Trial · NCT03266159
Registered outcomes57
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 57
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Part 1: Number of subjects with adverse events (AEs) and serious adverse events (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. |
| Primary | Part 1: Number of subjects with dose limiting toxicities (DLT) as a measure of safety | 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. |
| Primary | Part 1: Area under the plasma concentration time curve from time 0 to last time of quantifiable concentration (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. |
| Primary | Part 1: Pre-dose (trough) concentration at the end of a dosing interval (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. |
| Primary | Part 1: Maximum observed plasma concentration (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. |
| Primary | Part 1: Time to Cmax (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. |
| Primary | Part 1: Change from Baseline in the phosphorylation of extracellular signal-regulated kinase (pERK) levels | Baseline and up to Week 3 | The pERK levels will be assessed in pre-therapy and on-therapy tumor samples. |
| Primary | Part 1: Change from Baseline circulating protein or ribonucleic acid (RNA) biomarkers | Baseline and up to Week 3 | The circulating protein or RNA biomarkers including to monocyte chemoattractant protein-1 (MCP-1) will be assessed in pre-therapy and on-therapy blood samples. |
| Primary | Part 1: Change from Baseline transcriptional levels and mitogen activated protein (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. |
| Primary | Part 1: Overall response rate (ORR) | Up to 12 months | ORR is defined as the percentage of subjects with a confirmed complete response (CR) or partial response (PR) at any time as per disease-specific criteria. |
| Primary | Part 1: Disease control rate (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. |
| Primary | Part 1: Duration of response (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. |
| Primary | Part 2: ORR | Up to 24 months | ORR is defined as the percentage of subjects with a confirmed CR or PR at any time as per disease-specific criteria. |
| Primary | Part 2: Clinical response | Up to 24 months | Clinical response is defined as confirmed ORR as per standard evaluation criteria. ORR is the percentage of subjects with a confirmed CR or PR at any time as per disease-specific criteria. |
| Primary | Part 2: Number of subjects with AEs and SAEs | Up to 24 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. |
| Primary | Part 2: Number of subjects with dose reductions or delays as a measure of safety | Up to 24 months | Dose reductions or delays will be evaluated until the end of treatment. |
| Primary | Part 2: Number of subjects withdrawals due to toxicities | Up to 24 months | Withdrawals will be collected until the end of treatment. |
| Primary | Part 2: Number of subjects with abnormal clinical chemistry laboratory tests | Up to 24 months | Clinical chemistry parameters will be analyzed as a measure of safety. |
| Primary | Part 2: Number of subjects with abnormal hematology laboratory tests | Up to 24 months | Hematology parameters will be analyzed as a measure of safety. |
| Primary | Part 2: Number of subjects with abnormal routine urinalysis laboratory tests | Up to 24 months | Urinalysis will be carried out as a measure of safety. |
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