Trial · NCT01559363
Outcomes28
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 28
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Phase 1b: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAE) | From Baseline (Day 1) until 30 days after the last dose of study drug (maximum duration: up to 37 months) | Analysis was performed on safety population. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Phase 1b: Pharmacokinetics (PK): Plasma Concentrations of Tesevatinib 100 mg and 150 mg | Pre-dose, 1, 2, 4, 8, and 24 hours post-dose on Day 1 and pre-dose, 1, 2, 4, and 24 hours post-dose on Day 14 | Analysis was performed on PK Population which consisted of all participants who received at least one dose of tesevatinib 100 mg (in Phase 1b: Cohort 2) and 150 mg (in Phase 1b: Cohort 3) and had quantifiable PK data available. Here, 'number analyzed' = participants with available data for each specified category. | nanograms per milliliter (ng/mL) | MEAN |
| PRIMARY | Phase 1b: Pharmacokinetics: Plasma Concentrations of Tesevatinib 50 mg | Pre-dose, 1, 2, 4, 8, and 24 hours post-dose on Day 1 and pre-dose, 1, 2, 4, and 24 hours post-dose on Day 14 | Analysis was performed on PK Population which consisted of all participants who received at least one dose of tesevatinib 50 mg in Phase 1b and had quantifiable PK data available. Here, overall number of participants analyzed = participants evaluable for this outcome measure (OM) and 'number analyzed' = participants with available data for each specified category. | ng/mL | MEAN |
| PRIMARY | Phase 1b: Pharmacokinetics: Maximum Observed Plasma Concentration (Cmax) of Tesevatinib 100 mg and 150 mg | Pre-dose, 1, 2, 4, 8, and 24 hours post-dose on Day 1 and pre-dose, 1, 2, 4, and 24 hours post-dose on Day 14 | Analysis was performed on PK Population. | ng/mL | MEAN |
| PRIMARY | Phase 1b: Pharmacokinetics: Maximum Observed Plasma Concentration of Tesevatinib 50 mg | Pre-dose, 1, 2, 4, 8, and 24 hours post-dose on Day 1 and pre-dose, 1, 2, 4, and 24 hours post-dose on Day 14 | Analysis was performed on PK Population. Here, overall number of participants analyzed = participants evaluable for this OM and 'number analyzed' = participants with available data for each specified category. | ng/mL | MEAN |
| PRIMARY | Phase 1b: Pharmacokinetics: Time of the Maximum Observed Plasma Concentration (Tmax) of Tesevatinib 100 mg and 150 mg | Pre-dose, 1, 2, 4, 8, and 24 hours post-dose on Day 1 and pre-dose, 1, 2, 4, and 24 hours post-dose on Day 14 | Analysis was performed on PK Population. | hours | MEAN |
| PRIMARY | Phase 1b: Pharmacokinetics: Time of the Maximum Observed Plasma Concentration of Tesevatinib 50 mg | Pre-dose, 1, 2, 4, 8, and 24 hours post-dose on Day 1 and pre-dose, 1, 2, 4, and 24 hours post-dose on Day 14 | Analysis was performed on PK Population. Here, overall number of participants analyzed = participants evaluable for this OM and 'number analyzed' = participants with available data for each specified category. | hours | MEAN |
| PRIMARY | Phase 1b: Pharmacokinetics: Time of the Last Quantifiable Plasma Concentration (Tlast) of Tesevatinib 100 mg and 150 mg | Pre-dose, 1, 2, 4, 8, and 24 hours post-dose on Day 1 and pre-dose, 1, 2, 4, and 24 hours post-dose on Day 14 | Analysis was performed on PK Population. Here, 'number analyzed' = participants with available data for each specified category. | hours | MEAN |
| PRIMARY | Phase 1b: Pharmacokinetics: Time of the Last Quantifiable Plasma Concentration of Tesevatinib 50 mg | Pre-dose, 1, 2, 4, 8, and 24 hours post-dose on Day 1 and pre-dose, 1, 2, 4, and 24 hours post-dose on Day 14 | Analysis was performed on PK Population. Here, overall number of participants analyzed = participants evaluable for this OM and 'number analyzed' = participants with available data for each specified category. | hours | MEAN |
| PRIMARY | Phase 1b: Pharmacokinetics: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of Last Quantifiable Concentration (AUC0-t) of Tesevatinib 100 mg and 150 mg | Pre-dose, 1, 2, 4, 8, and 24 hours post-dose on day 1 and pre-dose, 1, 2, 4, and 24 hours post-dose on Day 14 | Analysis was performed on PK Population. Here, 'number analyzed' = participants with available data for each specified category. | hour*nanograms per milliliter (hr*ng/mL) | MEAN |
| PRIMARY | Phase 1b: Pharmacokinetics: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of Last Quantifiable Concentration of Tesevatinib 50 mg | Pre-dose, 1, 2, 4, 8, and 24 hours post-dose on day 1 and pre-dose, 1, 2, 4, and 24 hours post-dose on Day 14 | Analysis was performed on PK Population. Here, overall number of participants analyzed = participants evaluable for this OM and 'number analyzed' = participants with available data for each specified category. | hr*ng/mL | MEAN |
| PRIMARY | Phase 1b: Pharmacokinetics: Area Under the Plasma Concentration-time Curve From Time Zero to 24 Hours Post-dose (AUC0-24) of Tesevatinib 100 mg and 150 mg | Pre-dose, 1, 2, 4, 8, and 24 hours post-dose on Day 1 and pre-dose, 1, 2, 4, and 24 hours post-dose on Day 14 | Analysis was performed on PK Population. Here, 'number analyzed' = participants with available data for each specified category. | hr*ng/mL | MEAN |
| PRIMARY | Phase 1b: Pharmacokinetics: Area Under the Plasma Concentration-time Curve From Time 0 to 24 Hours Post-dose of Tesevatinib 50 mg | Pre-dose, 1, 2, 4, 8, and 24 hours post-dose on Day 1 and pre-dose, 1, 2, 4, and 24 hours post-dose on Day 14 | Analysis was performed on PK Population. Here, overall number of participants analyzed = participants evaluable for this OM and 'number analyzed' = participants with available data for each specified category. | hr*ng/mL | MEAN |
| PRIMARY | Phase 1b: Pharmacokinetics: Trough Plasma Concentrations (Ctrough) of Tesevatinib 100 mg and 500 mg | Pre-dose on Days 7, 14, 21, 28 and Months 2, 3, 4, 5 and 6 | Analysis was performed on PK Population. Here, 'number analyzed' = participants with available data for each specified category. | ng/mL | MEAN |
| PRIMARY | Phase 1b: Pharmacokinetics: Trough Plasma Concentrations of Tesevatinib 50 mg | Pre-dose on Days 7, 14, 21, 28 and Months 2, 3, 4, 5 and 6 | Analysis was performed on PK Population. Here, overall number of participants analyzed = participants evaluable for this OM and 'number analyzed' = participants with available data for each specified category. | ng/mL | MEAN |
| PRIMARY | Phase 1b: Maximum Tolerated Dose (MTD) of Tesevatinib | Cycle 1 (Up to 28 days) | Analysis was performed on safety population. Data for this OM was not planned to be collected and analyzed for Phase 2a participants as pre specified in protocol. | milligrams | NUMBER |
| PRIMARY | Phase 2a: Annualized Percent Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) | Baseline (Day 1), Months 6, 12, 18, 24 and at end of study (i.e., anytime up to 37 months) | Analyzed on modified intent-to-treat (mITT) population which included all participants who completed 25 days (Phase 2a participants in the Monday/Thursday dosing cohort), 26 days (Phase 2a participants in the Monday/Wednesday/Friday dosing cohort), and 28 days (SILK Cohort). Here, 'number analyzed' = participants with available data for each specified category. Data for this OM was not planned to be collected and analyzed for Phase 1b participants as pre specified in protocol. | percent change/participant-year | MEAN |
| SECONDARY | Phase 2a: Annualized Percent Change From Baseline in Height Adjusted Total Kidney Volume (htTKV) at Month 6, 12, 18, 24 and End of Study | Baseline (Day 1), Months 6, 12, 18, 24 and at end of study (i.e., anytime up to 37 months) | Analysis was performed on mITT population. Here, 'number analyzed' = participants with available data for each specified category. Data for this OM was not planned to be collected and analyzed for Phase 1b participants as pre specified in protocol. | percent change/participant-year | MEAN |
| SECONDARY | Phase 2a: Annualized Percent Change From Baseline in the Reciprocal of Serum Creatinine at End of Study | Baseline (Day 1), at end of study (i.e., anytime up to 37 months) | Analysis was performed on mITT Population. Data for this OM was not planned to be collected and analyzed for Phase 1b participants as pre specified in protocol. | percent change per participant-year | MEAN |
| SECONDARY | Phase 2a: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (TESAE) | From Baseline (Day 1) until 30 days after the last dose of study drug (i.e., up to 29 months) | Analysis was performed on safety population. | 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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