Trial · NCT03266159
Registered outcomes57
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
41 to 57 of 57
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Secondary | Part 1: Number of subjects with abnormal pulse rate | Up to 12 months | Pulse rate will be measured in a semi-supine position after 5 minutes of rest. |
| Secondary | Part 1: Number of subjects with abnormal respiratory rate | Up to 12 months | Respiratory rate will be measured in a semi-supine position after 5 minutes of rest. |
| Secondary | Part 1: Number of subjects with abnormal body temperature | Up to 12 months | Body temperature will be measured in a semi-supine position after 5 minutes of rest. |
| Secondary | Part 1: Number of subjects with abnormal ECG findings | Up to 12 months | Triplicate 12-lead ECGs will be obtained at each time point using an ECG machine to measure PR, QRS, QT, and QTc. |
| Secondary | Part 1: Number of subjects with cardiotoxicity and GI toxicity | Up to 12 months | Echocardiography (ECHO) or multigated acquisition (MUGA) scan will be performed to assess cardiotoxicity and GI effects will be monitored. |
| Secondary | Part 1: (AUC [0-T]) of GSK525762 and trametinib | Pre-dose,30minutes ±5minutes,1 hour±5minutes,2hours±10 minutes,3hours±10minutes, 4hours±15minutes,6±1hour,8±1hour, and 24±2hours at Day1 Week1;Day1 Week3. Pre-dose;1hour±10minutes post-dose at Day1 Week2,Day1 Week 4;every 8 Weeks from Week8 to Week52 | Blood samples will be collected at the indicated time points for pharmacokinetic analysis and concentration of GSK525762 and trametinib will be determined in plasma. |
| Secondary | Part 1: Ctau of GSK525762 and trametinib | Pre-dose,30minutes ±5minutes,1 hour±5minutes,2hours±10 minutes,3hours±10minutes, 4hours±15minutes,6±1hour,8±1hour, and 24±2hours at Day1 Week1;Day1 Week3. Pre-dose;1hour±10minutes post-dose at Day1 Week2,Day1 Week 4;every 8 Weeks from Week8 to Week52 | Blood samples will be collected at the indicated time points for pharmacokinetic analysis and concentration of GSK525762 and trametinib will be determined in plasma. |
| Secondary | Part 1: Cmax of GSK525762 and trametinib | Pre-dose,30minutes ±5minutes,1 hour±5minutes,2hours±10 minutes,3hours±10minutes, 4hours±15minutes,6±1hour,8±1hour, and 24±2hours at Day1 Week1;Day1 Week3. Pre-dose;1hour±10minutes post-dose at Day1 Week2,Day1 Week 4;every 8 Weeks from Week8 to Week52 | Blood samples will be collected at the indicated time points for pharmacokinetic analysis and concentration of GSK525762 and trametinib will be determined in plasma. |
| Secondary | Part 1: Tmax of GSK525762 and trametinib | Pre-dose,30minutes ±5minutes,1 hour±5minutes,2hours±10 minutes,3hours±10minutes, 4hours±15minutes,6±1hour,8±1hour, and 24±2hours at Day1 Week1;Day1 Week3. Pre-dose;1hour±10minutes post-dose at Day1 Week2,Day1 Week 4;every 8 Weeks from Week8 to Week52 | Blood samples will be collected at the indicated time points for pharmacokinetic analysis and concentration of GSK525762 and trametinib will be determined in plasma. |
| Secondary | Part 1: ORR | Up to 12 months | ORR is defined as the percentage of subjects with a CR or PR at any time as per disease-specific criteria. |
| Secondary | Part 1: DCR | Up to 12 months | DCR is defined as the percentage of subjects with a confirmed CR, PR, or SD at any time as per disease-specific criteria. |
| Secondary | Part 1: DOR | Up to 12 months | The DOR is defined as, in the subset of subjects who show a confirmed CR or PR, the time from first documented evidence of CR or PR until the first documented sign of disease progression or death. |
| Secondary | Part 1: Progression-free survival (PFS) | Up to 12 months | PFS defined as the time from first dose of study treatment until the disease progression or death due to any cause. |
| Secondary | Part 2: PFS | Up to 24 months | PFS defined as the time from first dose of study treatment until the disease progression or death due to any cause. |
| Secondary | Part 2: DOR | Up to 24 months | The DOR is defined as, in the subset of subjects who show a confirmed CR or PR, the time from first documented evidence of CR or PR until the first documented sign of disease progression or death. |
| Secondary | Part 2: DCR | Up to 24 months | DCR is defined as the percentage of subjects with a confirmed CR, PR, or SD at any time as per disease-specific criteria. |
| Secondary | Part 2 :Concentrations of GSK525762 and its relevant metabolite(s) and trametinib following repeat dose oral administration. | Pre-dose, and 0.5hour±5 minutes, 1-2 hours, 4-6hours post-dose at Day1 Week 1, Day1 Week3, and every 8 Weeks from Week8 to Week52 | Plasma samples will be collected at the indicated time points to measure concentrations of GSK525762 and its relevant metabolite(s) and trametinib following repeat dose oral administration. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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
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GET https://conductscience.org/api/trials/v1/NCT03266159/registered?page=3