Trial · NCT02367859
Dabrafenib and Trametinib in Treating Patients With BRAF Mutated Ameloblastoma
NCT02367859, Phase 2, Completed, Stanford University; results first posted 2020-01-21
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Dabrafenib and Trametinib in Treating Patients With BRAF Mutated Ameloblastoma. Trials, record NCT02367859. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02367859
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Dabrafenib and Trametinib in Treating Patients With BRAF Mutated Ameloblastoma
- NCT number
- NCT02367859
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 1 participants, actual
- Lead sponsor
- Stanford University
- Conditions
- Ameloblastoma, BRAF Gene Mutation
- Interventions
- Dabrafenib, Trametinib
- First posted
- 2015-02-20
- Last updated
- 2024-01-30
- Results first posted
- 2020-01-21
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Tumor Response | 6 weeks | Tumor response was assessed per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Overall tumor response was assessed as the number of participants achieving either a complete response (CR) or a partial response (PR). The criteria are: * CR = Disappearance of all target lesions * PR = ≥ 30% decrease in the sum of the longest diameter of target lesions * Overall Response (OR) = CR + PR * Progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions, and/or the appearance of one or more new lesion(s) * Stable disease (SD) = Small changes that do not meet any of the above criteria The outcome is reported as the number of participants achieving the different levels of tumor response per RECIST, a number without dispersion. |
| Secondary | Percent Tumor Necrosis | 6 weeks | Percent of tumor necrosis at the time of endpoint biopsy or surgical resection will be assessed. The tumor specimen from resection will be examined and the volume of the necrosis compared to the volume of the total tumor determined by central pathology. Percent tumor necrosis, in increments of 10%, will be determined. The outcome will be reported as the mean percent tumor necrosis, with standard deviation. |
| Secondary | Change in Proliferation | 6 weeks | An immunohistochemical laboratory analysis to assess proliferation will be performed on the initial pre-treatment biopsy (baseline) vs either the endpoint tumor biopsy or the tumor specimen from the resection. Ki-67 immunohistochemistry will be scored by at least 2 pathologists using percentage positive cells as the primary metric. Proliferation will be assessed as the difference from baseline in Ki-67 labeling to the end of treatment (tumor biopsy or the tumor specimen). The outcome will be expressed as the mean, with standard deviation. |
| Secondary | Phosphorylation of Tumor Markers MEK and ERK | 6 weeks | An immunohistochemical laboratory analysis to assess phosphorylation of the tumor markers MEK and ERK on the initial pre-treatment biopsy (baseline) vs either the endpoint tumor biopsy or the tumor specimen from the resection. Immunohistochemistry will be scored by at least 2 pathologists using percentage positive cells and intensity of staining as the primary metrics. Phosphorylation of MEK and ERK will be assessed as the observed difference in phosphorylated MEK and ERK labeling from baseline to the end of treatment (tumor biopsy or the tumor specimen). The outcome will be expressed as the mean, with standard deviation. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Tumor Response | 6 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Percent Tumor Necrosis | 6 weeks | On the basis of futility due to study closure with inadequate accrual, post-surgical research specimens were not analyzed. | ||
| SECONDARY | Change in Proliferation | 6 weeks | On the basis of futility due to study closure with inadequate accrual, post-surgical research specimens were not analyzed. | ||
| SECONDARY | Phosphorylation of Tumor Markers MEK and ERK | 6 weeks | On the basis of futility due to study closure with inadequate accrual, post-surgical research specimens were not analyzed. |
Source ClinicalTrials.gov
Results by group5
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Tumor Response | Treatment (Dabrafenib) | Complete Response (CR) | 0 | Participants | |
| Tumor Response | Treatment (Dabrafenib) | Partial Response (PR) | 0 | Participants | |
| Tumor Response | Treatment (Dabrafenib) | Overall Response (OR) | 0 | Participants | |
| Tumor Response | Treatment (Dabrafenib) | Progressive disease (PD) | 0 | Participants | |
| Tumor Response | Treatment (Dabrafenib) | Stable disease (SD) | 1 | Participants |
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 | Treatment (Dabrafenib) | 1 | |
| Overall Study | COMPLETED | Treatment (Dabrafenib) | 1 | |
| Overall Study | NOT COMPLETED | Treatment (Dabrafenib) | 0 |
Source ClinicalTrials.gov
Adverse events8
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 | Flu like symptoms | General disorders | Treatment (Dabrafenib) | 1 | 1 | 1 |
| other | Headache | Nervous system disorders | Treatment (Dabrafenib) | 1 | 1 | 1 |
| other | Fatigue | General disorders | Treatment (Dabrafenib) | 1 | 1 | 1 |
| other | Myalgia | Musculoskeletal and connective tissue disorders | Treatment (Dabrafenib) | 1 | 1 | 1 |
| other | Rash acneform | Skin and subcutaneous tissue disorders | Treatment (Dabrafenib) | 1 | 1 | 1 |
| other | Weight loss | Investigations | Treatment (Dabrafenib) | 1 | 1 | 1 |
| other | Anorexia | Metabolism and nutrition disorders | Treatment (Dabrafenib) | 1 | 1 | 1 |
| other | Dermatologic syndrome | Skin and subcutaneous tissue disorders | Treatment (Dabrafenib) | 1 | 1 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment (Dabrafenib) | 0 | 1 |
| Total, other adverse events | Treatment (Dabrafenib) | 1 | 1 |
| Total, serious adverse events | Treatment (Dabrafenib) | 0 | 1 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT02367859
GET https://conductscience.org/api/trials/v1/NCT02367859/registered