Trial · NCT00920140

Open-label Study to Evaluate the Safety, PK, and PD of MEK Inhibitor GSK1120212 in Subjects With Relapsed or Refractory Leukemias

NCT00920140, Phase 2, Completed, GlaxoSmithKline; results first posted 2014-02-28

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Open-label Study to Evaluate the Safety, PK, and PD of MEK Inhibitor GSK1120212 in Subjects With Relapsed or Refractory Leukemias. Trials, record NCT00920140. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00920140

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Open-label Study to Evaluate the Safety, PK, and PD of MEK Inhibitor GSK1120212 in Subjects With Relapsed or Refractory Leukemias
NCT number: NCT00920140
Status: Completed
Phases: Phase 2
Enrollment: 97 participants, actual
Lead sponsor: GlaxoSmithKline
Conditions: Cancer
Interventions: GSK1120212, GSK1120212
First posted: 2009-06-15
Last updated: 2014-04-02
Results first posted: 2014-02-28

Source ClinicalTrials.gov

Registered outcomes14

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) by Dose	From the start of the study drug until the final study visit (up to approximately 407 days)	An AE is any untoward medical occurrence in a participant (par.) or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered 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, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury. Refer to the general Adverse AE/SAE module for a complete list of AEs and SAEs.
Primary	Number of Participants With a Change From Baseline Grade to Grade 3 and 4 for the Indicated Hematology Parameters by Dose	From the start of the study drug until the final study visit (up to approximately 407 days)	Hematology and clinical chemistry data were summarized according to National Cancer Institutes (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade, version 3.0. Grade 1, Mild; Grade 2, Moderate; Grade 3, Severe; Grade 4, Life-threatening or disabling; Grade 5, Death. Data are presented for only those parameters for which an increase to Grade 3 or Grade 4 occurred. Hematology tests where the toxicity grade is defined by NCI-CTCAE includes hemoglobin, international normalized ratio (INR), lymphocytes, total neutrophils, platelet count, and partial thromboplastin time (PTT). Participants with missing baseline grades were assumed to have a baseline grade of 0. Only those participants (par.) with laboratory values for worst-case on-therapy (defined as the worst shift that occurred at any time during the treatment period) are presented.
Primary	Number of Participants With a Change From Baseline Grade to Grade 3 and 4 for the Indicated Clinical Chemistry Parameters by Dose	From the start of the study drug until the final study visit (up to approximately 407 days)	Hematology and clinical chemistry data were summarized according to NCI-CTCAE grade, version 3.0. Grade 1, Mild; Grade 2, Moderate; Grade 3, Severe; Grade 4, Life-threatening or disabling; Grade 5, Death. Data are presented for only those parameters for which an increase to Grade 3 or Grade 4 occurred. Clinical chemistry tests where the toxicity grade is defined by NCI-CTCAE includes albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase (AST), total bilirubin, calcium, creatinine, glucose, bicarbonate, potassium, magnesium, sodium, and phosphorus. Participants with missing Baseline grades were assumed to have a Baseline grade of 0. Only those participants (par.) with laboratory values for worst-case on-therapy are presented.
Primary	Number of Participants With a Change From Baseline in Heart Rate by Dose	From the start of the study drug until the final study visit (up to approximately 407 days)	Change from Baseline in heart rate is categorized as decrease to \<60 beats per minute (bpm), change to normal or no change, and increase to \>100 bpm. Participants with a missing Baseline value are assumed to have a normal Baseline value. Participants are counted twice if the participant heart rate value decreased to \<60 bpm and increased to \>100 bpm post-baseline. Only those participants (par.) with heart rate values for worst-case on-therapy are presented.
Primary	Number of Participants With a Change From Baseline in Systolic and Diastolic Blood Pressure by Dose	From the start of the study drug until the final study visit (up to approximately 407 days)	Change from Baseline in systolic blood pressure (SBP) is categorized as: Grade 0 (\<120 millimeters of mercury \[mmHg\]), Grade 1 (120-139 mmHg), Grade 2 (140-159 mmHg), and Grade 3/4 (\>=160 mmHg). Change from Baseline in diastolic blood pressure (DBP) is categorized as: Grade 0 (\<80 mmHg), Grade 1 (80-89 mmHg), Grade 2 (90-99 mmHg), and Grade 3/4 (\>=100 mmHg). An increase is defined as an increase in the CTCAE grade relative to the Baseline grade. Participants with missing Baseline values are assumed to have a Baseline value of grade 0. Only those participants (par.) with blood pressure values for worst-case on-therapy are presented.
Primary	Number of Participants With a Change From Baseline in Temperature by Dose	From the start of the study drug until the final study visit (up to approximately 407 days)	Change from Baseline in temperature is categorized as a decrease to \<=35 degrees celsius (C), change to normal or no change, and increase to \>=38 degrees C. Participants with a missing Baseline value are assumed to have a normal Baseline value. Participants (par.) are counted twice if the participant temperature value decreased to \<=35 degrees C and increased to \>=38 degrees C post-Baseline. Only those participants with temperature values for worst-case on-therapy are presented.
Primary	Number of Participants With an Investigator-assessed Best Response (Achieving Complete Response [CR], Marrow CR, Partial Response [PR], Complete Response Without Platelet Recovery [CRp] or Morphologic Leukaemia-free State[MLFS]) by Cohort	From the start of the study drug until the final study visit (up to approximately 407 days)	Overall response rate (ORR=CR+CRp+Marrow CR+MLFS+PR) was calculated from the investigator's assessment of response recorded within the first eight weeks of treatment. CR includes complete remission. Complete remission is a state in which the participant must be free of all symptoms related to leukemia and have an absolute neutrophil count \>=1 x 10\^9/L, platelet count \>=100 x 10\^9/L, and normal marrow differential (\<=5% blasts). PR includes partial remission. Partial remission is a state in which the participant has a CR with 6 to 25% abnormal cells in the marrow or 50% decrease in bone marrow blasts. CRp is as per CR but platelet count \<100 x 10\^9/L. MLFS is a state in which the participant has a normal marrow differential (\<5% blasts), neutrophil, and platelet counts are not considered.
Secondary	AUC(0-24), AUC(0-t), and AUC(0-tau) of GSK1120212 in Part 1	Cycle 1 Day 1 and Cycle 1 Day 15	Area under the concentration-time (AUC) curve from time zero (pre-dose) to 24 hours (AUC\[0-24\]) for Cycle 1 Day 1 (C1D1), from time zero to the last time of a quantifiable concentration (AUC\[0-t\]) for C1D1 and Cylce 1 Day 15 (C1D15) and AUC curve over the dosing interval AUC\[0-tau\] for C1D15 were measured. Blood samples for PK analysis were taken on Day 1 and Day 15 (within 30 minutes \[min\] before study drug administration) and at 0.5 hour (h), 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 8 h, and 24 h post-dose. All other PK sampling were done pre-dose (i.e., within 30 min before study drug administration).
Secondary	Cmin and Cmax of GSK1120212 in Part 1	Cycle 1 Day 1 and Cycle 1 Day 15	Cmax is defined as the maximum observed concentration of GSK1120212 and was measured for C1D1 and C1D15. Cmin is defined as the minimal observed concentration of GSK1120212 and was measured for C1D15. Blood samples for PK analysis were taken on Day 1 and Day 15 (within 30 min before study drug administration) and at 0.5 h, 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 8 h, and 24 h post-dose. All other PK sampling were done pre-dose (i.e., within 30 min before study drug administration).
Secondary	t1/2 at C1D1 and t1/2 Effective (Eff.) at C1D15 of GSK1120212 in Part 1	Cycle 1 Day 1 (t1/2) and Cycle 1 Day 15 (t1/2eff)	t1/2 is defined as terminal phase half-life, which is the time required for the amount of the drug in the body to decrease by half and was measured for C1D1. t1/2eff. is defined as the effective half-life and was measured for C1D15. Blood samples for PK analysis were taken on Day 1 and Day 15 (within 30 min before study drug administration) and at 0.5 h, 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 8 h, and 24 h post-dose. All other PK sampling were done pre-dose (i.e., within 30 min before study drug administration).

1 to 10 of 14Source ClinicalTrials.gov

See all 14 registered outcomes

Outcomes14

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) by Dose	From the start of the study drug until the final study visit (up to approximately 407 days)	All Treated Population: all participants who received at least one dose of study medication. Safety data was evaluated based on this population. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed.	Participants	NUMBER
PRIMARY	Number of Participants With a Change From Baseline Grade to Grade 3 and 4 for the Indicated Hematology Parameters by Dose	From the start of the study drug until the final study visit (up to approximately 407 days)	All Treated Population (ATP). Only those par. available at the specified time points were analyzed. Different par. may have been analyzed for different parameters; the overall number analyzed reflects everyone in the ATP. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed.	Participants	NUMBER
PRIMARY	Number of Participants With a Change From Baseline Grade to Grade 3 and 4 for the Indicated Clinical Chemistry Parameters by Dose	From the start of the study drug until the final study visit (up to approximately 407 days)	All Treated Population (ATP). Only those par. available at the specified time points were analyzed. Different par. may have been analyzed for different parameters; the overall number analyzed reflects everyone in the ATP. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed.	Participants	NUMBER
PRIMARY	Number of Participants With a Change From Baseline in Heart Rate by Dose	From the start of the study drug until the final study visit (up to approximately 407 days)	All Treated Population (ATP). Only those par. available at the specified time points were analyzed. Different par. may have been analyzed for different parameters; the overall number analyzed reflects everyone in the ATP. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed.	Participants	NUMBER
PRIMARY	Number of Participants With a Change From Baseline in Systolic and Diastolic Blood Pressure by Dose	From the start of the study drug until the final study visit (up to approximately 407 days)	All Treated Population (ATP). Only those par. available at the specified time points were analyzed. Different par. may have been analyzed for different parameters; the overall number analyzed reflects everyone in the ATP. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed.	Participants	NUMBER
PRIMARY	Number of Participants With a Change From Baseline in Temperature by Dose	From the start of the study drug until the final study visit (up to approximately 407 days)	All Treated Population (ATP). Only those par. available at the specified time points were analyzed. Different par. may have been analyzed for different parameters; the overall number analyzed reflects everyone in the ATP. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed.	Participants	NUMBER
PRIMARY	Number of Participants With an Investigator-assessed Best Response (Achieving Complete Response [CR], Marrow CR, Partial Response [PR], Complete Response Without Platelet Recovery [CRp] or Morphologic Leukaemia-free State[MLFS]) by Cohort	From the start of the study drug until the final study visit (up to approximately 407 days)	Efficacy Population: all participants included in the All Treated Population who had received at least one dose of 2 mg of study drug in Phase 2. The number of participants for the Cohort 2: AML/MDS/CMML with RAS wt/Unknown treatment group is equal to the 8 participants from Phase 1 plus the 22 participants from Phase 2 (total of 30).	Participants	NUMBER
SECONDARY	AUC(0-24), AUC(0-t), and AUC(0-tau) of GSK1120212 in Part 1	Cycle 1 Day 1 and Cycle 1 Day 15	Pharmacokinetic Population: all participants included in the All Treated Population for whom a PK sample was obtained and analyzed. Only participants with data available at the indicated time points were analyzed.	nanograms*hour/milliliter	GEOMETRIC_MEAN
SECONDARY	Cmin and Cmax of GSK1120212 in Part 1	Cycle 1 Day 1 and Cycle 1 Day 15	Pharmacokinetic Population. Only participants with data available at the indicated time points were analyzed.	nanograms per milliliter (ng/mL)	GEOMETRIC_MEAN
SECONDARY	t1/2 at C1D1 and t1/2 Effective (Eff.) at C1D15 of GSK1120212 in Part 1	Cycle 1 Day 1 (t1/2) and Cycle 1 Day 15 (t1/2eff)	Pharmacokinetic Population. Only participants with data available at the indicated time points were analyzed.	Hours	GEOMETRIC_MEAN

1 to 10 of 14Source ClinicalTrials.gov

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Results by group197

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) by Dose	GSK1120212 <2 mg OD	Any AE	6	Participants
Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) by Dose	GSK1120212 2 mg OD	Any AE	91	Participants
Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) by Dose	GSK1120212 <2 mg OD	Any SAE	2	Participants
Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) by Dose	GSK1120212 2 mg OD	Any SAE	64	Participants
Number of Participants With a Change From Baseline Grade to Grade 3 and 4 for the Indicated Hematology Parameters by Dose	GSK1120212 <2 mg OD	Hemoglobin (Low), Grade 3, n=6, 91	3	Participants
Number of Participants With a Change From Baseline Grade to Grade 3 and 4 for the Indicated Hematology Parameters by Dose	GSK1120212 2 mg OD	Hemoglobin (Low), Grade 3, n=6, 91	28	Participants
Number of Participants With a Change From Baseline Grade to Grade 3 and 4 for the Indicated Hematology Parameters by Dose	GSK1120212 <2 mg OD	Hemoglobin (Low), Grade 4, n=6, 91	0	Participants
Number of Participants With a Change From Baseline Grade to Grade 3 and 4 for the Indicated Hematology Parameters by Dose	GSK1120212 2 mg OD	Hemoglobin (Low), Grade 4, n=6, 91	7	Participants
Number of Participants With a Change From Baseline Grade to Grade 3 and 4 for the Indicated Hematology Parameters by Dose	GSK1120212 <2 mg OD	INR (High), Grade 3, n=6, 75	0	Participants
Number of Participants With a Change From Baseline Grade to Grade 3 and 4 for the Indicated Hematology Parameters by Dose	GSK1120212 2 mg OD	INR (High), Grade 3, n=6, 75	0	Participants

1 to 10 of 197Source ClinicalTrials.gov

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Participant flow30

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Phase 1 (Dose Escalation)	STARTED	GSK1120212 < 2 mg OD	5
Phase 1 (Dose Escalation)	STARTED	GSK1120212 2 mg OD	9
Phase 1 (Dose Escalation)	STARTED	Cohort 1: AML/MDS With RAS Mutation	0
Phase 1 (Dose Escalation)	STARTED	Cohort 2: AML/MDS/CMML With RAS wt/Unknown	0
Phase 1 (Dose Escalation)	STARTED	Cohort 3: CMML With RAS Mutation	0
Phase 1 (Dose Escalation)	COMPLETED	GSK1120212 < 2 mg OD	0
Phase 1 (Dose Escalation)	COMPLETED	GSK1120212 2 mg OD	0
Phase 1 (Dose Escalation)	COMPLETED	Cohort 1: AML/MDS With RAS Mutation	0
Phase 1 (Dose Escalation)	COMPLETED	Cohort 2: AML/MDS/CMML With RAS wt/Unknown	0
Phase 1 (Dose Escalation)	COMPLETED	Cohort 3: CMML With RAS Mutation	0

1 to 10 of 30Source ClinicalTrials.gov

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Adverse events336

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
other	Diarrhoea	Gastrointestinal disorders	GSK1120212 <2 mg OD	5	6
other	Diarrhoea	Gastrointestinal disorders	GSK1120212 2 mg OD	43	91
other	Nausea	Gastrointestinal disorders	GSK1120212 <2 mg OD	3	6
other	Nausea	Gastrointestinal disorders	GSK1120212 2 mg OD	24	91
other	Vomiting	Gastrointestinal disorders	GSK1120212 <2 mg OD	2	6
other	Vomiting	Gastrointestinal disorders	GSK1120212 2 mg OD	18	91
other	Constipation	Gastrointestinal disorders	GSK1120212 <2 mg OD	1	6
other	Constipation	Gastrointestinal disorders	GSK1120212 2 mg OD	12	91
other	Abdominal pain	Gastrointestinal disorders	GSK1120212 <2 mg OD	0	6
other	Abdominal pain	Gastrointestinal disorders	GSK1120212 2 mg OD	11	91

1 to 10 of 336Source ClinicalTrials.gov

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Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	GSK1120212 <2 mg OD
Total, all-cause mortality	GSK1120212 2 mg OD
Total, other adverse events	GSK1120212 <2 mg OD	6	6
Total, other adverse events	GSK1120212 2 mg OD	90	91
Total, serious adverse events	GSK1120212 <2 mg OD	2	6
Total, serious adverse events	GSK1120212 2 mg OD	64	91

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

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
GSK1120212 <2 mg OD vs GSK1120212 2 mg OD: 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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT00920140

GET https://conductscience.org/api/trials/v1/NCT00920140/results?page=2

API reference For AI assistants