Trial · NCT02281760
Dabrafenib and Trametinib in People With BRAF V600E Mutation Positive Lesions in Erdheim Chester Disease
NCT02281760, Phase 2, Completed, National Human Genome Research Institute (NHGRI); results first posted 2021-06-07
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Dabrafenib and Trametinib in People With BRAF V600E Mutation Positive Lesions in Erdheim Chester Disease. Trials, record NCT02281760. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02281760
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Dabrafenib and Trametinib in People With BRAF V600E Mutation Positive Lesions in Erdheim Chester Disease
- NCT number
- NCT02281760
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 9 participants, actual
- Lead sponsor
- National Human Genome Research Institute (NHGRI)
- Conditions
- BRAF V600E Mutation
- Interventions
- Dabrafenib Mesylate, Trametinib Dimethyl Sulfoxide
- First posted
- 2014-11-04
- Last updated
- 2021-08-31
- Results first posted
- 2021-06-07
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Partial Response to Dabrafenib and Trametinib | 24 months | Efficacy of dabrafenib and trametinib as combination therapy in patients with BRAFV600E positive Erdheim Chester Disease based on RECIST 1.1 criteria of a partial response greater than or equal to 30% decrease in at least one target lesion size. |
| Primary | Number of Participants With Adverse Events to Dabrafenib and/or Trametinib | 24 months | Safety of dabrafenib and trametinib as combination therapy, or either drug as single-agent therapy among participants, as measured by the adverse event characteristics of participants. See the adverse event table for list of specific adverse events experienced. |
| Primary | Clinical Response Rate to Dabrafenib/Trametinib Combination Therapy in a Cohort of Patients With BRAFV600E Positive Erdheim Chester Disease. | 24 months | Clinical response rate to dabrafenib and trametinib combination therapy in patients as measured by the percentage of patients who met RECIST 1.1 criteria for a partial response. |
| Secondary | Progression-free Survival in a Cohort of Patients With BRAFV600E Positive Erdheim Chester Disease | 24 months | Progression free survival rate using RECIST 1.1 criteria among participants during the entire study period of 24 months. Progression is defined as a 20% increase in the diameter of target lesions, or a significant increase in a non-target lesion, or the appearance of new lesions. |
| Secondary | Overall Survival in a Cohort of Patients With BRAFV600E Positive Erdheim Chester Disease | 24 months | Overall survival rate among participants defined as the number of patients alive at the end of the 24-month study period. |
| Secondary | Disease Resistance to Dabrafenib/Trametinib Combination Therapy in a Cohort of Patients With BRAFV600E Positive Erdheim Chester Disease | 12 months | Disease resistance to the combination therapy during the active treatment phase of the study. Resistance is defined as evidence of disease progression per RECIST 1.1 in a participant previously exhibiting stable disease or at least a partial response according to RECIST 1.1 criteria. Also, disease progression is defined as the requirement of dosage escalation in order to maintain current efficacy. |
| Secondary | Time Response to Dabrafenib/Trametinib Combination Therapy in a Cohort of Patients With BRAFV600E Positive Erdheim Chester Disease. | 12 months | Time to response to combination therapy defined as the minimum length of time elapsed during the active treatment phase to reach at least a partial response, as defined by RECIST 1.1 criteria. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Partial Response to Dabrafenib and Trametinib | 24 months | All patients who received dabrafenib and trametinib as combination therapy with BRAFV600E positive Erdheim Chester Disease. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Adverse Events to Dabrafenib and/or Trametinib | 24 months | All patients who received dabrafenib and trametinib as combination therapy with BRAFV600E positive Erdheim Chester Disease. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Clinical Response Rate to Dabrafenib/Trametinib Combination Therapy in a Cohort of Patients With BRAFV600E Positive Erdheim Chester Disease. | 24 months | All patients who received dabrafenib and trametinib as combination therapy with BRAFV600E positive Erdheim Chester Disease. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Progression-free Survival in a Cohort of Patients With BRAFV600E Positive Erdheim Chester Disease | 24 months | All patients who received dabrafenib and trametinib as combination therapy with BRAFV600E positive Erdheim Chester Disease. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Overall Survival in a Cohort of Patients With BRAFV600E Positive Erdheim Chester Disease | 24 months | All patients who received dabrafenib and trametinib as combination therapy with BRAFV600E positive Erdheim Chester Disease. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Disease Resistance to Dabrafenib/Trametinib Combination Therapy in a Cohort of Patients With BRAFV600E Positive Erdheim Chester Disease | 12 months | All patients who received dabrafenib and trametinib as combination therapy with BRAFV600E positive Erdheim Chester Disease. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time Response to Dabrafenib/Trametinib Combination Therapy in a Cohort of Patients With BRAFV600E Positive Erdheim Chester Disease. | 12 months | All patients who received dabrafenib and trametinib as combination therapy with BRAFV600E positive Erdheim Chester Disease. | months | MEAN |
Source ClinicalTrials.gov
Results by group7
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Partial Response to Dabrafenib and Trametinib | Combination Therapy With Dabrafenib and Trametinib in Patients With ECD | 4 | Participants | ||
| Number of Participants With Adverse Events to Dabrafenib and/or Trametinib | Combination Therapy With Dabrafenib and Trametinib in Patients With ECD | 6 | Participants | ||
| Clinical Response Rate to Dabrafenib/Trametinib Combination Therapy in a Cohort of Patients With BRAFV600E Positive Erdheim Chester Disease. | Combination Therapy With Dabrafenib and Trametinib in Patients With ECD | 4 | Participants | ||
| Progression-free Survival in a Cohort of Patients With BRAFV600E Positive Erdheim Chester Disease | Combination Therapy With Dabrafenib and Trametinib in Patients With ECD | 5 | Participants | ||
| Overall Survival in a Cohort of Patients With BRAFV600E Positive Erdheim Chester Disease | Combination Therapy With Dabrafenib and Trametinib in Patients With ECD | 6 | Participants | ||
| Disease Resistance to Dabrafenib/Trametinib Combination Therapy in a Cohort of Patients With BRAFV600E Positive Erdheim Chester Disease | Combination Therapy With Dabrafenib and Trametinib in Patients With ECD | 0 | Participants | ||
| Time Response to Dabrafenib/Trametinib Combination Therapy in a Cohort of Patients With BRAFV600E Positive Erdheim Chester Disease. | Combination Therapy With Dabrafenib and Trametinib in Patients With ECD | 5.5 | Full Range 0 to 12 | months |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Combination Therapy With Dabrafenib and Trametinib in Patients With ECD | 6 | |
| Overall Study | COMPLETED | Combination Therapy With Dabrafenib and Trametinib in Patients With ECD | 5 | |
| Overall Study | NOT COMPLETED | Combination Therapy With Dabrafenib and Trametinib in Patients With ECD | 1 |
Source ClinicalTrials.gov
Adverse events73
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 | Combination Therapy With Dabrafenib and Trametinib in Patients With ECD | 6 | 6 | |
| other | Leukopenia | Blood and lymphatic system disorders | Combination Therapy With Dabrafenib and Trametinib in Patients With ECD | 1 | 6 | |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Combination Therapy With Dabrafenib and Trametinib in Patients With ECD | 1 | 6 | |
| other | Dyspnoea | Cardiac disorders | Combination Therapy With Dabrafenib and Trametinib in Patients With ECD | 1 | 6 | |
| other | Syncope | Cardiac disorders | Combination Therapy With Dabrafenib and Trametinib in Patients With ECD | 1 | 6 | |
| other | Vertigo | Ear and labyrinth disorders | Combination Therapy With Dabrafenib and Trametinib in Patients With ECD | 1 | 6 | |
| other | Hyperglycaemia | Endocrine disorders | Combination Therapy With Dabrafenib and Trametinib in Patients With ECD | 1 | 6 | |
| other | Abdominal pain | Gastrointestinal disorders | Combination Therapy With Dabrafenib and Trametinib in Patients With ECD | 2 | 6 | |
| other | Diarrhoea | Gastrointestinal disorders | Combination Therapy With Dabrafenib and Trametinib in Patients With ECD | 3 | 6 | |
| other | Dyspepsia | Gastrointestinal disorders | Combination Therapy With Dabrafenib and Trametinib in Patients With ECD | 2 | 6 |
1 to 10 of 73Source ClinicalTrials.gov
See all 73 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Combination Therapy With Dabrafenib and Trametinib in Patients With ECD | 0 | 6 |
| Total, other adverse events | Combination Therapy With Dabrafenib and Trametinib in Patients With ECD | 6 | 6 |
| Total, serious adverse events | Combination Therapy With Dabrafenib and Trametinib in Patients With ECD | 1 | 6 |
Source ClinicalTrials.gov
Papers3
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/NCT02281760
GET https://conductscience.org/api/trials/v1/NCT02281760/events?page=2