Trial · NCT01979523
Trametinib With or Without GSK2141795 in Treating Patients With Metastatic Uveal Melanoma
NCT01979523, Phase 2, Active not recruiting, National Cancer Institute (NCI); results first posted 2020-02-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Trametinib With or Without GSK2141795 in Treating Patients With Metastatic Uveal Melanoma. Trials, record NCT01979523. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01979523
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Trametinib With or Without GSK2141795 in Treating Patients With Metastatic Uveal Melanoma
- NCT number
- NCT01979523
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 42 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Recurrent Uveal Melanoma, Stage IV Uveal Melanoma AJCC v7
- Interventions
- Laboratory Biomarker Analysis, Pharmacological Study, Trametinib, Uprosertib
- First posted
- 2013-11-08
- Last updated
- 2026-08-06
- Results first posted
- 2020-02-24
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to Progression (Progression-free Survival [PFS]), Defined From the Date of Randomization to the Date of Documented Progression or Death Per RECIST | from randomization to the earlier date of objective disease progression or death | Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), 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 | Number of Participants With Toxicity, Graded According to the National Cancer Institute CTCAE v4.0, Who Were Treated and Did Not Withdraw Consent | From date of randomization until the date of death from any cause or 4 weeks from last treatment of the initial treatment assignment, whichever came first, assessed up to 12 months | Graded according to the National Cancer Institute CTCAE v4.0. Please see AE/SAE Section for specifics. |
| Secondary | Overall Survival (OS) Per RECIST Criteria | up to 36 months | OS curves will be generated using Kaplan-Meier methodology. |
| Secondary | Response Rate (Complete Response+ Partial Response) Using the RECIST Criteria | From date of randomization until the date of death from any cause or 4 weeks from last treatment of the initial treatment assignment, whichever came first, assessed up to 12 months | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI and/or CT: Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for a Partial Response nor sufficient increase to qualify for Progression of Disease (PD); PD, 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; Complete Response (CR), Disappearance of all target lesions. |
| Other | Change in Apoptosis in Paired Samples as Assessed by Caspase 3 Cleavage | Baseline to 4 weeks from last treatment | |
| Other | Change in Suppression of Phosphorylated (p)-ERK, AKT, and Cyclin-D1 | Baseline to 4 weeks from last treatment | Association between suppression and response to treatment will be assessed using Fisher's exact test. |
| Other | Circulating Tumor DNA Levels | Up to 4 weeks from last treatment | The numeric data will be summarized by clinical response. |
| Other | Gnaq/11 Mutational Status | Up to 4 weeks from last treatment | Clinical response will be associated with Gnaq/11 mutational status using Wilcoxon rank sum test. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time to Progression (Progression-free Survival [PFS]), Defined From the Date of Randomization to the Date of Documented Progression or Death Per RECIST | from randomization to the earlier date of objective disease progression or death | This assessment corresponds to the participants' initial treatment assignment. | weeks | MEDIAN |
| SECONDARY | Number of Participants With Toxicity, Graded According to the National Cancer Institute CTCAE v4.0, Who Were Treated and Did Not Withdraw Consent | From date of randomization until the date of death from any cause or 4 weeks from last treatment of the initial treatment assignment, whichever came first, assessed up to 12 months | This assessment corresponds to the participants' initial treatment assignment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Overall Survival (OS) Per RECIST Criteria | up to 36 months | This assessment corresponds to the participants' initial treatment assignment. | weeks | MEDIAN |
| SECONDARY | Response Rate (Complete Response+ Partial Response) Using the RECIST Criteria | From date of randomization until the date of death from any cause or 4 weeks from last treatment of the initial treatment assignment, whichever came first, assessed up to 12 months | This assessment corresponds to the participants' initial treatment assignment. | participants | NUMBER |
| OTHER_PRE_SPECIFIED | Change in Apoptosis in Paired Samples as Assessed by Caspase 3 Cleavage | Baseline to 4 weeks from last treatment | The size of the cores from the acquired samples in almost all participants were small and the quality was insufficient to analyze across the sample set. | ||
| OTHER_PRE_SPECIFIED | Change in Suppression of Phosphorylated (p)-ERK, AKT, and Cyclin-D1 | Baseline to 4 weeks from last treatment | The size of the cores from the acquired samples in almost all participants were small and the quality was insufficient to analyze across the sample set. | ||
| OTHER_PRE_SPECIFIED | Circulating Tumor DNA Levels | Up to 4 weeks from last treatment | Data were not analyzed due to lack of funding. | ||
| OTHER_PRE_SPECIFIED | Gnaq/11 Mutational Status | Up to 4 weeks from last treatment | Analysis across the sample set unable to be completed due to patient-specific issues (participants skipped biopsy for safety, insufficient cores for extra DNA extraction) |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time to Progression (Progression-free Survival [PFS]), Defined From the Date of Randomization to the Date of Documented Progression or Death Per RECIST | Arm A (Trametinib) | 16.6 | Full Range 3.3 to 43.7 | weeks | |
| Time to Progression (Progression-free Survival [PFS]), Defined From the Date of Randomization to the Date of Documented Progression or Death Per RECIST | Arm B (Trametinib, Akt Inhibitor GSK2141795) | 15.6 | Full Range 3.9 to 137 | weeks | |
| Number of Participants With Toxicity, Graded According to the National Cancer Institute CTCAE v4.0, Who Were Treated and Did Not Withdraw Consent | Arm A (Trametinib) | 21 | Participants | ||
| Number of Participants With Toxicity, Graded According to the National Cancer Institute CTCAE v4.0, Who Were Treated and Did Not Withdraw Consent | Arm B (Trametinib, Akt Inhibitor GSK2141795) | 21 | Participants | ||
| Overall Survival (OS) Per RECIST Criteria | Arm A (Trametinib) | 69 | Full Range 3.3 to 139 | weeks | |
| Overall Survival (OS) Per RECIST Criteria | Arm B (Trametinib, Akt Inhibitor GSK2141795) | 88 | Full Range 4.1 to 152 | weeks | |
| Response Rate (Complete Response+ Partial Response) Using the RECIST Criteria | Arm A (Trametinib) | Partial Response | 2 | participants | |
| Response Rate (Complete Response+ Partial Response) Using the RECIST Criteria | Arm B (Trametinib, Akt Inhibitor GSK2141795) | Partial Response | 1 | participants | |
| Response Rate (Complete Response+ Partial Response) Using the RECIST Criteria | Arm A (Trametinib) | Progression of Disease | 8 | participants | |
| Response Rate (Complete Response+ Partial Response) Using the RECIST Criteria | Arm B (Trametinib, Akt Inhibitor GSK2141795) | Progression of Disease | 4 | participants |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm A (Trametinib) | 21 | |
| Overall Study | STARTED | Arm B (Trametinib, Akt Inhibitor GSK2141795) | 21 | |
| Overall Study | COMPLETED | Arm A (Trametinib) | 20 | |
| Overall Study | COMPLETED | Arm B (Trametinib, Akt Inhibitor GSK2141795) | 21 | |
| Overall Study | NOT COMPLETED | Arm A (Trametinib) | 1 | |
| Overall Study | NOT COMPLETED | Arm B (Trametinib, Akt Inhibitor GSK2141795) | 0 |
Source ClinicalTrials.gov
Adverse events369
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 | Alanine aminotransferase increased | Investigations | Arm A (Trametinib) | 0 | 20 | |
| other | Alanine aminotransferase increased | Investigations | Arm B (Trametinib, Akt Inhibitor GSK2141795) | 5 | 21 | |
| other | Alanine aminotransferase increased | Investigations | Crossover Arm | 5 | 11 | |
| other | Alkaline phosphatase increased | Investigations | Arm A (Trametinib) | 3 | 20 | |
| other | Alkaline phosphatase increased | Investigations | Arm B (Trametinib, Akt Inhibitor GSK2141795) | 6 | 21 | |
| other | Alkaline phosphatase increased | Investigations | Crossover Arm | 2 | 11 | |
| other | Alopecia | Skin and subcutaneous tissue disorders | Arm A (Trametinib) | 1 | 20 | |
| other | Alopecia | Skin and subcutaneous tissue disorders | Arm B (Trametinib, Akt Inhibitor GSK2141795) | 1 | 21 | |
| other | Alopecia | Skin and subcutaneous tissue disorders | Crossover Arm | 0 | 11 | |
| other | Anemia | Blood and lymphatic system disorders | Arm A (Trametinib) | 0 | 20 |
1 to 10 of 369Source ClinicalTrials.gov
See all 369 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm A (Trametinib) | 5 | 20 |
| Total, all-cause mortality | Arm B (Trametinib, Akt Inhibitor GSK2141795) | 13 | 21 |
| Total, all-cause mortality | Crossover Arm | 8 | 11 |
| Total, other adverse events | Arm A (Trametinib) | 20 | 20 |
| Total, other adverse events | Arm B (Trametinib, Akt Inhibitor GSK2141795) | 21 | 21 |
| Total, other adverse events | Crossover Arm | 11 | 11 |
| Total, serious adverse events | Arm A (Trametinib) | 8 | 20 |
| Total, serious adverse events | Arm B (Trametinib, Akt Inhibitor GSK2141795) | 12 | 21 |
| Total, serious adverse events | Crossover Arm | 11 | 11 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P30CA008748 | Cancer Center Support Grant | Rudin, Charles M. | SLOAN-KETTERING INST CAN RESEARCH | NATIONAL CANCER INSTITUTE | 1985 to 2026 |
Source NIH RePORTER
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
Arm A (Trametinib) vs Arm B (Trametinib, Akt Inhibitor GSK2141795): Number of Participants With Toxicity, Graded According to the National Cancer Institute CTCAE v4.0, Who Were Treated and Did Not Withdraw Consent |
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/NCT01979523
GET https://conductscience.org/api/trials/v1/NCT01979523/events?page=2