Trial · NCT01143402
Temozolomide or Selumetinib in Treating Patients With Metastatic Melanoma of the Eye
NCT01143402, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2017-05-18
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Temozolomide or Selumetinib in Treating Patients With Metastatic Melanoma of the Eye. Trials, record NCT01143402. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01143402
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Temozolomide or Selumetinib in Treating Patients With Metastatic Melanoma of the Eye
- NCT number
- NCT01143402
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 120 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Iris Melanoma, Medium/Large Size Posterior Uveal Melanoma, Ocular Melanoma With Extraocular Extension, Recurrent Uveal Melanoma, Small Size Posterior Uveal Melanoma, Stage IV Uveal Melanoma
- Interventions
- Dacarbazine, Laboratory Biomarker Analysis, Quality-of-Life Assessment, Selumetinib, Temozolomide
- First posted
- 2010-06-14
- Last updated
- 2017-07-26
- Results first posted
- 2017-05-18
- Limitations and caveats
Limitations of this study include the unblinded trial design and the lack of central review of imaging studies. Additionally, this trial was designed before activating mutations in exon 4 of GNAQ and GNA11 were reported.
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free Survival (PFS) (Evaluable Randomized Patients) | The time from randomization to the earlier date of objective disease progression per Response Evaluation Criteria In Solid Tumors (RECIST) criteria or death due to any cause in the absence of progression, assessed up to 5 years | The primary analysis will be performed among the Gnaq/Gna11 mutant patients. A stratified logrank test will be performed stratified by mutation status, M stage, and number of prior systemic therapies for metastatic disease. Due to the potential for a large number of strata and small strata sizes, the standard asymptotic stratified logrank test will be verified for robustness utilizing a permutation reference distribution. |
| Secondary | Median Overall Survival (Evaluable Randomized Patients) | The time from randomization to death due to any cause, assessed up to 5 years | The primary analysis will be performed among the Gnaq/Gna11 mutant patients. A stratified logrank test will be performed stratified by mutation status, M stage, and number of prior systemic therapies for metastatic disease. Due to the potential for a large number of strata and small strata sizes, the standard asymptotic stratified logrank test will be verified for robustness utilizing a permutation reference distribution. |
| Other | Objective Disease Progression | assessed up to 5 years | per Response Evaluation Criteria In Solid Tumors (RECIST) criteria or death due to any cause in the absence of progression |
| Other | Overall Survival | The time from randomization to death due to any cause, assessed up to 5 years | The primary analysis will be performed among the Gnaq/Gna11 mutant patients. A stratified logrank test will be performed stratified by mutation status, M stage, and number of prior systemic therapies for metastatic disease. Due to the potential for a large number of strata and small strata sizes, the standard asymptotic stratified logrank test will be verified for robustness utilizing a permutation reference distribution. |
| Other | Response Rate (Complete and Partial Response) | Up to 5 years | Calculated along with a 95% confidence interval. |
| Other | Toxicity According to the National Cancer Institute Common Toxicity Criteria | Up to 5 years | Toxicity will be reported by type, frequency, and severity. Please see adverse events. |
| Other | PFS (Group 3) | 4 months | Evaluated using a Simon mini-max design. Curves will be generated using Kaplan-Meier methodology. |
| Other | Apoptosis in the Paired Samples, Performed by Caspase 3 Cleavage | Up to 5 years | Changes will be assessed by a Wilcoxon test |
| Other | Change in Ki67 | Baseline up to 4 months | Correlated with disease status using Fishers exact test. |
| Other | Change in p-AKT | Baseline up to 4 months | Correlated with disease status using Fishers exact test. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-free Survival (PFS) (Evaluable Randomized Patients) | The time from randomization to the earlier date of objective disease progression per Response Evaluation Criteria In Solid Tumors (RECIST) criteria or death due to any cause in the absence of progression, assessed up to 5 years | Analysis of progression-free survival in all evaluable randomized patients | weeks | MEDIAN |
| SECONDARY | Median Overall Survival (Evaluable Randomized Patients) | The time from randomization to death due to any cause, assessed up to 5 years | Months | MEDIAN | |
| OTHER_PRE_SPECIFIED | Objective Disease Progression | assessed up to 5 years | |||
| OTHER_PRE_SPECIFIED | Overall Survival | The time from randomization to death due to any cause, assessed up to 5 years | |||
| OTHER_PRE_SPECIFIED | Response Rate (Complete and Partial Response) | Up to 5 years | |||
| OTHER_PRE_SPECIFIED | Toxicity According to the National Cancer Institute Common Toxicity Criteria | Up to 5 years | |||
| OTHER_PRE_SPECIFIED | PFS (Group 3) | 4 months | |||
| OTHER_PRE_SPECIFIED | Apoptosis in the Paired Samples, Performed by Caspase 3 Cleavage | Up to 5 years | |||
| OTHER_PRE_SPECIFIED | Change in Ki67 | Baseline up to 4 months | |||
| OTHER_PRE_SPECIFIED | Change in p-AKT | Baseline up to 4 months |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-free Survival (PFS) (Evaluable Randomized Patients) | Arm I (Temozolomide) | 7 | 95% Confidence Interval 4.3 to 8.4 | weeks | |
| Progression-free Survival (PFS) (Evaluable Randomized Patients) | Arm II (Selumetinib) | 15.9 | 95% Confidence Interval 8.4 to 21.1 | weeks | |
| Median Overall Survival (Evaluable Randomized Patients) | Arm I (Temozolomide) | 9.1 | 95% Confidence Interval 6.1 to 11.1 | Months | |
| Median Overall Survival (Evaluable Randomized Patients) | Arm II (Selumetinib) | 11.8 | 95% Confidence Interval 9.8 to 15.7 | Months |
Source ClinicalTrials.gov
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm I (Temozolomide) | 51 | |
| Overall Study | STARTED | Arm II (Selumetinib) | 50 | |
| Overall Study | STARTED | Non-Randomized (Selumetinib) | 19 | |
| Overall Study | COMPLETED | Arm I (Temozolomide) | 50 | |
| Overall Study | COMPLETED | Arm II (Selumetinib) | 49 | |
| Overall Study | COMPLETED | Non-Randomized (Selumetinib) | 18 | |
| Overall Study | NOT COMPLETED | Arm I (Temozolomide) | 1 | |
| Overall Study | NOT COMPLETED | Arm II (Selumetinib) | 1 | |
| Overall Study | NOT COMPLETED | Non-Randomized (Selumetinib) | 1 |
Source ClinicalTrials.gov
Adverse events168
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 | Anemia | Blood and lymphatic system disorders | Arm I (Temozolomide) | 8 | 50 | |
| other | Anemia | Blood and lymphatic system disorders | Arm II (Selumetinib) | 15 | 49 | |
| other | Anemia | Blood and lymphatic system disorders | Non-Randomized (Selumetinib) | 6 | 18 | |
| other | Leukopenia | Blood and lymphatic system disorders | Arm I (Temozolomide) | 9 | 50 | |
| other | Leukopenia | Blood and lymphatic system disorders | Arm II (Selumetinib) | 6 | 49 | |
| other | Leukopenia | Blood and lymphatic system disorders | Non-Randomized (Selumetinib) | 6 | 18 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Arm I (Temozolomide) | 5 | 50 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Arm II (Selumetinib) | 4 | 49 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Non-Randomized (Selumetinib) | 4 | 18 | |
| other | Neutropenia | Blood and lymphatic system disorders | Arm I (Temozolomide) | 5 | 50 |
1 to 10 of 168Source ClinicalTrials.gov
See all 168 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm I (Temozolomide) | ||
| Total, all-cause mortality | Arm II (Selumetinib) | ||
| Total, all-cause mortality | Non-Randomized (Selumetinib) | ||
| Total, other adverse events | Arm I (Temozolomide) | 50 | 50 |
| Total, other adverse events | Arm II (Selumetinib) | 49 | 49 |
| Total, other adverse events | Non-Randomized (Selumetinib) | 18 | 18 |
| Total, serious adverse events | Arm I (Temozolomide) | 18 | 50 |
| Total, serious adverse events | Arm II (Selumetinib) | 19 | 49 |
| Total, serious adverse events | Non-Randomized (Selumetinib) | 7 | 18 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants2
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 | Source |
|---|---|---|---|---|---|---|
| P30CA008748 | Cancer Center Support Grant | Rudin, Charles M. | SLOAN-KETTERING INST CAN RESEARCH | NATIONAL CANCER INSTITUTE | 1985 to 2026 | NIH RePORTER |
| U01CA132123 | Princess Margaret Hospital Phase I Consortium | SIU, LILLIAN L | UNIVERSITY HEALTH NETWORK | NATIONAL CANCER INSTITUTE | 2008 to 2013 | NIH RePORTER |
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/NCT01143402
GET https://conductscience.org/api/trials/v1/NCT01143402/events?page=2