Trial · NCT01231581
Study of GSK1120212 Plus Gemcitabine vs Placebo Plus Gemcitabine in Metastatic Pancreatic Cancer
NCT01231581, Phase 2, Completed, GlaxoSmithKline; results first posted 2013-09-26
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of GSK1120212 Plus Gemcitabine vs Placebo Plus Gemcitabine in Metastatic Pancreatic Cancer. Trials, record NCT01231581. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01231581
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of GSK1120212 Plus Gemcitabine vs Placebo Plus Gemcitabine in Metastatic Pancreatic Cancer
- NCT number
- NCT01231581
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 160 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Cancer
- Interventions
- GSK1120212, Gemcitabine, Placebo
- First posted
- 2010-11-01
- Last updated
- 2013-09-26
- Results first posted
- 2013-09-26
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival | From randomization until death due to any cause or until the data cutoff of 15-March-2013 (up to 24 months) | Overall survival is defined as the time from randomization until death due to any cause. For the analysis of overall survival, the last date of known contact was used for those participants who were not dead at the time of analysis; such participants were considered censored. |
| Secondary | Progression-free Survival (PFS) as Assessed by the Investigator | From randomization until disease progression (PD) or death due to any cause or until the data cutoff of 17-April-2012 (up to 15 months) | PFS is defined as the time from randomization until the earliest date of radiological PD or death due to any cause. PD was based on radiographic or photographic evidence, and assessments were made by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g., percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5 millimeters (mm). PD was also based on unequivocal progression of existing non-target lesions. If the participant received subsequent anti-cancer therapy prior to the date of documented progression or death, or did not have a documented date of progression or death, PFS was censored at the last adequate assessment. |
| Secondary | Number of Participants With an Investigator-assessed Best Response, With or Without Confirmation, of Complete Response (CR) or Partial Response (PR) | From randomization until disease progression or death due to any cause or until the data cutoff of 17-April-2012 (up to 15 months) | CR is defined as the disappearance of all target and non-target lesions. Any pathological lymph nodes must be \<10 mm in the short axis. PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters (e.g., percent change from baseline). CR and PR were evaluated by the Investigator using standard criteria (RECIST version 1.1). Confirmation of response was not required. |
| Secondary | Investigator-Assessed Duration of Response | From the first documented CR or PR until disease progression or death due to any cause or until the data cutoff of 17-April-2012 (up to 13 months) | Duration of response is defined, for the subset of participants with a CR or PR, as the time from the first documented evidence of CR or PR until the first documented disease progression or death due to any cause. CR is defined as the disappearance of all target and non-target lesions. Any pathological lymph nodes must be \<10 mm in the short axis. PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters (e.g., percent change from baseline). PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g., percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). |
| Secondary | Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE) | From the start of the first dose of study treatment until 28 days following discontinuation of the study treatment or until the data cutoff of 15-March-2013 (up to 21 months) | An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury. Per protocol other events were considered SAEs like symptomatic left ventricular ejection fraction (LVEF) decreases or cases of central serous retinopathy (CSR) or retinal vein occlusion (RVO). AE and SAE data were collected from the start of the first dose of study treatment and continued until 28 days following discontinuation of the study treatment or death. Refer to the general AE/SAE module for a complete list of AEs and SAEs. |
| Secondary | Number of Participants (Par.) With a Worst-case Change to Grade 3 or Grade 4 From Baseline Grade in Chemistry Parameters | From the start of the first dose of study treatment until 28 days following discontinuation of the study treatment or until the data cutoff of 17-April-2012 (up to 17 months) | A grading (severity) scale is provided for each laboratory toxicity. Grade refers to the severity of the toxicity. The Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 displays Grades 1 through 5 based on the general guideline: Grade 1, mild toxicity; Grade 2, moderate toxicity; Grade 3, severe toxicity; Grade 4, life-threatening or disabling toxicity; Grade 5, death related to toxicity. |
| Secondary | Number of Participants With Change From Baseline Increase to Grade 3/Grade 4 in Lab Hematology Test Measurements | From the start of the first dose of study treatment until 28 days following discontinuation of the study treatment or until the data cutoff of 17-April-2012 (up to 17 months) | A grading (severity) scale is provided for each laboratory toxicity. Grade refers to the severity of the toxicity. The CTCAE version 3.0 displays Grades 1 through 5, with unique clinical descriptions of the severity for each toxicity based on the general guideline: Grade 1, mild toxicity; Grade 2, moderate toxicity; Grade 3, severe toxicity; Grade 4, life-threatening or disabling toxicity; Grade 5, death related to toxicity. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival | From randomization until death due to any cause or until the data cutoff of 15-March-2013 (up to 24 months) | Intent-to-Treat (ITT) Population: all randomized participants regardless of whether or not treatment was administered | months | MEDIAN |
| SECONDARY | Progression-free Survival (PFS) as Assessed by the Investigator | From randomization until disease progression (PD) or death due to any cause or until the data cutoff of 17-April-2012 (up to 15 months) | ITT Population | weeks | MEDIAN |
| SECONDARY | Number of Participants With an Investigator-assessed Best Response, With or Without Confirmation, of Complete Response (CR) or Partial Response (PR) | From randomization until disease progression or death due to any cause or until the data cutoff of 17-April-2012 (up to 15 months) | Measurable Disease (MD) Population: all randomized participants regardless of whether or not treatment was administered who had measurable disease at baseline | participants | NUMBER |
| SECONDARY | Investigator-Assessed Duration of Response | From the first documented CR or PR until disease progression or death due to any cause or until the data cutoff of 17-April-2012 (up to 13 months) | MD Population. Duration of response was assessed for only those participants with a CR or PR. | Weeks | MEDIAN |
| SECONDARY | Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE) | From the start of the first dose of study treatment until 28 days following discontinuation of the study treatment or until the data cutoff of 15-March-2013 (up to 21 months) | Safety Population: all participants who were randomized and took at least one dose of study medication. This population was based on the actual treatment received, if it differed from that to which the participant was randomized. | participants | NUMBER |
| SECONDARY | Number of Participants (Par.) With a Worst-case Change to Grade 3 or Grade 4 From Baseline Grade in Chemistry Parameters | From the start of the first dose of study treatment until 28 days following discontinuation of the study treatment or until the data cutoff of 17-April-2012 (up to 17 months) | Safety Population. Only those par. with laboratory values for worst-case on therapy were analyzed. The same par. were not necessarily analyzed for each laboratory parameter; thus, the number of par. analyzed reflects all par. in the Safety Population. The number of par. analyzed for a particular parameter is included in the parameter title. | participants | NUMBER |
| SECONDARY | Number of Participants With Change From Baseline Increase to Grade 3/Grade 4 in Lab Hematology Test Measurements | From the start of the first dose of study treatment until 28 days following discontinuation of the study treatment or until the data cutoff of 17-April-2012 (up to 17 months) | Safety Population. Only those par. with laboratory values for worst-case on therapy were analyzed. The same par. were not necessarily analyzed for each laboratory parameter; thus, the number of par. analyzed reflects all par. in the Safety Population. The number of par. analyzed for a particular parameter is included in the parameter title. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group94
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival | Trametinib + Gemcitabine | 8.4 | 95% Confidence Interval 7.8 to 10.3 | months | |
| Overall Survival | Placebo + Gemcitabine | 6.7 | 95% Confidence Interval 5.3 to 9.9 | months | |
| Progression-free Survival (PFS) as Assessed by the Investigator | Trametinib + Gemcitabine | 16.1 | 95% Confidence Interval 14.0 to 23.4 | weeks | |
| Progression-free Survival (PFS) as Assessed by the Investigator | Placebo + Gemcitabine | 15.1 | 95% Confidence Interval 8.6 to 21.7 | weeks | |
| Number of Participants With an Investigator-assessed Best Response, With or Without Confirmation, of Complete Response (CR) or Partial Response (PR) | Trametinib + Gemcitabine | CR | 1 | participants | |
| Number of Participants With an Investigator-assessed Best Response, With or Without Confirmation, of Complete Response (CR) or Partial Response (PR) | Placebo + Gemcitabine | CR | 0 | participants | |
| Number of Participants With an Investigator-assessed Best Response, With or Without Confirmation, of Complete Response (CR) or Partial Response (PR) | Trametinib + Gemcitabine | PR | 16 | participants | |
| Number of Participants With an Investigator-assessed Best Response, With or Without Confirmation, of Complete Response (CR) or Partial Response (PR) | Placebo + Gemcitabine | PR | 14 | participants | |
| Investigator-Assessed Duration of Response | Trametinib + Gemcitabine | 23.9 | 95% Confidence Interval 9.0 to 28.9 | Weeks | |
| Investigator-Assessed Duration of Response | Placebo + Gemcitabine | 16.1 | 95% Confidence Interval 8.3 to NA | Weeks |
1 to 10 of 94Source ClinicalTrials.gov
See all 94 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Trametinib + Gemcitabine | 80 | |
| Overall Study | STARTED | Placebo + Gemcitabine | 80 | |
| Overall Study | Ongoing | Trametinib + Gemcitabine | 1 | |
| Overall Study | Ongoing | Placebo + Gemcitabine | 0 | |
| Overall Study | COMPLETED | Trametinib + Gemcitabine | 0 | |
| Overall Study | COMPLETED | Placebo + Gemcitabine | 0 | |
| Overall Study | NOT COMPLETED | Trametinib + Gemcitabine | 80 | |
| Overall Study | NOT COMPLETED | Placebo + Gemcitabine | 80 |
Source ClinicalTrials.gov
Adverse events320
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 | Nausea | Gastrointestinal disorders | Trametinib + Gemcitabine | 43 | 80 | |
| other | Nausea | Gastrointestinal disorders | Placebo + Gemcitabine | 41 | 80 | |
| other | Vomiting | Gastrointestinal disorders | Trametinib + Gemcitabine | 38 | 80 | |
| other | Vomiting | Gastrointestinal disorders | Placebo + Gemcitabine | 36 | 80 | |
| other | Diarrhoea | Gastrointestinal disorders | Trametinib + Gemcitabine | 43 | 80 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo + Gemcitabine | 22 | 80 | |
| other | Constipation | Gastrointestinal disorders | Trametinib + Gemcitabine | 23 | 80 | |
| other | Constipation | Gastrointestinal disorders | Placebo + Gemcitabine | 20 | 80 | |
| other | Stomatitis | Gastrointestinal disorders | Trametinib + Gemcitabine | 29 | 80 | |
| other | Stomatitis | Gastrointestinal disorders | Placebo + Gemcitabine | 6 | 80 |
1 to 10 of 320Source ClinicalTrials.gov
See all 320 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Trametinib + Gemcitabine | ||
| Total, all-cause mortality | Placebo + Gemcitabine | ||
| Total, other adverse events | Trametinib + Gemcitabine | 80 | 80 |
| Total, other adverse events | Placebo + Gemcitabine | 80 | 80 |
| Total, serious adverse events | Trametinib + Gemcitabine | 42 | 80 |
| Total, serious adverse events | Placebo + Gemcitabine | 37 | 80 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 24915778 | 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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Trametinib + Gemcitabine vs Placebo + Gemcitabine: 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/NCT01231581
GET https://conductscience.org/api/trials/v1/NCT01231581/results?page=2