Trial · NCT00050986
Phase I/II Evaluation of Temozolomide and ZARNESTRA (R115777) for Recurrent and Progressive Glioblastoma Multiforme
NCT00050986, Phase 1, Phase 2, Completed, M.D. Anderson Cancer Center; results first posted 2010-09-16
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Phase I/II Evaluation of Temozolomide and ZARNESTRA (R115777) for Recurrent and Progressive Glioblastoma Multiforme. Trials, record NCT00050986. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00050986
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase I/II Evaluation of Temozolomide and ZARNESTRA (R115777) for Recurrent and Progressive Glioblastoma Multiforme
- NCT number
- NCT00050986
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 55 participants, actual
- Lead sponsor
- M.D. Anderson Cancer Center
- Conditions
- Glioblastoma Multiforme
- Interventions
- Temozolomide, R115777
- First posted
- 2003-01-03
- Last updated
- 2020-09-22
- Results first posted
- 2010-09-16
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximal Tolerating Dose (MTD for Phase I) | End of first cycle (4 weeks) evaluation | Phase I Dose limiting toxicity evaluation at end of first cycle based on blood tests every two weeks and participants' subjective and objective symptoms. Start Dose Level 100 mg/m² Temozolomide once daily + 400 mg ZARNESTRA twice daily; Dose Level 1 100 mg/m² Temozolomide once daily + 500 mg ZARNESTRA twice daily; Dose Level 2 150 mg/m² Temozolomide once daily + 500 mg ZARNESTRA twice daily; Dose Level 3 150 mg/m² Temozolomide once daily + 600 mg ZARNESTRA twice daily; Dose Level 4 150 mg/m² Temozolomide once daily + 800 mg ZARNESTRA twice daily |
| Secondary | Progression-free Survival (Phase II) | 6 months | Efficacy measured by 6 month progression-free survival assessment. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Maximal Tolerating Dose (MTD for Phase I) | End of first cycle (4 weeks) evaluation | As treated. | participants | NUMBER |
| SECONDARY | Progression-free Survival (Phase II) | 6 months |
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 |
|---|---|---|---|---|---|
| Maximal Tolerating Dose (MTD for Phase I) | Temozolomide and R115777 | Dose Level 1 | 3 | participants | |
| Maximal Tolerating Dose (MTD for Phase I) | Temozolomide and R115777 | Dose Level 2 | 3 | participants | |
| Maximal Tolerating Dose (MTD for Phase I) | Temozolomide and R115777 | Dose Level 3 | 6 | participants | |
| Maximal Tolerating Dose (MTD for Phase I) | Temozolomide and R115777 | Dose Level 4 | 3 | 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 and R115777 | 55 | |
| Overall Study | COMPLETED | Temozolomide and R115777 | 53 | |
| Overall Study | NOT COMPLETED | Temozolomide and R115777 | 2 |
Source ClinicalTrials.gov
Adverse events54
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 | Abdominal pain | Gastrointestinal disorders | Temozolomide and R115777 | 1 | 53 | 1 |
| other | ALT | Metabolism and nutrition disorders | Temozolomide and R115777 | 2 | 53 | 2 |
| other | Hemoglobin | Blood and lymphatic system disorders | Temozolomide and R115777 | 5 | 53 | 6 |
| other | Anorexia | Gastrointestinal disorders | Temozolomide and R115777 | 1 | 53 | 1 |
| other | Ataxia | Nervous system disorders | Temozolomide and R115777 | 1 | 53 | 1 |
| other | Constipation | Gastrointestinal disorders | Temozolomide and R115777 | 2 | 53 | 4 |
| other | decubitus Ulcer | Skin and subcutaneous tissue disorders | Temozolomide and R115777 | 2 | 53 | 2 |
| other | Dehydration | Gastrointestinal disorders | Temozolomide and R115777 | 2 | 53 | 2 |
| other | Dry mouth | Gastrointestinal disorders | Temozolomide and R115777 | 1 | 53 | 1 |
| other | Dyspnea | Respiratory, thoracic and mediastinal disorders | Temozolomide and R115777 | 1 | 53 | 1 |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Temozolomide and R115777 | ||
| Total, other adverse events | Temozolomide and R115777 | 47 | 53 |
| Total, serious adverse events | Temozolomide and R115777 | 24 | 53 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT00050986
GET https://conductscience.org/api/trials/v1/NCT00050986/events?page=2