicalTrials.gov
Adverse events68
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | NEUTROPENIA | Blood and lymphatic system disorders | Temozolomide | 7 | 120 | 7 |
| other | VISION BLURRED | Eye disorders | Temozolomide | 7 | 120 | 8 |
| other | CONSTIPATION | Gastrointestinal disorders | Temozolomide | 15 | 120 | 16 |
| other | DIARRHOEA | Gastrointestinal disorders | Temozolomide | 8 | 120 | 9 |
| other | DYSPEPSIA | Gastrointestinal disorders | Temozolomide | 7 | 120 | 7 |
| other | NAUSEA | Gastrointestinal disorders | Temozolomide | 35 | 120 | 40 |
| other | VOMITING | Gastrointestinal disorders | Temozolomide | 24 | 120 | 29 |
| other | ASTHENIA | General disorders | Temozolomide | 8 | 120 | 9 |
| other | FATIGUE | General disorders | Temozolomide | 48 | 120 | 64 |
| other | GAIT DISTURBANCE | General disorders | Temozolomide | 13 | 120 | 18 |
1 to 10 of 68Source ClinicalTrials.gov
See all 68 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Temozolomide | ||
| Total, other adverse events | Temozolomide | 111 | 120 |
| Total, serious adverse events | Temozolomide | 27 | 120 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 20308655 | RESULT |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00392171
GET https://conductscience.org/api/trials/v1/NCT00392171/events?page=2