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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

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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

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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.

ListOutcomeTime frameDescription
PrimaryProgression Free Survival at 6 Months6 monthsPercentage of participants who are alive and progression-free at 6 months.
SecondaryOverall SurvivalTime between the first day of treatment and the day of death, up to 1.5 yearsTime between the first day of treatment and the day of death.
SecondaryNumber of Participants With Adverse Events70 months and 19 daysHere is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYProgression Free Survival at 6 Months6 monthsThe group data is displayed per the report provided to the Food and Drug Administration.percentage of participantsNUMBER
SECONDARYOverall SurvivalTime between the first day of treatment and the day of death, up to 1.5 yearsThe group data is displayed per the report provided to the Food and Drug Administration.MonthsMEDIAN
SECONDARYNumber of Participants With Adverse Events70 months and 19 daysparticipantsNUMBER

Results by group11

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
Progression Free Survival at 6 MonthsGlioblastoma (Combination)1.71percentage of participants
Progression Free Survival at 6 MonthsGlioblastoma (Carboplatin Alone)0.89percentage of participants
Progression Free Survival at 6 MonthsAnaplastic Astrocytomas (Combination)8.7percentage of participants
Progression Free Survival at 6 MonthsAnaplastic Astrocytomas (Carboplatin Alone)17.4percentage of participants
Overall SurvivalGlioblastoma (Combination)5.5895% Confidence Interval 4.60 to 8.65Months
Overall SurvivalGlioblastoma (Carboplation Alone)5.2295% Confidence Interval 3.78 to 7.46Months
Overall SurvivalAnaplastic Astrocytoma (Combination)6.595% Confidence Interval 5.42 to 11.7Months
Overall SurvivalAnaplastic Astrocytoma (Carboplatin Alone)9.2795% Confidence Interval 5.52 to 43.86Months
Number of Participants With Adverse EventsCarboplatin55participants
Number of Participants With Adverse EventsVandetanib With Carboplatin56participants

Participant flow8

How many started, completed or left each group, period by period.

PeriodMilestoneGroupParticipantsUnits counted
Overall StudySTARTEDCarboplatin56
Overall StudySTARTEDVandetanib With Carboplatin56
Overall StudyCrossover to VandetanibCarboplatin42
Overall StudyCrossover to VandetanibVandetanib With Carboplatin0
Overall StudyCOMPLETEDCarboplatin39
Overall StudyCOMPLETEDVandetanib With Carboplatin54
Overall StudyNOT COMPLETEDCarboplatin17
Overall StudyNOT COMPLETEDVandetanib With Carboplatin2

Adverse events651

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

TypeEventOrgan systemGroupAffectedAt riskEvents
otherActivated partial thromboplastin time prolongedInvestigationsCarboplatin2562
otherActivated partial thromboplastin time prolongedInvestigationsVandetanib With Carboplatin55611
otherActivated partial thromboplastin time prolongedInvestigationsCrossover to Vandetanib1421
otherAlanine aminotransferase increasedInvestigationsCarboplatin195629
otherAlanine aminotransferase increasedInvestigationsVandetanib With Carboplatin435674
otherAlanine aminotransferase increasedInvestigationsCrossover to Vandetanib244229
otherAlkaline phosphatase increasedInvestigationsCarboplatin4564
otherAlkaline phosphatase increasedInvestigationsVandetanib With Carboplatin175620
otherAlkaline phosphatase increasedInvestigationsCrossover to Vandetanib6426
otherAnemiaBlood and lymphatic system disordersCarboplatin305667

Adverse event totals9

The totals the trial posted for each group.

TotalGroupAffectedAt risk
Total, all-cause mortalityCarboplatin
Total, all-cause mortalityVandetanib With Carboplatin
Total, all-cause mortalityCrossover to Vandetanib
Total, other adverse eventsCarboplatin5556
Total, other adverse eventsVandetanib With Carboplatin5656
Total, other adverse eventsCrossover to Vandetanib4042
Total, serious adverse eventsCarboplatin1056
Total, serious adverse eventsVandetanib With Carboplatin2156
Total, serious adverse eventsCrossover to Vandetanib1342

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMIDListed asSource
8931682BACKGROUNDPubMed
12672281BACKGROUNDPubMed

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.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

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