Palbociclib Isethionate in Treating Younger Patients With Recurrent, Progressive, or Refractory Central Nervous System Tumors

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

Rolling-6 design was used to estimate MTD. The MTD was empirically defined as the highest dose level at which six patients were treated with at most one patient experiencing a dose-limiting toxicity (DLT) and the next higher dose level had been determined to be too toxic. Stratum I consisted of less-heavily pre-treated patients.

Patients who were enrolled on stratum I and were evaluable for dose finding assessment were used to determine the MTD for stratum I.

→

primary · POSTED

Rolling-6 design was used to estimate MTD. The MTD was empirically defined as the highest dose level at which six patients were treated with at most one patient experiencing a DLT and the next higher dose level had been determined to be too toxic. Stratum II consisted of heavily pre-treated patients.

Patients who were enrolled on stratum II and were evaluable for dose finding assessment were used to determine the MTD for stratum II.

→

primary · POSTED

DLTs were defined as any of the following adverse events that were at least possibly related to palbociclib that occurred during the first 4 weeks of therapy regardless of expectedness. Hematologic DLTs included grade 3 neutropenia with fever and sepsis, grade 3 thrombocytopenia and/or requiring a platelet transfusion on 2 separate days within a 7-day period, or any grade 4 hematologic toxicity except lymphopenia. Non-hematologic DLTs included any grade 4 non-hematologic toxicity, any grade 3 non-hematologic toxicity with some exceptions (e.g., nausea and vomiting of \< 5 days; diarrhea and/or electrolyte disturbances which have not been maximally treated; AST/ALT elevation that returns to levels meeting eligibility criteria within 7 days of study drug interruption and does not recur upon restarting drug), or any grade 2 non-hematologic toxicity that persists for \> 7 days and is considered medically significant or sufficiently intolerable by patients requires treatment interruption.

Patients who received at least one dose of palbociclib were included in the analysis. One patient in stratum II dose level 2 who withdrew prior to beginning protocol therapy was excluded.

→

primary · POSTED

On day 1 of course 1, series blood samples for palbociclib pharmacokinetic studies were collected at pre-dose, 0.5, 1, 2, 4, 8 (±1), 10 (±0.5) optional, 24 (±4), 48 (±4) hours after the oral dose of palbociclib. Apparent volume of central compartment (Vc/F) was estimated using a non-compartmental method.

Patients with blood samples collected for pharmacokinetic studies on days 1-3 of course 1 were included.

→

primary · POSTED

On day 1 of course 1, series blood samples for palbociclib pharmacokinetic studies were collected at pre-dose, 0.5, 1, 2, 4, 8 (±1), 10 (±0.5) optional, 24 (±4), 48 (±4) hours after the oral dose of palbociclib. Elimination rate constant (Ke) was estimated using a non-compartmental method.

Patients with blood samples collected for pharmacokinetic studies on days 1-3 of course 1 were included.

→

primary · POSTED

On day 1 of course 1, series blood samples for palbociclib pharmacokinetic studies were collected at pre-dose, 0.5, 1, 2, 4, 8 (±1), 10 (±0.5) optional, 24 (±4), 48 (±4) hours after the oral dose of palbociclib. Half-life (t1/2) was estimated using a non-compartmental method.

Patients with blood samples collected for pharmacokinetic studies on days 1-3 of course 1 were included.

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-recurrent-childhood-anaplastic-oligodendroglioma
nct id: NCT02255461
trial label: Palbociclib Isethionate in Treating Younger Patients With Recurrent, Progressive, or Refractory Central Nervous System Tumors
applicability: narrower
applicability note: Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z
provenance class: regulator-cited
discovery note: Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
outcome Count: 6
harms Count: 5
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-recurrent-childhood-anaplastic-oligodendroglioma
nct id
NCT02255461
outcome key
om-0000
source section id
NCT02255461-om-0000
source outcome index
0
endpoint
Maximum Tolerated Dose (MTD) of Palbociclib in Stratum I
endpoint definition
Rolling-6 design was used to estimate MTD. The MTD was empirically defined as the highest dose level at which six patients were treated with at most one patient experiencing a dose-limiting toxicity (DLT) and the next higher dose level had been determined to be too toxic. Stratum I consisted of less-heavily pre-treated patients.
time origin
4 weeks
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Patients who were enrolled on stratum I and were evaluable for dose finding assessment were used to determine the MTD for stratum I.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-recurrent-childhood-anaplastic-oligodendroglioma
nct id
NCT02255461
outcome key
om-0001
source section id
NCT02255461-om-0001
source outcome index
1
endpoint
Maximum Tolerated Dose (MTD) of Palbociclib in Stratum II
endpoint definition
Rolling-6 design was used to estimate MTD. The MTD was empirically defined as the highest dose level at which six patients were treated with at most one patient experiencing a DLT and the next higher dose level had been determined to be too toxic. Stratum II consisted of heavily pre-treated patients.
time origin
4 weeks
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Patients who were enrolled on stratum II and were evaluable for dose finding assessment were used to determine the MTD for stratum II.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-recurrent-childhood-anaplastic-oligodendroglioma
nct id
NCT02255461
outcome key
om-0002
source section id
NCT02255461-om-0002
source outcome index
2
endpoint
Number of Patients Who Experienced Dose Limiting Toxicities (DLTs)
endpoint definition
DLTs were defined as any of the following adverse events that were at least possibly related to palbociclib that occurred during the first 4 weeks of therapy regardless of expectedness. Hematologic DLTs included grade 3 neutropenia with fever and sepsis, grade 3 thrombocytopenia and/or requiring a platelet transfusion on 2 separate days within a 7-day period, or any grade 4 hematologic toxicity except lymphopenia. Non-hematologic DLTs included any grade 4 non-hematologic toxicity, any grade 3 non-hematologic toxicity with some exceptions (e.g., nausea and vomiting of \< 5 days; diarrhea and/or electrolyte disturbances which have not been maximally treated; AST/ALT elevation that returns to levels meeting eligibility criteria within 7 days of study drug interruption and does not recur upon restarting drug), or any grade 2 non-hematologic toxicity that persists for \> 7 days and is considered medically significant or sufficiently intolerable by patients requires treatment interruption.
time origin
4 weeks
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Patients who received at least one dose of palbociclib were included in the analysis. One patient in stratum II dose level 2 who withdrew prior to beginning protocol therapy was excluded.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-recurrent-childhood-anaplastic-oligodendroglioma
nct id
NCT02255461
outcome key
om-0003
source section id
NCT02255461-om-0003
source outcome index
3
endpoint
Single Dose Apparent Volume of Central Compartment (Vc/F)
endpoint definition
On day 1 of course 1, series blood samples for palbociclib pharmacokinetic studies were collected at pre-dose, 0.5, 1, 2, 4, 8 (±1), 10 (±0.5) optional, 24 (±4), 48 (±4) hours after the oral dose of palbociclib. Apparent volume of central compartment (Vc/F) was estimated using a non-compartmental method.
time origin
Up to day 3
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Patients with blood samples collected for pharmacokinetic studies on days 1-3 of course 1 were included.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-recurrent-childhood-anaplastic-oligodendroglioma
nct id
NCT02255461
outcome key
om-0004
source section id
NCT02255461-om-0004
source outcome index
4
endpoint
Single Dose Elimination Rate Constant (Ke)
endpoint definition
On day 1 of course 1, series blood samples for palbociclib pharmacokinetic studies were collected at pre-dose, 0.5, 1, 2, 4, 8 (±1), 10 (±0.5) optional, 24 (±4), 48 (±4) hours after the oral dose of palbociclib. Elimination rate constant (Ke) was estimated using a non-compartmental method.
time origin
Up to day 3
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Patients with blood samples collected for pharmacokinetic studies on days 1-3 of course 1 were included.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-recurrent-childhood-anaplastic-oligodendroglioma
nct id
NCT02255461
outcome key
om-0005
source section id
NCT02255461-om-0005
source outcome index
5
endpoint
Single Dose Half-life (t1/2)
endpoint definition
On day 1 of course 1, series blood samples for palbociclib pharmacokinetic studies were collected at pre-dose, 0.5, 1, 2, 4, 8 (±1), 10 (±0.5) optional, 24 (±4), 48 (±4) hours after the oral dose of palbociclib. Half-life (t1/2) was estimated using a non-compartmental method.
time origin
Up to day 3
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Patients with blood samples collected for pharmacokinetic studies on days 1-3 of course 1 were included.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

arms

release id
clinical-indications-draft-1
disease state id
ds-recurrent-childhood-anaplastic-oligodendroglioma
nct id
NCT02255461
outcome key
om-0000
arm key
OG000
arm label
Stratum I
regimen
Of 21 patients enrolled on stratum I, 2 patients were not evaluable for dose finding assessment due to receiving less than required dose of study drug. The remaining 19 patients were used to determine the MTD for stratum I.
analyzed count
19
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02255461-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-recurrent-childhood-anaplastic-oligodendroglioma
nct id
NCT02255461
outcome key
om-0001
arm key
OG000
arm label
Stratum II
regimen
Of 14 patients enrolled on stratum II, 3 patients were not evaluable for dose finding assessment: 2 patients due to receiving less than required dose of study drug and 1 due to withdrawal consent prior to beginning protocol therapy. The remaining 11 patients were used to determine the MTD for stratum II.
analyzed count
11
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02255461-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-recurrent-childhood-anaplastic-oligodendroglioma
nct id
NCT02255461
outcome key
om-0002
arm key
OG000
arm label
Stratum I, Dose Level 1 (50 mg/m2)
regimen
Less-heavily pre-treated patients received oral palbociclib daily at 50 mg/m2/day for 21 days followed by a week rest (one course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02255461-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-recurrent-childhood-anaplastic-oligodendroglioma
nct id
NCT02255461
outcome key
om-0002
arm key
OG001
arm label
Stratum I, Dose Level 2 (75 mg/m2)
regimen
Less-heavily pre-treated patients received oral palbociclib daily at 75 mg/m2/day for 21 days followed by a week rest (one course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.
analyzed count
12
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02255461-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-recurrent-childhood-anaplastic-oligodendroglioma
nct id
NCT02255461
outcome key
om-0002
arm key
OG002
arm label
Stratum I, Dose Level 3 (95 mg/m2)
regimen
Less-heavily pre-treated patients received oral palbociclib daily at 95 mg/m2/day for 21 days followed by a week rest (one course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.
analyzed count
6
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02255461-om-0002#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-recurrent-childhood-anaplastic-oligodendroglioma
nct id
NCT02255461
outcome key
om-0002
arm key
OG003
arm label
Stratum II, Dose Level 1 (50 mg/m2)
regimen
Heavily pre-treated patients received oral palbociclib daily at 50 mg/m2/day for 21 days followed by a week rest (one course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.
analyzed count
4
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02255461-om-0002#groups/OG003
release id
clinical-indications-draft-1
disease state id
ds-recurrent-childhood-anaplastic-oligodendroglioma
nct id
NCT02255461
outcome key
om-0002
arm key
OG004
arm label
Stratum II, Dose Level 2 (75mg/m2)
regimen
Heavily pre-treated patients received oral palbociclib daily at 75 mg/m2/day for 21 days followed by a week rest (one course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.
analyzed count
9
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02255461-om-0002#groups/OG004
release id
clinical-indications-draft-1
disease state id
ds-recurrent-childhood-anaplastic-oligodendroglioma
nct id
NCT02255461
outcome key
om-0003
arm key
OG000
arm label
Stratum I, Dose Level 1 (50 mg/m2)
regimen
Less-heavily pre-treated patients received oral palbociclib daily at 50 mg/m2/day for 21 days followed by a week rest (one course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02255461-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-recurrent-childhood-anaplastic-oligodendroglioma
nct id
NCT02255461
outcome key
om-0003
arm key
OG001
arm label
Stratum I, Dose Level 2 (75 mg/m2)
regimen
Less-heavily pre-treated patients received oral palbociclib daily at 75 mg/m2/day for 21 days followed by a week rest (one course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.
analyzed count
12
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02255461-om-0003#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-recurrent-childhood-anaplastic-oligodendroglioma
nct id
NCT02255461
outcome key
om-0003
arm key
OG002
arm label
Stratum I, Dose Level 3 (95 mg/m2)
regimen
Less-heavily pre-treated patients received oral palbociclib daily at 95 mg/m2/day for 21 days followed by a week rest (one course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.
analyzed count
6
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02255461-om-0003#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-recurrent-childhood-anaplastic-oligodendroglioma
nct id
NCT02255461
outcome key
om-0003
arm key
OG003
arm label
Stratum II, Dose Level 1 (50 mg/m2)
regimen
Heavily pre-treated patients received oral palbociclib daily at 50 mg/m2/day for 21 days followed by a week rest (one course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.
analyzed count
4
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02255461-om-0003#groups/OG003
release id
clinical-indications-draft-1
disease state id
ds-recurrent-childhood-anaplastic-oligodendroglioma
nct id
NCT02255461
outcome key
om-0003
arm key
OG004
arm label
Stratum II, Dose Level 2 (75mg/m2)
regimen
Heavily pre-treated patients received oral palbociclib daily at 75 mg/m2/day for 21 days followed by a week rest (one course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.
analyzed count
9
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02255461-om-0003#groups/OG004

harms

release id
clinical-indications-draft-1
disease state id
ds-recurrent-childhood-anaplastic-oligodendroglioma
nct id
NCT02255461
harm key
EG000
source section id
NCT02255461-ae
event group key
EG000
event group label
Stratum I, Dose Level 1 (50 mg/m2)
serious affected
0
serious at risk
3
other affected
3
other at risk
3
frequency threshold
5
collection period
Up to 2 years after starting treatment
event definition
Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-recurrent-childhood-anaplastic-oligodendroglioma
nct id
NCT02255461
harm key
EG001
source section id
NCT02255461-ae
event group key
EG001
event group label
Stratum I, Dose Level 2 (75 mg/m2)
serious affected
1
serious at risk
12
other affected
12
other at risk
12
frequency threshold
5
collection period
Up to 2 years after starting treatment
event definition
Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-recurrent-childhood-anaplastic-oligodendroglioma
nct id
NCT02255461
harm key
EG002
source section id
NCT02255461-ae
event group key
EG002
event group label
Stratum I, Dose Level 3 (95 mg/m2)
serious affected
1
serious at risk
6
other affected
5
other at risk
6
frequency threshold
5
collection period
Up to 2 years after starting treatment
event definition
Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-recurrent-childhood-anaplastic-oligodendroglioma
nct id
NCT02255461
harm key
EG003
source section id
NCT02255461-ae
event group key
EG003
event group label
Stratum II, Dose Level 1 (50 mg/m2)
serious affected
0
serious at risk
4
other affected
4
other at risk
4
frequency threshold
5
collection period
Up to 2 years after starting treatment
event definition
Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-recurrent-childhood-anaplastic-oligodendroglioma
nct id
NCT02255461
harm key
EG004
source section id
NCT02255461-ae
event group key
EG004
event group label
Stratum II, Dose Level 2 (75mg/m2)
serious affected
0
serious at risk
9
other affected
9
other at risk
9
frequency threshold
5
collection period
Up to 2 years after starting treatment
event definition
Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

quality of life

setting source links

Preserved source evidence · Not medical advice