Trial Outcomes & Findings for 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 NCT02530320)
NCT ID: NCT02530320
Last Updated: 2024-11-22
Results Overview
Percentage of patients who have progressed / no progress after 6 months of treatment
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
34 participants
Primary outcome timeframe
6 months
Results posted on
2024-11-22
Participant Flow
A total of 79 patients were screened and eventually 34 patients fulfilled all the inclusion and exclusion criteria.
Participant milestones
| Measure |
Palbociclib (PD0332991)
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.
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|---|---|
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Overall Study
STARTED
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34
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Overall Study
COMPLETED
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34
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
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
Baseline characteristics by cohort
| Measure |
Patients With Recurrent Anaplastic (Grade III) Oligodendrogliomas.
n=34 Participants
All patients included in the study received treatment with the experimental drug, Palbociclib, at a dose of 125 mg/day on days 1-21 in 28-day cycles. The IMP was administered for 21 days followed by 7 days off. Treatment cycles continued until there was unacceptable toxicity, tumor progression, withdrawal of consent or death.
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|---|---|
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Age, Continuous
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50.7 years
n=5 Participants
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Sex: Female, Male
Female
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11 Participants
n=5 Participants
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Sex: Female, Male
Male
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23 Participants
n=5 Participants
|
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Asian
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
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Race (NIH/OMB)
Black or African American
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
34 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
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ECOG, Categorical
ECOG 0
|
10 Participants
n=5 Participants
|
|
ECOG, Categorical
ECOG 1
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19 Participants
n=5 Participants
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ECOG, Categorical
ECOG 2
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5 Participants
n=5 Participants
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Prior treatment Temozolomide
Temozolamide
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30 Participants
n=5 Participants
|
|
Prior treatment Temozolomide
Nitrosoureas
|
23 Participants
n=5 Participants
|
|
Prior treatment Temozolomide
Radiotherapy
|
34 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: 6 monthsPercentage of patients who have progressed / no progress after 6 months of treatment
Outcome measures
| Measure |
Patients With Recurrent Anaplastic (Grade III) Oligodendrogliomas.
n=34 Participants
Patients with recurrent anaplastic (Grade III) oligodendrogliomas ith preservation of activity of the RB protein.
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|---|---|
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Progression-free Survival (PFS) at Six Months (PFS6m)
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21 Percentage of participants
Interval 11.0 to 41.0
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SECONDARY outcome
Timeframe: Three yearsPopulation: 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.
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.
Outcome measures
| Measure |
Patients With Recurrent Anaplastic (Grade III) Oligodendrogliomas.
n=34 Participants
Patients with recurrent anaplastic (Grade III) oligodendrogliomas ith preservation of activity of the RB protein.
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|---|---|
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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.)
Adverse envents (any)
|
33 Participants
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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.)
Adverse events (≥ Grade 3)
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25 Participants
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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.)
TRAEs (any)
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29 Participants
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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.)
TRAEs (≥ Grade 3)
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22 Participants
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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.)
SAE (any)
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7 Participants
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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.)
SAE no related
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7 Participants
|
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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.)
Toxicity (any)
|
29 Participants
|
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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.)
Toxicity grade≥3
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22 Participants
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SECONDARY outcome
Timeframe: 30 monthsPopulation: Patients with recurrent anaplastic (Grade III) oligodendrogliomas
According to RANO criteria, assessed by the PI of each center. There will be a central review.
Outcome measures
| Measure |
Patients With Recurrent Anaplastic (Grade III) Oligodendrogliomas.
n=34 Participants
Patients with recurrent anaplastic (Grade III) oligodendrogliomas ith preservation of activity of the RB protein.
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|---|---|
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Anti-tumor Response According to RANO Criteria
No evaluated
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1 Participants
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Anti-tumor Response According to RANO Criteria
Stable disease (SD)
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13 Participants
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Anti-tumor Response According to RANO Criteria
Progression disease (PD)
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20 Participants
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SECONDARY outcome
Timeframe: With a median follow-up of 12 (0.9-52.2) monthsTime from randomization to death by any cause.
Outcome measures
| Measure |
Patients With Recurrent Anaplastic (Grade III) Oligodendrogliomas.
n=34 Participants
Patients with recurrent anaplastic (Grade III) oligodendrogliomas ith preservation of activity of the RB protein.
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|---|---|
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Overall Survival (OS)
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32 months
Interval 11.0 to
upper limit of confidence interval not estimable due to an insufficient number of participants with events
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SECONDARY outcome
Timeframe: 30 monthsPopulation: Percentage of patients decreasing doses of corticosteroids during treatment. Corticoids evolution
Percentage of patients decreasing doses of corticosteroids during treatment. Corticoids evolution
Outcome measures
| Measure |
Patients With Recurrent Anaplastic (Grade III) Oligodendrogliomas.
n=34 Participants
Patients with recurrent anaplastic (Grade III) oligodendrogliomas ith preservation of activity of the RB protein.
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|---|---|
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Changes in the Use of Glucocorticoids
No corticoids
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21 Participants
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Changes in the Use of Glucocorticoids
NA or not reported
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7 Participants
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Changes in the Use of Glucocorticoids
Decrease
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1 Participants
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Changes in the Use of Glucocorticoids
Increase
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3 Participants
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Changes in the Use of Glucocorticoids
Stable
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2 Participants
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Adverse Events
Patients With Recurrent Anaplastic (Grade III) Oligodendrogliomas.
Serious events: 7 serious events
Other events: 24 other events
Deaths: 16 deaths
Serious adverse events
| Measure |
Patients With Recurrent Anaplastic (Grade III) Oligodendrogliomas.
n=34 participants at risk
Patients with recurrent anaplastic (Grade III) oligodendrogliomas ith preservation of activity of the RB protein.
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|---|---|
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Nervous system disorders
Ataxia - G2
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2.9%
1/34 • Number of events 1 • Adverse events will be monitored from first dose of study treatment until 30+/-3 days after end of treatment, an average of three years Events will be followed up until resolved or deemed irreversible, which what happens later.
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General disorders
Cognitive disturbance - G3
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2.9%
1/34 • Number of events 1 • Adverse events will be monitored from first dose of study treatment until 30+/-3 days after end of treatment, an average of three years Events will be followed up until resolved or deemed irreversible, which what happens later.
|
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General disorders
Seizure - G2
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2.9%
1/34 • Number of events 1 • Adverse events will be monitored from first dose of study treatment until 30+/-3 days after end of treatment, an average of three years Events will be followed up until resolved or deemed irreversible, which what happens later.
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General disorders
Dysphasia - G3
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2.9%
1/34 • Number of events 1 • Adverse events will be monitored from first dose of study treatment until 30+/-3 days after end of treatment, an average of three years Events will be followed up until resolved or deemed irreversible, which what happens later.
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Surgical and medical procedures
Surgical and medical procedures - Other, glioma exeresis - G1
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2.9%
1/34 • Number of events 1 • Adverse events will be monitored from first dose of study treatment until 30+/-3 days after end of treatment, an average of three years Events will be followed up until resolved or deemed irreversible, which what happens later.
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General disorders
Cognitive impairment - G3
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2.9%
1/34 • Number of events 1 • Adverse events will be monitored from first dose of study treatment until 30+/-3 days after end of treatment, an average of three years Events will be followed up until resolved or deemed irreversible, which what happens later.
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General disorders
General disorders and administration site conditions - Other, clinical deterioration - G3
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2.9%
1/34 • Number of events 1 • Adverse events will be monitored from first dose of study treatment until 30+/-3 days after end of treatment, an average of three years Events will be followed up until resolved or deemed irreversible, which what happens later.
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Metabolism and nutrition disorders
Hyperglycaemia - G4
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2.9%
1/34 • Number of events 1 • Adverse events will be monitored from first dose of study treatment until 30+/-3 days after end of treatment, an average of three years Events will be followed up until resolved or deemed irreversible, which what happens later.
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General disorders
Confusion - G3
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2.9%
1/34 • Number of events 1 • Adverse events will be monitored from first dose of study treatment until 30+/-3 days after end of treatment, an average of three years Events will be followed up until resolved or deemed irreversible, which what happens later.
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Musculoskeletal and connective tissue disorders
Muscle weakness left-sided - G2
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2.9%
1/34 • Number of events 1 • Adverse events will be monitored from first dose of study treatment until 30+/-3 days after end of treatment, an average of three years Events will be followed up until resolved or deemed irreversible, which what happens later.
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Other adverse events
| Measure |
Patients With Recurrent Anaplastic (Grade III) Oligodendrogliomas.
n=34 participants at risk
Patients with recurrent anaplastic (Grade III) oligodendrogliomas ith preservation of activity of the RB protein.
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|---|---|
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Immune system disorders
Neutrophil count decreased
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70.6%
24/34 • Number of events 24 • Adverse events will be monitored from first dose of study treatment until 30+/-3 days after end of treatment, an average of three years Events will be followed up until resolved or deemed irreversible, which what happens later.
|
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Respiratory, thoracic and mediastinal disorders
Fatigue
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58.8%
20/34 • Number of events 20 • Adverse events will be monitored from first dose of study treatment until 30+/-3 days after end of treatment, an average of three years Events will be followed up until resolved or deemed irreversible, which what happens later.
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Blood and lymphatic system disorders
Platelet count decreased
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50.0%
17/34 • Number of events 17 • Adverse events will be monitored from first dose of study treatment until 30+/-3 days after end of treatment, an average of three years Events will be followed up until resolved or deemed irreversible, which what happens later.
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Blood and lymphatic system disorders
Anaemia
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23.5%
8/34 • Number of events 8 • Adverse events will be monitored from first dose of study treatment until 30+/-3 days after end of treatment, an average of three years Events will be followed up until resolved or deemed irreversible, which what happens later.
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Gastrointestinal disorders
Diarrhoea
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20.6%
7/34 • Number of events 7 • Adverse events will be monitored from first dose of study treatment until 30+/-3 days after end of treatment, an average of three years Events will be followed up until resolved or deemed irreversible, which what happens later.
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Gastrointestinal disorders
Nausea
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17.6%
6/34 • Number of events 6 • Adverse events will be monitored from first dose of study treatment until 30+/-3 days after end of treatment, an average of three years Events will be followed up until resolved or deemed irreversible, which what happens later.
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Nervous system disorders
Cognitive disturbance
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14.7%
5/34 • Number of events 5 • Adverse events will be monitored from first dose of study treatment until 30+/-3 days after end of treatment, an average of three years Events will be followed up until resolved or deemed irreversible, which what happens later.
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Nervous system disorders
Seizure
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11.8%
4/34 • Number of events 4 • Adverse events will be monitored from first dose of study treatment until 30+/-3 days after end of treatment, an average of three years Events will be followed up until resolved or deemed irreversible, which what happens later.
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General disorders
Flu like symptoms
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14.7%
5/34 • Number of events 5 • Adverse events will be monitored from first dose of study treatment until 30+/-3 days after end of treatment, an average of three years Events will be followed up until resolved or deemed irreversible, which what happens later.
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Gastrointestinal disorders
Dyspepsia
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14.7%
5/34 • Number of events 5 • Adverse events will be monitored from first dose of study treatment until 30+/-3 days after end of treatment, an average of three years Events will be followed up until resolved or deemed irreversible, which what happens later.
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Nervous system disorders
Cephalea
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14.7%
5/34 • Number of events 5 • Adverse events will be monitored from first dose of study treatment until 30+/-3 days after end of treatment, an average of three years Events will be followed up until resolved or deemed irreversible, which what happens later.
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Skin and subcutaneous tissue disorders
Pruritus
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11.8%
4/34 • Number of events 4 • Adverse events will be monitored from first dose of study treatment until 30+/-3 days after end of treatment, an average of three years Events will be followed up until resolved or deemed irreversible, which what happens later.
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Gastrointestinal disorders
Vomiting
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8.8%
3/34 • Number of events 3 • Adverse events will be monitored from first dose of study treatment until 30+/-3 days after end of treatment, an average of three years Events will be followed up until resolved or deemed irreversible, which what happens later.
|
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Musculoskeletal and connective tissue disorders
Muscle weakness left-sided
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8.8%
3/34 • Number of events 3 • Adverse events will be monitored from first dose of study treatment until 30+/-3 days after end of treatment, an average of three years Events will be followed up until resolved or deemed irreversible, which what happens later.
|
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General disorders
Fever
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8.8%
3/34 • Number of events 3 • Adverse events will be monitored from first dose of study treatment until 30+/-3 days after end of treatment, an average of three years Events will be followed up until resolved or deemed irreversible, which what happens later.
|
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Respiratory, thoracic and mediastinal disorders
Epistaxis
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8.8%
3/34 • Number of events 3 • Adverse events will be monitored from first dose of study treatment until 30+/-3 days after end of treatment, an average of three years Events will be followed up until resolved or deemed irreversible, which what happens later.
|
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Nervous system disorders
Dizziness
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8.8%
3/34 • Number of events 3 • Adverse events will be monitored from first dose of study treatment until 30+/-3 days after end of treatment, an average of three years Events will be followed up until resolved or deemed irreversible, which what happens later.
|
|
Psychiatric disorders
Confusion
|
5.9%
2/34 • Number of events 2 • Adverse events will be monitored from first dose of study treatment until 30+/-3 days after end of treatment, an average of three years Events will be followed up until resolved or deemed irreversible, which what happens later.
|
|
Nervous system disorders
Cognitive impairment
|
5.9%
2/34 • Number of events 2 • Adverse events will be monitored from first dose of study treatment until 30+/-3 days after end of treatment, an average of three years Events will be followed up until resolved or deemed irreversible, which what happens later.
|
|
Blood and lymphatic system disorders
White blood cell decreased
|
5.9%
2/34 • Number of events 2 • Adverse events will be monitored from first dose of study treatment until 30+/-3 days after end of treatment, an average of three years Events will be followed up until resolved or deemed irreversible, which what happens later.
|
|
Renal and urinary disorders
Urinary incontinence
|
5.9%
2/34 • Number of events 2 • Adverse events will be monitored from first dose of study treatment until 30+/-3 days after end of treatment, an average of three years Events will be followed up until resolved or deemed irreversible, which what happens later.
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications - other, Lip wound
|
5.9%
2/34 • Number of events 2 • Adverse events will be monitored from first dose of study treatment until 30+/-3 days after end of treatment, an average of three years Events will be followed up until resolved or deemed irreversible, which what happens later.
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|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
5.9%
2/34 • Number of events 2 • Adverse events will be monitored from first dose of study treatment until 30+/-3 days after end of treatment, an average of three years Events will be followed up until resolved or deemed irreversible, which what happens later.
|
|
Gastrointestinal disorders
Dysphagia
|
5.9%
2/34 • Number of events 2 • Adverse events will be monitored from first dose of study treatment until 30+/-3 days after end of treatment, an average of three years Events will be followed up until resolved or deemed irreversible, which what happens later.
|
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Musculoskeletal and connective tissue disorders
Back pain
|
5.9%
2/34 • Number of events 2 • Adverse events will be monitored from first dose of study treatment until 30+/-3 days after end of treatment, an average of three years Events will be followed up until resolved or deemed irreversible, which what happens later.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place