Trial · NCT03332589
E6201 Plus Dabrafenib for the Treatment of Metastatic Melanoma Central Nervous System Metastases (CNS)
NCT03332589, Phase 1, Terminated, Spirita Oncology, LLC; results first posted 2022-05-20
3 sourcestrials-2026-11-12-0.4.0
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ConductScience Library. E6201 Plus Dabrafenib for the Treatment of Metastatic Melanoma Central Nervous System Metastases (CNS). Trials, record NCT03332589. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03332589
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- E6201 Plus Dabrafenib for the Treatment of Metastatic Melanoma Central Nervous System Metastases (CNS)
- NCT number
- NCT03332589
- Status
- Terminated
- Phases
- Phase 1
- Enrollment
- 4 participants, actual
- Lead sponsor
- Spirita Oncology, LLC
- Conditions
- Malignant Melanoma, Brain Metastases
- Interventions
- E6201, E6201 plus dabrafenib
- First posted
- 2017-11-06
- Last updated
- 2022-05-20
- Results first posted
- 2022-05-20
- Limitations and caveats
- Due to the departure of the study PI from the institution, the study was terminated early.
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Intracranial Disease Overall Response Rate by RANO-BM | At the end of Cycle 2 and every 2 cycles through 6 months following last dose of study drug (each cycle is 28 days) up to 1 year. | CNS disease response will be assessed by Response Assessment in Neuro-Oncology - Brain Metastases (RANO-BM) |
| Primary | Intracranial Disease Overall Response Rate by RECIST 1.1 | At the end of Cycle 2 and every 2 cycles through 6 months following last dose of study drug (each cycle is 28 days) up to 1 year. | CNS disease response will be assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 |
| Secondary | Intracranial Disease Duration of Response | At the end of Cycle 2 and every 2 cycles through 6 months following last dose of study drug (each cycle is 28 days) up to 1 year. | Length of time from the first evidence of Objective Response (complete response or partial response) to the first evidence of progression |
| Secondary | Systemic Disease Overall Response Rate (Other Than in the CNS) | At the end of Cycle 2 and every 2 cycles through 6 months following last dose of study drug (each cycle is 28 days) up to 1 year. | Systemic disease response will be assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1RECIST 1.1. |
| Secondary | Progression-Free Survival | From Cycle 1 Day 1 through 6 months following the last dose of study drug (each cycle is 28 days) up to 1 year. | Length of time from the date of first administration of study drug to the first evidence of disease progression or death, whichever is earlier |
| Secondary | Overall Survival | From Cycle 1 Day 1 through 6 months following the last dose of study drug or death, whichever is earlier (each cycle is 28 days) up to 1 year. | Length of time from the date of first administration of study drug to the date of death from any cause |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Intracranial Disease Overall Response Rate by RANO-BM | At the end of Cycle 2 and every 2 cycles through 6 months following last dose of study drug (each cycle is 28 days) up to 1 year. | The analysis population was the per-protocol set (PPS). The PPS included all participants in the full analysis set (FAS) who had a valid baseline and one or more post-treatment assessments for a specific measure. No participants were enrolled in the Combination Safety Run-In or Expansion Phases of the study. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Intracranial Disease Overall Response Rate by RECIST 1.1 | At the end of Cycle 2 and every 2 cycles through 6 months following last dose of study drug (each cycle is 28 days) up to 1 year. | The analysis population was the per-protocol set (PPS). The PPS included all participants in the full analysis set (FAS) who had a valid baseline and one or more post-treatment assessments for a specific measure. No participants were enrolled in the Combination Safety Run-In or Expansion phases of the study. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Intracranial Disease Duration of Response | At the end of Cycle 2 and every 2 cycles through 6 months following last dose of study drug (each cycle is 28 days) up to 1 year. | There were no Objective Responses during the study. Thus, Duration of Response could not be calculated. | ||
| SECONDARY | Systemic Disease Overall Response Rate (Other Than in the CNS) | At the end of Cycle 2 and every 2 cycles through 6 months following last dose of study drug (each cycle is 28 days) up to 1 year. | The analysis population was the per-protocol set (PPS). The PPS included all participants in the full analysis set (FAS) who had a valid baseline and one or more post-treatment assessments for a specific measure. No subjects were enrolled in the Combination Safety Run-In or Expansion Phases of the study. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Progression-Free Survival | From Cycle 1 Day 1 through 6 months following the last dose of study drug (each cycle is 28 days) up to 1 year. | The analysis population was the per-protocol set (PPS). The PPS included all participants in the full analysis set (FAS) who had a valid baseline and one or more post-treatment assessments for a specific measure. No subjects were enrolled in the Combination Safety Run-In or Expansion Phases of the study. | months | MEDIAN |
| SECONDARY | Overall Survival | From Cycle 1 Day 1 through 6 months following the last dose of study drug or death, whichever is earlier (each cycle is 28 days) up to 1 year. | The analysis population was the per-protocol set (PPS). The PPS included all participants in the full analysis set (FAS) who had a valid baseline and one or more post-treatment assessments for a specific measure. No subjects were enrolled in the Combination Safety Run-In or Expansion Phases of the study. | months | MEDIAN |
Source ClinicalTrials.gov
Results by group47
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Intracranial Disease Overall Response Rate by RANO-BM | Monotherapy Safety Run-in: E6201 | Complete Response | 0 | Participants | |
| Intracranial Disease Overall Response Rate by RANO-BM | Combination Safety Run-in: E6201 Plus Dabrafenib | Complete Response | 0 | Participants | |
| Intracranial Disease Overall Response Rate by RANO-BM | Expansion: E6201 Plus Dabrafenib | Complete Response | 0 | Participants | |
| Intracranial Disease Overall Response Rate by RANO-BM | Monotherapy Safety Run-in: E6201 | Partial Response | 0 | Participants | |
| Intracranial Disease Overall Response Rate by RANO-BM | Combination Safety Run-in: E6201 Plus Dabrafenib | Partial Response | 0 | Participants | |
| Intracranial Disease Overall Response Rate by RANO-BM | Expansion: E6201 Plus Dabrafenib | Partial Response | 0 | Participants | |
| Intracranial Disease Overall Response Rate by RANO-BM | Monotherapy Safety Run-in: E6201 | Stable Disease | 2 | Participants | |
| Intracranial Disease Overall Response Rate by RANO-BM | Combination Safety Run-in: E6201 Plus Dabrafenib | Stable Disease | 0 | Participants | |
| Intracranial Disease Overall Response Rate by RANO-BM | Expansion: E6201 Plus Dabrafenib | Stable Disease | 0 | Participants | |
| Intracranial Disease Overall Response Rate by RANO-BM | Monotherapy Safety Run-in: E6201 | Progressive Disease | 1 | Participants |
1 to 10 of 47Source ClinicalTrials.gov
See all 47 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Monotherapy Safety Run-in: E6201 | 4 | |
| Overall Study | STARTED | Combination Safety Run-in: E6201 Plus Dabrafenib | 0 | |
| Overall Study | STARTED | Expansion: E6201 Plus Dabrafenib | 0 | |
| Overall Study | COMPLETED | Monotherapy Safety Run-in: E6201 | 0 | |
| Overall Study | COMPLETED | Combination Safety Run-in: E6201 Plus Dabrafenib | 0 | |
| Overall Study | COMPLETED | Expansion: E6201 Plus Dabrafenib | 0 | |
| Overall Study | NOT COMPLETED | Monotherapy Safety Run-in: E6201 | 4 | |
| Overall Study | NOT COMPLETED | Combination Safety Run-in: E6201 Plus Dabrafenib | 0 | |
| Overall Study | NOT COMPLETED | Expansion: E6201 Plus Dabrafenib | 0 |
Source ClinicalTrials.gov
Adverse events81
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 | Thrombocytopenia | Blood and lymphatic system disorders | Monotherapy Safety Run-in: E6201 | 1 | 4 | 1 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Combination Safety Run-in: E6201 Plus Dabrafenib | 0 | 0 | 0 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Expansion: E6201 Plus Dabrafenib | 0 | 0 | 0 |
| other | Tachycardia | Cardiac disorders | Monotherapy Safety Run-in: E6201 | 1 | 4 | 1 |
| other | Tachycardia | Cardiac disorders | Combination Safety Run-in: E6201 Plus Dabrafenib | 0 | 0 | 0 |
| other | Tachycardia | Cardiac disorders | Expansion: E6201 Plus Dabrafenib | 0 | 0 | 0 |
| other | Blurred vision | Eye disorders | Monotherapy Safety Run-in: E6201 | 1 | 4 | 1 |
| other | Blurred vision | Eye disorders | Combination Safety Run-in: E6201 Plus Dabrafenib | 0 | 0 | 0 |
| other | Blurred vision | Eye disorders | Expansion: E6201 Plus Dabrafenib | 0 | 0 | 0 |
| other | Abdominal distension | Gastrointestinal disorders | Monotherapy Safety Run-in: E6201 | 1 | 4 | 1 |
1 to 10 of 81Source ClinicalTrials.gov
See all 81 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Monotherapy Safety Run-in: E6201 | 1 | 4 |
| Total, all-cause mortality | Combination Safety Run-in: E6201 Plus Dabrafenib | 0 | 0 |
| Total, all-cause mortality | Expansion: E6201 Plus Dabrafenib | 0 | 0 |
| Total, other adverse events | Monotherapy Safety Run-in: E6201 | 4 | 4 |
| Total, other adverse events | Combination Safety Run-in: E6201 Plus Dabrafenib | 0 | 0 |
| Total, other adverse events | Expansion: E6201 Plus Dabrafenib | 0 | 0 |
| Total, serious adverse events | Monotherapy Safety Run-in: E6201 | 3 | 4 |
| Total, serious adverse events | Combination Safety Run-in: E6201 Plus Dabrafenib | 0 | 0 |
| Total, serious adverse events | Expansion: E6201 Plus Dabrafenib | 0 | 0 |
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.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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/NCT03332589
GET https://conductscience.org/api/trials/v1/NCT03332589/results?page=2