Trial · NCT00441142
Zactima With Temodar During Radiation Treatment for Newly Diagnosed Stage IV Brain Tumors
NCT00441142, Phase 1, Phase 2, Completed, Patrick Y. Wen, MD; results first posted 2015-03-02
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Zactima With Temodar During Radiation Treatment for Newly Diagnosed Stage IV Brain Tumors. Trials, record NCT00441142. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00441142
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Zactima With Temodar During Radiation Treatment for Newly Diagnosed Stage IV Brain Tumors
- NCT number
- NCT00441142
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 119 participants, actual
- Lead sponsor
- Patrick Y. Wen, MD
- Conditions
- Glioblastoma Multiforme, Gliosarcoma
- Interventions
- ZD6474, temozolomide, Radiation Therapy
- First posted
- 2007-02-28
- Last updated
- 2019-03-05
- Results first posted
- 2015-03-02
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants That Experienced a Dose-limiting Toxicity (DLT) | 2 years | The primary outcome of Phase I of this trial was to determine the maximum tolerated dose (MTD) of ZD6474 (Vandetanib) in patients with newly-diagnosed glioblastomas multiforme (GBM) and gliosarcomas who are also receiving radiation therapy with concomitant and adjuvant temozolomide. The MTD is the dose level at which 0/6 or 1/6 patients experience a dose-limiting toxicity (DLT) with the next higher dose having at least 2/3 or 2/6 patients encountering DLT. |
| Primary | Median Overall Survival (OS) of Phase II Patients | 3 years | The primary outcome of Phase II of this trial was to determine the efficacy of ZD6474 (Vandetanib) in combination with radiation therapy and concomitant and adjuvant temozolomide in patients with newly-diagnosed GBM and gliosarcomas as measured by overall survival and median survival. |
| Secondary | Median Progression-free Survival (PFS), as Calculated by the # of Months Patients Remain Progression-free | 3 years | A secondary outcome of Phase II of this trial is the median progression-free survival (PFS), as calculated by the # of months patients remain progression-free |
| Secondary | PHASE II: Percentage of Grade 3-5 Treatment-Related Adverse Events | Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study treatment until 30 days after the last dose of study treatment), maximum timeframe was 6 years. | The percentage of adverse events (based on CTCAEv3) reported on study (via case report forms and Reportable AE submissions) that are both high-grade (grade 3, 4, or 5) and considered at least possibly related to study treatment. |
| Secondary | PHASE I: Percentage of Grade 3-5 Treatment-Related Adverse Events | Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study treatment until 30 days after the last dose of study treatment), maximum timeframe was 7 years. | The percentage of adverse events (based on CTCAEv3) reported on study (via case report forms and Reportable AE submissions) that are both high-grade (grade 3, 4, or 5) and considered at least possibly related to study treatment. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants That Experienced a Dose-limiting Toxicity (DLT) | 2 years | This measure was only assessed in Participants enrolled into the Phase I part of the study who had available data for analysis. | Participants | NUMBER |
| PRIMARY | Median Overall Survival (OS) of Phase II Patients | 3 years | This measure was only assessed in Participants in Phase II part of the study, who had available data for analysis | months | MEDIAN |
| SECONDARY | Median Progression-free Survival (PFS), as Calculated by the # of Months Patients Remain Progression-free | 3 years | This is an outcome for Phase II participants only; 0 Phase I participants were included in the analysis. | months | MEDIAN |
| SECONDARY | PHASE II: Percentage of Grade 3-5 Treatment-Related Adverse Events | Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study treatment until 30 days after the last dose of study treatment), maximum timeframe was 6 years. | percentage of events | NUMBER | |
| SECONDARY | PHASE I: Percentage of Grade 3-5 Treatment-Related Adverse Events | Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study treatment until 30 days after the last dose of study treatment), maximum timeframe was 7 years. | percentage of events | NUMBER |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants That Experienced a Dose-limiting Toxicity (DLT) | Phase I: Dose Level -1: RT + TMZ + Vandetanib @ 200 mg/Day | 3 | Participants | ||
| Number of Participants That Experienced a Dose-limiting Toxicity (DLT) | Phase I: Dose Level -2: RT + TMZ + Vandetanib @ 100 mg/Day | 0 | Participants | ||
| Median Overall Survival (OS) of Phase II Patients | Phase II: Arm A (Control Group: RT + TMZ) | 15.9 | 95% Confidence Interval 11.0 to 22.5 | months | |
| Median Overall Survival (OS) of Phase II Patients | Phase II: Arm B (Experimental Group: RT + TMZ + Vandetanib) | 16.6 | 95% Confidence Interval 14.9 to 20.1 | months | |
| Median Progression-free Survival (PFS), as Calculated by the # of Months Patients Remain Progression-free | Phase II: Arm A (Control Group: RT + TMZ) | 6.2 | 95% Confidence Interval 3.9 to 10.4 | months | |
| Median Progression-free Survival (PFS), as Calculated by the # of Months Patients Remain Progression-free | Phase II: Arm B (Experimental Group: RT + TMZ + Vandetanib) | 7.7 | 95% Confidence Interval 5.5 to 10.1 | months | |
| PHASE II: Percentage of Grade 3-5 Treatment-Related Adverse Events | Phase II - Arm A - Participants | 4.16 | 95% Confidence Interval 2.56 to 6.35 | percentage of events | |
| PHASE II: Percentage of Grade 3-5 Treatment-Related Adverse Events | Phase II - Arm B - Participants | 8.37 | 95% Confidence Interval 6.85 to 10.10 | percentage of events | |
| PHASE I: Percentage of Grade 3-5 Treatment-Related Adverse Events | Phase I Participants - Vandetanib @ 200 mg/Day | 9.48 | 95% Confidence Interval 5.15 to 15.68 | percentage of events | |
| PHASE I: Percentage of Grade 3-5 Treatment-Related Adverse Events | Phase I Participants - Vandetanib @ 100 mg/Day | 4.43 | 95% Confidence Interval 1.8 to 8.92 | percentage of events |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Phase I: Dose Level -1: RT + TMZ + Vandetanib @ 200 mg/Day | 6 | |
| Overall Study | STARTED | Phase I: Dose Level -2: RT + TMZ + Vandetanib @ 100 mg/Day | 7 | |
| Overall Study | STARTED | Phase II: Arm A (Control Group: RT + TMZ) | 29 | |
| Overall Study | STARTED | Phase II: Arm B (Experimental Group: RT + TMZ + Vandetanib) | 69 | |
| Overall Study | COMPLETED | Phase I: Dose Level -1: RT + TMZ + Vandetanib @ 200 mg/Day | 0 | |
| Overall Study | COMPLETED | Phase I: Dose Level -2: RT + TMZ + Vandetanib @ 100 mg/Day | 0 | |
| Overall Study | COMPLETED | Phase II: Arm A (Control Group: RT + TMZ) | 7 | |
| Overall Study | COMPLETED | Phase II: Arm B (Experimental Group: RT + TMZ + Vandetanib) | 1 | |
| Overall Study | NOT COMPLETED | Phase I: Dose Level -1: RT + TMZ + Vandetanib @ 200 mg/Day | 6 | |
| Overall Study | NOT COMPLETED | Phase I: Dose Level -2: RT + TMZ + Vandetanib @ 100 mg/Day | 7 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events342
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 | hemoglobin | Blood and lymphatic system disorders | Phase I & Phase II-Arm B Pts: RT + TMZ + Vandetanib | 38 | 82 | |
| other | hemoglobin | Blood and lymphatic system disorders | Phase II-Arm A Pts (Control Group): RT + TMZ | 19 | 29 | |
| other | leukocytes | Blood and lymphatic system disorders | Phase I & Phase II-Arm B Pts: RT + TMZ + Vandetanib | 34 | 82 | |
| other | leukocytes | Blood and lymphatic system disorders | Phase II-Arm A Pts (Control Group): RT + TMZ | 12 | 29 | |
| other | lymphopenia | Blood and lymphatic system disorders | Phase I & Phase II-Arm B Pts: RT + TMZ + Vandetanib | 43 | 82 | |
| other | lymphopenia | Blood and lymphatic system disorders | Phase II-Arm A Pts (Control Group): RT + TMZ | 16 | 29 | |
| other | neutrophils | Blood and lymphatic system disorders | Phase I & Phase II-Arm B Pts: RT + TMZ + Vandetanib | 21 | 82 | |
| other | neutrophils | Blood and lymphatic system disorders | Phase II-Arm A Pts (Control Group): RT + TMZ | 9 | 29 | |
| other | platelets | Blood and lymphatic system disorders | Phase I & Phase II-Arm B Pts: RT + TMZ + Vandetanib | 48 | 82 | |
| other | platelets | Blood and lymphatic system disorders | Phase II-Arm A Pts (Control Group): RT + TMZ | 13 | 29 |
1 to 10 of 342Source ClinicalTrials.gov
See all 342 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Phase I & Phase II-Arm B Pts: RT + TMZ + Vandetanib | ||
| Total, all-cause mortality | Phase II-Arm A Pts (Control Group): RT + TMZ | ||
| Total, other adverse events | Phase I & Phase II-Arm B Pts: RT + TMZ + Vandetanib | 81 | 82 |
| Total, other adverse events | Phase II-Arm A Pts (Control Group): RT + TMZ | 28 | 29 |
| Total, serious adverse events | Phase I & Phase II-Arm B Pts: RT + TMZ + Vandetanib | 52 | 82 |
| Total, serious adverse events | Phase II-Arm A Pts (Control Group): RT + TMZ | 15 | 30 |
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 |
|---|
| Phase I & Phase II-Arm B Pts: RT + TMZ + Vandetanib vs Phase II-Arm A Pts (Control Group): RT + TMZ: 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/NCT00441142
GET https://conductscience.org/api/trials/v1/NCT00441142/events?page=2