CancerPhase 1NCT01658553
A Study to Look at the Electrical Activity of the Heart in Subjects With Solid Tumor Cancers, Before and After Receiving the Study Treatment, GSK1120212
A Phase 1 study testing GSK1120212 in people with Cancer, run by GlaxoSmithKline at 2 sites in United States.
Trial summary
A multicenter, non-randomized, placebo-controlled, single dosing schedule, subject-blinded study to evaluate the effect of GSK1120212 on the electrical activity of the heart as compared to placebo in subjects with solid tumor cancers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- GSK1120212
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- 19 Sep 2012to 5 Apr 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Has provided signed, written informed consent.
- Male or female, age greater than and equal to 18 years of age at the time of signing the informed consent form.
- Has histologically or cytologically confirmed diagnosis of a solid tumor malignancy that is not responsive to standard therapy(ies) or for which there is no approved therapy.
- Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Able to swallow and retain oral medication.
- Has adequate baseline organ function as follows: System: Hematologic - absolute neutrophil count, Laboratory values: greater than and equal to 1.2 × 109/L;System: Hematologic - Hemoglobin, laboratory values: greater than and equal to 9 g/dL; System: Hematologic-platelets, laboratory values: greater than and equal to 75 × 109/L; System: Hematologic - Prothrombin time (PT), INR (international normalizing ratio - a blood clotting test))and Partial thromboplastin time (PTT), laboratory values: less than and equal to 1.5 times ULN(Upper limit of normal); System - Hepatic - Total bilirubin, laboratory values: less than and equal to 1.5 times ULN; System: Hepatic-ALT(Alanine aminotransferase), laboratory values: less than and equal to 2.5 times ULN; System: Renal-Creatine, laboratory values: less than anad equal to 1.5 times ULN; or System: Renal-Calculated creatinine clearance, laboratory values: greater than and equal to 50 mL/min; or System: Renal-24hour urine creatine clearance, laboratory values: greater than and equal to 50 mL/min; System: Cardiac-LVEF, laboratory values: greater than and equal to LLN (Lower limit of normal) by ECHO or MUGA(Multigated acquisition scan). Abbreviations: ALT, alanine aminotransferase; AST, aspartate aminotransferase; ECHO, echocardiogram; INR; LLN,lower limit of normal; LVEF, left ventricular ejection fraction; MUGA; PT, prothrombin time; PTT, partial thromboplastin time; ULN, upper limit of normal. INR greater than 1.5 times ULN will be acceptable in case of subjects receiving therapeutic anticoagulants such as warfarin as long as INR is monitored during the study according to clinical practice; Calculated by the Cockcroft-Gault formula; If LLN is not defined for a given institution, then ejection fraction must be greater than and equal to 50%. NOTE: Subjects with aspartate aminotransferase (AST), ALT or bilirubin values outside the range(s) in the table due to Gilbert's syndrome or asymptomatic gallstones are not excluded. Laboratory results obtained during Screening should be used to determine eligibility criteria. In situations where laboratory results are outside the permitted range, the investigator may opt to retest the subject and the subsequent within-range screening result may be used to confirm eligibility.
- Have serum potassium, serum magnesium, and total serum calcium levels within normal limits. NOTE: If total serum calcium is below the LLN, then it will be necessary to determine the albumin-corrected total serum calcium level. Use the following calculation: Calcium (mg/dL) = measured total Calcium (mg/dL) + 0.8 (4.0 - serum albumin [g/dL]) NOTE: If serum potassium or magnesium level is below the LLN, supplementation is permitted in order to meet the inclusion criterion. Subject should be retested following supplementation. In order to avoid a situation where the subject cannot be dosed during the study due to electrolyte levels falling below the LLN, it is strongly recommended to maintain serum potassium levels greater than 4 mEq(Milliequivalent )/L and serum magnesium levels greater than 2.2 mg/dL whenever possible. Slight elevations of potassium or magnesium above the upper limit of normal may be seen during supplementation and will not exclude subjects from study entry.
- If a female subject of childbearing potential, must have a negative serum pregnancy test within 14 days of first dose of study treatment and agree to use effective contraception, as defined in the protocol. during the study and for 4 months following the last dose of study treatment.
Who cannot join
- History of prior exposure to a MEK(activated extracellular signal-regulated kinase) inhibitor or disease progression while receiving treatment with a MEK inhibitor.
- Any of the following ECG findings: QTcF (preferred) or QTcB(interval corrected for heart rate by Bazett's formula) interval greater than and equal to 480 msec; PR(Partial response) interval greater than 220 msec or less than and equal to 110 msec; Bradycardia defined as sinus rate less than 50 beats per minute (bpm)
- Cardiac conduction abnormalities denoted by any of the following: Evidence of second-degree (type II) or third-degree atrioventricular block; Evidence of ventricular pre-excitation; Electrocardiographic evidence of complete left bundle branch block (LBBB) NOTE: Right bundle branch block (RBBB), incomplete LBBB or incomplete RBBB will be exclusionary ONLY if QRS(a name for the combination of the graphical deflections seen on a typical electrocardiogram) duration is greater than 120 msec; Intraventricular conduction delay with QRS duration greater than 120 msec; Evidence of atrial fibrillation or history of atrial fibrillation within the past 6 months; Presence of cardiac pacemaker
- History or evidence of any one of the following cardiovascular conditions within the past 6 months: Class II, III, IV heart failure as defined by the New York Heart Association; Cardiac angioplasty or stenting; Myocardial infarction; Unstable angina; Symptomatic peripheral vascular disease or other clinically significant cardiac disease; Cardiac metastases
- Left ventricular ejection fraction (LVEF), as measured by ECHO or MUGA scan, below the institutional LLN, or if a LLN does not exist at an institution, less than 50%
- Personal or family history of long-QT syndrome.
Show all 20Show fewer
- Treatment-refractory hypertension defined as a blood pressure of SBP (Systolic blood pressure) greater than 140 mmHg and/or DBP(Diastolic blood pressure) greater than 90 mmHg which cannot be controlled by anti-hypertensive therapy or lifestyle modifications.
- Anti-cancer therapy (e.g., chemotherapy with delayed toxicity, extensive radiation therapy, immunotherapy, biologic therapy, or major surgery) within 21 days prior to enrollment; chemotherapy regimens without delayed toxicity within 14 days prior to enrollment; or use of an investigational anti-cancer drug within 28 days preceding the first dose of study treatment. NOTE: Subjects with a history of prior anthracycline exposure are excluded.
- Current use of a prohibited medication(s) or requires any of these medications during treatment with study treatment. NOTE: This includes medications that are listed as drugs that are generally accepted by the QTdrug.org (Advisory Board of the Arizona Center for Education and Research on Therapeutics to have a risk of causing Torsade de pointes (available at: http://www.azcert.org/medical-pros/drug-lists/bycategory.cfm).
- Current use of therapeutic warfarin. NOTE: Low molecular weight heparin and prophylactic low-dose warfarin are permitted.
- Any unresolved toxicity of greater than and equal to Grade 2, except alopecia or Grade 2 anemia, (NCI-CTCAE), version 4.0, from previous anti-cancer therapy.
- Pre-existing Grade 2 or greater peripheral neuropathy.
- History or current evidence/risk of RVO or CSR: History of RVO (Retinal vein occlusion) or CSR (Central serous retinopathy), or predisposing factors to RVO or CSR (i.e., uncontrolled glaucoma or ocular hypertension, uncontrolled systemic disease such as hypertension or diabetes mellitus, or history of hyperviscosity or hypercoagulability syndromes); Visible retinal pathology as assessed by ophthalmic examination that is considered a risk factor for RVO or CSR such as: Evidence of new optic disc cupping; Intraocular pressure >21 mmHg as measured by tonography
- History of interstitial lung disease or pneumonitis.
- Symptomatic or untreated leptomeningeal or brain metastases or spinal cord compression. NOTE: Subjects previously treated for these conditions that have had stable central nervous system disease (verified with consecutive imaging studies) for greater than 3 months, are asymptomatic and are not currently taking corticosteroids, or are on stable dose of corticosteroids for at least 30 days prior to Study Day 1 are permitted.
- Presence of clinically significant gastrointestinal (GI) abnormalities that may affect the absorption of study treatment(s) including, but not limited to: Active, uncontrolled GI disease; Malabsorption syndrome; Substantial resection of the stomach, small bowel or colon. If clarification is needed as to whether a condition will significantly affect the absorption of study treatment(s), contact the GSK Medical Monitor.
- History or presence of hepatic insufficiency (excluding metastatic hepatic carcinoma).
- Uncontrolled medical conditions (i.e., diabetes mellitus, hypertension), psychological,familial, sociological, or geographical conditions that do not permit compliance with the protocol; or unwillingness or inability to follow the procedures required in the protocol.
- Lactating or actively breastfeeding females.
- Known immediate or delayed hypersensitivity reaction or idiosyncrasy to DMSO (Dimethyl Sulfoxide).
Trial locations and contacts
2 sites in 1 country.
United States2 sites
GSK Investigational Site
Salt Lake City, Utah, 84112
GSK Investigational Site
San Antonio, Texas, 78229
About this study
Official title: A Phase I, Single-Sequence, Placebo-Controlled, Single-Blind Study to Evaluate the Effect of Repeat Oral Dosing of GSK1120212 on Cardiac Repolarization in Subjects With Solid Tumors
A multicenter, non-randomized, placebo-controlled, single dosing schedule, subject-blinded study to evaluate the effect of GSK1120212 on the electrical activity of the heart as compared to placebo in subjects with solid tumor cancers. All subjects will undergo Screening assessments within 21 days prior to the start of the study treatment to determine their eligibility for enrollment in the study. Eligible subjects will receive study treatment administered over a period of 15 days followed by a post-treatment follow-up visit. Study treatment (GSK1120212-matched placebo) will be blinded to subjects. Subjects will receive GSK1120212-matched placebo on one day during the first 14 days of dosing. On all other days the subject will receive a once-daily 2 mg dose of GSK1120212 except for Day 15 when the subject will receive 3mg dose of GSK1120212 12-lead ECG recordings will be obtained from continuous ECG recordings obtained via a 12-lead Holter monitor on Study Days 1 and 15 while subjects are in the clinical research unit. The effect of GSK1120212 on the electrical activity of the heart will be determined by time-matched ECGs obtained at the same time points relative to dosing on these days. Ambulatory blood pressure readings will be obtained from continuous 24-hour recordings via an ambulatory blood pressure monitor The effect of GSK1120212 on blood pressure parameters will be determined by blood pressure readings obtained at the same time points relative to dosing on Study Days 1 and 15. Serial blood samples to analyze the concentration of study drug in the subject's blood will be obtained at the same time points relative to dosing on Study Days 1 and 15. Subjects who are eligible for continued treatment with GSK1120212 may continue treatment under the rollover study MEK114375 (drug study number). A post-treatment follow-up visit will be conducted within 28 days of the last dose of study treatment for all subjects who do not continue treatment in the rollover study MEK114375.
Read the detailed description
GSK1120212 is an orally administered, potent and highly selective small molecule inhibitor of MEK1(mitogen-activated extracellular signal-regulated kinase-1)/MEK2 (mitogen-activated extracellular signal-regulated kinase-2) activation and kinase activity. As monotherapy, GSK1120212 has shown an acceptable risk-benefit profile with encouraging efficacy in various oncologic settings. This Phase I, single-sequence, placebo-controlled, singleblind, multicenter study is designed to evaluate the effects of repeat oral dosing of GSK1120212 on electrocardiographic parameters with a particular focus on its effect on cardiac repolarization (Corrected QT interval [QTc] duration) as compared to placebo in subjects with solid tumor cancers. A single dose of placebo will be administered on Study Day 1 followed by administration of a once-daily 2 mg dose of GSK1120212 for 13 days (Study Days 2 through 14) and on Study Day 15 a dose of 3 mg of GSK1120212 will be given. Digital 12-lead electrocardiograms (ECGs) will be extracted from continuous ECG recordings obtained via Holter monitor on Study Days 1 and 2 after the administration of placebo and on Study Days 15 and 16 after the administration of GSK1120212. Pharmacokinetic samples will be time-matched with the Holter ECGs. This study will also assess the exposure-QTc relationship between plasma concentrations of GSK1120212 and its effect, if any, on cardiac repolarization, specifically on the QTc interval. Continuous 24-hour ambulatory blood pressure monitoring will be conducted to assess the effect of GSK1120212 on blood pressure parameters on Study Days 1 and 15. Safety assessments, including assessment of adverse events, clinical laboratory tests (hematology and clinical chemistry) and vital signs, will be performed throughout the study. Following completion of study treatment, eligible subjects may transition to the open-label, rollover study MEK114375 to continue treatment with GSK1120212.
- Conditions
- Cancer
- Being tested
- GSK1120212
- Keywords
- solid tumors
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSK1120212Drug
GSK1120212 - placebo match oral dose on day 1 with GSK1120212 3 mg oral dose on day 15. GSK1120212 2mg and 2 tablets of GSK1120212 -placebo matched 0.5 mg oral dose daily from day 2 to day 14. 24 hour holter monitoring will be performed on day 1 and day 15 to compare the subjects cardiac repolarization while on placebo and after having received GSK1120212 for 14 days
| Study group | Role | What they receive |
|---|---|---|
| GSK1120212 Qtc study | Experimental | Single-Sequence, Placebo-Controlled, Single-Blind Study to Evaluate the Effect of Repeat Oral Dosing of GSK1120212 on Cardiac Repolarization in Subjects with Solid Tumors Receives: Drug: GSK1120212 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the effect of GSK1120212 on the baseline-adjusted, placebo-corrected, time-matched QTcF(QT interval corrected for heart rate by Fridericia's formula) interval duration in subjects with solid tumor cancers
Measured: from baseline to day 15
Secondary outcomes (4)
Evidence of the relationships between the change in QTc(Corrected QT interval) from baseline and the plasma concentrations of GSK1120212 and predicted change in QTc(Corrected QT interval)
Measured: From baseline as compared to study day 15
Plasma concentrations and PK (Pharmacokinetic) parameters of GSK1120212, including AUC(Area under concentration-time curve)(0-24), concentration at time t (Ct), Cmax (Maximum observed concentration) and time to Cmax (tmax).
Measured: From placebo dosing on day 1 to day 15
Safety parameters: AEs, vital sign (blood pressure, pulse rate and temperature), ECGs, and clinical laboratory assessments
Measured: From baseline until follow up(maximum 42 days)
Change in blood pressure parameters, including PP(Pulse pressure) and MABP(Mean arterial blood pressure)
Measured: from baseline to Study Day 15.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2012 (estimated)
- Study start19 Sep 2012
- Primary completion5 Apr 2014
- Study completion5 Apr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01658553
- Sponsor's protocol ID
- 114655
- Status last verified
- Nov 2017
- First submitted
- 28 Jun 2012
- Last updated
- 13 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Single-Sequence, Placebo-Controlled, Single-Blind Study to Evaluate the Effect of Repeat Oral Dosing of GSK1120212 on Cardiac Repolarization in Subjects With Solid Tumors
- ClinicalTrials.gov ID
- NCT01658553
- Acronym / sponsor ID
- 114655
- Conditions
- Cancer
- Keywords
- solid tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 19 Sep 2012 (actual)
- Primary completion
- 5 Apr 2014 (actual)
- Study completion
- 5 Apr 2014 (actual)
- First posted
- 7 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A multicenter, non-randomized, placebo-controlled, single dosing schedule, subject-blinded study to evaluate the effect of GSK1120212 on the electrical activity of the heart as compared to placebo in subjects with solid tumor cancers. All subjects will undergo Screening assessments within 21 days prior to the start of the study treatment to determine their eligibility for enrollment in the study. Eligible subjects will receive study treatment administered over a period of 15 days followed by a post-treatment follow-up visit. Study treatment (GSK1120212-matched placebo) will be blinded to subjects. Subjects will receive GSK1120212-matched placebo on one day during the first 14 days of dosing. On all other days the subject will receive a once-daily 2 mg dose of GSK1120212 except for Day 15 when the subject will receive 3mg dose of GSK1120212 12-lead ECG recordings will be obtained from continuous ECG recordings obtained via a 12-lead Holter monitor on Study Days 1 and 15 while subjects are in the clinical research unit. The effect of GSK1120212 on the electrical activity of the heart will be determined by time-matched ECGs obtained at the same time points relative to dosing on these days. Ambulatory blood pressure readings will be obtained from continuous 24-hour recordings via an ambulatory blood pressure monitor The effect of GSK1120212 on blood pressure parameters will be determined by blood pressure readings obtained at the same time points relative to dosing on Study Days 1 and 15. Serial blood samples to analyze the concentration of study drug in the subject's blood will be obtained at the same time points relative to dosing on Study Days 1 and 15. Subjects who are eligible for continued treatment with GSK1120212 may continue treatment under the rollover study MEK114375 (drug study number). A post-treatment follow-up visit will be conducted within 28 days of the last dose of study treatment for all subjects who do not continue treatment in the rollover study MEK114375.
Detailed description
GSK1120212 is an orally administered, potent and highly selective small molecule inhibitor of MEK1(mitogen-activated extracellular signal-regulated kinase-1)/MEK2 (mitogen-activated extracellular signal-regulated kinase-2) activation and kinase activity. As monotherapy, GSK1120212 has shown an acceptable risk-benefit profile with encouraging efficacy in various oncologic settings. This Phase I, single-sequence, placebo-controlled, singleblind, multicenter study is designed to evaluate the effects of repeat oral dosing of GSK1120212 on electrocardiographic parameters with a particular focus on its effect on cardiac repolarization (Corrected QT interval [QTc] duration) as compared to placebo in subjects with solid tumor cancers. A single dose of placebo will be administered on Study Day 1 followed by administration of a once-daily 2 mg dose of GSK1120212 for 13 days (Study Days 2 through 14) and on Study Day 15 a dose of 3 mg of GSK1120212 will be given. Digital 12-lead electrocardiograms (ECGs) will be extracted from continuous ECG recordings obtained via Holter monitor on Study Days 1 and 2 after the administration of placebo and on Study Days 15 and 16 after the administration of GSK1120212. Pharmacokinetic samples will be time-matched with the Holter ECGs. This study will also assess the exposure-QTc relationship between plasma concentrations of GSK1120212 and its effect, if any, on cardiac repolarization, specifically on the QTc interval. Continuous 24-hour ambulatory blood pressure monitoring will be conducted to assess the effect of GSK1120212 on blood pressure parameters on Study Days 1 and 15. Safety assessments, including assessment of adverse events, clinical laboratory tests (hematology and clinical chemistry) and vital signs, will be performed throughout the study. Following completion of study treatment, eligible subjects may transition to the open-label, rollover study MEK114375 to continue treatment with GSK1120212.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GSK1120212 Qtc study | Experimental | Drug: GSK1120212Single-Sequence, Placebo-Controlled, Single-Blind Study to Evaluate the Effect of Repeat Oral Dosing of GSK1120212 on Cardiac Repolarization in Subjects with Solid Tumors |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Has provided signed, written informed consent.
- Male or female, age greater than and equal to 18 years of age at the time of signing the informed consent form.
- Has histologically or cytologically confirmed diagnosis of a solid tumor malignancy that is not responsive to standard therapy(ies) or for which there is no approved therapy.
- Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Able to swallow and retain oral medication.
Key exclusion criteria (20 listed)
- History of prior exposure to a MEK(activated extracellular signal-regulated kinase) inhibitor or disease progression while receiving treatment with a MEK inhibitor.
- Any of the following ECG findings: QTcF (preferred) or QTcB(interval corrected for heart rate by Bazett's formula) interval greater than and equal to 480 msec; PR(Partial response) interval greater than 220 msec or less than and equal to 110 msec; Bradycardia defined as sinus rate less than 50 beats per minute (bpm)
- Cardiac conduction abnormalities denoted by any of the following: Evidence of second-degree (type II) or third-degree atrioventricular block; Evidence of ventricular pre-excitation; Electrocardiographic evidence of complete left bundle branch block (LBBB) NOTE: Right bundle branch block (RBBB), incomplete LBBB or incomplete RBBB will be exclusionary ONLY if QRS(a name for the combination of the graphical deflections seen on a typical electrocardiogram) duration is greater than 120 msec; Intraventricular conduction delay with QRS duration greater than 120 msec; Evidence of atrial fibrillation or history of atrial fibrillation within the past 6 months; Presence of cardiac pacemaker
- History or evidence of any one of the following cardiovascular conditions within the past 6 months: Class II, III, IV heart failure as defined by the New York Heart Association; Cardiac angioplasty or stenting; Myocardial infarction; Unstable angina; Symptomatic peripheral vascular disease or other clinically significant cardiac disease; Cardiac metastases
- Left ventricular ejection fraction (LVEF), as measured by ECHO or MUGA scan, below the institutional LLN, or if a LLN does not exist at an institution, less than 50%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GSK1120212GSK1120212 - placebo match oral dose on day 1 with GSK1120212 3 mg oral dose on day 15. GSK1120212 2mg and 2 tablets of GSK1120212 -placebo matched 0.5 mg oral dose daily from day 2 to day 14. 24 hour holter monitoring will be performed on day 1 and day 15 to compare the subjects cardiac repolarization while on placebo and after having received GSK1120212 for 14 days | Drug | GSK1120212 Qtc study |
Primary outcome
Compare the effect of GSK1120212 on the baseline-adjusted, placebo-corrected, time-matched QTcF(QT interval corrected for heart rate by Fridericia's formula) interval duration in subjects with solid tumor cancers
Time frame: from baseline to day 15
4 secondary outcomes
Evidence of the relationships between the change in QTc(Corrected QT interval) from baseline and the plasma concentrations of GSK1120212 and predicted change in QTc(Corrected QT interval)
Time frame: From baseline as compared to study day 15
Plasma concentrations and PK (Pharmacokinetic) parameters of GSK1120212, including AUC(Area under concentration-time curve)(0-24), concentration at time t (Ct), Cmax (Maximum observed concentration) and time to Cmax (tmax).
Time frame: From placebo dosing on day 1 to day 15
Safety parameters: AEs, vital sign (blood pressure, pulse rate and temperature), ECGs, and clinical laboratory assessments
Time frame: From baseline until follow up(maximum 42 days)
Change in blood pressure parameters, including PP(Pulse pressure) and MABP(Mean arterial blood pressure)
Time frame: from baseline to Study Day 15.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2017.
- Results for study 114655 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GSK1120212 in people with Cancer, run by GlaxoSmithKline at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare the effect of GSK1120212 on the baseline-adjusted, placebo-corrected, time-matched QTcF(QT interval corrected for heart rate by Fridericia's formula) interval duration in subjects with solid tumor cancers (time frame: from baseline to day 15). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2017.