Trial · NCT01974752
Selumetinib (AZD6244: ARRY-142886) (Hyd-Sulfate) in Metastatic Uveal Melanoma (SUMIT)
NCT01974752, Phase 3, Completed, AstraZeneca; results first posted 2016-09-28
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Selumetinib (AZD6244: ARRY-142886) (Hyd-Sulfate) in Metastatic Uveal Melanoma (SUMIT). Trials, record NCT01974752. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01974752
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Selumetinib (AZD6244: ARRY-142886) (Hyd-Sulfate) in Metastatic Uveal Melanoma (SUMIT)
- NCT number
- NCT01974752
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 152 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- Metastatic, Uveal Melanoma
- Interventions
- 75mg selumetinib, placebo, Dacarbazine
- First posted
- 2013-11-04
- Last updated
- 2017-01-05
- Results first posted
- 2016-09-28
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Assessment of the Efficacy of Selumetinib in Combination With Dacarbazine Compared With Placebo in Combination With Dacarbazine Measured as Progression Free Survival (PFS) Using BICR According to RECIST 1.1. | From Randomization, then every 6 weeks up until progression or death (whichever is sooner) assessed up to 15th May 2015 | Progression free survival (PFS) using blinded independent central review (BICR) according to the Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST 1.1). Progression is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. |
| Secondary | Assessment of the Efficacy of Selumetinib in Combination With Dacarbazine Compared With Placebo in Combination With Dacarbazine in Terms of Objective Response Rate (ORR) by BICR | From Randomization, then every 6 weeks up until progression or death (whichever is sooner) assessed up to 15th May 2015 | ORR at Week 6 using BICR according to RECIST 1.1 |
| Secondary | Assessment of the Efficacy of Selumetinib in Combination With Dacarbazine Compared With Placebo in Combination With Dacarbazine in Terms of Change in Tumour Size at Week 6 by BICR | From Randomization, then every 6 weeks up until progression or death (whichever is sooner) assessed up to 15th May 2015 | Percent change in tumour size at Week 6 using BICR according to RECIST 1.1 |
| Secondary | Assessment of the Overall Survival (OS) in Patients Taking Selumetinib in Combination With Dacarbazine Compared With Those Taking Placebo in Combination With Dacarbazine | From Randomization, up until death assessed up to 15th May 2015 | Overall Survival |
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 | Assessment of the Efficacy of Selumetinib in Combination With Dacarbazine Compared With Placebo in Combination With Dacarbazine Measured as Progression Free Survival (PFS) Using BICR According to RECIST 1.1. | From Randomization, then every 6 weeks up until progression or death (whichever is sooner) assessed up to 15th May 2015 | All randomised patients and will compare the treatment groups on the basis of randomised treatment, regardless of the treatment actually received. Note, this is also known as the Full Analysis set (FAS). | number of progression events | NUMBER |
| SECONDARY | Assessment of the Efficacy of Selumetinib in Combination With Dacarbazine Compared With Placebo in Combination With Dacarbazine in Terms of Objective Response Rate (ORR) by BICR | From Randomization, then every 6 weeks up until progression or death (whichever is sooner) assessed up to 15th May 2015 | Full Analysis Set | number of responders | NUMBER |
| SECONDARY | Assessment of the Efficacy of Selumetinib in Combination With Dacarbazine Compared With Placebo in Combination With Dacarbazine in Terms of Change in Tumour Size at Week 6 by BICR | From Randomization, then every 6 weeks up until progression or death (whichever is sooner) assessed up to 15th May 2015 | All randomised patients and will compare the treatment groups on the basis of randomised treatment, regardless of the treatment actually received. Note, this is also known as the Full Analysis set (FAS). | percent change | MEAN |
| SECONDARY | Assessment of the Overall Survival (OS) in Patients Taking Selumetinib in Combination With Dacarbazine Compared With Those Taking Placebo in Combination With Dacarbazine | From Randomization, up until death assessed up to 15th May 2015 | All randomised patients and will compare the treatment groups on the basis of randomised treatment, regardless of the treatment actually received. Note, this is also known as the Full Analysis set (FAS). | Number of Overall Survival Events | NUMBER |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
Assessment of the Efficacy of Selumetinib in Combination With Dacarbazine Compared With Placebo in Combination With Dacarbazine Measured as Progression Free Survival (PFS) Using BICR According to RECIST 1.1. | Selumetinib 75 mg BD + Dacarbazine 1000 mg/m2 | 82 | 2.8 to 2.8 | number of progression events | |
Assessment of the Efficacy of Selumetinib in Combination With Dacarbazine Compared With Placebo in Combination With Dacarbazine Measured as Progression Free Survival (PFS) Using BICR According to RECIST 1.1. | Placebo + Dacarbazine 1000 mg/m2 | 24 | 1.8 to 1.8 | number of progression events | |
| Assessment of the Efficacy of Selumetinib in Combination With Dacarbazine Compared With Placebo in Combination With Dacarbazine in Terms of Objective Response Rate (ORR) by BICR | Selumetinib 75 mg BD + Dacarbazine 1000 mg/m2 | 3 | number of responders | ||
| Assessment of the Efficacy of Selumetinib in Combination With Dacarbazine Compared With Placebo in Combination With Dacarbazine in Terms of Objective Response Rate (ORR) by BICR | Placebo + Dacarbazine 1000 mg/m2 | 0 | number of responders | ||
| Assessment of the Efficacy of Selumetinib in Combination With Dacarbazine Compared With Placebo in Combination With Dacarbazine in Terms of Change in Tumour Size at Week 6 by BICR | Selumetinib 75 mg BD + Dacarbazine 1000 mg/m2 | 6.94 | Standard Deviation 18.001 | percent change | |
| Assessment of the Efficacy of Selumetinib in Combination With Dacarbazine Compared With Placebo in Combination With Dacarbazine in Terms of Change in Tumour Size at Week 6 by BICR | Placebo + Dacarbazine 1000 mg/m2 | 19.76 | Standard Deviation 38.264 | percent change | |
| Assessment of the Overall Survival (OS) in Patients Taking Selumetinib in Combination With Dacarbazine Compared With Those Taking Placebo in Combination With Dacarbazine | Selumetinib 75 mg BD + Dacarbazine 1000 mg/m2 | 34 | Number of Overall Survival Events | ||
| Assessment of the Overall Survival (OS) in Patients Taking Selumetinib in Combination With Dacarbazine Compared With Those Taking Placebo in Combination With Dacarbazine | Placebo + Dacarbazine 1000 mg/m2 | 14 | Number of Overall Survival Events |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Selumetinib 75 mg BD + Dacarbazine 1000 mg/m2 | 97 | |
| Overall Study | STARTED | Placebo + Dacarbazine 1000 mg/m2 | 32 | |
| Overall Study | COMPLETED | Selumetinib 75 mg BD + Dacarbazine 1000 mg/m2 | 60 | |
| Overall Study | COMPLETED | Placebo + Dacarbazine 1000 mg/m2 | 17 | |
| Overall Study | NOT COMPLETED | Selumetinib 75 mg BD + Dacarbazine 1000 mg/m2 | 37 | |
| Overall Study | NOT COMPLETED | Placebo + Dacarbazine 1000 mg/m2 | 15 |
Source ClinicalTrials.gov
Adverse events196
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 | Placebo + Dacarbazine 1000 mg/m2 | 4 | 32 | 6 |
| other | ANAEMIA | Blood and lymphatic system disorders | Selumetinib 75 mg BD + Dacarbazine 1000 mg/m2 | 18 | 97 | 22 |
| other | NEUTROPENIA | Blood and lymphatic system disorders | Placebo + Dacarbazine 1000 mg/m2 | 11 | 32 | 14 |
| other | NEUTROPENIA | Blood and lymphatic system disorders | Selumetinib 75 mg BD + Dacarbazine 1000 mg/m2 | 25 | 97 | 35 |
| other | THROMBOCYTOPENIA | Blood and lymphatic system disorders | Placebo + Dacarbazine 1000 mg/m2 | 4 | 32 | 4 |
| other | THROMBOCYTOPENIA | Blood and lymphatic system disorders | Selumetinib 75 mg BD + Dacarbazine 1000 mg/m2 | 26 | 97 | 39 |
| other | CONSTIPATION | Gastrointestinal disorders | Placebo + Dacarbazine 1000 mg/m2 | 14 | 32 | 19 |
| other | CONSTIPATION | Gastrointestinal disorders | Selumetinib 75 mg BD + Dacarbazine 1000 mg/m2 | 37 | 97 | 46 |
| other | ASTHENIA | General disorders | Placebo + Dacarbazine 1000 mg/m2 | 4 | 32 | 5 |
| other | ASTHENIA | General disorders | Selumetinib 75 mg BD + Dacarbazine 1000 mg/m2 | 20 | 97 | 21 |
1 to 10 of 196Source ClinicalTrials.gov
See all 196 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo + Dacarbazine 1000 mg/m2 | ||
| Total, all-cause mortality | Selumetinib 75 mg BD + Dacarbazine 1000 mg/m2 | ||
| Total, other adverse events | Placebo + Dacarbazine 1000 mg/m2 | 32 | 32 |
| Total, other adverse events | Selumetinib 75 mg BD + Dacarbazine 1000 mg/m2 | 97 | 97 |
| Total, serious adverse events | Placebo + Dacarbazine 1000 mg/m2 | 2 | 32 |
| Total, serious adverse events | Selumetinib 75 mg BD + Dacarbazine 1000 mg/m2 | 20 | 97 |
Source ClinicalTrials.gov
Papers2
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Placebo + Dacarbazine 1000 mg/m2 vs Selumetinib 75 mg BD + Dacarbazine 1000 mg/m2: serious adverse events |
Source Trial comparisons
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/NCT01974752
GET https://conductscience.org/api/trials/v1/NCT01974752/events?page=2