Trial · NCT01307397
A Study of Vemurafenib in Participants With Metastatic Melanoma
NCT01307397, Phase 3, Completed, Hoffmann-La Roche; results first posted 2017-12-18
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Vemurafenib in Participants With Metastatic Melanoma. Trials, record NCT01307397. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01307397
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Vemurafenib in Participants With Metastatic Melanoma
- NCT number
- NCT01307397
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 3,219 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Malignant Melanoma
- Interventions
- Vemurafenib
- First posted
- 2011-03-02
- Last updated
- 2017-12-18
- Other registries' IDs
- eudract:2010-023526-21
- Results first posted
- 2017-12-18
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Experiencing Any Grade 3 or 4 Adverse Events (AEs) as Determined by National Cancer Institute-Common Toxicity Criteria for Adverse Events (NCI-CTCAE) Version 4.0 | Baseline up to 28 days post end of treatment (maximum up to 46 months) | The intensity of AEs were graded on a 5-point scale (Grade 1 to 5) according to the NCI-CTCAE version 4.0, where Grade 1 indicates "Mild" severity and Grade 5 indicates "Death". The CTCAE defines Grades 3 and 4 as follows: Grade 3 means "Severe"; Inability to work or perform normal daily activity; treatment or medical intervention is indicated in order to improve the overall well-being or symptoms; delaying the onset of treatment is not putting the survival of the participant at direct risk. Grade 4 means "Life-threatening, Disabling"; based on extreme limitation in activity; significant medical intervention/therapy required; and hospitalization probable. |
| Primary | Percentage of Participants With at Least 1 AE Leading to Study Drug Interruption or Drug Discontinuation | Baseline up to 28 days post end of treatment (maximum up to 46 months) | An AE was considered as any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Pre existing conditions that worsened during the study and laboratory or clinical tests that resulted in a change in treatment or discontinuation from study drug were reported as adverse events. Percentage of participants with dose interruption or discontinuation due to AE was presented. |
| Primary | Percentage of Participants With AEs of Special Interest | Baseline up to 28 days post end of treatment (maximum up to 46 months) | AEs of special interest included cutaneous squamous cell carcinoma (SCC), rash, photosensitivity, liver injury, arthralgia, fatigue, gastrointestinal (GI) polyps, pancreatitis, potentiation of radiation toxicity, prolongation of cardiac repolarization or arrhythmia, non-cutaneous SCC and other primary malignancies (other than cutaneous SCC or new primary melanoma). |
| Primary | Mean Cumulative Dose of Vemurafenib | Baseline up to end of treatment or death (maximum up to 46 months) | |
| Primary | Duration of Vemurafenib Treatment | Baseline up to end of treatment or death (maximum upto 46 months) | Exposure excluding treatment interruptions: Duration during which participants actually took vemurafenib. Any time without dose-taken due to adverse events, non-compliance or any other reasons was not counted. Exposure including treatment interruptions: date of last dose - date of first dose + 1; duration during which participants actually took vemurafenib as well as duration on which medication was not taken were included in this calculation. |
| Primary | Mean Total Vemurafenib Dose Per Day | Baseline up to end of treatment or death (maximum up to 46 months) | Exposure excluding treatment interruptions: Duration during which participants actually took vemurafenib. Any time without dose-taken due to adverse events, non-compliance or any other reasons was not counted. Exposure including treatment interruptions: date of last dose - date of first dose + 1; duration during which participants actually took vemurafenib as well as duration on which medication was not taken were included in this calculation. Average total dose per day: total actual dose taken divided by total actual days on treatment. |
| Primary | Dose Intensity of Vemurafenib | Baseline up to end of treatment or death (maximum upto 46 months) | Dose intensity was defined as (total actual doses taken/total planned doses) \*100, where total planned doses = prescribed doses \* planned days on treatment, where planned days on treatment were defined as the interval between date of first dose and date of last dose. |
| Secondary | Percentage of Participants With Improvement in Eastern Cooperative Group (ECOG) Performance Status | Baseline, Day 1 of each 28 day cycle up to end of treatment (up to 46 months) | ECOG Performance Status was measured on-therapy assessed participant's performance status on 5 point scale: 0 = fully active/able to carry on all pre-disease activities without restriction; 1=restricted in physically strenuous activity, ambulatory/able to carry out light or sedentary work; 2=ambulatory (greater than \[\>\] 50% of waking hours \[hrs\]), capable of all self care, unable to carry out any work activities; 3=capable of only limited self care, confined to bed/chair \>50% of waking hrs; 4=completely disabled, cannot carry on any self care, totally confined to bed/chair; 5=dead. Percentage of participants who had at least one point improvement from baseline at any assessment visit as well as at last study visit was reported. |
| Secondary | Percentage of Participants Who Received Any Concomitant Medications | Baseline up to 46 months | Concomitant medications were all medications taken during the study, including those started before but ongoing at first dose. No medications for Melanoma were included. Percentage of participants who received at least one concomitant medication was reported. |
| Secondary | Percentage of Participants With Best Overall Response (BOR) of Confirmed Complete Response (CR) or Partial Response (PR), as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) | Baseline until first documentation of confirmed CR or PR (assessed at baseline, at Weeks 8, 16, as per institution standard of care thereafter but a minimum every 16 weeks thereafter until the end of the study [up to 46 months]) | BOR was assessed by the investigator according to RECIST v1.1. BOR was defined as having confirmed CR or PR. CR: disappearance of all target and non-target lesions and no new lesions, all pathological lymph nodes must have decreased to less than (\<) 10 millimeter (mm) in short axis; PR: at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesion, and no new lesions. Confirmed responses were those that persisted on repeat imaging greater than or equal to (\>=) 4 weeks after initial response. |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Experiencing Any Grade 3 or 4 Adverse Events (AEs) as Determined by National Cancer Institute-Common Toxicity Criteria for Adverse Events (NCI-CTCAE) Version 4.0 | Baseline up to 28 days post end of treatment (maximum up to 46 months) | Safety population. Number of participants analyzed = participants with measurable disease at baseline | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With at Least 1 AE Leading to Study Drug Interruption or Drug Discontinuation | Baseline up to 28 days post end of treatment (maximum up to 46 months) | Safety population | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With AEs of Special Interest | Baseline up to 28 days post end of treatment (maximum up to 46 months) | Safety population | Percentage of participants | NUMBER |
| PRIMARY | Mean Cumulative Dose of Vemurafenib | Baseline up to end of treatment or death (maximum up to 46 months) | Safety population | Grams | MEAN |
| PRIMARY | Duration of Vemurafenib Treatment | Baseline up to end of treatment or death (maximum upto 46 months) | Safety population | Months | MEAN |
| PRIMARY | Mean Total Vemurafenib Dose Per Day | Baseline up to end of treatment or death (maximum up to 46 months) | Safety population | Grams | MEAN |
| PRIMARY | Dose Intensity of Vemurafenib | Baseline up to end of treatment or death (maximum upto 46 months) | Safety Population | Percentage of planned dose | MEAN |
| SECONDARY | Percentage of Participants With Improvement in Eastern Cooperative Group (ECOG) Performance Status | Baseline, Day 1 of each 28 day cycle up to end of treatment (up to 46 months) | Safety population | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants Who Received Any Concomitant Medications | Baseline up to 46 months | Safety population | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With Best Overall Response (BOR) of Confirmed Complete Response (CR) or Partial Response (PR), as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) | Baseline until first documentation of confirmed CR or PR (assessed at baseline, at Weeks 8, 16, as per institution standard of care thereafter but a minimum every 16 weeks thereafter until the end of the study [up to 46 months]) | Safety population. Number of participants analyzed = participants with measurable disease at baseline. | Percentage of Participants | NUMBER |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 outcomesResults by group32
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Experiencing Any Grade 3 or 4 Adverse Events (AEs) as Determined by National Cancer Institute-Common Toxicity Criteria for Adverse Events (NCI-CTCAE) Version 4.0 | Vemurafenib | 52.8 | Percentage of participants | ||
| Percentage of Participants With at Least 1 AE Leading to Study Drug Interruption or Drug Discontinuation | Vemurafenib | AE Leading to Drug Discontinuation | 7.0 | Percentage of participants | |
| Percentage of Participants With at Least 1 AE Leading to Study Drug Interruption or Drug Discontinuation | Vemurafenib | AE Leading to Study Drug Interruption | 34.0 | Percentage of participants | |
| Percentage of Participants With AEs of Special Interest | Vemurafenib | Arthralgia | 42.3 | Percentage of participants | |
| Percentage of Participants With AEs of Special Interest | Vemurafenib | Rash | 47.9 | Percentage of participants | |
| Percentage of Participants With AEs of Special Interest | Vemurafenib | Photosensitivity | 28.4 | Percentage of participants | |
| Percentage of Participants With AEs of Special Interest | Vemurafenib | Fatigue | 36.8 | Percentage of participants | |
| Percentage of Participants With AEs of Special Interest | Vemurafenib | Cutaneous SCC | 14.6 | Percentage of participants | |
| Percentage of Participants With AEs of Special Interest | Vemurafenib | Non Cutaneous SCC | 0.1 | Percentage of participants | |
| Percentage of Participants With AEs of Special Interest | Vemurafenib | New Primary Melanoma | 1.7 | Percentage of participants |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Vemurafenib | 3,219 | |
| Overall Study | COMPLETED | Vemurafenib | 3,219 | |
| Overall Study | NOT COMPLETED | Vemurafenib | 0 |
Source ClinicalTrials.gov
Adverse events474
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 | Diarrhoea | Gastrointestinal disorders | Vemurafenib | 584 | 3,219 | |
| other | Nausea | Gastrointestinal disorders | Vemurafenib | 718 | 3,219 | |
| other | Vomiting | Gastrointestinal disorders | Vemurafenib | 449 | 3,219 | |
| other | Fatigue | General disorders | Vemurafenib | 834 | 3,219 | |
| other | Pyrexia | General disorders | Vemurafenib | 363 | 3,219 | |
| other | Weight decreased | Investigations | Vemurafenib | 414 | 3,219 | |
| other | Decreased appetite | Metabolism and nutrition disorders | Vemurafenib | 482 | 3,219 | |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Vemurafenib | 1,357 | 3,219 | |
| other | Myalgia | Musculoskeletal and connective tissue disorders | Vemurafenib | 308 | 3,219 | |
| other | Skin papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Vemurafenib | 621 | 3,219 |
1 to 10 of 474Source ClinicalTrials.gov
See all 474 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Vemurafenib | ||
| Total, other adverse events | Vemurafenib | 2,956 | 3,219 |
| Total, serious adverse events | Vemurafenib | 1,114 | 3,219 |
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 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/NCT01307397
GET https://conductscience.org/api/trials/v1/NCT01307397/results?page=2