Trial · NCT00995007
A Randomized Phase II Trial of Vandetanib (ZD6474) in Combination With Carboplatin Versus Carboplatin Alone Followed by Vandetanib Alone in Adults With Recurrent High-Grade Gliomas
NCT00995007, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2016-03-29
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Randomized Phase II Trial of Vandetanib (ZD6474) in Combination With Carboplatin Versus Carboplatin Alone Followed by Vandetanib Alone in Adults With Recurrent High-Grade Gliomas. Trials, record NCT00995007. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00995007
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Randomized Phase II Trial of Vandetanib (ZD6474) in Combination With Carboplatin Versus Carboplatin Alone Followed by Vandetanib Alone in Adults With Recurrent High-Grade Gliomas
- NCT number
- NCT00995007
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 112 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Glioblastoma Multiforme, Gliosarcoma, Anaplastic Astrocytoma, Anaplastic Oligodendroglioma, Anaplastic Mixed Oligoastrocytoma
- Interventions
- ZD6474 (Vandetanib), Carboplatin
- First posted
- 2009-10-14
- Last updated
- 2016-03-29
- Results first posted
- 2016-03-29
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression Free Survival at 6 Months | 6 months | Percentage of participants who are alive and progression-free at 6 months. |
| Secondary | Overall Survival | Time between the first day of treatment and the day of death, up to 1.5 years | Time between the first day of treatment and the day of death. |
| Secondary | Number of Participants With Adverse Events | 70 months and 19 days | Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression Free Survival at 6 Months | 6 months | The group data is displayed per the report provided to the Food and Drug Administration. | percentage of participants | NUMBER |
| SECONDARY | Overall Survival | Time between the first day of treatment and the day of death, up to 1.5 years | The group data is displayed per the report provided to the Food and Drug Administration. | Months | MEDIAN |
| SECONDARY | Number of Participants With Adverse Events | 70 months and 19 days | participants | NUMBER |
Source ClinicalTrials.gov
Results by group11
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression Free Survival at 6 Months | Glioblastoma (Combination) | 1.71 | percentage of participants | ||
| Progression Free Survival at 6 Months | Glioblastoma (Carboplatin Alone) | 0.89 | percentage of participants | ||
| Progression Free Survival at 6 Months | Anaplastic Astrocytomas (Combination) | 8.7 | percentage of participants | ||
| Progression Free Survival at 6 Months | Anaplastic Astrocytomas (Carboplatin Alone) | 17.4 | percentage of participants | ||
| Overall Survival | Glioblastoma (Combination) | 5.58 | 95% Confidence Interval 4.60 to 8.65 | Months | |
| Overall Survival | Glioblastoma (Carboplation Alone) | 5.22 | 95% Confidence Interval 3.78 to 7.46 | Months | |
| Overall Survival | Anaplastic Astrocytoma (Combination) | 6.5 | 95% Confidence Interval 5.42 to 11.7 | Months | |
| Overall Survival | Anaplastic Astrocytoma (Carboplatin Alone) | 9.27 | 95% Confidence Interval 5.52 to 43.86 | Months | |
| Number of Participants With Adverse Events | Carboplatin | 55 | participants | ||
| Number of Participants With Adverse Events | Vandetanib With Carboplatin | 56 | participants |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Carboplatin | 56 | |
| Overall Study | STARTED | Vandetanib With Carboplatin | 56 | |
| Overall Study | Crossover to Vandetanib | Carboplatin | 42 | |
| Overall Study | Crossover to Vandetanib | Vandetanib With Carboplatin | 0 | |
| Overall Study | COMPLETED | Carboplatin | 39 | |
| Overall Study | COMPLETED | Vandetanib With Carboplatin | 54 | |
| Overall Study | NOT COMPLETED | Carboplatin | 17 | |
| Overall Study | NOT COMPLETED | Vandetanib With Carboplatin | 2 |
Source ClinicalTrials.gov
Adverse events651
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 | Activated partial thromboplastin time prolonged | Investigations | Carboplatin | 2 | 56 | 2 |
| other | Activated partial thromboplastin time prolonged | Investigations | Vandetanib With Carboplatin | 5 | 56 | 11 |
| other | Activated partial thromboplastin time prolonged | Investigations | Crossover to Vandetanib | 1 | 42 | 1 |
| other | Alanine aminotransferase increased | Investigations | Carboplatin | 19 | 56 | 29 |
| other | Alanine aminotransferase increased | Investigations | Vandetanib With Carboplatin | 43 | 56 | 74 |
| other | Alanine aminotransferase increased | Investigations | Crossover to Vandetanib | 24 | 42 | 29 |
| other | Alkaline phosphatase increased | Investigations | Carboplatin | 4 | 56 | 4 |
| other | Alkaline phosphatase increased | Investigations | Vandetanib With Carboplatin | 17 | 56 | 20 |
| other | Alkaline phosphatase increased | Investigations | Crossover to Vandetanib | 6 | 42 | 6 |
| other | Anemia | Blood and lymphatic system disorders | Carboplatin | 30 | 56 | 67 |
1 to 10 of 651Source ClinicalTrials.gov
See all 651 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Carboplatin | ||
| Total, all-cause mortality | Vandetanib With Carboplatin | ||
| Total, all-cause mortality | Crossover to Vandetanib | ||
| Total, other adverse events | Carboplatin | 55 | 56 |
| Total, other adverse events | Vandetanib With Carboplatin | 56 | 56 |
| Total, other adverse events | Crossover to Vandetanib | 40 | 42 |
| Total, serious adverse events | Carboplatin | 10 | 56 |
| Total, serious adverse events | Vandetanib With Carboplatin | 21 | 56 |
| Total, serious adverse events | Crossover to Vandetanib | 13 | 42 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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/NCT00995007
GET https://conductscience.org/api/trials/v1/NCT00995007/events?page=2