Trial · NCT00290771
Efficacy and Safety of Imatinib Mesylate Plus Hydroxyurea (HU) in Patients With Recurrent Glioblastoma Multiforme (GBM)
NCT00290771, Phase 2, Terminated, Novartis; results first posted 2011-05-16
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Efficacy and Safety of Imatinib Mesylate Plus Hydroxyurea (HU) in Patients With Recurrent Glioblastoma Multiforme (GBM). Trials, record NCT00290771. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00290771
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Imatinib Mesylate Plus Hydroxyurea (HU) in Patients With Recurrent Glioblastoma Multiforme (GBM)
- NCT number
- NCT00290771
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 231 participants, actual
- Lead sponsor
- Novartis
- Conditions
- Recurrent Glioblastoma Multiforme (GBM)
- Interventions
- Imatinib tablets, Hydroxyurea capsules
- First posted
- 2006-02-13
- Last updated
- 2011-05-16
- Results first posted
- 2011-05-16
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Patients With an Objective Overall Response (OOR) | Baseline to end of study (Month 24) | Patients with an OOR were those whose best response to treatment was a complete response (CR) or a partial response (PR) assessed with magnetic resonance imaging. A patient had a CR if the target tumors disappeared. A patient had a PR if there was a ≥ 50% reduction in the sum of the products of the largest perpendicular diameters of the target tumors compared to the baseline value. A best response of CR required at least 2 determinations of CR at least 4 weeks apart. A best response of PR required at least 2 determinations of PR or better at least 4 weeks apart (and not qualifying for CR). |
| Secondary | Duration of Objective Overall Response (OOR) | Baseline to end of study (Month 24) | Duration of OOR only included patients whose best overall response was complete response (CR) or partial response (PR). The start date was the date of the first documented response (CR or PR); the end date was the date of the first documented disease progression (PD) or death from any cause. (PD) was defined as ≥ 25% increase in size of the sum of the products of the largest perpendicular diameters of the target tumors compared to the smallest value recorded at or after baseline. If a patient had not progressed or died, the duration of OOR was censored at the time of the last OOR assessment. |
| Secondary | Percentage of Patients Who Had Clinical Benefit | Baseline to end of study (Month 24) | Patients who had clinical benefit were patients with a best response of complete response (CR), partial response (PR), or stable disease (SD) lasting for more than 6 months from the start of treatment until the first documented disease progression (PD) or death from any cause. (PD) was defined as ≥ 25% increase in size of the sum of the products of the largest perpendicular diameters of the target tumors compared to the smallest value recorded at or after baseline. SD was defined as insufficient tumor shrinkage to qualify for PR or CR and no increase in lesions which would qualify as PD. |
| Secondary | Percentage of Patients With Progression-free Survival at Months 6 and 12 | Months 6 and 12 | Progression-free survival (PFS) was defined as the time from the start of treatment to the date of the first documented disease progression (PD) or death due to any cause. (PD) was defined as ≥ 25% increase in size of the sum of the products of the largest perpendicular diameters of the target tumors compared to the smallest value recorded at or after baseline. If a patient had not progressed or died, progression-free survival was censored at the time of the last overall response assessment. |
| Secondary | Percentage of Patients Surviving at Months 6, 12, and 24 | Months 6, 12, and 24 | Patients not known to have died were censored at the time of last survival follow-up. |
| Secondary | Number of Patients With at Least 1 Adverse Event | Baseline to end of study (Month 24) | An adverse event (AE) is any undesirable sign, symptom, or medical condition occurring after starting study drug even if the event is not considered to be related to study drug. Study drug refers to imatinib or hydroxyurea. The study treatment is the combination of these two study drugs. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Patients With an Objective Overall Response (OOR) | Baseline to end of study (Month 24) | Intent-to-treat (ITT) population: All patients who received at least 1 dose of any of the 2 study drugs. | Percentage of participants | NUMBER |
| SECONDARY | Duration of Objective Overall Response (OOR) | Baseline to end of study (Month 24) | Intent-to-treat (ITT) population: All patients who received at least 1 dose of any of the 2 study drugs. | Weeks | MEDIAN |
| SECONDARY | Percentage of Patients Who Had Clinical Benefit | Baseline to end of study (Month 24) | Intent-to-treat (ITT) population: All patients who received at least 1 dose of any of the 2 study drugs. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Patients With Progression-free Survival at Months 6 and 12 | Months 6 and 12 | Intent-to-treat (ITT) population: All patients who received at least 1 dose of any of the 2 study drugs. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Patients Surviving at Months 6, 12, and 24 | Months 6, 12, and 24 | Intent-to-treat (ITT) population: All patients who received at least 1 dose of any of the 2 study drugs. | Percentage of participants | NUMBER |
| SECONDARY | Number of Patients With at Least 1 Adverse Event | Baseline to end of study (Month 24) | Safety population: All patients who received at least 1 dose of either of the 2 study drugs and who had at least 1 post-baseline safety assessment. | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group27
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Patients With an Objective Overall Response (OOR) | Imatinib 600 mg + Hydroxyurea 1000 mg | 3.8 | 95% Confidence Interval 1.3 to 8.7 | Percentage of participants | |
| Percentage of Patients With an Objective Overall Response (OOR) | Imatinib 1000 mg + Hydroxyurea 1000 mg | 3.0 | 95% Confidence Interval 0.6 to 8.5 | Percentage of participants | |
| Percentage of Patients With an Objective Overall Response (OOR) | All Patients - Imatinib 600 or 1000 mg + Hydroxyurea 1000 mg | 3.5 | 95% Confidence Interval 1.5 to 6.7 | Percentage of participants | |
| Duration of Objective Overall Response (OOR) | Imatinib 600 mg + Hydroxyurea 1000 mg | 41.1 | 95% Confidence Interval 32.1 to 53.6 | Weeks | |
| Duration of Objective Overall Response (OOR) | Imatinib 1000 mg + Hydroxyurea 1000 mg | 32.1 | 95% Confidence Interval 20.1 to NA | Weeks | |
| Duration of Objective Overall Response (OOR) | All Patients - Imatinib 600 or 1000 mg + Hydroxyurea 1000 mg | 37.1 | 95% Confidence Interval 32.1 to 53.6 | Weeks | |
| Percentage of Patients Who Had Clinical Benefit | Imatinib 600 mg + Hydroxyurea 1000 mg | 9.9 | 95% Confidence Interval 5.4 to 16.4 | Percentage of participants | |
| Percentage of Patients Who Had Clinical Benefit | Imatinib 1000 mg + Hydroxyurea 1000 mg | 6.0 | 95% Confidence Interval 2.2 to 12.6 | Percentage of participants | |
| Percentage of Patients Who Had Clinical Benefit | All Patients - Imatinib 600 or 1000 mg + Hydroxyurea 1000 mg | 8.2 | 95% Confidence Interval 5.0 to 12.5 | Percentage of participants | |
| Percentage of Patients With Progression-free Survival at Months 6 and 12 | Imatinib 600 mg + Hydroxyurea 1000 mg | 6 Months | 11.2 | 95% Confidence Interval 5.7 to 16.6 | Percentage of participants |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Imatinib 600 mg + Hydroxyurea 1000 mg | 131 | |
| Overall Study | STARTED | Imatinib 1000 mg + Hydroxyurea 1000 mg | 100 | |
| Overall Study | COMPLETED | Imatinib 600 mg + Hydroxyurea 1000 mg | 4 | |
| Overall Study | COMPLETED | Imatinib 1000 mg + Hydroxyurea 1000 mg | 3 | |
| Overall Study | NOT COMPLETED | Imatinib 600 mg + Hydroxyurea 1000 mg | 127 | |
| Overall Study | NOT COMPLETED | Imatinib 1000 mg + Hydroxyurea 1000 mg | 97 |
Source ClinicalTrials.gov
Adverse events352
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 600 mg + Hydroxyurea 1000 mg | 19 | 131 | |
| other | Anaemia | Blood and lymphatic system disorders | Imatinib 1000 mg + Hydroxyurea 1000 mg | 10 | 99 | |
| other | Leukopenia | Blood and lymphatic system disorders | Imatinib 600 mg + Hydroxyurea 1000 mg | 8 | 131 | |
| other | Leukopenia | Blood and lymphatic system disorders | Imatinib 1000 mg + Hydroxyurea 1000 mg | 9 | 99 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Imatinib 600 mg + Hydroxyurea 1000 mg | 3 | 131 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Imatinib 1000 mg + Hydroxyurea 1000 mg | 7 | 99 | |
| other | Neutropenia | Blood and lymphatic system disorders | Imatinib 600 mg + Hydroxyurea 1000 mg | 15 | 131 | |
| other | Neutropenia | Blood and lymphatic system disorders | Imatinib 1000 mg + Hydroxyurea 1000 mg | 6 | 99 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Imatinib 600 mg + Hydroxyurea 1000 mg | 19 | 131 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Imatinib 1000 mg + Hydroxyurea 1000 mg | 10 | 99 |
1 to 10 of 352Source ClinicalTrials.gov
See all 352 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Imatinib 600 mg + Hydroxyurea 1000 mg | ||
| Total, all-cause mortality | Imatinib 1000 mg + Hydroxyurea 1000 mg | ||
| Total, other adverse events | Imatinib 600 mg + Hydroxyurea 1000 mg | 122 | 131 |
| Total, other adverse events | Imatinib 1000 mg + Hydroxyurea 1000 mg | 95 | 99 |
| Total, serious adverse events | Imatinib 600 mg + Hydroxyurea 1000 mg | 62 | 131 |
| Total, serious adverse events | Imatinib 1000 mg + Hydroxyurea 1000 mg | 53 | 99 |
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Imatinib 600 mg + Hydroxyurea 1000 mg vs Imatinib 1000 mg + Hydroxyurea 1000 mg: serious adverse events |
Source Trial comparisons
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/NCT00290771
GET https://conductscience.org/api/trials/v1/NCT00290771/results?page=2