Trial · NCT04447755
Outcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Objective Response Rate (ORR) At Week 16 Per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1) or Response Assessment in Neuro-Oncology (RANO) Criteria (for High Grade Glioma [HGG] Only), by Investigator Assessment | Up to 16 weeks | All participants who had measurable disease present at baseline and at least one efficacy assessment, unless they discontinued prior to the first efficacy assessment due to progressive disease. | Percentage of Participants | NUMBER |
| SECONDARY | ORR Per RECIST 1.1 or RANO Criteria (for HGG Only), by Investigator Assessment | Up to approximately 21 months | All participants who had measurable disease present at baseline and at least one efficacy assessment, unless they discontinued prior to the first efficacy assessment due to progressive disease. | Percentage of Participants | NUMBER |
| SECONDARY | Progression Free Survival (PFS) Per RECIST 1.1 or RANO (for HGG Only), by Investigator Assessment | Up to approximately 21 months | All participants who had measurable disease present at baseline and at least one efficacy assessment, unless they discontinued prior to the first efficacy assessment due to progressive disease. | Months | MEDIAN |
| SECONDARY | Best Overall Response (BOR) Per RECIST 1.1 or RANO (for HGG Only), by Investigator Assessment | Up to approximately 21 months | All participants who had measurable disease present at baseline and at least one efficacy assessment, unless they discontinued prior to the first efficacy assessment due to progressive disease. | Percentage of Participants | NUMBER |
| SECONDARY | Duration of Response (DOR) Per RECIST 1.1 or RANO (for HGG Only), by Investigator Assessment | Up to approximately 21 months | All participants who had measurable disease present at baseline and at least one efficacy assessment, unless they discontinued prior to the first efficacy assessment due to progressive disease, and demonstrated CR or PR. | Months | MEDIAN |
| SECONDARY | Disease Control Rate (DCR) Per RECIST 1.1 or RANO (for HGG Only), by Investigator Assessment | Up to approximately 21 months | All participants who had measurable disease present at baseline and at least one efficacy assessment, unless they discontinued prior to the first efficacy assessment due to progressive disease. | Percentage of Participants | NUMBER |
| SECONDARY | Clinical Benefit Rate (CBR) Per RECIST 1.1 or RANO (for HGG Only), by Investigator Assessment | Up to approximately 21 months | All participants who had measurable disease present at baseline and at least one efficacy assessment, unless they discontinued prior to the first efficacy assessment due to progressive disease. | Percentage of Participants | NUMBER |
| SECONDARY | Number of Participants Who Experienced an Adverse Event (AE) | Up to approximately 50 months | All participants who received at least one dose of study treatment were analyzed. | Participants | NUMBER |
| SECONDARY | Number of Participants Who Discontinued Study Treatment Due to an AE | Up to approximately 38 months | All participants who received at least one dose of study treatment were analyzed. | Participants | NUMBER |
| SECONDARY | Palatability Questionnaire For Lenvatinib Suspension Formulation: Participant Responses by Taste Category | Cycle 1 Day 1 (cycle = 28 days) | Per protocol, all participants who received suspension formulation were analyzed. Data were summarized in an overall safety analysis set irrespective of tumor type. | Participants | NUMBER |
| SECONDARY | Palatability Questionnaire For Lenvatinib Suspension Formulation: Participant Responses by Appearance Category | Cycle 1 Day 1 (cycle = 28 days) | Per protocol, all participants who received suspension formulation were analyzed. Data were summarized in an overall safety analysis set irrespective of tumor type. | Participants | NUMBER |
| SECONDARY | Palatability Questionnaire For Lenvatinib Suspension Formulation: Participant Responses by Smell Category | Cycle 1 Day 1 (cycle = 28 days) | Per protocol, all participants who received suspension formulation were analyzed. Data were summarized in an overall safety analysis set irrespective of tumor type. | Participants | NUMBER |
| SECONDARY | Palatability Questionnaire For Lenvatinib Suspension Formulation: Participant Responses by Mouth Feel Category | Cycle 1 Day 1 (cycle = 28 days) | Per protocol, all participants who received suspension formulation were analyzed. Data were summarized in an overall safety analysis set irrespective of tumor type. | Participants | NUMBER |
| SECONDARY | Palatability Questionnaire For Lenvatinib Suspension Formulation: Participant Responses by Overall Acceptability Category | Cycle 1 Day 1 (cycle = 28 days) | Per protocol, all participants who received suspension formulation were analyzed. Data were summarized in an overall safety analysis set irrespective of tumor type. | Participants | NUMBER |
| SECONDARY | Area Under the Concentration-Time Curve of Lenvatinib at Steady State (AUCss) | Cycle 1 Day 1 (0.5-4 and 6-10 hours post-dose), Cycle 1 Day 15 (pre-dose, 0.5-4, and 6-10 hours post-dose), and Cycle 2 Day 1 (pre-dose and 2-12 hours post-dose). A cycle is 28 days. | All participants who received at least one dose of study treatment and had at least one measurable postdose plasma concentration with an adequately documented dosing history were analyzed. Lenvatinib exposures are reported by the four protocol pre-specified cohorts at the time of enrollment (EWS, RMS, HGG, and Other Solid Tumors excluding Osteosarcoma). For the purposes of the analysis, AUCss was reported for participants with Other Solid Tumors irrespective of tumor type. | ng*hr/ml | GEOMETRIC_MEAN |
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.
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