Trial · NCT02255461
Palbociclib Isethionate in Treating Younger Patients With Recurrent, Progressive, or Refractory Central Nervous System Tumors
NCT02255461, Phase 1, Terminated, Pediatric Brain Tumor Consortium; results first posted 2020-04-08
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Palbociclib Isethionate in Treating Younger Patients With Recurrent, Progressive, or Refractory Central Nervous System Tumors. Trials, record NCT02255461. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02255461
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Palbociclib Isethionate in Treating Younger Patients With Recurrent, Progressive, or Refractory Central Nervous System Tumors
- NCT number
- NCT02255461
- Status
- Terminated
- Phases
- Phase 1
- Enrollment
- 35 participants, actual
- Lead sponsor
- Pediatric Brain Tumor Consortium
- Conditions
Childhood Choroid Plexus Tumor, Childhood Ependymoblastoma, Childhood Grade III Meningioma, Childhood High-grade Cerebellar Astrocytoma, Childhood High-grade Cerebral Astrocytoma, Childhood Medulloepithelioma, Recurrent Childhood Anaplastic Astrocytoma, Recurrent Childhood Anaplastic Oligoastrocytoma, Recurrent Childhood Anaplastic Oligodendroglioma, Recurrent Childhood Brain Stem Glioma, Recurrent Childhood Cerebellar Astrocytoma, Recurrent Childhood Cerebral Astrocytoma, Recurrent Childhood Giant Cell Glioblastoma, Recurrent Childhood Glioblastoma, Recurrent Childhood Gliomatosis Cerebri, Recurrent Childhood Gliosarcoma, Recurrent Childhood Medulloblastoma, Recurrent Childhood Pineoblastoma, Recurrent Childhood Supratentorial Primitive Neuroectodermal Tumor
- Interventions
- palbociclib isethionate, pharmacological study, laboratory biomarker analysis
- First posted
- 2014-10-02
- Last updated
- 2021-03-02
- Results first posted
- 2020-04-08
Source ClinicalTrials.gov
Registered outcomes25
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum Tolerated Dose (MTD) of Palbociclib in Stratum I | 4 weeks | 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. |
| Primary | Maximum Tolerated Dose (MTD) of Palbociclib in Stratum II | 4 weeks | 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. |
| Primary | Number of Patients Who Experienced Dose Limiting Toxicities (DLTs) | 4 weeks | 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. |
| Primary | Single Dose Apparent Volume of Central Compartment (Vc/F) | Up to day 3 | 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. |
| Primary | Single Dose Elimination Rate Constant (Ke) | Up to day 3 | 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. |
| Primary | Single Dose Half-life (t1/2) | Up to day 3 | 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. |
| Primary | Single Dose Apparent Oral Clearance (CL/F) | Up to day 3 | 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 oral clearance (CL/F) was estimated using a non-compartmental method. |
| Primary | Single Dose Area Under the Plasma Concentration Time Curve (AUC) | Up to day 3 | 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. Area under the plasma concentration time curve (AUC) was estimated using a non-compartmental method. |
| Primary | Steady State Apparent Volume of Central Compartment (Vc/F) | Up to day 22 | On day 21 of course 1, series blood samples for palbociclib pharmacokinetic studies were collected at pre-dose, 1, 2, 4, 8 (±1), 10 (±0.5) optional, and 24 (±4) hours after the dose. Apparent volume of central compartment (Vc/F) was estimated using a non-compartmental method. |
| Primary | Steady State Elimination Rate Constant (Ke) | Up to day 22 | On day 21 of course 1, series blood samples for palbociclib pharmacokinetic studies were collected at pre-dose, 1, 2, 4, 8 (±1), 10 (±0.5) optional, and 24 (±4) hours after the dose. Elimination rate constant (Ke) was estimated using a non-compartmental method. |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 registered outcomesOutcomes25
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Maximum Tolerated Dose (MTD) of Palbociclib in Stratum I | 4 weeks | Patients who were enrolled on stratum I and were evaluable for dose finding assessment were used to determine the MTD for stratum I. | mg/m2/day | NUMBER |
| PRIMARY | Maximum Tolerated Dose (MTD) of Palbociclib in Stratum II | 4 weeks | Patients who were enrolled on stratum II and were evaluable for dose finding assessment were used to determine the MTD for stratum II. | mg/m2/day | NUMBER |
| PRIMARY | Number of Patients Who Experienced Dose Limiting Toxicities (DLTs) | 4 weeks | 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. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Single Dose Apparent Volume of Central Compartment (Vc/F) | Up to day 3 | Patients with blood samples collected for pharmacokinetic studies on days 1-3 of course 1 were included. | L/m^2 | MEDIAN |
| PRIMARY | Single Dose Elimination Rate Constant (Ke) | Up to day 3 | Patients with blood samples collected for pharmacokinetic studies on days 1-3 of course 1 were included. | per hour | MEDIAN |
| PRIMARY | Single Dose Half-life (t1/2) | Up to day 3 | Patients with blood samples collected for pharmacokinetic studies on days 1-3 of course 1 were included. | hour | MEDIAN |
| PRIMARY | Single Dose Apparent Oral Clearance (CL/F) | Up to day 3 | Patients with blood samples collected for pharmacokinetic studies on days 1-3 of course 1 were included. | L/h/m^2 | MEDIAN |
| PRIMARY | Single Dose Area Under the Plasma Concentration Time Curve (AUC) | Up to day 3 | Patients with blood samples collected for pharmacokinetic studies on days 1-3 of course 1 were included. | h*ng/mL | MEDIAN |
| PRIMARY | Steady State Apparent Volume of Central Compartment (Vc/F) | Up to day 22 | Patients with blood samples collected for pharmacokinetic studies on days 21-22 of course 1 were included. | L/m^2 | MEDIAN |
| PRIMARY | Steady State Elimination Rate Constant (Ke) | Up to day 22 | Patients with blood samples collected for pharmacokinetic studies on days 21-22 of course 1 were included. | per hour | MEDIAN |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 outcomesResults by group71
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Maximum Tolerated Dose (MTD) of Palbociclib in Stratum I | Stratum I | 75 | mg/m2/day | ||
| Maximum Tolerated Dose (MTD) of Palbociclib in Stratum II | Stratum II | 75 | mg/m2/day | ||
| Number of Patients Who Experienced Dose Limiting Toxicities (DLTs) | Stratum I, Dose Level 1 (50 mg/m2) | 0 | Participants | ||
| Number of Patients Who Experienced Dose Limiting Toxicities (DLTs) | Stratum I, Dose Level 2 (75 mg/m2) | 2 | Participants | ||
| Number of Patients Who Experienced Dose Limiting Toxicities (DLTs) | Stratum I, Dose Level 3 (95 mg/m2) | 2 | Participants | ||
| Number of Patients Who Experienced Dose Limiting Toxicities (DLTs) | Stratum II, Dose Level 1 (50 mg/m2) | 0 | Participants | ||
| Number of Patients Who Experienced Dose Limiting Toxicities (DLTs) | Stratum II, Dose Level 2 (75mg/m2) | 1 | Participants | ||
| Single Dose Apparent Volume of Central Compartment (Vc/F) | Stratum I, Dose Level 1 (50 mg/m2) | 672 | Full Range 622 to 1189 | L/m^2 | |
| Single Dose Apparent Volume of Central Compartment (Vc/F) | Stratum I, Dose Level 2 (75 mg/m2) | 741 | Full Range 562 to 1856 | L/m^2 | |
| Single Dose Apparent Volume of Central Compartment (Vc/F) | Stratum I, Dose Level 3 (95 mg/m2) | 708 | Full Range 601 to 819 | L/m^2 |
1 to 10 of 71Source ClinicalTrials.gov
See all 71 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Stratum I, Dose Level 1 (50 mg/m2) | 3 | |
| Overall Study | STARTED | Stratum I, Dose Level 2 (75 mg/m2) | 12 | |
| Overall Study | STARTED | Stratum I, Dose Level 3 (95 mg/m2) | 6 | |
| Overall Study | STARTED | Stratum II, Dose Level 1 (50 mg/m2) | 4 | |
| Overall Study | STARTED | Stratum II, Dose Level 2 (75mg/m2) | 10 | |
| Overall Study | COMPLETED | Stratum I, Dose Level 1 (50 mg/m2) | 3 | |
| Overall Study | COMPLETED | Stratum I, Dose Level 2 (75 mg/m2) | 10 | |
| Overall Study | COMPLETED | Stratum I, Dose Level 3 (95 mg/m2) | 5 | |
| Overall Study | COMPLETED | Stratum II, Dose Level 1 (50 mg/m2) | 4 | |
| Overall Study | COMPLETED | Stratum II, Dose Level 2 (75mg/m2) | 8 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events275
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 | Anemia | Blood and lymphatic system disorders | Stratum I, Dose Level 1 (50 mg/m2) | 0 | 3 | 0 |
| other | Anemia | Blood and lymphatic system disorders | Stratum I, Dose Level 2 (75 mg/m2) | 5 | 12 | 6 |
| other | Anemia | Blood and lymphatic system disorders | Stratum I, Dose Level 3 (95 mg/m2) | 2 | 6 | 3 |
| other | Anemia | Blood and lymphatic system disorders | Stratum II, Dose Level 1 (50 mg/m2) | 4 | 4 | 8 |
| other | Anemia | Blood and lymphatic system disorders | Stratum II, Dose Level 2 (75mg/m2) | 6 | 9 | 11 |
| other | Sinus bradycardia | Cardiac disorders | Stratum I, Dose Level 1 (50 mg/m2) | 0 | 3 | 0 |
| other | Sinus bradycardia | Cardiac disorders | Stratum I, Dose Level 2 (75 mg/m2) | 0 | 12 | 0 |
| other | Sinus bradycardia | Cardiac disorders | Stratum I, Dose Level 3 (95 mg/m2) | 1 | 6 | 1 |
| other | Sinus bradycardia | Cardiac disorders | Stratum II, Dose Level 1 (50 mg/m2) | 0 | 4 | 0 |
| other | Sinus bradycardia | Cardiac disorders | Stratum II, Dose Level 2 (75mg/m2) | 0 | 9 | 0 |
1 to 10 of 275Source ClinicalTrials.gov
See all 275 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Stratum I, Dose Level 1 (50 mg/m2) | 0 | 3 |
| Total, all-cause mortality | Stratum I, Dose Level 2 (75 mg/m2) | 3 | 12 |
| Total, all-cause mortality | Stratum I, Dose Level 3 (95 mg/m2) | 1 | 6 |
| Total, all-cause mortality | Stratum II, Dose Level 1 (50 mg/m2) | 1 | 4 |
| Total, all-cause mortality | Stratum II, Dose Level 2 (75mg/m2) | 1 | 9 |
| Total, other adverse events | Stratum I, Dose Level 1 (50 mg/m2) | 3 | 3 |
| Total, other adverse events | Stratum I, Dose Level 2 (75 mg/m2) | 12 | 12 |
| Total, other adverse events | Stratum I, Dose Level 3 (95 mg/m2) | 5 | 6 |
| Total, other adverse events | Stratum II, Dose Level 1 (50 mg/m2) | 4 | 4 |
| Total, other adverse events | Stratum II, Dose Level 2 (75mg/m2) | 9 | 9 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 37553297 | DERIVED |
Source PubMed
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U01CA081457 | Pediatric Brain Tumor Consortium (PBTC) | BOYETT, JAMES MILFORD | ST. JUDE CHILDREN'S RESEARCH HOSPITAL | NATIONAL CANCER INSTITUTE | 1999 to 2013 |
Source NIH RePORTER
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/NCT02255461
GET https://conductscience.org/api/trials/v1/NCT02255461/registered?page=2