Trial · NCT02530320
Safety and Efficacy of PD0332991 (Palbociclib), a Cyclin-dependent Kinase 4 and 6 Inhibitor, in Patients With Oligodendroglioma or Recurrent Oligoastrocytoma Anaplastic With the Activity of the Protein RB Preserved
NCT02530320, Phase 2, Completed, Grupo Español de Investigación en Neurooncología; results first posted 2024-11-22
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety and Efficacy of PD0332991 (Palbociclib), a Cyclin-dependent Kinase 4 and 6 Inhibitor, in Patients With Oligodendroglioma or Recurrent Oligoastrocytoma Anaplastic With the Activity of the Protein RB Preserved. Trials, record NCT02530320. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02530320
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
Safety and Efficacy of PD0332991 (Palbociclib), a Cyclin-dependent Kinase 4 and 6 Inhibitor, in Patients With Oligodendroglioma or Recurrent Oligoastrocytoma Anaplastic With the Activity of the Protein RB Preserved
- NCT number
- NCT02530320
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 34 participants, actual
- Lead sponsor
- Grupo Español de Investigación en Neurooncología
- Conditions
- Oligodendroglioma, Oligoastrocytoma
- Interventions
- Palbociclib
- First posted
- 2015-08-21
- Last updated
- 2024-11-22
- Results first posted
- 2024-11-22
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free Survival (PFS) at Six Months (PFS6m) | 6 months | Percentage of patients who have progressed / no progress after 6 months of treatment |
| Secondary | Safety and Tolerability of Oral Administration of PD0332991 (Reported Adverse Events, Physical Examinations and Laboratory Tests. Toxicity Will be Classified and Tabulated by NCI-CTCAE v 4.0.) | Three years | Type, incidence, severity, frequency, severity and relationship with IMP of reported adverse events, physical examinations and laboratory tests. Toxicity will be classified and tabulated by NCI-CTCAE v 4.0. |
| Secondary | Anti-tumor Response According to RANO Criteria | 30 months | According to RANO criteria, assessed by the PI of each center. There will be a central review. |
| Secondary | Overall Survival (OS) | With a median follow-up of 12 (0.9-52.2) months | Time from randomization to death by any cause. |
| Secondary | Changes in the Use of Glucocorticoids | 30 months | Percentage of patients decreasing doses of corticosteroids during treatment. Corticoids evolution |
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 | Progression-free Survival (PFS) at Six Months (PFS6m) | 6 months | Percentage of participants | NUMBER | |
| SECONDARY | Safety and Tolerability of Oral Administration of PD0332991 (Reported Adverse Events, Physical Examinations and Laboratory Tests. Toxicity Will be Classified and Tabulated by NCI-CTCAE v 4.0.) | Three years | Palbociclib will be administrated orally at a dose of 125 mg/day during 21 days followed by a break of 7 days. All patients included will be treated in the same arm. Treatment will be administrated until disease progression, unacceptable adverse side effects or study end.~Palbociclib: Palbociclib will be administered orally at a dose of 125 mg/day, until disease progression, unacceptable adverse side effects or study end. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Anti-tumor Response According to RANO Criteria | 30 months | Patients with recurrent anaplastic (Grade III) oligodendrogliomas | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Overall Survival (OS) | With a median follow-up of 12 (0.9-52.2) months | months | MEDIAN | |
| SECONDARY | Changes in the Use of Glucocorticoids | 30 months | Percentage of patients decreasing doses of corticosteroids during treatment. Corticoids evolution | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-free Survival (PFS) at Six Months (PFS6m) | Patients With Recurrent Anaplastic (Grade III) Oligodendrogliomas. | 21 | 95% Confidence Interval 11 to 41 | Percentage of participants | |
| Safety and Tolerability of Oral Administration of PD0332991 (Reported Adverse Events, Physical Examinations and Laboratory Tests. Toxicity Will be Classified and Tabulated by NCI-CTCAE v 4.0.) | Palbociclib (PD0332991) | Adverse envents (any) | 33 | Participants | |
| Safety and Tolerability of Oral Administration of PD0332991 (Reported Adverse Events, Physical Examinations and Laboratory Tests. Toxicity Will be Classified and Tabulated by NCI-CTCAE v 4.0.) | Palbociclib (PD0332991) | Adverse events (≥ Grade 3) | 25 | Participants | |
| Safety and Tolerability of Oral Administration of PD0332991 (Reported Adverse Events, Physical Examinations and Laboratory Tests. Toxicity Will be Classified and Tabulated by NCI-CTCAE v 4.0.) | Palbociclib (PD0332991) | TRAEs (any) | 29 | Participants | |
| Safety and Tolerability of Oral Administration of PD0332991 (Reported Adverse Events, Physical Examinations and Laboratory Tests. Toxicity Will be Classified and Tabulated by NCI-CTCAE v 4.0.) | Palbociclib (PD0332991) | TRAEs (≥ Grade 3) | 22 | Participants | |
| Safety and Tolerability of Oral Administration of PD0332991 (Reported Adverse Events, Physical Examinations and Laboratory Tests. Toxicity Will be Classified and Tabulated by NCI-CTCAE v 4.0.) | Palbociclib (PD0332991) | SAE (any) | 7 | Participants | |
| Safety and Tolerability of Oral Administration of PD0332991 (Reported Adverse Events, Physical Examinations and Laboratory Tests. Toxicity Will be Classified and Tabulated by NCI-CTCAE v 4.0.) | Palbociclib (PD0332991) | SAE no related | 7 | Participants | |
| Safety and Tolerability of Oral Administration of PD0332991 (Reported Adverse Events, Physical Examinations and Laboratory Tests. Toxicity Will be Classified and Tabulated by NCI-CTCAE v 4.0.) | Palbociclib (PD0332991) | Toxicity (any) | 29 | Participants | |
| Safety and Tolerability of Oral Administration of PD0332991 (Reported Adverse Events, Physical Examinations and Laboratory Tests. Toxicity Will be Classified and Tabulated by NCI-CTCAE v 4.0.) | Palbociclib (PD0332991) | Toxicity grade≥3 | 22 | Participants | |
| Anti-tumor Response According to RANO Criteria | Patients With Recurrent Anaplastic (Grade III) Oligodendrogliomas. | No evaluated | 1 | Participants |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Palbociclib (PD0332991) | 34 | |
| Overall Study | COMPLETED | Palbociclib (PD0332991) | 34 | |
| Overall Study | NOT COMPLETED | Palbociclib (PD0332991) | 0 |
Source ClinicalTrials.gov
Adverse events35
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 | Neutrophil count decreased | Immune system disorders | Patients With Recurrent Anaplastic (Grade III) Oligodendrogliomas. | 24 | 34 | 24 |
| other | Fatigue | Respiratory, thoracic and mediastinal disorders | Patients With Recurrent Anaplastic (Grade III) Oligodendrogliomas. | 20 | 34 | 20 |
| other | Platelet count decreased | Blood and lymphatic system disorders | Patients With Recurrent Anaplastic (Grade III) Oligodendrogliomas. | 17 | 34 | 17 |
| other | Anaemia | Blood and lymphatic system disorders | Patients With Recurrent Anaplastic (Grade III) Oligodendrogliomas. | 8 | 34 | 8 |
| other | Diarrhoea | Gastrointestinal disorders | Patients With Recurrent Anaplastic (Grade III) Oligodendrogliomas. | 7 | 34 | 7 |
| other | Nausea | Gastrointestinal disorders | Patients With Recurrent Anaplastic (Grade III) Oligodendrogliomas. | 6 | 34 | 6 |
| other | Cognitive disturbance | Nervous system disorders | Patients With Recurrent Anaplastic (Grade III) Oligodendrogliomas. | 5 | 34 | 5 |
| other | Seizure | Nervous system disorders | Patients With Recurrent Anaplastic (Grade III) Oligodendrogliomas. | 4 | 34 | 4 |
| other | Flu like symptoms | General disorders | Patients With Recurrent Anaplastic (Grade III) Oligodendrogliomas. | 5 | 34 | 5 |
| other | Dyspepsia | Gastrointestinal disorders | Patients With Recurrent Anaplastic (Grade III) Oligodendrogliomas. | 5 | 34 | 5 |
1 to 10 of 35Source ClinicalTrials.gov
See all 35 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Patients With Recurrent Anaplastic (Grade III) Oligodendrogliomas. | 16 | 34 |
| Total, other adverse events | Patients With Recurrent Anaplastic (Grade III) Oligodendrogliomas. | 24 | 34 |
| Total, serious adverse events | Patients With Recurrent Anaplastic (Grade III) Oligodendrogliomas. | 7 | 34 |
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 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/NCT02530320
GET https://conductscience.org/api/trials/v1/NCT02530320/events?page=2