Trial Outcomes & Findings for Study of GSK1120212 Plus Gemcitabine vs Placebo Plus Gemcitabine in Metastatic Pancreatic Cancer (NCT NCT01231581)

Last Updated: 2013-09-26

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

160 participants

Primary outcome timeframe

From randomization until death due to any cause or until the data cutoff of 15-March-2013 (up to 24 months)

Results posted on

2013-09-26

Participant Flow

Participant milestones

Participant milestones
Measure	Trametinib + Gemcitabine Participants received 2 milligrams (mg) trametinib orally once daily in combination with 1000 mg/m\^2 of gemcitabine given as intravenous (IV) infusion over 30 minutes (min). In the first cycle, gemcitabine was infused weekly for 7 weeks followed by a week of rest from treatment and then subsequent cycles on Day 1, 8, and 15 followed by 1 week of rest from treatment for each 28-day treatment cycle until progressive disease (PD), unacceptable toxicity, or permanent discontinuation from study treatment for any reason.	Placebo + Gemcitabine Participants received placebo orally once daily in combination with 1000 mg/m\^2 of gemcitabine given as IV infusion over 30 min. In the first cycle, gemcitabine was infused weekly for 7 weeks followed by a week of rest from treatment and then subsequent cycles on Day 1, 8, and 15 followed by 1 week of rest from treatment for each 28-day treatment cycle until PD, unacceptable toxicity, or permanent discontinuation from study treatment for any reason.
Overall Study STARTED	80	80
Overall Study Ongoing	1	0
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	80	80

Reasons for withdrawal

Reasons for withdrawal
Measure	Trametinib + Gemcitabine Participants received 2 milligrams (mg) trametinib orally once daily in combination with 1000 mg/m\^2 of gemcitabine given as intravenous (IV) infusion over 30 minutes (min). In the first cycle, gemcitabine was infused weekly for 7 weeks followed by a week of rest from treatment and then subsequent cycles on Day 1, 8, and 15 followed by 1 week of rest from treatment for each 28-day treatment cycle until progressive disease (PD), unacceptable toxicity, or permanent discontinuation from study treatment for any reason.	Placebo + Gemcitabine Participants received placebo orally once daily in combination with 1000 mg/m\^2 of gemcitabine given as IV infusion over 30 min. In the first cycle, gemcitabine was infused weekly for 7 weeks followed by a week of rest from treatment and then subsequent cycles on Day 1, 8, and 15 followed by 1 week of rest from treatment for each 28-day treatment cycle until PD, unacceptable toxicity, or permanent discontinuation from study treatment for any reason.
Overall Study Lost to Follow-up	2	2
Overall Study Withdrawal by Subject	6	9
Overall Study Study Closed/Terminated	6	5
Overall Study Death	65	64
Overall Study Ongoing	1	0

Baseline Characteristics

Study of GSK1120212 Plus Gemcitabine vs Placebo Plus Gemcitabine in Metastatic Pancreatic Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Trametinib + Gemcitabine n=80 Participants Participants received 2 milligrams (mg) trametinib orally once daily in combination with 1000 mg/m\^2 of gemcitabine given as intravenous (IV) infusion over 30 minutes (min). In the first cycle, gemcitabine was infused weekly for 7 weeks followed by a week of rest from treatment and then subsequent cycles on Day 1, 8, and 15 followed by 1 week of rest from treatment for each 28-day treatment cycle until progressive disease (PD), unacceptable toxicity, or permanent discontinuation from study treatment for any reason.	Placebo + Gemcitabine n=80 Participants Participants received placebo orally once daily in combination with 1000 mg/m\^2 of gemcitabine given as IV infusion over 30 min. In the first cycle, gemcitabine was infused weekly for 7 weeks followed by a week of rest from treatment and then subsequent cycles on Day 1, 8, and 15 followed by 1 week of rest from treatment for each 28-day treatment cycle until PD, unacceptable toxicity, or permanent discontinuation from study treatment for any reason.	Total n=160 Participants Total of all reporting groups
Age Continuous	62.3 Years STANDARD_DEVIATION 10.35 • n=5 Participants	62.2 Years STANDARD_DEVIATION 9.56 • n=7 Participants	62.3 Years STANDARD_DEVIATION 9.93 • n=5 Participants
Sex: Female, Male Female	41 Participants n=5 Participants	34 Participants n=7 Participants	75 Participants n=5 Participants
Sex: Female, Male Male	39 Participants n=5 Participants	46 Participants n=7 Participants	85 Participants n=5 Participants
Race/Ethnicity, Customized White - White/Caucasian/European Heritage	50 Participants n=5 Participants	59 Participants n=7 Participants	109 Participants n=5 Participants
Race/Ethnicity, Customized Asian - East Asian Heritage	24 Participants n=5 Participants	13 Participants n=7 Participants	37 Participants n=5 Participants
Race/Ethnicity, Customized African American Africa	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants
Race/Ethnicity, Customized Asian - Central/South Asian Heritage	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Asian - South East Asian Heritage	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized White - Arabic/North African Heritage	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: From randomization until death due to any cause or until the data cutoff of 15-March-2013 (up to 24 months)

Population: Intent-to-Treat (ITT) Population: all randomized participants regardless of whether or not treatment was administered

Outcome measures

Outcome measures
Measure	Trametinib + Gemcitabine n=80 Participants Participants received 2 milligrams (mg) trametinib orally once daily in combination with 1000 mg/m\^2 of gemcitabine given as intravenous (IV) infusion over 30 minutes (min). In the first cycle, gemcitabine was infused weekly for 7 weeks followed by a week of rest from treatment and then subsequent cycles on Day 1, 8, and 15 followed by 1 week of rest from treatment for each 28-day treatment cycle until progressive disease (PD), unacceptable toxicity, or permanent discontinuation from study treatment for any reason.	Placebo + Gemcitabine n=80 Participants Participants received placebo orally once daily in combination with 1000 mg/m\^2 of gemcitabine given as IV infusion over 30 min. In the first cycle, gemcitabine was infused weekly for 7 weeks followed by a week of rest from treatment and then subsequent cycles on Day 1, 8, and 15 followed by 1 week of rest from treatment for each 28-day treatment cycle until PD, unacceptable toxicity, or permanent discontinuation from study treatment for any reason.
Overall Survival	8.4 months Interval 7.8 to 10.3	6.7 months Interval 5.3 to 9.9

SECONDARY outcome

Timeframe: 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)

Population: ITT Population

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.

Outcome measures

Outcome measures
Measure	Trametinib + Gemcitabine n=80 Participants Participants received 2 milligrams (mg) trametinib orally once daily in combination with 1000 mg/m\^2 of gemcitabine given as intravenous (IV) infusion over 30 minutes (min). In the first cycle, gemcitabine was infused weekly for 7 weeks followed by a week of rest from treatment and then subsequent cycles on Day 1, 8, and 15 followed by 1 week of rest from treatment for each 28-day treatment cycle until progressive disease (PD), unacceptable toxicity, or permanent discontinuation from study treatment for any reason.	Placebo + Gemcitabine n=80 Participants Participants received placebo orally once daily in combination with 1000 mg/m\^2 of gemcitabine given as IV infusion over 30 min. In the first cycle, gemcitabine was infused weekly for 7 weeks followed by a week of rest from treatment and then subsequent cycles on Day 1, 8, and 15 followed by 1 week of rest from treatment for each 28-day treatment cycle until PD, unacceptable toxicity, or permanent discontinuation from study treatment for any reason.
Progression-free Survival (PFS) as Assessed by the Investigator	16.1 weeks Interval 14.0 to 23.4	15.1 weeks Interval 8.6 to 21.7

SECONDARY outcome

Timeframe: From randomization until disease progression or death due to any cause or until the data cutoff of 17-April-2012 (up to 15 months)

Population: Measurable Disease (MD) Population: all randomized participants regardless of whether or not treatment was administered who had measurable disease at baseline

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.

Outcome measures

Outcome measures
Measure	Trametinib + Gemcitabine n=77 Participants Participants received 2 milligrams (mg) trametinib orally once daily in combination with 1000 mg/m\^2 of gemcitabine given as intravenous (IV) infusion over 30 minutes (min). In the first cycle, gemcitabine was infused weekly for 7 weeks followed by a week of rest from treatment and then subsequent cycles on Day 1, 8, and 15 followed by 1 week of rest from treatment for each 28-day treatment cycle until progressive disease (PD), unacceptable toxicity, or permanent discontinuation from study treatment for any reason.	Placebo + Gemcitabine n=77 Participants Participants received placebo orally once daily in combination with 1000 mg/m\^2 of gemcitabine given as IV infusion over 30 min. In the first cycle, gemcitabine was infused weekly for 7 weeks followed by a week of rest from treatment and then subsequent cycles on Day 1, 8, and 15 followed by 1 week of rest from treatment for each 28-day treatment cycle until PD, unacceptable toxicity, or permanent discontinuation from study treatment for any reason.
Number of Participants With an Investigator-assessed Best Response, With or Without Confirmation, of Complete Response (CR) or Partial Response (PR) CR	1 participants	0 participants
Number of Participants With an Investigator-assessed Best Response, With or Without Confirmation, of Complete Response (CR) or Partial Response (PR) PR	16 participants	14 participants

SECONDARY outcome

Timeframe: 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)

Population: MD Population. Duration of response was assessed for only those participants with a CR or PR.

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).

Outcome measures

Outcome measures
Measure	Trametinib + Gemcitabine n=17 Participants Participants received 2 milligrams (mg) trametinib orally once daily in combination with 1000 mg/m\^2 of gemcitabine given as intravenous (IV) infusion over 30 minutes (min). In the first cycle, gemcitabine was infused weekly for 7 weeks followed by a week of rest from treatment and then subsequent cycles on Day 1, 8, and 15 followed by 1 week of rest from treatment for each 28-day treatment cycle until progressive disease (PD), unacceptable toxicity, or permanent discontinuation from study treatment for any reason.	Placebo + Gemcitabine n=14 Participants Participants received placebo orally once daily in combination with 1000 mg/m\^2 of gemcitabine given as IV infusion over 30 min. In the first cycle, gemcitabine was infused weekly for 7 weeks followed by a week of rest from treatment and then subsequent cycles on Day 1, 8, and 15 followed by 1 week of rest from treatment for each 28-day treatment cycle until PD, unacceptable toxicity, or permanent discontinuation from study treatment for any reason.
Investigator-Assessed Duration of Response	23.9 Weeks Interval 9.0 to 28.9	16.1 Weeks Interval 8.3 to There were too few events to provide an estimable upper limit of the confidence interval.

SECONDARY outcome

Timeframe: 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)

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Trametinib + Gemcitabine n=80 Participants Participants received 2 milligrams (mg) trametinib orally once daily in combination with 1000 mg/m\^2 of gemcitabine given as intravenous (IV) infusion over 30 minutes (min). In the first cycle, gemcitabine was infused weekly for 7 weeks followed by a week of rest from treatment and then subsequent cycles on Day 1, 8, and 15 followed by 1 week of rest from treatment for each 28-day treatment cycle until progressive disease (PD), unacceptable toxicity, or permanent discontinuation from study treatment for any reason.	Placebo + Gemcitabine n=80 Participants Participants received placebo orally once daily in combination with 1000 mg/m\^2 of gemcitabine given as IV infusion over 30 min. In the first cycle, gemcitabine was infused weekly for 7 weeks followed by a week of rest from treatment and then subsequent cycles on Day 1, 8, and 15 followed by 1 week of rest from treatment for each 28-day treatment cycle until PD, unacceptable toxicity, or permanent discontinuation from study treatment for any reason.
Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE) Any AE	80 participants	80 participants
Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE) SAE	42 participants	37 participants

SECONDARY outcome

Timeframe: 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)

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Trametinib + Gemcitabine n=80 Participants Participants received 2 milligrams (mg) trametinib orally once daily in combination with 1000 mg/m\^2 of gemcitabine given as intravenous (IV) infusion over 30 minutes (min). In the first cycle, gemcitabine was infused weekly for 7 weeks followed by a week of rest from treatment and then subsequent cycles on Day 1, 8, and 15 followed by 1 week of rest from treatment for each 28-day treatment cycle until progressive disease (PD), unacceptable toxicity, or permanent discontinuation from study treatment for any reason.	Placebo + Gemcitabine n=80 Participants Participants received placebo orally once daily in combination with 1000 mg/m\^2 of gemcitabine given as IV infusion over 30 min. In the first cycle, gemcitabine was infused weekly for 7 weeks followed by a week of rest from treatment and then subsequent cycles on Day 1, 8, and 15 followed by 1 week of rest from treatment for each 28-day treatment cycle until PD, unacceptable toxicity, or permanent discontinuation from study treatment for any reason.
Number of Participants (Par.) With a Worst-case Change to Grade 3 or Grade 4 From Baseline Grade in Chemistry Parameters Albumin, Grade 3, n=73, 73	7 participants	4 participants
Number of Participants (Par.) With a Worst-case Change to Grade 3 or Grade 4 From Baseline Grade in Chemistry Parameters Albumin, Grade 4, n=73, 73	0 participants	0 participants
Number of Participants (Par.) With a Worst-case Change to Grade 3 or Grade 4 From Baseline Grade in Chemistry Parameters Alkaline Phosphatase, Grade 3, n=74, 73	7 participants	4 participants
Number of Participants (Par.) With a Worst-case Change to Grade 3 or Grade 4 From Baseline Grade in Chemistry Parameters Alkaline Phosphatase, Grade 4, n=74, 73	0 participants	0 participants
Number of Participants (Par.) With a Worst-case Change to Grade 3 or Grade 4 From Baseline Grade in Chemistry Parameters Alanine Amino Transferase, Grade 3, n=74, 73	7 participants	7 participants
Number of Participants (Par.) With a Worst-case Change to Grade 3 or Grade 4 From Baseline Grade in Chemistry Parameters Alanine Amino Transferase, Grade 4, n=74, 73	0 participants	0 participants
Number of Participants (Par.) With a Worst-case Change to Grade 3 or Grade 4 From Baseline Grade in Chemistry Parameters Aspartate Aminotransferase, Grade 3, n=73, 72	6 participants	7 participants
Number of Participants (Par.) With a Worst-case Change to Grade 3 or Grade 4 From Baseline Grade in Chemistry Parameters Aspartate Aminotransferase, Grade 4, n=73, 72	0 participants	0 participants
Number of Participants (Par.) With a Worst-case Change to Grade 3 or Grade 4 From Baseline Grade in Chemistry Parameters Total Bilirubin, Grade 3, n=74, 73	1 participants	7 participants
Number of Participants (Par.) With a Worst-case Change to Grade 3 or Grade 4 From Baseline Grade in Chemistry Parameters Total Bilirubin, Grade 4, n=74, 73	0 participants	1 participants
Number of Participants (Par.) With a Worst-case Change to Grade 3 or Grade 4 From Baseline Grade in Chemistry Parameters Calcium (hypercalcemia), Grade 3, n=73, 73	1 participants	1 participants
Number of Participants (Par.) With a Worst-case Change to Grade 3 or Grade 4 From Baseline Grade in Chemistry Parameters Calcium (hypercalcemia), Grade 4, n=73, 73	0 participants	0 participants
Number of Participants (Par.) With a Worst-case Change to Grade 3 or Grade 4 From Baseline Grade in Chemistry Parameters Calcium (hypocalcemia), Grade 3, n=73, 73	1 participants	2 participants
Number of Participants (Par.) With a Worst-case Change to Grade 3 or Grade 4 From Baseline Grade in Chemistry Parameters Calcium (hypocalcemia), Grade 4, n=73, 73	0 participants	0 participants
Number of Participants (Par.) With a Worst-case Change to Grade 3 or Grade 4 From Baseline Grade in Chemistry Parameters Creatinine, Grade 3, n=74, 75	0 participants	0 participants
Number of Participants (Par.) With a Worst-case Change to Grade 3 or Grade 4 From Baseline Grade in Chemistry Parameters Creatinine, Grade 4, n=74, 75	1 participants	0 participants
Number of Participants (Par.) With a Worst-case Change to Grade 3 or Grade 4 From Baseline Grade in Chemistry Parameters Glucose (hyperglycemia), Grade 3, n=74, 72	9 participants	10 participants
Number of Participants (Par.) With a Worst-case Change to Grade 3 or Grade 4 From Baseline Grade in Chemistry Parameters Glucose (hyperglycemia), Grade 4, n=74, 72	0 participants	1 participants
Number of Participants (Par.) With a Worst-case Change to Grade 3 or Grade 4 From Baseline Grade in Chemistry Parameters Glucose (hypoglycemia), Grade 3, n=74, 72	0 participants	0 participants
Number of Participants (Par.) With a Worst-case Change to Grade 3 or Grade 4 From Baseline Grade in Chemistry Parameters Glucose (hypoglycemia), Grade 4, n=74, 72	1 participants	0 participants
Number of Participants (Par.) With a Worst-case Change to Grade 3 or Grade 4 From Baseline Grade in Chemistry Parameters Potassium (hyperkalemia), Grade 3, n=74, 72	2 participants	1 participants
Number of Participants (Par.) With a Worst-case Change to Grade 3 or Grade 4 From Baseline Grade in Chemistry Parameters Potassium (hyperkalemia), Grade 4, n=74, 72	0 participants	0 participants
Number of Participants (Par.) With a Worst-case Change to Grade 3 or Grade 4 From Baseline Grade in Chemistry Parameters Potassium (hypokalemia), Grade 3, n=74, 72	4 participants	1 participants
Number of Participants (Par.) With a Worst-case Change to Grade 3 or Grade 4 From Baseline Grade in Chemistry Parameters Potassium (hypokalemia), Grade 4, n=74, 72	0 participants	0 participants
Number of Participants (Par.) With a Worst-case Change to Grade 3 or Grade 4 From Baseline Grade in Chemistry Parameters Sodium (hyponatremia), Grade 3, n=74, 74	5 participants	3 participants
Number of Participants (Par.) With a Worst-case Change to Grade 3 or Grade 4 From Baseline Grade in Chemistry Parameters Sodium (hyponatremia), Grade 4, n=74, 74	2 participants	0 participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Trametinib + Gemcitabine n=80 Participants Participants received 2 milligrams (mg) trametinib orally once daily in combination with 1000 mg/m\^2 of gemcitabine given as intravenous (IV) infusion over 30 minutes (min). In the first cycle, gemcitabine was infused weekly for 7 weeks followed by a week of rest from treatment and then subsequent cycles on Day 1, 8, and 15 followed by 1 week of rest from treatment for each 28-day treatment cycle until progressive disease (PD), unacceptable toxicity, or permanent discontinuation from study treatment for any reason.	Placebo + Gemcitabine n=80 Participants Participants received placebo orally once daily in combination with 1000 mg/m\^2 of gemcitabine given as IV infusion over 30 min. In the first cycle, gemcitabine was infused weekly for 7 weeks followed by a week of rest from treatment and then subsequent cycles on Day 1, 8, and 15 followed by 1 week of rest from treatment for each 28-day treatment cycle until PD, unacceptable toxicity, or permanent discontinuation from study treatment for any reason.
Number of Participants With Change From Baseline Increase to Grade 3/Grade 4 in Lab Hematology Test Measurements Hemoglobin (Increased), Grade 4, n=80, 79	0 participants	0 participants
Number of Participants With Change From Baseline Increase to Grade 3/Grade 4 in Lab Hematology Test Measurements Hemoglobin (Increased), Grade 3, n=80, 79	3 participants	0 participants
Number of Participants With Change From Baseline Increase to Grade 3/Grade 4 in Lab Hematology Test Measurements Hemoglobin (Anemia), Grade 3, n=80, 79	24 participants	13 participants
Number of Participants With Change From Baseline Increase to Grade 3/Grade 4 in Lab Hematology Test Measurements Hemoglobin (Anemia), Grade 4, n=80, 79	0 participants	0 participants
Number of Participants With Change From Baseline Increase to Grade 3/Grade 4 in Lab Hematology Test Measurements Lymphocytes (Increased), Grade 3, n=80, 79	1 participants	0 participants
Number of Participants With Change From Baseline Increase to Grade 3/Grade 4 in Lab Hematology Test Measurements Lymphocytes (Increased), Grade 4, n=80, 79	0 participants	0 participants
Number of Participants With Change From Baseline Increase to Grade 3/Grade 4 in Lab Hematology Test Measurements Lymphocytes (Decreased), Grade 3, n=80, 79	9 participants	12 participants
Number of Participants With Change From Baseline Increase to Grade 3/Grade 4 in Lab Hematology Test Measurements Lymphocytes (Decreased), Grade 4, n=80, 79	3 participants	6 participants
Number of Participants With Change From Baseline Increase to Grade 3/Grade 4 in Lab Hematology Test Measurements Absolute Neutrophil Count, Grade 3, n=80, 79	23 participants	20 participants
Number of Participants With Change From Baseline Increase to Grade 3/Grade 4 in Lab Hematology Test Measurements Absolute Neutrophil Count, Grade 4, n=80, 79	7 participants	10 participants
Number of Participants With Change From Baseline Increase to Grade 3/Grade 4 in Lab Hematology Test Measurements Platelet count, Grade 3, n=80, 79	11 participants	10 participants
Number of Participants With Change From Baseline Increase to Grade 3/Grade 4 in Lab Hematology Test Measurements Platelet count, Grade 4, n=80, 79	1 participants	4 participants
Number of Participants With Change From Baseline Increase to Grade 3/Grade 4 in Lab Hematology Test Measurements White Blood Cell count, Grade 3, n=80, 79	15 participants	14 participants
Number of Participants With Change From Baseline Increase to Grade 3/Grade 4 in Lab Hematology Test Measurements White Blood Cell count, Grade 4, n=80, 79	1 participants	4 participants

Adverse Events

Trametinib + Gemcitabine

Serious events: 42 serious events

Other events: 80 other events

Deaths: 0 deaths

Placebo + Gemcitabine

Serious events: 37 serious events

Other events: 80 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER