Trial · NCT02649972
Single-agent Cobimetinib for Adults With Histiocytic Disorders
NCT02649972, Phase 2, Completed, Memorial Sloan Kettering Cancer Center; results first posted 2023-11-18
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Single-agent Cobimetinib for Adults With Histiocytic Disorders. Trials, record NCT02649972. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02649972
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Single-agent Cobimetinib for Adults With Histiocytic Disorders
- NCT number
- NCT02649972
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 35 participants, actual
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Conditions
- Histiocytic Disorders
- Interventions
- Cobimetinib
- First posted
- 2016-01-08
- Last updated
- 2023-11-18
- Results first posted
- 2023-11-18
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Best Overall Response | 1 year | by PET Response Criterial (PRC), with a dichotomous BOR of CR or PR versus neither of those. Assuming we use this binary endpoint of response, defined as best overall response of CR or PR versus not using the PET Response Criteria (PRC), a sample size of 18 patients provides 90% power to test the hypothesis that the response rate is promising (defined as 35% or higher) against a non-promising rate of 10% or lower. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Best Overall Response | 1 year | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Best Overall Response | Cobimetinib | Complete Metabolic Response | 21 | Participants | |
| Best Overall Response | Cobimetinib | Partial Metabolic Response | 5 | Participants | |
| Best Overall Response | Cobimetinib | Stable Metabolic Disease | 3 | Participants | |
| Best Overall Response | Cobimetinib | Not evaluable | 6 | 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 | Cobimetinib | 35 | |
| Overall Study | COMPLETED | Cobimetinib | 34 | |
| Overall Study | NOT COMPLETED | Cobimetinib | 1 |
Source ClinicalTrials.gov
Adverse events94
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 | CPK Increased | Investigations | Cobimetinib | 22 | 35 | |
| other | Rash acneiform | Skin and subcutaneous tissue disorders | Cobimetinib | 22 | 35 | |
| other | Diarrhea | Gastrointestinal disorders | Cobimetinib | 20 | 35 | |
| other | Anemia | Blood and lymphatic system disorders | Cobimetinib | 19 | 35 | |
| other | Alanine aminotransferase increased | Investigations | Cobimetinib | 16 | 35 | |
| other | Aspartate aminotransferase increasd | Investigations | Cobimetinib | 16 | 35 | |
| other | Fatigue | General disorders | Cobimetinib | 15 | 35 | |
| other | Hypomagnesemia | Metabolism and nutrition disorders | Cobimetinib | 15 | 35 | |
| other | Lymphocyte count decreased | Investigations | Cobimetinib | 15 | 35 | |
| other | Alkaline phosphatase increaseed | Investigations | Cobimetinib | 14 | 35 |
1 to 10 of 94Source ClinicalTrials.gov
See all 94 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cobimetinib | 8 | 35 |
| Total, other adverse events | Cobimetinib | 35 | 35 |
| Total, serious adverse events | Cobimetinib | 10 | 35 |
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/NCT02649972
GET https://conductscience.org/api/trials/v1/NCT02649972/events?page=2