Trial · NCT00154375
Study of Imatinib Mesylate in Combination With Hydroxyurea Versus Hydroxyurea Alone as an Oral Therapy in Patients With Temozolomide Resistant Progressive Glioblastoma
NCT00154375, Phase 3, Completed, Novartis Pharmaceuticals; results first posted 2011-02-02
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of Imatinib Mesylate in Combination With Hydroxyurea Versus Hydroxyurea Alone as an Oral Therapy in Patients With Temozolomide Resistant Progressive Glioblastoma. Trials, record NCT00154375. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00154375
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Imatinib Mesylate in Combination With Hydroxyurea Versus Hydroxyurea Alone as an Oral Therapy in Patients With Temozolomide Resistant Progressive Glioblastoma
- NCT number
- NCT00154375
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 240 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Glioblastoma Multiforme, Astrocytoma
- Interventions
- Imatinib mesylate, Hydroxyurea
- First posted
- 2005-09-12
- Last updated
- 2011-04-26
- Results first posted
- 2011-02-02
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Progression Free Survival (PFS) During the Study Duration | 6 months -1 year | PFS was defined as the time from the date of randomization to the date of the first documented progression according to the MacDonald criteria, or death due to any cause. MacDonald criteria are standard criteria in neurooncology. Tumor assessment was made according to the adapted MacDonald criteria based on the combined evaluation of 1) assessment of the MRI scan for measurable, evaluable, and new lesions (made by the independent external expert too), 2) overall assessment of neurological performance (made by the investigator), 3) concomitant steroid use (as reported by the investigator). |
| Secondary | Number of Participants With Death, Other Serious or Clinically Significant Adverse Events (AEs) or Related Discontinuations | 6 months - 1 year | National Cancer Institute (NCI)/ National Institute of Health (NIH) provides a grading (severity) scale for each AE term. Grade 3 refers to severe AE and Grade 4 refers to life-threatening or disabling AE. According to FDA 21CFR 314.80, a serious adverse event (SAE) is described as any adverse event that leads to death, is life threatening ( NIH criteria Grade 4), causes or prolongs hospitalization, results in a congenital anomaly, or any other important medical event not described above. |
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 | Percentage of Participants With Progression Free Survival (PFS) During the Study Duration | 6 months -1 year | The ITT population consists of all randomized patients, analyzed according to their randomized treatment. | Percentage of Participants | NUMBER |
| SECONDARY | Number of Participants With Death, Other Serious or Clinically Significant Adverse Events (AEs) or Related Discontinuations | 6 months - 1 year | The safety population consisted of randomized patients with at least one dose of randomized medication. | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Progression Free Survival (PFS) During the Study Duration | Imatinib Mesylate + Hydroxyurea (HU) | 6 months | 5.3 | 95% Confidence Interval 1.0 to 9.7 | Percentage of Participants |
| Percentage of Participants With Progression Free Survival (PFS) During the Study Duration | Hydroxyurea Alone | 6 months | 6.6 | 95% Confidence Interval 2.1 to 11.1 | Percentage of Participants |
| Percentage of Participants With Progression Free Survival (PFS) During the Study Duration | Imatinib Mesylate + Hydroxyurea (HU) | 12 months | 2.1 | 95% Confidence Interval 0.0 to 5.0 | Percentage of Participants |
| Percentage of Participants With Progression Free Survival (PFS) During the Study Duration | Hydroxyurea Alone | 12 months | 2.1 | 95% Confidence Interval 0.0 to 5.5 | Percentage of Participants |
| Number of Participants With Death, Other Serious or Clinically Significant Adverse Events (AEs) or Related Discontinuations | Imatinib Mesylate + Hydroxyurea (HU) | Deaths | 84 | Participants | |
| Number of Participants With Death, Other Serious or Clinically Significant Adverse Events (AEs) or Related Discontinuations | Hydroxyurea Alone | Deaths | 91 | Participants | |
| Number of Participants With Death, Other Serious or Clinically Significant Adverse Events (AEs) or Related Discontinuations | Imatinib Mesylate + Hydroxyurea (HU) | Death due to disease progression | 76 | Participants | |
| Number of Participants With Death, Other Serious or Clinically Significant Adverse Events (AEs) or Related Discontinuations | Hydroxyurea Alone | Death due to disease progression | 77 | Participants | |
| Number of Participants With Death, Other Serious or Clinically Significant Adverse Events (AEs) or Related Discontinuations | Imatinib Mesylate + Hydroxyurea (HU) | Serious Adverse Events (SAEs) | 64 | Participants | |
| Number of Participants With Death, Other Serious or Clinically Significant Adverse Events (AEs) or Related Discontinuations | Hydroxyurea Alone | Serious Adverse Events (SAEs) | 79 | Participants |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Imatinib Mesylate + Hydroxyurea (HU) | 120 | |
| Overall Study | STARTED | Hydroxyurea Alone | 120 | |
| Overall Study | Discontinued Study Treatment | Imatinib Mesylate + Hydroxyurea (HU) | 111 | |
| Overall Study | Discontinued Study Treatment | Hydroxyurea Alone | 104 | |
| Overall Study | Not Exposed to Study Treatment | Imatinib Mesylate + Hydroxyurea (HU) | 2 | |
| Overall Study | Not Exposed to Study Treatment | Hydroxyurea Alone | 2 | |
| Overall Study | COMPLETED | Imatinib Mesylate + Hydroxyurea (HU) | 7 | |
| Overall Study | COMPLETED | Hydroxyurea Alone | 14 | |
| Overall Study | NOT COMPLETED | Imatinib Mesylate + Hydroxyurea (HU) | 113 | |
| Overall Study | NOT COMPLETED | Hydroxyurea Alone | 106 |
Source ClinicalTrials.gov
Adverse events459
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 | ANAEMIA | Blood and lymphatic system disorders | Imatinib Mesylate + Hydroxyurea (HU) | 13 | 118 | |
| other | ANAEMIA | Blood and lymphatic system disorders | Period With Hydroxyurea Alone | 8 | 118 | |
| other | ANAEMIA | Blood and lymphatic system disorders | Period After Switch to Combination | 13 | 85 | |
| other | LEUKOPENIA | Blood and lymphatic system disorders | Imatinib Mesylate + Hydroxyurea (HU) | 16 | 118 | |
| other | LEUKOPENIA | Blood and lymphatic system disorders | Period With Hydroxyurea Alone | 14 | 118 | |
| other | LEUKOPENIA | Blood and lymphatic system disorders | Period After Switch to Combination | 14 | 85 | |
| other | THROMBOCYTOPENIA | Blood and lymphatic system disorders | Imatinib Mesylate + Hydroxyurea (HU) | 24 | 118 | |
| other | THROMBOCYTOPENIA | Blood and lymphatic system disorders | Period With Hydroxyurea Alone | 15 | 118 | |
| other | THROMBOCYTOPENIA | Blood and lymphatic system disorders | Period After Switch to Combination | 17 | 85 | |
| other | CUSHINGOID | Endocrine disorders | Imatinib Mesylate + Hydroxyurea (HU) | 6 | 118 |
1 to 10 of 459Source ClinicalTrials.gov
See all 459 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Imatinib Mesylate + Hydroxyurea (HU) | ||
| Total, all-cause mortality | Period With Hydroxyurea Alone | ||
| Total, all-cause mortality | Period After Switch to Combination | ||
| Total, other adverse events | Imatinib Mesylate + Hydroxyurea (HU) | 104 | 118 |
| Total, other adverse events | Period With Hydroxyurea Alone | 80 | 118 |
| Total, other adverse events | Period After Switch to Combination | 65 | 85 |
| Total, serious adverse events | Imatinib Mesylate + Hydroxyurea (HU) | 64 | 118 |
| Total, serious adverse events | Period With Hydroxyurea Alone | 46 | 118 |
| Total, serious adverse events | Period After Switch to Combination | 49 | 85 |
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/NCT00154375
GET https://conductscience.org/api/trials/v1/NCT00154375/events?page=2