Trial · NCT03245151
Outcomes19
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 19 of 19
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Phase 1: Maximum Tolerated Dose (MTD) of Lenvatinib in Combination With Everolimus | Cycle 1 (Each cycle was of 28 days) | SAS included all participants who received at least one dose of study drug (Lenvatinib or Everolimus). | milligram per square meter (mg/m^2) | NUMBER |
| PRIMARY | Phase 1: Recommended Phase 2 Dose (RP2D) of Lenvatinib in Combination With Everolimus | Cycle 1 (Each cycle was of 28 days) | SAS included all participants who received at least one dose of study drug (Lenvatinib or Everolimus). | mg/m^2 | NUMBER |
| PRIMARY | Phase 1: Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | From date of first dose up to 28 days after the last dose of study treatment (Up to 17.5 months) | SAS included all participants who received at least one dose of study drug (Lenvatinib or Everolimus). | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Phase 1: Number of Participants With Any Treatment-emergent Serious Adverse Event (TESAE) | From date of first dose up to 28 days after the last dose of study treatment (Up to 17.5 months) | SAS included all participants who received at least one dose of study drug (Lenvatinib or Everolimus). | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Phase 2: Objective Response Rate (ORR) at Week 16 | Week 16 | Evaluable analysis set included all evaluable participants who have measurable disease present at baseline, and at least one postbaseline efficacy assessment, unless they have discontinued prior to the first efficacy assessment due to progressive disease. | percentage of participants | NUMBER |
| SECONDARY | Phase 1: Objective Response Rate (ORR) | From the date of the first dose of study drug to the date of first documentation of disease progression or death, whichever occurred first (up to 16.5 months) | SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus). Here, 'overall number of participants analyzed' signifies participants who were evaluable for this outcome measure. | percentage of participants | NUMBER |
| SECONDARY | Phase 2: Objective Response Rate (ORR) | From the date of the first dose of study drug to the date of first documentation of disease progression or death, which ever occurred first (up to 6.5 months) | Evaluable analysis set included all evaluable participants who have measurable disease present at baseline, and at least one postbaseline efficacy assessment, unless they have discontinued prior to the first efficacy assessment due to progressive disease. | percentage of participants | NUMBER |
| SECONDARY | Phase 1: Disease Control Rate (DCR) | From first dose of study drug until PD or death, whichever occurred first (up to 16.5 months) | SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus). | percentage of participants | NUMBER |
| SECONDARY | Phase 2: Disease Control Rate (DCR) | From first dose of study drug until PD or death, whichever occurred first (up to 6.5 months) | Evaluable analysis set included all evaluable participants who have measurable disease present at baseline, and at least one postbaseline efficacy assessment, unless they have discontinued prior to the first efficacy assessment due to progressive disease. | percentage of participants | NUMBER |
| SECONDARY | Phase 1: Clinical Benefit Rate (CBR) | From first dose of study drug until PD or death, whichever occurred first (up to 16.5 months) | SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus). | percentage of participants | NUMBER |
| SECONDARY | Phase 2: Clinical Benefit Rate (CBR) | From first dose of study drug until PD or death, whichever occurred first (up to 6.5 months) | Evaluable analysis set included all evaluable participants who have measurable disease present at baseline, and at least one postbaseline efficacy assessment, unless they have discontinued prior to the first efficacy assessment due to PD. | percentage of participants | NUMBER |
| SECONDARY | Phase 1: Duration of Response (DOR) | From date of the first observation of CR or PR until the date of first observation of progression or date of death (up to 16.5 months) | SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus). Here, 'overall number of participants analyzed' signifies participants who had CR or PR (0 participants hence, none were analyzed for this outcome measure). | ||
| SECONDARY | Phase 2: Duration of Response (DOR) | From date of the first observation of CR or PR until the date of first observation of progression or date of death (up to 6.5 months) | Evaluable analysis set included all evaluable participants who have measurable disease present at baseline, and at least one postbaseline efficacy assessment, unless they have discontinued prior to first efficacy assessment due to progressive disease. Here, 'overall number of participants analyzed' signifies participants who had CR or PR. | months | MEDIAN |
| SECONDARY | Phase 1: Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration of Lenvatinib (AUC[0-t Hours]) | Cycle 1 Days 1 and 15: 0-8 hours post-dose (Cycle length=28 days) | Pharmacokinetic analysis set included participants who had at least one measurable postdose plasma concentration with an adequately documented drug administration history. Here, 'number analyzed' signifies participants who were evaluable for given timepoints of this outcome measure. Pharmacokinetic data was planned to be analyzed for Phase 1 only. | nanogram*hour per milliliter (ng*hr/mL) | MEAN |
| SECONDARY | Phase 1: Maximum Plasma Concentration of Lenvatinib (Cmax) | Cycle 1 Days 1 and 15: 0-8 hours post-dose (Cycle length=28 days) | Pharmacokinetic analysis set included participants who had at least one measurable postdose plasma concentration with an adequately documented drug administration history. Here, 'number analyzed' signifies participants who were evaluable for given timepoints of this outcome measure. Pharmacokinetic data was planned to be analyzed for Phase 1 only. | nanogram per milliliter (ng/mL) | MEAN |
| SECONDARY | Phase 1: Time to Reach Maximum Plasma Concentration (Cmax) of Lenvatinib (Tmax) | Cycle 1 Days 1 and 15: 0-8 hours post-dose (Cycle length=28 days) | Pharmacokinetic analysis set included participants who had at least one measurable postdose plasma concentration with an adequately documented drug administration history. Here, 'number analyzed' signifies participants who were evaluable for given timepoints of this outcome measure. Pharmacokinetic data was planned to be analyzed for Phase 1 only. | hours | MEDIAN |
| SECONDARY | Phase 1: Trough Concentrations (Ctrough) of Everolimus When Administered in Combination With Lenvatinib | Cycle 1 Days 1, 2, 15 and 22: Pre-dose (Cycle length=28 days) | Pharmacokinetic analysis set included participants who had at least one measurable postdose plasma concentration with an adequately documented drug administration history. Here, 'overall number of participants analyzed' signifies participants who were evaluable for this outcome measure and 'number analyzed' signifies participants who were evaluable for given timepoints of this outcome measure. Pharmacokinetic data was planned to be analyzed for Phase 1 only. | ng/mL | MEAN |
| SECONDARY | Phase 2: Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | From date of first dose up to 28 days after the last dose of study treatment (up to 7.5 months) | SAS included all participants who received at least one dose of study drug (Lenvatinib or Everolimus). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Phase 2: Number of Participants With Any Treatment-emergent Serious Adverse Event (TESAE) | From date of first dose up to 28 days after the last dose of study treatment (up to 7.5 months) | SAS included all participants who received at least one dose of study drug (Lenvatinib or Everolimus). | Participants | COUNT_OF_PARTICIPANTS |
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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