Trial · NCT03266159
Registered outcomes57
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
21 to 40 of 57
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Part 2: Number of subjects with abnormal systolic blood pressure (SBP) and diastolic blood pressure (DBP) as a measure of safety | Up to 24 months | Systolic and diastolic blood pressure will be measured in semi-supine position after 5 minutes of rest. |
| Primary | Part 2: Number of subjects with abnormal pulse rate | Up to 24 months | Pulse rate will be measured in a semi-supine position after 5 minutes of rest.. |
| Primary | Part 2: Number of subjects with abnormal respiratory rate | Up to 24 months | Respiratory rate will be measured in a semi-supine position after 5 minutes of rest. |
| Primary | Part 2: Number of subjects with abnormal body temperature | Up to 24 months | Body temperature will be measured in a semi-supine position after 5 minutes of rest. |
| Primary | Part 2: Number of subjects with abnormal electrocardiogram (ECG) findings | Up to 24 months | Triplicate 12-lead ECGs will be obtained at each time point using an ECG machine to measure PR, QRS, QT, and Corrected QT interval (QTc). |
| Primary | Part 2: Number of subjects with cardiotoxicity and gastrointestinal (GI) toxicity | Up to 24 months | Echocardiography (ECHO) or multigated acquisition (MUGA) scan will be performed to assess cardiotoxicity and GI effects will be monitored. |
| Primary | Part 2: AUC [0-T] of GSK525762 and trametinib | 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 | Blood samples will be collected at the indicated time points for pharmacokinetic analysis and concentration of GSK525762 AND TRAMETINIB will be determined in plasma. |
| Primary | Part 2: Ctau of GSK525762 and trametinib | 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 | Blood samples will be collected at the indicated time points for pharmacokinetic analysis and concentration of GSK525762 and trametinib will be determined in plasma. |
| Primary | Part 2: Cmax of GSK525762 and trametinib | 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 | Blood samples will be collected at the indicated time points for pharmacokinetic analysis and concentration of GSK525762 and trametinib will be determined in plasma. |
| Primary | Part 2: Tmax of GSK525762 and trametinib | 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 | Blood samples will be collected at the indicated time points for pharmacokinetic analysis and concentration of GSK525762 and trametinib will be determined in plasma. |
| Primary | Part 2: Change from Baseline in the pERK levels | Baseline and up to Week 3 | The pERK levels will be assessed in pre-therapy and on-therapy tumor samples. |
| Primary | Part 2: Change from Baseline circulating protein or RNA biomarkers | Baseline and up to Week 3 | The circulating protein or RNA biomarkers including to MCP-1 will be assessed in pre-therapy and on-therapy blood samples. |
| Primary | Part 2: Change from Baseline transcriptional levels and MAP kinase signaling | Baseline and up to Week 3 | The transcriptional levels and MAP kinase signaling will be assessed in pre-therapy and on-therapy tumor and/or blood samples. |
| Secondary | Part 1: Number of subjects with AEs and SAEs | Up to 12 months | An AE is any untoward medical occurrence in a subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgement will be categorized as SAE. |
| Secondary | Part 1: Number of subjects with dose reductions or delays as a measure of safety | Up to 12 months | Subjects will be evaluated for dose reductions and delays. An event will be considered a DLT if it occurs within the first 21 days of treatment and meets the DLT criteria. |
| Secondary | Part 1: Number of subject withdrawals due to toxicities | Up to 12 months | DLT is defined by the occurrence of severe toxicities during the first cycle of cancer therapy. An event will be considered a DLT if it occurs within the first 21 days of treatment and meets the DLT criteria. |
| Secondary | Part 1: Number of subjects with abnormal clinical chemistry laboratory tests | Up to 12 months | Clinical chemistry parameters will be analyzed as a measure of safety. |
| Secondary | Part 1: Number of subjects with abnormal hematology laboratory tests | Up to 12 months | Hematology parameters will be analyzed as a measure of safety. |
| Secondary | Part 1: Number of subjects with abnormal routine urinalysis laboratory tests | Up to 12 months | Urinalysis will be carried out as a measure of safety. |
| Secondary | Part 1: Number of subjects with abnormal SBP and DBP as a measure of safety | Up to 12 months | Systolic and diastolic blood pressure will be measured in semi-supine position after 5 minutes of rest. |
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
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT03266159/registered?page=2