Trial · NCT01693068
Phase II Trial of Pimasertib Versus Dacarbazine in N-Ras Mutated Cutaneous Melanoma
NCT01693068, Phase 2, Completed, EMD Serono; results first posted 2018-01-05
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Phase II Trial of Pimasertib Versus Dacarbazine in N-Ras Mutated Cutaneous Melanoma. Trials, record NCT01693068. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01693068
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase II Trial of Pimasertib Versus Dacarbazine in N-Ras Mutated Cutaneous Melanoma
- NCT number
- NCT01693068
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 194 participants, actual
- Lead sponsor
- EMD Serono
- Conditions
- N-Ras Mutated Locally Advanced or Metastasis Malignant Cutaneous Melanoma
- Interventions
- Pimasertib, Dacarbazine
- First posted
- 2012-09-26
- Last updated
- 2018-01-05
- Other registries' IDs
- eudract:2012-002669-37
- Results first posted
- 2018-01-05
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression Free Survival (PFS) | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to cut-off date (04-Jul-2015) | PFS was defined as the duration (in weeks) from randomization until the first progressive disease (PD) observation as assessed by the Investigator according to Response Evaluation Criteria for Solid Tumors (RECIST) version 1.1, or death due to any cause when death occurred within 12 weeks after the last tumor assessment (otherwise censored), whichever occurred first. PD was defined as at least a 20% increase in the sum of diameters of the target lesions, taking as reference the smallest sum since the treatment started (including baseline), or appearance of one or more new lesions, and/or unequivocal progression of existing non-target lesions. |
| Secondary | Objective Response Rate (ORR) | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to cut-off date (04-Jul-2015) | ORR was defined as the percentage of subjects with complete response (CR) or partial response (PR) according to RECIST version 1.1 criteria. CR: defined as disappearance of all target and all non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<) 10 millimeter (mm). PR: defined as at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters along with absence of new lesions and disease progression in non-target lesions. |
| Secondary | Disease Control Rate (DCR) | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to cut-off date (04-Jul-2015) | DCR was defined as the percentage of subjects with CR, PR, or stable disease (SD) for greater than (\>) 3 months assessed by investigator according to RECIST version 1.1. CR: defined as disappearance of all target and all non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than \<10 mm. PR: defined as at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters along with absence of new lesions and disease progression in non-target lesions. SD: defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. |
| Secondary | Percentage of Subjects With Progression-free Survival (PFS) at 6 Months | 6 months | PFS was defined as the duration (in weeks) from randomization until the first progressive disease (PD) observation as assessed by the Investigator according to Response Evaluation Criteria for Solid Tumors (RECIST) version 1.1, or death due to any cause when death occurred within 12 weeks after the last tumor assessment, whichever occurred first. PD was defined as at least a 20% increase in the sum of diameters of the target lesions, taking as reference the smallest sum since the treatment started (including baseline), or appearance of one or more new lesions, and/or unequivocal progression of existing non-target lesions. Percentage of Subjects with PFS at 6 Months were reported. |
| Secondary | Overall Survival (OS) | From date of randomization until date of death from any cause, assessed up to cut-off date (04-Jul-2015) | OS was defined as the time (in months) from randomization to death due to any cause. Subjects without a death date were to be censored at the minimum of last known date alive, defined as the latest date available on the electronic case report form, and cut-off date. |
| Secondary | Percentage of Subjects With Overall Survival (OS) at 12 Months | 12 months | OS was defined as the time (in months) from randomization to death due to any cause. Subjects without a death date were to be censored at the minimum of last known date alive, defined as the latest date available on the electronic case report form, and cut-off date. Percentage of Subjects with OS at 12 months were reported. |
| Secondary | Change From Baseline in Subject-reported Quality of Life Assessed by Functional Assessment Cancer Therapy - Melanoma Total Score (FACT-M TS) at Day 1 of Pre-Specified Cycles and End of Treatment (EOT) | Baseline, Day 1 of Cycle 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 30, 31, 32, 33, 35, 36, 37 and EOT (up to cut-off date [04-Jul-2015]) | QoL assessed using Function Assessment Cancer Therapy-melanoma (FACT-M) assessment tool. This includes 27-item FACT-General (FACT-G) questionnaire which consists of 24 questions;7 relating to physical well-being (PWB),7 relating to social/family well-being (SWB),6 relating to emotional well-being (EWB) and 7 relating to functional well-being (FWB). Also, it includes melanoma-specific subscale consists of 16 questions for Melanoma Subscale (MS) and 8 questions for Melanoma Surgery Scale (MSS).Each of these questions could have a response of Not at all, a little bit, somewhat, quite a bit and very much. The responses were given a value between 0 and 4 with 4 being best response. The FACT-M Total Score (FACT-M TS) ranges from 0 to 172 and is derived as follows: FACT-M TS= PWB Score + SWB Score + EWB Score + FWB Score + MS Score. Higher scores represent a better quality of life. |
| Secondary | Change From Baseline in Subject-reported Quality of Life Assessed by Functional Assessment Cancer Therapy - Melanoma Trial Outcome Index (FACT-M TOI) at Day 1 of Pre-Specified Cycles and End of Treatment (EOT) | Baseline, Day 1 of Cycle 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 30, 31, 32, 33, 35, 36, 37 and EOT (up to cut-off date [04-Jul-2015]) | QoL assessed using FACT-M assessment tool. This includes 27-item FACT-G questionnaire which consists of 24 questions; 7 relating to PWB, 7 relating to SWB, 6 relating to EWB and 7 relating to FWB. Also, it includes melanoma-specific subscale consists of 16 questions for MS and 8 questions for the MSS. Each of these questions could have a response of Not at all, a little bit, somewhat, quite a bit and very much. The responses were given a value between 0 and 4 with 4 being best response. The FACT-M Trial Outcome Index (FACT-M TOI) ranges from 0 to a high of 120 and is derived as: FACT-M TOI = PWB Score + FWB Score +MS Score. Higher scores represent a better quality of life. |
| Secondary | Number of Subjects With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Discontinuation or TEAEs Leading to Death | Baseline up to cut-off date (04-Jul-2015) | AE was defined as any untoward medical occurrence which does not necessarily have a causal relationship with this the study drug. An AE was defined as any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A serious AE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. Treatment-emergent are events between first dose of study drug and up to 33 days after last dose that were absent before treatment or that worsened relative to pre-treatment state. TEAEs include both Serious TEAEs and non-serious TEAEs. TEAEs were to be reported separately for dacarbazine, pimasertib and pimasertib (crossover) reporting arms. |
| Secondary | Number of Subjects With Adverse Events (AEs) of Special Interest | Baseline up to cut-off date (04-Jul-2015) | Adverse events of special interest included ocular retinal vein occlusion, serious retinal detachment or similar retinal abnormality characterized by accumulation of serous fluid in the retina, creatine phosphokinase (CPK) elevation and isoenzyme TEAE of Special Interest (Grade \>=2) and acute renal failure (Grade \>=2). Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
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) | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to cut-off date (04-Jul-2015) | ITT analysis set included all subjects who were randomized to trial treatment. | weeks | MEDIAN |
| SECONDARY | Objective Response Rate (ORR) | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to cut-off date (04-Jul-2015) | ITT analysis set included all subjects who were randomized to trial treatment. | percentage of subjects | NUMBER |
| SECONDARY | Disease Control Rate (DCR) | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to cut-off date (04-Jul-2015) | ITT analysis set included all subjects who were randomized to trial treatment. | percentage of subjects | NUMBER |
| SECONDARY | Percentage of Subjects With Progression-free Survival (PFS) at 6 Months | 6 months | ITT analysis set included all subjects who were randomized to trial treatment. | percentage of subjects | NUMBER |
| SECONDARY | Overall Survival (OS) | From date of randomization until date of death from any cause, assessed up to cut-off date (04-Jul-2015) | ITT analysis set included all subjects who were randomized to trial treatment. | months | MEDIAN |
| SECONDARY | Percentage of Subjects With Overall Survival (OS) at 12 Months | 12 months | ITT analysis set included all subjects who were randomized to trial treatment. | percentage of subjects | NUMBER |
| SECONDARY | Change From Baseline in Subject-reported Quality of Life Assessed by Functional Assessment Cancer Therapy - Melanoma Total Score (FACT-M TS) at Day 1 of Pre-Specified Cycles and End of Treatment (EOT) | Baseline, Day 1 of Cycle 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 30, 31, 32, 33, 35, 36, 37 and EOT (up to cut-off date [04-Jul-2015]) | ITT analysis set. Here Number of Subjects Analyzed = subjects evaluable for this outcome and Number Analyzed = subjects evaluable at specified time points for each arm, respectively. There were no subjects analyzed at certain time points (that is, Number Analyzed = 0) because there was no data collected for respective arms at those time points. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Subject-reported Quality of Life Assessed by Functional Assessment Cancer Therapy - Melanoma Trial Outcome Index (FACT-M TOI) at Day 1 of Pre-Specified Cycles and End of Treatment (EOT) | Baseline, Day 1 of Cycle 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 30, 31, 32, 33, 35, 36, 37 and EOT (up to cut-off date [04-Jul-2015]) | ITT analysis set. Here Number of Subjects Analyzed = subjects evaluable for this outcome and Number Analyzed = subjects evaluable at specified time points for each arm, respectively. There were no subjects analyzed at certain time points (that is, Number Analyzed = 0) because there was no data collected for respective arms at those time points. | units on a scale | MEAN |
| SECONDARY | Number of Subjects With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Discontinuation or TEAEs Leading to Death | Baseline up to cut-off date (04-Jul-2015) | Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. | subjects | NUMBER |
| SECONDARY | Number of Subjects With Adverse Events (AEs) of Special Interest | Baseline up to cut-off date (04-Jul-2015) | Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment. | subjects | NUMBER |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group176
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) | Dacarbazine | 6.86 | 95% Confidence Interval 6.00 to 12.14 | weeks | |
| Progression Free Survival (PFS) | Pimasertib | 13.00 | 95% Confidence Interval 12.29 to 17.71 | weeks | |
| Objective Response Rate (ORR) | Dacarbazine | 14.1 | 95% Confidence Interval 6.6 to 25.0 | percentage of subjects | |
| Objective Response Rate (ORR) | Pimasertib | 26.9 | 95% Confidence Interval 19.5 to 35.4 | percentage of subjects | |
| Disease Control Rate (DCR) | Dacarbazine | 15.6 | 95% Confidence Interval 7.8 to 26.9 | percentage of subjects | |
| Disease Control Rate (DCR) | Pimasertib | 33.1 | 95% Confidence Interval 25.1 to 41.9 | percentage of subjects | |
| Percentage of Subjects With Progression-free Survival (PFS) at 6 Months | Dacarbazine | 9.4 | 95% Confidence Interval 3.6 to 18.6 | percentage of subjects | |
| Percentage of Subjects With Progression-free Survival (PFS) at 6 Months | Pimasertib | 17.3 | 95% Confidence Interval 10.2 to 26.0 | percentage of subjects | |
| Overall Survival (OS) | Dacarbazine | 10.61 | 95% Confidence Interval 7.26 to 16.49 | months | |
| Overall Survival (OS) | Pimasertib | 8.87 | 95% Confidence Interval 7.46 to 15.51 | months |
1 to 10 of 176Source ClinicalTrials.gov
See all 176 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Randomization Period | STARTED | Dacarbazine | 64 | |
| Randomization Period | STARTED | Pimasertib | 130 | |
| Randomization Period | STARTED | Pimasertib (Crossover) | 0 | |
| Randomization Period | Treated | Dacarbazine | 61 | |
| Randomization Period | Treated | Pimasertib | 130 | |
| Randomization Period | Treated | Pimasertib (Crossover) | 0 | |
| Randomization Period | COMPLETED | Dacarbazine | 62 | |
| Randomization Period | COMPLETED | Pimasertib | 125 | |
| Randomization Period | COMPLETED | Pimasertib (Crossover) | 0 | |
| Randomization Period | NOT COMPLETED | Dacarbazine | 2 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events2,064
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 | Dacarbazine | 8 | 61 | |
| other | Anaemia | Blood and lymphatic system disorders | Pimasertib | 13 | 130 | |
| other | Anaemia | Blood and lymphatic system disorders | Pimasertib (Crossover) | 3 | 41 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Dacarbazine | 12 | 61 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Pimasertib | 8 | 130 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Pimasertib (Crossover) | 3 | 41 | |
| other | Neutropenia | Blood and lymphatic system disorders | Dacarbazine | 13 | 61 | |
| other | Neutropenia | Blood and lymphatic system disorders | Pimasertib | 1 | 130 | |
| other | Neutropenia | Blood and lymphatic system disorders | Pimasertib (Crossover) | 0 | 41 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Dacarbazine | 1 | 61 |
1 to 10 of 2,064Source ClinicalTrials.gov
See all 2,064 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dacarbazine | ||
| Total, all-cause mortality | Pimasertib | ||
| Total, all-cause mortality | Pimasertib (Crossover) | ||
| Total, other adverse events | Dacarbazine | 59 | 61 |
| Total, other adverse events | Pimasertib | 130 | 130 |
| Total, other adverse events | Pimasertib (Crossover) | 41 | 41 |
| Total, serious adverse events | Dacarbazine | 12 | 61 |
| Total, serious adverse events | Pimasertib | 74 | 130 |
| Total, serious adverse events | Pimasertib (Crossover) | 26 | 41 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 32610581 | DERIVED |
Source PubMed
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.
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