Trial · NCT01928940
Japan PhI/II of GSK2118436 and GSK1120212 Combination in Subjects With BRAF V600E/K Mutation Positive Advanced Solid Tumors (Phase I Part) or Cutaneous Melanoma (Phase II Part)
NCT01928940, Phase 2, Completed, GlaxoSmithKline; results first posted 2015-10-02
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Japan PhI/II of GSK2118436 and GSK1120212 Combination in Subjects With BRAF V600E/K Mutation Positive Advanced Solid Tumors (Phase I Part) or Cutaneous Melanoma (Phase II Part). Trials, record NCT01928940. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01928940
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Japan PhI/II of GSK2118436 and GSK1120212 Combination in Subjects With BRAF V600E/K Mutation Positive Advanced Solid Tumors (Phase I Part) or Cutaneous Melanoma (Phase II Part)
- NCT number
- NCT01928940
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 12 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Solid Tumours
- Interventions
- dabrafenib, trametinib
- First posted
- 2013-08-27
- Last updated
- 2017-07-24
- Results first posted
- 2015-10-02
Source ClinicalTrials.gov
Registered outcomes37
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Phase I: Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE) | From the start of study treatment until 30 days after study treatment discontinuation (average of 1.38 year) | An AE is defined as any untoward medical occurrence (MO) in a part. temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP and can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with its use. SAE is defined as any untoward MO that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, a congenital anomaly/birth defect and protocol-specific SAEs:ALT\>=3xupper limit of normal(ULN) and bilirubin\>=2xULN(\>35% direct) (or ALT\>=3xULN, international normalized ratio\>1.5), any new primary cancers, treatment emergent malignancies except basal cell carcinoma, symptomatic or asymptomatic LVEF decrease, retinal pigment epithelial detachment or retinal vein occlusion, pyrexia with hypotension,or dehydration or renal insufficiency,or severe (\>=G3) rigor/chills. |
| Primary | Phase I: Number of Participants With a Dose-limiting Toxicity (DLT) | From the start of study treatment until 21 days | A DLT was defined as an event occurred during the first 21 days after the first dose of study drugs and met any of the following criteria, according to National Cancer Institutes (NCI) common terminology criteria for AE (CTCAE) grade (G) version 4.0: G4 hematological toxicity; G3 or G4 non-hematologic toxicity (including rash, nausea, vomiting and diarrhea only if uncontrolled with supportive therapy); rash \>=G3 that required dose reduction despite supportive care; a G2 or greater non-hematological toxicity that in the judgment of the investigator and medical monitor; dose interruption of greater than 14 consecutive days due to unresolved toxicity; any new G2 or greater valvular heart disease and significant alteration in cardiac valve morphology from Baseline. |
| Primary | Phase I: Number of Participants With the Indicated Worst-case Change From Baseline (BL) in the Indicated Clinical Chemistry Parameters (CCPs) | From Baseline until the post-treatment Visit (average of 1.38 year) | CCPs were graded according to NCI CTCAE grade version 4.0 as: G1, Mild; G2, Moderate; G3, Severe; G4, Life-threatening or disabling; G5, Death. Data are presented for only those parameters (para) for which an increase to G3 or G4 from BL G occurred. CCPs that were not G according to NCI CTCAE criteria, were categorized as High and Low with respect to the normal range. Data are presented only for those para for which the category decreased to Low or increased to High relative to the BL category. The worst-case during the on-therapy period was determined taking into account both scheduled and unscheduled assessments. CCPs included: albumin, alkaline phosphatase, alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin, calcium, creatinine, glucose, potassium, magnesium, sodium, inorganic phosphorus, chloride, lactate dehydrogenase (LDH), total protein, urea/blood urea nitrogen (BUN) and uric acid. |
| Primary | Phase I: Number of Participants With the Indicated Worst-case Change From Baseline in the Indicated Hematology Parameters | From Baseline until the post-treatment Visit (average of 1.38 year) | Hematology parameters were summarized according to NCI CTCAE G, version 4.0 as: G1, Mild; G2, Moderate; G3, Severe; G4, Life-threatening or disabling; G5, Death. Data are presented for only those parameters for which an increase to G3 or G4 from Baseline G occurred. For hematology parameters that were not graded according to NCI CTCAE criteria, were categorized as High and Low with respect to the normal range. Data are presented only for those parameters for which the category decreased to Low or increased to High relative to the Baseline category. The worst-case during the on-therapy period was determined taking into account both scheduled and unscheduled assessments. Hematology parameters included: hemoglobin, lymphocytes, total neutrophils, platelet count, white blood cell (WBC) counts, basophils, eosinophils, hematocrit, mean corpuscular hemoglobin concentration (MCHC), mean corpuscular hemoglobin (MCH), mean corpuscular volume (MCV), monocytes and red blood cell (RBC) count. |
| Primary | Phase I: Number of Participants With the Indicated Urinalysis Parameters | From Baseline until the post-treatment Visit (average of 1.38 year) | Urine samples were collected for urine dipstick analysis at Baseline and at the post-treatment Visit. The number of participants with negative (absence) and positive (presence: trace, 1+, 2+, 3+, 4+ or 5+) results for urine occult blood (UOB), urine glucose (UGLU), urine ketones (UKET), urine protein (UP) and urine urobilinogen (UUBIL) were summarized. The Baseline value is defined as the last pre-treatment value observed. |
| Primary | Phase I: Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance (Pef) Status | From Baseline until the post-treatment Visit (average of 1.38 year) | The ECOG pef status 5-point scale is used to assess how a participant's disease is progressing, to assess how the disease affects the daily living abilities of the par. and to determine appropriate treatment and prognosis: G0, fully active, able to carry on all pre-disease pef without restriction. G1, restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, example, light house work, office work. G2, ambulatory and capable of all selfcare, but unable to carry out any work activities; up and about \>50 percent (%) of waking hrs. G3, capable of only limited selfcare; confined to bed or chair \>50% of waking hrs. G4, completely disabled; cannot carry on any selfcare; totally confined to bed or chair. G5, dead. The worst-case during the on-therapy period was determined taking into account both scheduled and unscheduled assessments. Number of par. who improved, had no change, or deteriorated in pef status from BL is summarized. |
| Primary | Phase I: Number of Participants With Worst-case On-therapy Increase From Baseline in Systolic and Diastolic Blood Pressure to Grade 2 or Grade 3 | From Baseline until the post-treatment Visit (average of 1.38 year) | Systolic blood pressure (SBP) and diastolic blood pressure (DBP) values were graded using (NCI CTCAE version 4.0). SBP was categorized as: G1 (Increase to \>=120 to 140 millimeters of mercury \[mmHg\]), G2 (Increase to \>=140 to \<160 mmHg), and G3 (Increase to \>=160 mmHg). DBP was categorized as: G1 (Increase to \>=80 to \<90 mmHg), G2 (Increase to \>=90 to \<100 mmHg), and G3 (Increase to \>=100 mmHg). The worst-case during the on-therapy period was determined taking into account both scheduled and unscheduled assessments. An increase is defined as an increase in the CTCAE grade relative to the Baseline grade. Participants with missing Baseline values were assumed to have a Baseline value of G0. |
| Primary | Phase I: Number of Participants With Worst-case On-therapy Change From Baseline in Heart Rate | From Baseline until the post-treatment Visit (average of 1.38 year) | 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 relative to the Baseline value. Participants with a missing Baseline value are assumed to have a normal Baseline value. Participants were counted twice if the participant's heart rate value decreased to \<60 bpm and increased to \>100 bpm post-Baseline. The worst-case during the on-therapy period was determined taking into account both scheduled and unscheduled assessments. |
| Primary | Phase I: Number of Participants With Worst-case On-therapy Change From Baseline in Temperature | From Baseline until the post-treatment Visit (average of 1.38 years) | Change from Baseline in temperature is categorized as a decrease to \<=35 degrees celsius (C), change to normal or no change as 35-38 degrees C, and increase to \>=38 degrees C relative to the Baseline value. Participants with a missing Baseline value are assumed to have a normal Baseline value. Participants were counted twice if the participant temperature value decreased to \<=35 degrees C and increased to \>=38 degrees C post-Baseline. The worst-case during the on-therapy period was determined taking into account both scheduled and unscheduled assessments. |
| Primary | Phase I: Change From Baseline in Oxygen Saturation (SpO2) Measured Via Pulse Oxymetry at the Indicated Time Points | From Baseline until the post-treatment Visit (average of 1.38 year) | Oxygen saturation measures the capacity of blood to transport oxygen to other parts of the body. Oxygen binds to hemoglobin in red blood cells when moving through the lungs. A pulse oximeter uses two frequencies of light (red and infrared) to determine the percentage of hemoglobin in the blood that is saturated with oxygen,that is called as blood oxygen saturation or SpO2. Change from Baseline was calculated as the individual post-Baseline value (Days 8,15; Weeks 3 to 136 and post-treatment Visit) minus the Baseline value. The Baseline value is defined as the last pre-treatment value observed. |
1 to 10 of 37Source ClinicalTrials.gov
See all 37 registered outcomesOutcomes37
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Phase I: Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE) | From the start of study treatment until 30 days after study treatment discontinuation (average of 1.38 year) | All Treated Subject (ATS) Population: all participants who received at least one dose of study medication. | Participants | NUMBER |
| PRIMARY | Phase I: Number of Participants With a Dose-limiting Toxicity (DLT) | From the start of study treatment until 21 days | DLT assessment Population: all participants for whom DLT assessment was appropriately conducted | Participants | NUMBER |
| PRIMARY | Phase I: Number of Participants With the Indicated Worst-case Change From Baseline (BL) in the Indicated Clinical Chemistry Parameters (CCPs) | From Baseline until the post-treatment Visit (average of 1.38 year) | ATS Population | Participants | NUMBER |
| PRIMARY | Phase I: Number of Participants With the Indicated Worst-case Change From Baseline in the Indicated Hematology Parameters | From Baseline until the post-treatment Visit (average of 1.38 year) | ATS Population | Participants | NUMBER |
| PRIMARY | Phase I: Number of Participants With the Indicated Urinalysis Parameters | From Baseline until the post-treatment Visit (average of 1.38 year) | ATS Population | Participants | NUMBER |
| PRIMARY | Phase I: Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance (Pef) Status | From Baseline until the post-treatment Visit (average of 1.38 year) | ATS Population | Participants | NUMBER |
| PRIMARY | Phase I: Number of Participants With Worst-case On-therapy Increase From Baseline in Systolic and Diastolic Blood Pressure to Grade 2 or Grade 3 | From Baseline until the post-treatment Visit (average of 1.38 year) | ATS Population | Participants | NUMBER |
| PRIMARY | Phase I: Number of Participants With Worst-case On-therapy Change From Baseline in Heart Rate | From Baseline until the post-treatment Visit (average of 1.38 year) | ATS Population | Participants | NUMBER |
| PRIMARY | Phase I: Number of Participants With Worst-case On-therapy Change From Baseline in Temperature | From Baseline until the post-treatment Visit (average of 1.38 years) | ATS Population | Participants | NUMBER |
| PRIMARY | Phase I: Change From Baseline in Oxygen Saturation (SpO2) Measured Via Pulse Oxymetry at the Indicated Time Points | From Baseline until the post-treatment Visit (average of 1.38 year) | ATS Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). | Percentage of oxygen in blood | MEAN |
1 to 10 of 37Source ClinicalTrials.gov
See all 37 outcomesResults by group450
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Phase I: Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE) | Phase I: GSK2118436 150 mg + GSK1120212 2 mg | Any AEs | 6 | Participants | |
| Phase I: Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE) | Phase I: GSK2118436 150 mg + GSK1120212 2 mg | Any SAEs | 1 | Participants | |
| Phase I: Number of Participants With a Dose-limiting Toxicity (DLT) | Phase I: GSK2118436 150 mg + GSK1120212 2 mg | 0 | Participants | ||
| Phase I: Number of Participants With the Indicated Worst-case Change From Baseline (BL) in the Indicated Clinical Chemistry Parameters (CCPs) | Phase I: GSK2118436 150 mg + GSK1120212 2 mg | Alkaline Phosphatase, G3 | 1 | Participants | |
| Phase I: Number of Participants With the Indicated Worst-case Change From Baseline (BL) in the Indicated Clinical Chemistry Parameters (CCPs) | Phase I: GSK2118436 150 mg + GSK1120212 2 mg | ALT, G3 | 1 | Participants | |
| Phase I: Number of Participants With the Indicated Worst-case Change From Baseline (BL) in the Indicated Clinical Chemistry Parameters (CCPs) | Phase I: GSK2118436 150 mg + GSK1120212 2 mg | Inorganic Phosphorous, G4 | 1 | Participants | |
| Phase I: Number of Participants With the Indicated Worst-case Change From Baseline (BL) in the Indicated Clinical Chemistry Parameters (CCPs) | Phase I: GSK2118436 150 mg + GSK1120212 2 mg | Chloride, Low | 2 | Participants | |
| Phase I: Number of Participants With the Indicated Worst-case Change From Baseline (BL) in the Indicated Clinical Chemistry Parameters (CCPs) | Phase I: GSK2118436 150 mg + GSK1120212 2 mg | LDH, Low | 1 | Participants | |
| Phase I: Number of Participants With the Indicated Worst-case Change From Baseline (BL) in the Indicated Clinical Chemistry Parameters (CCPs) | Phase I: GSK2118436 150 mg + GSK1120212 2 mg | LDH, High | 3 | Participants | |
| Phase I: Number of Participants With the Indicated Worst-case Change From Baseline (BL) in the Indicated Clinical Chemistry Parameters (CCPs) | Phase I: GSK2118436 150 mg + GSK1120212 2 mg | Total Protein, Low | 2 | Participants |
1 to 10 of 450Source ClinicalTrials.gov
See all 450 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Phase I: GSK2118436 150 mg + GSK1120212 2 mg | 6 | |
| Overall Study | STARTED | Phase II: GSK2118436 150 mg + GSK1120212 2 mg | 6 | |
| Overall Study | COMPLETED | Phase I: GSK2118436 150 mg + GSK1120212 2 mg | 6 | |
| Overall Study | COMPLETED | Phase II: GSK2118436 150 mg + GSK1120212 2 mg | 5 | |
| Overall Study | NOT COMPLETED | Phase I: GSK2118436 150 mg + GSK1120212 2 mg | 0 | |
| Overall Study | NOT COMPLETED | Phase II: GSK2118436 150 mg + GSK1120212 2 mg | 1 |
Source ClinicalTrials.gov
Adverse events164
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 | Pyrexia | General disorders | Phase I: GSK2118436 150 mg + GSK1120212 2 mg | 5 | 6 | |
| other | Pyrexia | General disorders | Phase II: GSK2118436 150 mg + GSK1120212 2 mg | 4 | 6 | |
| other | Oedema peripheral | General disorders | Phase I: GSK2118436 150 mg + GSK1120212 2 mg | 2 | 6 | |
| other | Oedema peripheral | General disorders | Phase II: GSK2118436 150 mg + GSK1120212 2 mg | 4 | 6 | |
| other | Chills | General disorders | Phase I: GSK2118436 150 mg + GSK1120212 2 mg | 1 | 6 | |
| other | Chills | General disorders | Phase II: GSK2118436 150 mg + GSK1120212 2 mg | 1 | 6 | |
| other | Malaise | General disorders | Phase I: GSK2118436 150 mg + GSK1120212 2 mg | 1 | 6 | |
| other | Malaise | General disorders | Phase II: GSK2118436 150 mg + GSK1120212 2 mg | 1 | 6 | |
| other | Fatigue | General disorders | Phase I: GSK2118436 150 mg + GSK1120212 2 mg | 1 | 6 | |
| other | Fatigue | General disorders | Phase II: GSK2118436 150 mg + GSK1120212 2 mg | 0 | 6 |
1 to 10 of 164Source ClinicalTrials.gov
See all 164 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Phase I: GSK2118436 150 mg + GSK1120212 2 mg | ||
| Total, all-cause mortality | Phase II: GSK2118436 150 mg + GSK1120212 2 mg | ||
| Total, other adverse events | Phase I: GSK2118436 150 mg + GSK1120212 2 mg | 6 | 6 |
| Total, other adverse events | Phase II: GSK2118436 150 mg + GSK1120212 2 mg | 6 | 6 |
| Total, serious adverse events | Phase I: GSK2118436 150 mg + GSK1120212 2 mg | 1 | 6 |
| Total, serious adverse events | Phase II: GSK2118436 150 mg + GSK1120212 2 mg | 0 | 6 |
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 |
|---|
| Phase I: GSK2118436 150 mg + GSK1120212 2 mg vs Phase II: GSK2118436 150 mg + GSK1120212 2 mg: 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.
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GET https://conductscience.org/api/trials/v1/NCT01928940/registered?page=2