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Trial · NCT01227434

A Study of PD 0332991 in Patients With Recurrent Rb Positive Glioblastoma

NCT01227434, Phase 2, Terminated, University of California, San Francisco; results first posted 2015-06-12

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. A Study of PD 0332991 in Patients With Recurrent Rb Positive Glioblastoma. Trials, record NCT01227434. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01227434

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
A Study of PD 0332991 in Patients With Recurrent Rb Positive Glioblastoma
NCT number
NCT01227434
Status
Terminated
Phases
Phase 2
Enrollment
23 participants, actual
Lead sponsor
University of California, San Francisco
Conditions
Glioblastoma, Gliosarcoma, Anaplastic Astrocytoma
Interventions
PD 0332991 (pre-surgery), PD 0332991, Resection as clinical care
First posted
2010-10-25
Last updated
2015-07-17
Results first posted
2015-06-12

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryProgression Free Survivalup to 142 weeks
Efficacy of the small molecule CDK4/6 inhibitor PD 0332991 in patients with recurrent glioblastoma multiforme or gliosarcoma who are Rb positive was measured by progression free survival. A total of 30 patients was intended to be treated; up to 15 patients were to undergo a planned, intended surgical resection and receive drug for 7 days prior to surgery, followed by drug after recovery from surgery; and up to 15 patients were to receive drug without a planned surgical procedure.
SecondaryNumber of Participants With Adverse Events as a Measure of Safety and Tolerability1-2 yearsThe number of participants with protocol related toxicity described by CTCAE version 4.0

Outcomes2

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

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYProgression Free Survivalup to 142 weeksweeksMEAN
SECONDARYNumber of Participants With Adverse Events as a Measure of Safety and Tolerability1-2 yearsparticipantsNUMBER

Results by group4

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

OutcomeGroupCategoryValueSpreadUnits
Progression Free SurvivalSurgical Group4Full Range 3 to 6weeks
Progression Free SurvivalNon-surgical Group14Full Range 1 to 142weeks
Number of Participants With Adverse Events as a Measure of Safety and TolerabilitySurgical Group6participants
Number of Participants With Adverse Events as a Measure of Safety and TolerabilityNon-surgical Group16participants

Participant flow6

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

PeriodMilestoneGroupParticipantsUnits counted
Overall StudySTARTEDSurgical Group6
Overall StudySTARTEDNon-surgical Group16
Overall StudyCOMPLETEDSurgical Group6
Overall StudyCOMPLETEDNon-surgical Group16
Overall StudyNOT COMPLETEDSurgical Group0
Overall StudyNOT COMPLETEDNon-surgical Group0

Adverse events226

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

TypeEventOrgan systemGroupAffectedAt riskEvents
otherAtrial fibrillationCardiac disordersSurgical Group06
otherAtrial fibrillationCardiac disordersNon-surgical Group116
otherSinus tachycardiaCardiac disordersSurgical Group16
otherSinus tachycardiaCardiac disordersNon-surgical Group216
otherTinnitusEar and labyrinth disordersSurgical Group16
otherTinnitusEar and labyrinth disordersNon-surgical Group016
otherCushingoidEndocrine disordersSurgical Group06
otherCushingoidEndocrine disordersNon-surgical Group116
otherBlurred visionEye disordersSurgical Group16
otherBlurred visionEye disordersNon-surgical Group016

Adverse event totals6

The totals the trial posted for each group.

TotalGroupAffectedAt risk
Total, all-cause mortalitySurgical Group
Total, all-cause mortalityNon-surgical Group
Total, other adverse eventsSurgical Group46
Total, other adverse eventsNon-surgical Group1516
Total, serious adverse eventsSurgical Group56
Total, serious adverse eventsNon-surgical Group416

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMIDListed as
30151703DERIVED

Source PubMed

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 comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

ComparisonSource
Surgical Group vs Non-surgical Group: Number of Participants With Adverse Events as a Measure of Safety and TolerabilityTrial comparisons
Surgical Group vs Non-surgical Group: serious adverse eventsTrial 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.

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/NCT01227434

GET https://conductscience.org/api/trials/v1/NCT01227434/events?page=2