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
Cite this record
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
On this page
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.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression Free Survival | up 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. |
| Secondary | Number of Participants With Adverse Events as a Measure of Safety and Tolerability | 1-2 years | The number of participants with protocol related toxicity described by CTCAE version 4.0 |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression Free Survival | up to 142 weeks | weeks | MEAN | |
| SECONDARY | Number of Participants With Adverse Events as a Measure of Safety and Tolerability | 1-2 years | participants | NUMBER |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression Free Survival | Surgical Group | 4 | Full Range 3 to 6 | weeks | |
| Progression Free Survival | Non-surgical Group | 14 | Full Range 1 to 142 | weeks | |
| Number of Participants With Adverse Events as a Measure of Safety and Tolerability | Surgical Group | 6 | participants | ||
| Number of Participants With Adverse Events as a Measure of Safety and Tolerability | Non-surgical Group | 16 | participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Surgical Group | 6 | |
| Overall Study | STARTED | Non-surgical Group | 16 | |
| Overall Study | COMPLETED | Surgical Group | 6 | |
| Overall Study | COMPLETED | Non-surgical Group | 16 | |
| Overall Study | NOT COMPLETED | Surgical Group | 0 | |
| Overall Study | NOT COMPLETED | Non-surgical Group | 0 |
Source ClinicalTrials.gov
Adverse events226
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 | Atrial fibrillation | Cardiac disorders | Surgical Group | 0 | 6 | |
| other | Atrial fibrillation | Cardiac disorders | Non-surgical Group | 1 | 16 | |
| other | Sinus tachycardia | Cardiac disorders | Surgical Group | 1 | 6 | |
| other | Sinus tachycardia | Cardiac disorders | Non-surgical Group | 2 | 16 | |
| other | Tinnitus | Ear and labyrinth disorders | Surgical Group | 1 | 6 | |
| other | Tinnitus | Ear and labyrinth disorders | Non-surgical Group | 0 | 16 | |
| other | Cushingoid | Endocrine disorders | Surgical Group | 0 | 6 | |
| other | Cushingoid | Endocrine disorders | Non-surgical Group | 1 | 16 | |
| other | Blurred vision | Eye disorders | Surgical Group | 1 | 6 | |
| other | Blurred vision | Eye disorders | Non-surgical Group | 0 | 16 |
1 to 10 of 226Source ClinicalTrials.gov
See all 226 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Surgical Group | ||
| Total, all-cause mortality | Non-surgical Group | ||
| Total, other adverse events | Surgical Group | 4 | 6 |
| Total, other adverse events | Non-surgical Group | 15 | 16 |
| Total, serious adverse events | Surgical Group | 5 | 6 |
| Total, serious adverse events | Non-surgical Group | 4 | 16 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 30151703 | DERIVED |
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.
| Comparison | Source |
|---|---|
| Surgical Group vs Non-surgical Group: Number of Participants With Adverse Events as a Measure of Safety and Tolerability | Trial comparisons |
| Surgical Group vs Non-surgical Group: serious adverse events | 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/NCT01227434
GET https://conductscience.org/api/trials/v1/NCT01227434/events?page=2