Trial · NCT01677741
A Study to Determine Safety, Tolerability and Pharmacokinetics of Oral Dabrafenib In Children and Adolescent Subjects
NCT01677741, Phase 1, Phase 2, Completed, Novartis Pharmaceuticals; results first posted 2021-11-24
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. A Study to Determine Safety, Tolerability and Pharmacokinetics of Oral Dabrafenib In Children and Adolescent Subjects. Trials, record NCT01677741. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01677741
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Determine Safety, Tolerability and Pharmacokinetics of Oral Dabrafenib In Children and Adolescent Subjects
- NCT number
- NCT01677741
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 85 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Neoplasms, Brain
- Interventions
- Dabrafenib
- First posted
- 2012-09-03
- Last updated
- 2021-11-24
- Other registries' IDs
- eudract:2012-001499-12
- Results first posted
- 2021-11-24
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of Treatment Emergent Adverse Events (AEs) in Part 1 (Dose Escalation) | From study treatment start date till 28 days safety follow-up, assessed up to approximately 90 months | The distribution of adverse events was done via the analysis of frequencies for treatment emergent Adverse Events, Serious Adverse Events and Deaths due to AEs, through the monitoring of relevant clinical and laboratory safety parameters. Only descriptive analysis performed. |
| Primary | Maximum Concentration (Cmax) of Dabrafenib | Week 1 Day 1, Week 3 Day 15 | Venous whole blood samples were collected for activity-based pharmacokinetics characterization. Cmax of dabrafenib was listed and summarized using descriptive statistics. |
| Primary | Area Under the Concentration-time Curve Over the Dosing Interval (AUC(0-τ)) and AUC From Zero to Infinity (AUC(0-inf)) of Dabrafenib | Week 1 Day 1 | Venous whole blood samples were collected for activity-based pharmacokinetics characterization. AUC(0-τ) and AUC(0-inf) of dabrafenib were to be listed and summarized using descriptive statistics. |
| Secondary | Pre-dose (Trough) Concentration (C Tau) of Dabrafenib and Its Metabolites | Week 3 Day 15 | Venous whole blood samples were collected for activity-based pharmacokinetics characterization. Pre-dose (trough) concentration (C tau) was to be listed and summarized using descriptive statistics for dabrafenib and its metabolites (hydroxy-dabrafenib \[GSK2285403\], carboxy-dabrafenib \[GSK2298683\], and desmethyl-dabrafenib \[GSK2167542\]). |
| Secondary | The AUC(0-t) of Dabrafenib Metabolites | Week 1 Day 1, Week 3 Day 15 | Venous whole blood samples were collected for activity-based pharmacokinetics characterization. Area under the time-concentration curve from time zero (pre-dose) to last time of quantifiable concentration (AUC\[0-t\]) dabrafenib metabolites (hydroxy-dabrafenib \[GSK2285403\], carboxy-dabrafenib \[GSK2298683\], and desmethyl-dabrafenib \[GSK2167542\]) were to be listed and summarized using descriptive statistics. |
| Secondary | The AUC(0-tau) of Dabrafenib and Its Metabolites | Week 1 Day 1, Week 3 Day 15 | Venous whole blood samples were collected for activity-based pharmacokinetics characterization. Area under the time-concentration curve from time zero (pre-dose) to last time of quantifiable concentration (AUC(0-tau) of dabrafenib and its metabolites (hydroxy-dabrafenib \[GSK2285403\], carboxy-dabrafenib \[GSK2298683\], and desmethyl-dabrafenib \[GSK2167542\]) were to be listed and summarized using descriptive statistics. |
| Secondary | Apparent Total Clearance of the Drug From Plasma After Oral Administration (CL/F) of Dabrafenib | Week 1 Day 1, Week 3 Day 15 | Venous whole blood samples were collected for activity-based pharmacokinetics characterization. CL/F of dabrafenib was to be listed and summarized using descriptive statistics. |
| Secondary | Maximum Concentration (Cmax) of Dabrafenib Metabolites | Week 1 Day 1, Week 3 Day 15 | Venous whole blood samples were collected for activity-based pharmacokinetics characterization. Cmax of dabrafenib metabolites (hydroxy-dabrafenib \[GSK2285403\], carboxy-dabrafenib \[GSK2298683\], and desmethyl-dabrafenib \[GSK2167542\]) were listed and summarized using descriptive statistics. |
| Secondary | Time to Reach Maximum (Peak) Plasma Concentration Following Drug Administration (Tmax) of Dabrafenib and Its Metabolites | Week 1 Day 1, Week 3 Day 15 | Venous whole blood samples were collected for activity-based pharmacokinetics characterization. Tmax was listed and summarized using descriptive statistics for dabrafenib and its metabolites (hydroxy-dabrafenib \[GSK2285403\], carboxy-dabrafenib \[GSK2298683\], and desmethyl-dabrafenib \[GSK2167542\]). |
| Secondary | Elimination Half Life (T½) of Dabrafenib and Its Metabolites | Week 3 Day 15 | Venous whole blood samples were collected for activity-based pharmacokinetics characterization. T1/2 of dabrafenib and its metabolites (hydroxy-dabrafenib \[GSK2285403\], carboxy-dabrafenib \[GSK2298683\], and desmethyl-dabrafenib \[GSK2167542\]) was listed and summarized using descriptive statistics. |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes18
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Incidence of Treatment Emergent Adverse Events (AEs) in Part 1 (Dose Escalation) | From study treatment start date till 28 days safety follow-up, assessed up to approximately 90 months | Safety population. Deaths occurring more than 28 days after the last dose of study drug were not included in the on-treatment deaths. All deaths included on-treatment deaths and those occurring more than 28 days after the last dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Maximum Concentration (Cmax) of Dabrafenib | Week 1 Day 1, Week 3 Day 15 | Pharmacokinetic population. Only participants with an evaluable PK sample collected at each timepoint were included in the analysis. | ng/mL | GEOMETRIC_MEAN |
| PRIMARY | Area Under the Concentration-time Curve Over the Dosing Interval (AUC(0-τ)) and AUC From Zero to Infinity (AUC(0-inf)) of Dabrafenib | Week 1 Day 1 | Pharmacokinetic population. Due to limited dabrafenib PK data collected for Day 1 (up to 4 hours post-dose PK data only), no reliable AUC(0-t) and AUC (0-inf) PK parameters were collected/calculated. | ||
| SECONDARY | Pre-dose (Trough) Concentration (C Tau) of Dabrafenib and Its Metabolites | Week 3 Day 15 | Pharmacokinetic population. For each parameter, only participants with an evaluable PK sample collected were included in the analysis. | ng/mL | GEOMETRIC_MEAN |
| SECONDARY | The AUC(0-t) of Dabrafenib Metabolites | Week 1 Day 1, Week 3 Day 15 | Pharmacokinetic population. Due to limited dabrafenib PK data collected for Day 1 (up to 4 hours post-dose PK data only), no reliable AUC(0-t) PK parameters were collected/calculated. | ||
| SECONDARY | The AUC(0-tau) of Dabrafenib and Its Metabolites | Week 1 Day 1, Week 3 Day 15 | Pharmacokinetic population. Due to limited dabrafenib PK data collected for Day 1 (up to 4 hours post-dose PK data only), no reliable AUC(0-tau) PK parameters were collected/calculated. | ||
| SECONDARY | Apparent Total Clearance of the Drug From Plasma After Oral Administration (CL/F) of Dabrafenib | Week 1 Day 1, Week 3 Day 15 | Pharmacokinetic population. Due to limited dabrafenib PK data collected for Day 1 (up to 4 hours post-dose PK data only), no reliable CL/F PK parameters were collected/calculated. | ||
| SECONDARY | Maximum Concentration (Cmax) of Dabrafenib Metabolites | Week 1 Day 1, Week 3 Day 15 | Pharmacokinetic population. For each parameter, only participants with an evaluable PK sample collected at each timepoint were included in the analysis. | ng/mL | GEOMETRIC_MEAN |
| SECONDARY | Time to Reach Maximum (Peak) Plasma Concentration Following Drug Administration (Tmax) of Dabrafenib and Its Metabolites | Week 1 Day 1, Week 3 Day 15 | Pharmacokinetic population. For each parameter, only participants with an evaluable PK sample collected at each timepoint were included in the analysis. | Hour (hr) | MEDIAN |
| SECONDARY | Elimination Half Life (T½) of Dabrafenib and Its Metabolites | Week 3 Day 15 | Pharmacokinetic population. For each parameter, only participants with an evaluable PK sample collected were included in the analysis. | Hour (hr) | MEAN |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 outcomesResults by group243
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Incidence of Treatment Emergent Adverse Events (AEs) in Part 1 (Dose Escalation) | Part 1 (Dose Escalation): Dabrafenib Treatment (3 mg/kg) | All deaths | 0 | Participants | |
| Incidence of Treatment Emergent Adverse Events (AEs) in Part 1 (Dose Escalation) | Part 1 (Dose Escalation): Dabrafenib Treatment (3.75 mg/kg) | All deaths | 0 | Participants | |
| Incidence of Treatment Emergent Adverse Events (AEs) in Part 1 (Dose Escalation) | Part 1 (Dose Escalation): Dabrafenib Treatment (4.5 mg/kg) | All deaths | 0 | Participants | |
| Incidence of Treatment Emergent Adverse Events (AEs) in Part 1 (Dose Escalation) | Part 1 (Dose Escalation): Dabrafenib Treatment (5.25 mg/kg) | All deaths | 1 | Participants | |
| Incidence of Treatment Emergent Adverse Events (AEs) in Part 1 (Dose Escalation) | Part 1 (Dose Escalation): Dabrafenib Treatment (3 mg/kg) | On-treatment deaths | 0 | Participants | |
| Incidence of Treatment Emergent Adverse Events (AEs) in Part 1 (Dose Escalation) | Part 1 (Dose Escalation): Dabrafenib Treatment (3.75 mg/kg) | On-treatment deaths | 0 | Participants | |
| Incidence of Treatment Emergent Adverse Events (AEs) in Part 1 (Dose Escalation) | Part 1 (Dose Escalation): Dabrafenib Treatment (4.5 mg/kg) | On-treatment deaths | 0 | Participants | |
| Incidence of Treatment Emergent Adverse Events (AEs) in Part 1 (Dose Escalation) | Part 1 (Dose Escalation): Dabrafenib Treatment (5.25 mg/kg) | On-treatment deaths | 1 | Participants | |
| Incidence of Treatment Emergent Adverse Events (AEs) in Part 1 (Dose Escalation) | Part 1 (Dose Escalation): Dabrafenib Treatment (3 mg/kg) | Adverse Events (AEs) | 3 | Participants | |
| Incidence of Treatment Emergent Adverse Events (AEs) in Part 1 (Dose Escalation) | Part 1 (Dose Escalation): Dabrafenib Treatment (3.75 mg/kg) | Adverse Events (AEs) | 10 | Participants |
1 to 10 of 243Source ClinicalTrials.gov
See all 243 results by groupParticipant flow40
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Part 1 (Dose Escalation): Dabrafenib Treatment (3 mg/kg) | 3 | |
| Overall Study | STARTED | Part 1 (Dose Escalation): Dabrafenib Treatment (3.75 mg/kg) | 10 | |
| Overall Study | STARTED | Part 1 (Dose Escalation): Dabrafenib Treatment (4.5 mg/kg) | 8 | |
| Overall Study | STARTED | Part 1 (Dose Escalation): Dabrafenib Treatment (5.25 mg/kg) | 6 | |
| Overall Study | STARTED | Part 2 (Tumor Specific Expansion): Cohort 1 Low-Grade Gliomas (LGG) | 17 | |
| Overall Study | STARTED | Part 2 (Tumor Specific Expansion): Cohort 2 High-Grade Gliomas (HGG) | 28 | |
| Overall Study | STARTED | Part 2 (Tumor Specific Expansion): Cohort 3 Langerhans Cell Histiocytosis (LCH) | 11 | |
| Overall Study | STARTED | Part 2 (Tumor Specific Expansion): Cohort 4 Miscellaneous Tumors (Other) | 2 | |
| Overall Study | DLT Evaluable Population | Part 1 (Dose Escalation): Dabrafenib Treatment (3 mg/kg) | 3 | |
| Overall Study | DLT Evaluable Population | Part 1 (Dose Escalation): Dabrafenib Treatment (3.75 mg/kg) | 10 |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 participant flowAdverse events3,824
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 | Anaemia | Blood and lymphatic system disorders | Part 1 (Dose Escalation): Dabrafenib Treatment (3 mg/kg) | 2 | 3 | |
| other | Anaemia | Blood and lymphatic system disorders | Part 1 (Dose Escalation): Dabrafenib Treatment (3.75 mg/kg) | 2 | 10 | |
| other | Anaemia | Blood and lymphatic system disorders | Part 1 (Dose Escalation): Dabrafenib Treatment (4.5 mg/kg) | 2 | 8 | |
| other | Anaemia | Blood and lymphatic system disorders | Part 1 (Dose Escalation): Dabrafenib Treatment (5.25 mg/kg) | 3 | 6 | |
| other | Anaemia | Blood and lymphatic system disorders | Part 2 (Tumor Specific Expansion): Cohort 1 Low-Grade Gliomas (LGG) | 5 | 17 | |
| other | Anaemia | Blood and lymphatic system disorders | Part 2 (Tumor Specific Expansion): Cohort 2 High-Grade Gliomas (HGG) | 4 | 28 | |
| other | Anaemia | Blood and lymphatic system disorders | Part 2 (Tumor Specific Expansion): Cohort 3 Langerhans Cell Histiocytosis (LCH) | 3 | 11 | |
| other | Anaemia | Blood and lymphatic system disorders | Part 2 (Tumor Specific Expansion): Cohort 4 Miscellaneous Tumors (Other) | 0 | 2 | |
| other | Leukocytosis | Blood and lymphatic system disorders | Part 1 (Dose Escalation): Dabrafenib Treatment (3 mg/kg) | 0 | 3 | |
| other | Leukocytosis | Blood and lymphatic system disorders | Part 1 (Dose Escalation): Dabrafenib Treatment (3.75 mg/kg) | 0 | 10 |
1 to 10 of 3,824Source ClinicalTrials.gov
See all 3,824 adverse eventsAdverse event totals24
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Part 1 (Dose Escalation): Dabrafenib Treatment (3 mg/kg) | 0 | 3 |
| Total, all-cause mortality | Part 1 (Dose Escalation): Dabrafenib Treatment (3.75 mg/kg) | 0 | 10 |
| Total, all-cause mortality | Part 1 (Dose Escalation): Dabrafenib Treatment (4.5 mg/kg) | 0 | 8 |
| Total, all-cause mortality | Part 1 (Dose Escalation): Dabrafenib Treatment (5.25 mg/kg) | 1 | 6 |
| Total, all-cause mortality | Part 2 (Tumor Specific Expansion): Cohort 1 Low-Grade Gliomas (LGG) | 0 | 17 |
| Total, all-cause mortality | Part 2 (Tumor Specific Expansion): Cohort 2 High-Grade Gliomas (HGG) | 0 | 28 |
| Total, all-cause mortality | Part 2 (Tumor Specific Expansion): Cohort 3 Langerhans Cell Histiocytosis (LCH) | 0 | 11 |
| Total, all-cause mortality | Part 2 (Tumor Specific Expansion): Cohort 4 Miscellaneous Tumors (Other) | 0 | 2 |
| Total, other adverse events | Part 1 (Dose Escalation): Dabrafenib Treatment (3 mg/kg) | 3 | 3 |
| Total, other adverse events | Part 1 (Dose Escalation): Dabrafenib Treatment (3.75 mg/kg) | 10 | 10 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse event totalsPapers4
The papers the trial lists on ClinicalTrials.gov.
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/NCT01677741
GET https://conductscience.org/api/trials/v1/NCT01677741/results?page=2