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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1279-2764 | Other Identifier | UTN | |
| MAD17715 | Other Identifier | Sanofi study ID |
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The primary objective of this study Phase 1b was to determine the safety, plasma pharmacokinetics, and maximum tolerated dose (MTD) of tesevatinib when administered to participants with autosomal dominant polycystic kidney disease (ADPKD).
The primary objective of this study Phase 2a was to evaluate the annualized change in glomerular filtration rate (GFR) in participants with ADPKD when treated with tesevatinib.
Phase 1b:
Phase 2a:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 1b: Cohort 1: Tesevatinib 50 mg Once Daily Dosing | Experimental | Participants received tesevatinib 50 milligrams (mg) tablet orally once daily (QD) for 28 days. After initial 28 days treatment, at the investigator's discretion, participants continued to receive tesevatinib for a total of 24 months (since treatment initiation) or until the development of unacceptable toxicity, noncompliance, or withdrawal of consent by the participant, or investigator decision (maximum duration: up to 36 months). |
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| Phase 1b: Cohort 2: Tesevatinib 100 mg Once Daily Dosing | Experimental | Participants received tesevatinib 100 mg tablet orally QD for 28 days. After initial 28 days treatment, at the investigator's discretion, participants continued to receive tesevatinib for a total of 24 months (since treatment initiation) or until the development of unacceptable toxicity, noncompliance, or withdrawal of consent by the participant, or investigator decision (maximum exposure duration: up to 36 months). |
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| Phase 1b: Cohort 3: Tesevatinib 150 mg Once Daily Dosing | Experimental | Participants received tesevatinib 150 mg tablet orally QD for 28 days. After initial 28 days treatment, at the investigator's discretion, participants continued to receive tesevatinib for a total of 24 months (since treatment initiation) or until the development of unacceptable toxicity, noncompliance, or withdrawal of consent by the participant, or investigator decision (maximum exposure duration: up to 36 months). |
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| Phase 2a: Cohort 4: Tesevatinib: Bi-weekly Dosing |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tesevatinib | Drug | Pharmaceutical form: Tablets Route of administration: Oral |
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| Measure | Description | Time Frame |
|---|---|---|
| Phase 1b: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAE) | An adverse event (AE) was any untoward medical occurrence in a clinical study participant administered a medicinal product and which did not necessarily had to have a causal relationship with the treatment. An SAE was any untoward medical occurrence at any dose that: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a medically important event. TEAEs were AEs that developed or worsened or became serious from the first dose (Day 1) of the study drug until 30 days after the last dose of study drug. | From Baseline (Day 1) until 30 days after the last dose of study drug (maximum duration: up to 37 months) |
| Phase 1b: Pharmacokinetics (PK): Plasma Concentrations of Tesevatinib 100 mg and 150 mg | Plasma concentrations of tesevatinib was analyzed using non-compartmental analysis. | 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 |
| Phase 1b: Pharmacokinetics: Plasma Concentrations of Tesevatinib 50 mg | Plasma concentrations of tesevatinib was analyzed using non-compartmental analysis. | 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 |
| Phase 1b: Pharmacokinetics: Maximum Observed Plasma Concentration (Cmax) of Tesevatinib 100 mg and 150 mg | Cmax was defined as maximum observed plasma concentration. | 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 |
| Phase 1b: Pharmacokinetics: Maximum Observed Plasma Concentration of Tesevatinib 50 mg |
| Measure | Description | Time Frame |
|---|---|---|
| Phase 2a: Annualized Percent Change From Baseline in Height Adjusted Total Kidney Volume (htTKV) at Month 6, 12, 18, 24 and End of Study | htTKV was calculated using total kidney volume obtained from magnetic resonance imaging (MRI) divided by height in meters. The annualized percent change from Baseline was calculated as the percent change from Baseline divided by total duration in days*365.25. | Baseline (Day 1), Months 6, 12, 18, 24 and at end of study (i.e., anytime up to 37 months) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA Medical Center | Los Angeles | California | 90025 | United States | ||
| University of Colorado Denver |
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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Study consisted of 2 parts: Phase 1b with three sequential dosing cohort levels (50 milligrams [mg], 100 mg and 150 mg) and Phase 2a with two alternate dosing schedules cohorts (150 mg biweekly and triweekly) and one safety in larger kidneys (SILK) cohort.
The study was conducted at 11 active sites in the United States. A total of 126 participants were screened between 11 October 2012 and 07 March 2017, of which 69 participants were enrolled and treated.
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| ID | Title | Description |
|---|---|---|
| FG000 | Phase 1b: Cohort 1: Tesevatinib 50 mg Once Daily Dosing | Participants received tesevatinib 50 mg tablet orally once daily (QD) for initial 28 days. After initial 28 days treatment, at the investigator's discretion, participants continued to receive tesevatinib for a total of 24 months (since treatment initiation) or until the development of unacceptable toxicity, noncompliance, or withdrawal of consent by the participant, or investigator decision (maximum exposure duration: up to 36 months). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Phase 1b: Up to 36 Months |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 6, 2016 | Oct 12, 2022 |
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Participants received tesevatinib 150 mg tablet orally bi-weekly in alternative dosing schedules on Monday and Thursday for initial 25 days. After initial 25 days treatment, at the investigator's discretion, participants continued to receive tesevatinib for a total of 24 months (since treatment initiation) or until the development of unacceptable toxicity, noncompliance, or withdrawal of consent by the participant, or investigator decision (maximum exposure duration: up to 28 months). |
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| Phase 2a: Cohort 5: Tesevatinib: Tri-weekly Dosing | Experimental | Participants received tesevatinib 150 mg tablet orally tri-weekly in alternative dosing schedules on Monday, Wednesday and Friday for initial 26 days. After initial 26 days treatment, at the investigator's discretion, participants continued to receive tesevatinib for a total of 24 months (since treatment initiation) or until the development of unacceptable toxicity, noncompliance, or withdrawal of consent by the participant, or investigator decision (maximum exposure duration: up to 28 months). |
|
| Phase 2a: Safety in Larger Kidneys (SILK) Cohort: Tesevatinib 50 mg Once Daily Dosing | Experimental | Participants with autosomal dominant polycystic kidney disease (and Baseline estimated glomerular filtration rate (eGFR) greater than or equal to (>=) 35 milliliters per minute per 1.73 square meter (mL/min/1.73 m^2) and less than or equal to (<=) 80 mL/min/1.73 m^2, and height-adjusted total kidney volume (htTKV) >=1000 mL were enrolled and received tesevatinib 50 mg tablet orally QD for initial 28 days. After initial 28 days treatment, at the investigator's discretion, participants continued to receive tesevatinib for a total of 24 months (since treatment initiation) or until the development of unacceptable toxicity, noncompliance, or withdrawal of consent by the participant, or investigator decision (maximum exposure duration: up to 28 months). |
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Cmax was defined as maximum observed plasma concentration. |
| 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 |
| Phase 1b: Pharmacokinetics: Time of the Maximum Observed Plasma Concentration (Tmax) of Tesevatinib 100 mg and 150 mg | Tmax was defined as time to reach maximum observed plasma concentration. | 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 |
| Phase 1b: Pharmacokinetics: Time of the Maximum Observed Plasma Concentration of Tesevatinib 50 mg | Tmax was defined as time to reach maximum observed plasma concentration. | 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 |
| Phase 1b: Pharmacokinetics: Time of the Last Quantifiable Plasma Concentration (Tlast) of Tesevatinib 100 mg and 150 mg | Tlast was defined as time to reach last quantifiable plasma concentration. | 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 |
| Phase 1b: Pharmacokinetics: Time of the Last Quantifiable Plasma Concentration of Tesevatinib 50 mg | Tlast was defined as time to reach last quantifiable plasma concentration. | 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 |
| 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 | AUC0-last was defined as area under the concentration-time curve (AUC) from time 0 to the time of the last quantifiable concentration (tlast). | 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 |
| Phase 1b: Pharmacokinetics: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of Last Quantifiable Concentration of Tesevatinib 50 mg | AUC0-last was defined as area under the concentration-time curve (AUC) from time 0 to the time of the last quantifiable concentration (tlast). | 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 |
| 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 | AUC0-24 was defined as area under the plasma concentration versus time curve of study drug from time 0 to 24 hours post-dose. | 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 |
| Phase 1b: Pharmacokinetics: Area Under the Plasma Concentration-time Curve From Time 0 to 24 Hours Post-dose of Tesevatinib 50 mg | AUC0-24 was defined as area under the plasma concentration versus time curve of study drug from time 0 to 24 hours post-dose. | 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 |
| Phase 1b: Pharmacokinetics: Trough Plasma Concentrations (Ctrough) of Tesevatinib 100 mg and 500 mg | Ctrough was the plasma concentration observed at the time immediately before (pre-dose) study drug administration. | Pre-dose on Days 7, 14, 21, 28 and Months 2, 3, 4, 5 and 6 |
| Phase 1b: Pharmacokinetics: Trough Plasma Concentrations of Tesevatinib 50 mg | Ctrough was the plasma concentration observed at the time immediately before study drug administration. | Pre-dose on Days 7, 14, 21, 28 and Months 2, 3, 4, 5 and 6 |
| Phase 1b: Maximum Tolerated Dose (MTD) of Tesevatinib | The MTD was determined based on dose-limiting toxicities (DLTs) occurring in the first 28 days of study treatment. Any toxicity that the Investigator and the Sponsor deemed to be dose-limiting, regardless of the grade, was considered as DLT. | Cycle 1 (Up to 28 days) |
| Phase 2a: Annualized Percent Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) | eGFR: measures kidney function based on serum creatinine (Scr) and cystatin C (Scys). Annualized change in eGFR was calculated as: percent change from Baseline divided by total duration in days*365.25. eGFR was estimated using 3 formulas and is reported separately for each formula: 1) 4-variable modification of diet in renal disease (MDRD-4) : Black/African-American males:175*(Creatinine [Cr]^-1.154)*(Age^-0.203)*1.212, other males:175*(Cr^-1.154)*(Age^-0.203), females: male equation*0.742.; 2) cystatin C-based chronic kidney disease (CKD) epidemiology (EPI) (CKD-EPI2012cys) equation: based on Scyc levels, for males if <=0.8: 133*(Scys/0.8)^0.499*0.996^age, if >0.8: 133*(Scys/0.8)^-1.238*0.996^age; for female: male equation*0.932., 3) Scr- and Scys-based CKD-EPI (CKD EPI2012Scr-cys) equation: 135*(Scr/0.9)^XX*(Scys/0.8)^XXX*0.995^age*(× 1.08, if black)- XX and XXX had variable values based on different values of Scr and Scys. | Baseline (Day 1), Months 6, 12, 18, 24 and at end of study (i.e., anytime up to 37 months) |
| Phase 2a: Annualized Percent Change From Baseline in the Reciprocal of Serum Creatinine at End of Study | Reciprocal Creatinine was an indication for monitoring renal disease progression over time. The annualized percent change from Baseline was calculated as the percent change from Baseline divided by total duration in days*365.25. | Baseline (Day 1), at end of study (i.e., anytime up to 37 months) |
| Phase 2a: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (TESAE) | An AE was any untoward medical occurrence in a clinical study participant administered a medicinal product and which did not necessarily had to have a causal relationship with the treatment. An SAE was any untoward medical occurrence at any dose that: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a medically important event. TEAEs were AEs that developed or worsened or became serious from the first dose (Day 1) of the study drug until 30 days after the last dose of study drug. | From Baseline (Day 1) until 30 days after the last dose of study drug (i.e., up to 29 months) |
| Phase 2a: Change From Baseline in Serum Creatinine Levels | Serum creatinine levels indicated the renal function (normal or abnormal) over time. | Baseline, Day 1, 3, 7, 11, 12, 14, 21, 25, 26, 28, Month 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 16, 18, 20, 22, 24, and at end of study (i.e., anytime up to 37 months) |
| Phase 2a: Pharmacokinetics: Plasma Concentrations of Tesevatinib 150 mg | Plasma concentrations of tesevatinib was analyzed using non-compartmental analysis. | Bi-weekly: pre-dose, 1, 2, 4, 8, and 24 hours post-dose on Day 1 and Day 25; Tri-weekly: pre-dose, 1, 2, 4, 8, and 24 hours post-dose on Day 1; pre-dose, 1, 2, 4, and 24 hours post-dose on Day 12 |
| Phase 2a: Pharmacokinetics: Maximum Observed Plasma Concentration (Cmax) of Tesevatinib 150 mg | Cmax was defined as maximum observed plasma concentration. | Bi-weekly: pre-dose, 1, 2, 4, 8, and 24 hours post-dose on Day 1 and Day 25; Tri-weekly: pre-dose, 1, 2, 4, 8, and 24 hours post-dose on Day 1; pre-dose, 1, 2, 4, and 24 hours post-dose on Day 12 |
| Phase 2a: Pharmacokinetics: Time of the Maximum Observed Plasma Concentration (Tmax) of Tesevatinib 150 mg | Tmax was defined as time to reach maximum observed plasma concentration. | Bi-weekly: pre-dose, 1, 2, 4, 8, and 24 hours post-dose on Day 1 and Day 25; Tri-weekly: pre-dose, 1, 2, 4, 8, and 24 hours post-dose on Day 1; pre-dose, 1, 2, 4, and 24 hours post-dose on Day 12 |
| Phase 2a: Pharmacokinetics: Time of the Last Quantifiable Plasma Concentration (Tlast) of Tesevatinib 150 mg | Tlast was defined as time to reach last quantifiable plasma concentration. | Bi-weekly: pre-dose, 1, 2, 4, 8, and 24 hours post-dose on Day 1 and Day 25; Tri-weekly: pre-dose, 1, 2, 4, 8, and 24 hours post-dose on Day 1; pre-dose, 1, 2, 4, and 24 hours post-dose on Day 12 |
| Phase 2a: Pharmacokinetics: Area Under the Plasma Concentration-time Curve From Time 0 to the Last Quantifiable Concentration (AUC0-t) of Tesevatinib 150 mg | AUC0-last was defined as area under the concentration-time curve (AUC) from time 0 to the time of the last quantifiable concentration (tlast). | Bi-weekly: pre-dose, 1, 2, 4, 8, and 24 hours post-dose on Day 1 and Day 25; Tri-weekly: pre-dose, 1, 2, 4, 8, and 24 hours post-dose on Day 1; pre-dose, 1, 2, 4, and 24 hours post-dose on Day 12 |
| Phase 2a: Pharmacokinetics: Area Under the Plasma Concentration-time Curve From Time 0 to 24 Hours Post-dose (AUC0-24) of Tesevatinib 150 mg | AUC0-24 was defined as area under the plasma concentration versus time curve of study drug from time 0 to 24 hours post-dose. | Bi-weekly: pre-dose, 1, 2, 4, 8, and 24 hours post-dose on Day 1 and Day 25; Tri-weekly: pre-dose, 1, 2, 4, 8, and 24 hours post-dose on Day 1; pre-dose, 1, 2, 4, and 24 hours post-dose on Day 12 |
| Phase 2a: Pharmacokinetics: Concentration Immediately Before Dosing (Ctrough) of Tesevatinib 150 mg | Ctrough was the plasma concentration observed at the time immediately before study drug administration. | Bi-weekly: Pre-dose on Days 8, 11, 18 and 25; pre-dose on Months 2, 3, 4, 5 and 6; Tri-weekly: pre-dose on Days 3, 5, 8 and 12 |
| Denver |
| Colorado |
| 80045 |
| United States |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| New York University School of Medicine | New York | New York | 10016 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Clinical Advancement Center, PLLC | San Antonio | Texas | 78215 | United States |
| University of Virginia - Nephrology Clinical Research Center | Charlottesville | Virginia | 22908 | United States |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| FG001 | Phase 1b: Cohort 2: Tesevatinib 100 mg Once Daily Dosing | Participants received tesevatinib 100 mg tablet orally QD for initial 28 days. After initial 28 days treatment, at the investigator's discretion, participants continued to receive tesevatinib for a total of 24 months (since treatment initiation) or until the development of unacceptable toxicity, noncompliance, or withdrawal of consent by the participant, or investigator decision (maximum exposure duration: up to 36 months). |
| FG002 | Phase 1b: Cohort 3: Tesevatinib 150 mg Once Daily Dosing | Participants received tesevatinib 150 mg tablet orally QD for initial 28 days. After initial 28 days treatment, at the investigator's discretion, participants continued to receive tesevatinib for a total of 24 months (since treatment initiation) or until the development of unacceptable toxicity, noncompliance, or withdrawal of consent by the participant, or investigator decision (maximum exposure duration: up to 36 months). |
| FG003 | Phase 2a: Cohort 4: Tesevatinib: Bi-weekly Dosing | Participants received tesevatinib 150 mg tablet orally bi-weekly in alternative dosing schedules on Monday and Thursday for initial 25 days. After initial 25 days treatment, at the investigator's discretion, participants continued to receive tesevatinib for a total of 24 months (since treatment initiation) or until the development of unacceptable toxicity, noncompliance, or withdrawal of consent by the participant, or investigator decision (maximum exposure duration: up to 28 months). |
| FG004 | Phase 2a: Cohort 5: Tesevatinib: Tri-weekly Dosing | Participants received tesevatinib 150 mg tablet orally tri-weekly in alternative dosing schedules on Monday, Wednesday and Friday for initial 26 days. After initial 26 days treatment, at the investigator's discretion, participants continued to receive tesevatinib for a total of 24 months (since treatment initiation) or until the development of unacceptable toxicity, noncompliance, or withdrawal of consent by the participant, or investigator decision (maximum exposure duration: up to 28 months). |
| FG005 | Phase 2a: SILK Cohort: Tesevatinib 50 mg Once Daily Dosing | Participants with autosomal dominant polycystic kidney disease (ADPKD) and Baseline estimated glomerular filtration rate (eGFR) greater than or equal to (>=) 35 milliliters per minute per 1.73 square meter (mL/min/1.73 m^2) and less than or equal to (<=) 80 mL/min/1.73 m^2, and height-adjusted total kidney volume (htTKV) >=1000 mL were enrolled and received tesevatinib 50 mg tablet orally QD for initial 28 days. After initial 28 days treatment, at the investigator's discretion, participants continued to receive tesevatinib for a total of 24 months (since treatment initiation) or until the development of unacceptable toxicity, noncompliance, or withdrawal of consent by the participant, or investigator decision (maximum exposure duration: up to 28 months). |
| COMPLETED |
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| NOT COMPLETED |
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| Phase 2a: Up to 28 Months |
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Analysis was performed on safety population which included all participants who receive at least 1 dose of tesevatinib.
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| ID | Title | Description |
|---|---|---|
| BG000 | Phase 1b: Cohort 1: Tesevatinib 50 mg Once Daily Dosing | Participants received tesevatinib 50 mg tablet orally QD for initial 28 days. After initial 28 days treatment, at the investigator's discretion, participants continued to receive tesevatinib for a total of 24 months (since treatment initiation) or until the development of unacceptable toxicity, noncompliance, or withdrawal of consent by the participant, or investigator decision (maximum duration: up to 36 months). |
| BG001 | Phase 1b: Cohort 2: Tesevatinib 100 mg Once Daily Dosing | Participants received tesevatinib 100 mg tablet orally QD for initial 28 days. After initial 28 days treatment, at the investigator's discretion, participants continued to receive tesevatinib for a total of 24 months (since treatment initiation) or until the development of unacceptable toxicity, noncompliance, or withdrawal of consent by the participant, or investigator decision (maximum exposure duration: up to 36 months). |
| BG002 | Phase 1b: Cohort 3: Tesevatinib 150 mg Once Daily Dosing | Participants received tesevatinib 150 mg tablet orally QD for initial 28 days. After initial 28 days treatment, at the investigator's discretion, participants continued to receive tesevatinib for a total of 24 months (since treatment initiation) or until the development of unacceptable toxicity, noncompliance, or withdrawal of consent by the participant, or investigator decision (maximum exposure duration: up to 36 months). |
| BG003 | Phase 2a: Cohort 4: Tesevatinib: Bi-weekly Dosing | Participants received tesevatinib 150 mg tablet orally bi-weekly in alternative dosing schedules on Monday and Thursday for initial 25 days. After initial 25 days treatment, at the investigator's discretion, participants continued to receive tesevatinib for a total of 24 months (since treatment initiation) or until the development of unacceptable toxicity, noncompliance, or withdrawal of consent by the participant, or investigator decision (maximum exposure duration: up to 28 months). |
| BG004 | Phase 2a: Cohort 5: Tesevatinib: Tri-weekly Dosing | Participants received tesevatinib 150 mg tablet orally tri-weekly in alternative dosing schedules on Monday, Wednesday and Friday for initial 26 days. After initial 26 days treatment, at the investigator's discretion, participants continued to receive tesevatinib for a total of 24 months (since treatment initiation) or until the development of unacceptable toxicity, noncompliance, or withdrawal of consent by the participant, or investigator decision (maximum exposure duration: up to 28 months). |
| BG005 | Phase 2a: SILK Cohort: Tesevatinib 50 mg Once Daily Dosing | Participants with ADPKD and Baseline eGFR >=35 mL/min/1.73 m^2 and <=80 mL/min/1.73 m^2, and htTKV >=1000 mL were enrolled and received tesevatinib 50 mg tablet orally QD for initial 28 days. After initial 28 days treatment, at the investigator's discretion, participants continued to receive tesevatinib for a total of 24 months (since treatment initiation) or until the development of unacceptable toxicity, noncompliance, or withdrawal of consent by the participant, or investigator decision (maximum exposure duration: up to 28 months). |
| BG006 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
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| Primary | Phase 1b: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAE) | An adverse event (AE) was any untoward medical occurrence in a clinical study participant administered a medicinal product and which did not necessarily had to have a causal relationship with the treatment. An SAE was any untoward medical occurrence at any dose that: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a medically important event. TEAEs were AEs that developed or worsened or became serious from the first dose (Day 1) of the study drug until 30 days after the last dose of study drug. | Analysis was performed on safety population. | Posted | Count of Participants | Participants | From Baseline (Day 1) until 30 days after the last dose of study drug (maximum duration: up to 37 months) |
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| Primary | Phase 1b: Pharmacokinetics (PK): Plasma Concentrations of Tesevatinib 100 mg and 150 mg | Plasma concentrations of tesevatinib was analyzed using non-compartmental analysis. | 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. | Posted | Mean | Standard Deviation | nanograms per milliliter (ng/mL) | 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 |
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| Primary | Phase 1b: Pharmacokinetics: Plasma Concentrations of Tesevatinib 50 mg | Plasma concentrations of tesevatinib was analyzed using non-compartmental analysis. | 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. | Posted | Mean | Standard Deviation | ng/mL | 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 |
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| Primary | Phase 1b: Pharmacokinetics: Maximum Observed Plasma Concentration (Cmax) of Tesevatinib 100 mg and 150 mg | Cmax was defined as maximum observed plasma concentration. | Analysis was performed on PK Population. | Posted | Mean | Standard Deviation | ng/mL | 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 |
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| Primary | Phase 1b: Pharmacokinetics: Maximum Observed Plasma Concentration of Tesevatinib 50 mg | Cmax was defined as maximum observed plasma concentration. | 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. | Posted | Mean | Standard Deviation | ng/mL | 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 |
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| Primary | Phase 1b: Pharmacokinetics: Time of the Maximum Observed Plasma Concentration (Tmax) of Tesevatinib 100 mg and 150 mg | Tmax was defined as time to reach maximum observed plasma concentration. | Analysis was performed on PK Population. | Posted | Mean | Standard Deviation | hours | 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 |
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| Primary | Phase 1b: Pharmacokinetics: Time of the Maximum Observed Plasma Concentration of Tesevatinib 50 mg | Tmax was defined as time to reach maximum observed plasma concentration. | 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. | Posted | Mean | Standard Deviation | hours | 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 |
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| Primary | Phase 1b: Pharmacokinetics: Time of the Last Quantifiable Plasma Concentration (Tlast) of Tesevatinib 100 mg and 150 mg | Tlast was defined as time to reach last quantifiable plasma concentration. | Analysis was performed on PK Population. Here, 'number analyzed' = participants with available data for each specified category. | Posted | Mean | Standard Deviation | hours | 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 |
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| Primary | Phase 1b: Pharmacokinetics: Time of the Last Quantifiable Plasma Concentration of Tesevatinib 50 mg | Tlast was defined as time to reach last quantifiable plasma concentration. | 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. | Posted | Mean | Standard Deviation | hours | 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 |
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| 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 | AUC0-last was defined as area under the concentration-time curve (AUC) from time 0 to the time of the last quantifiable concentration (tlast). | Analysis was performed on PK Population. Here, 'number analyzed' = participants with available data for each specified category. | Posted | Mean | Standard Deviation | hour*nanograms per milliliter (hr*ng/mL) | 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 |
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| 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 | AUC0-last was defined as area under the concentration-time curve (AUC) from time 0 to the time of the last quantifiable concentration (tlast). | 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. | Posted | Mean | Standard Deviation | hr*ng/mL | 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 |
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| 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 | AUC0-24 was defined as area under the plasma concentration versus time curve of study drug from time 0 to 24 hours post-dose. | Analysis was performed on PK Population. Here, 'number analyzed' = participants with available data for each specified category. | Posted | Mean | Standard Deviation | hr*ng/mL | 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 |
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| Primary | Phase 1b: Pharmacokinetics: Area Under the Plasma Concentration-time Curve From Time 0 to 24 Hours Post-dose of Tesevatinib 50 mg | AUC0-24 was defined as area under the plasma concentration versus time curve of study drug from time 0 to 24 hours post-dose. | 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. | Posted | Mean | Standard Deviation | hr*ng/mL | 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 |
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| Primary | Phase 1b: Pharmacokinetics: Trough Plasma Concentrations (Ctrough) of Tesevatinib 100 mg and 500 mg | Ctrough was the plasma concentration observed at the time immediately before (pre-dose) study drug administration. | Analysis was performed on PK Population. Here, 'number analyzed' = participants with available data for each specified category. | Posted | Mean | Full Range | ng/mL | Pre-dose on Days 7, 14, 21, 28 and Months 2, 3, 4, 5 and 6 |
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| Primary | Phase 1b: Pharmacokinetics: Trough Plasma Concentrations of Tesevatinib 50 mg | Ctrough was the plasma concentration observed at the time immediately before study drug administration. | 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. | Posted | Mean | Standard Deviation | ng/mL | Pre-dose on Days 7, 14, 21, 28 and Months 2, 3, 4, 5 and 6 |
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| Primary | Phase 1b: Maximum Tolerated Dose (MTD) of Tesevatinib | The MTD was determined based on dose-limiting toxicities (DLTs) occurring in the first 28 days of study treatment. Any toxicity that the Investigator and the Sponsor deemed to be dose-limiting, regardless of the grade, was considered as DLT. | 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. | Posted | Number | milligrams | Cycle 1 (Up to 28 days) |
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| Primary | Phase 2a: Annualized Percent Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) | eGFR: measures kidney function based on serum creatinine (Scr) and cystatin C (Scys). Annualized change in eGFR was calculated as: percent change from Baseline divided by total duration in days*365.25. eGFR was estimated using 3 formulas and is reported separately for each formula: 1) 4-variable modification of diet in renal disease (MDRD-4) : Black/African-American males:175*(Creatinine [Cr]^-1.154)*(Age^-0.203)*1.212, other males:175*(Cr^-1.154)*(Age^-0.203), females: male equation*0.742.; 2) cystatin C-based chronic kidney disease (CKD) epidemiology (EPI) (CKD-EPI2012cys) equation: based on Scyc levels, for males if <=0.8: 133*(Scys/0.8)^0.499*0.996^age, if >0.8: 133*(Scys/0.8)^-1.238*0.996^age; for female: male equation*0.932., 3) Scr- and Scys-based CKD-EPI (CKD EPI2012Scr-cys) equation: 135*(Scr/0.9)^XX*(Scys/0.8)^XXX*0.995^age*(× 1.08, if black)- XX and XXX had variable values based on different values of Scr and Scys. | 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. | Posted | Mean | Standard Deviation | percent change/participant-year | Baseline (Day 1), Months 6, 12, 18, 24 and at end of study (i.e., anytime up to 37 months) |
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| 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 | htTKV was calculated using total kidney volume obtained from magnetic resonance imaging (MRI) divided by height in meters. The annualized percent change from Baseline was calculated as the percent change from Baseline divided by total duration in days*365.25. | 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. | Posted | Mean | Standard Deviation | percent change/participant-year | Baseline (Day 1), Months 6, 12, 18, 24 and at end of study (i.e., anytime up to 37 months) |
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| Secondary | Phase 2a: Annualized Percent Change From Baseline in the Reciprocal of Serum Creatinine at End of Study | Reciprocal Creatinine was an indication for monitoring renal disease progression over time. The annualized percent change from Baseline was calculated as the percent change from Baseline divided by total duration in days*365.25. | 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. | Posted | Mean | Standard Deviation | percent change per participant-year | Baseline (Day 1), at end of study (i.e., anytime up to 37 months) |
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| Secondary | Phase 2a: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (TESAE) | An AE was any untoward medical occurrence in a clinical study participant administered a medicinal product and which did not necessarily had to have a causal relationship with the treatment. An SAE was any untoward medical occurrence at any dose that: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a medically important event. TEAEs were AEs that developed or worsened or became serious from the first dose (Day 1) of the study drug until 30 days after the last dose of study drug. | Analysis was performed on safety population. | Posted | Count of Participants | Participants | From Baseline (Day 1) until 30 days after the last dose of study drug (i.e., up to 29 months) |
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| Secondary | Phase 2a: Change From Baseline in Serum Creatinine Levels | Serum creatinine levels indicated the renal function (normal or abnormal) over time. | Analysis was performed on safety population. Here, 'number analyzed' = participants with available data for each specified category and '0' in the number analyzed field signifies that none of the participants were evaluable at the specified timepoint. Data for this OM was not planned to be collected and analyzed for Phase 1b participants as pre specified in protocol. | Posted | Mean | Standard Deviation | micromoles per liter | Baseline, Day 1, 3, 7, 11, 12, 14, 21, 25, 26, 28, Month 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 16, 18, 20, 22, 24, and at end of study (i.e., anytime up to 37 months) |
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| Secondary | Phase 2a: Pharmacokinetics: Plasma Concentrations of Tesevatinib 150 mg | Plasma concentrations of tesevatinib was analyzed using non-compartmental analysis. | 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 and '0' in the number analyzed field signifies that none of the participants were evaluable at the specified timepoint. Data for this OM was not planned to be collected and analyzed for Phase 2a SILK cohort participants. | Posted | Mean | Standard Deviation | ng/mL | Bi-weekly: pre-dose, 1, 2, 4, 8, and 24 hours post-dose on Day 1 and Day 25; Tri-weekly: pre-dose, 1, 2, 4, 8, and 24 hours post-dose on Day 1; pre-dose, 1, 2, 4, and 24 hours post-dose on Day 12 |
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| Secondary | Phase 2a: Pharmacokinetics: Maximum Observed Plasma Concentration (Cmax) of Tesevatinib 150 mg | Cmax was defined as maximum observed plasma concentration. | 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 and '0' in the number analyzed field signifies that none of the participants were evaluable at the specified timepoint. Data for this OM was not planned to be collected and analyzed for Phase 2a SILK cohort participants. | Posted | Mean | Standard Deviation | ng/mL | Bi-weekly: pre-dose, 1, 2, 4, 8, and 24 hours post-dose on Day 1 and Day 25; Tri-weekly: pre-dose, 1, 2, 4, 8, and 24 hours post-dose on Day 1; pre-dose, 1, 2, 4, and 24 hours post-dose on Day 12 |
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| Secondary | Phase 2a: Pharmacokinetics: Time of the Maximum Observed Plasma Concentration (Tmax) of Tesevatinib 150 mg | Tmax was defined as time to reach maximum observed plasma concentration. | 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 and '0' in the number analyzed field signifies that none of the participants were evaluable at the specified timepoint. Data for this OM was not planned to be collected and analyzed for Phase 2a SILK cohort participants. | Posted | Mean | Standard Deviation | hours | Bi-weekly: pre-dose, 1, 2, 4, 8, and 24 hours post-dose on Day 1 and Day 25; Tri-weekly: pre-dose, 1, 2, 4, 8, and 24 hours post-dose on Day 1; pre-dose, 1, 2, 4, and 24 hours post-dose on Day 12 |
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| Secondary | Phase 2a: Pharmacokinetics: Time of the Last Quantifiable Plasma Concentration (Tlast) of Tesevatinib 150 mg | Tlast was defined as time to reach last quantifiable plasma concentration. | 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 and '0' in the number analyzed field signifies that none of the participants were evaluable at the specified timepoint. Data for this OM was not planned to be collected and analyzed for Phase 2a SILK cohort participants. | Posted | Mean | Standard Deviation | hours | Bi-weekly: pre-dose, 1, 2, 4, 8, and 24 hours post-dose on Day 1 and Day 25; Tri-weekly: pre-dose, 1, 2, 4, 8, and 24 hours post-dose on Day 1; pre-dose, 1, 2, 4, and 24 hours post-dose on Day 12 |
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| Secondary | Phase 2a: Pharmacokinetics: Area Under the Plasma Concentration-time Curve From Time 0 to the Last Quantifiable Concentration (AUC0-t) of Tesevatinib 150 mg | AUC0-last was defined as area under the concentration-time curve (AUC) from time 0 to the time of the last quantifiable concentration (tlast). | 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 and '0' in the number analyzed field signifies that none of the participants were evaluable at the specified timepoint. Data for this OM was not planned to be collected and analyzed for Phase 2a SILK cohort participants. | Posted | Mean | Standard Deviation | hr*ng/mL | Bi-weekly: pre-dose, 1, 2, 4, 8, and 24 hours post-dose on Day 1 and Day 25; Tri-weekly: pre-dose, 1, 2, 4, 8, and 24 hours post-dose on Day 1; pre-dose, 1, 2, 4, and 24 hours post-dose on Day 12 |
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| Secondary | Phase 2a: Pharmacokinetics: Area Under the Plasma Concentration-time Curve From Time 0 to 24 Hours Post-dose (AUC0-24) of Tesevatinib 150 mg | AUC0-24 was defined as area under the plasma concentration versus time curve of study drug from time 0 to 24 hours post-dose. | 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 and '0' in the number analyzed field signifies that none of the participants were evaluable at the specified timepoint. Data for this OM was not planned to be collected and analyzed for Phase 2a SILK cohort participants. | Posted | Mean | Standard Deviation | hr*ng/mL | Bi-weekly: pre-dose, 1, 2, 4, 8, and 24 hours post-dose on Day 1 and Day 25; Tri-weekly: pre-dose, 1, 2, 4, 8, and 24 hours post-dose on Day 1; pre-dose, 1, 2, 4, and 24 hours post-dose on Day 12 |
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| Secondary | Phase 2a: Pharmacokinetics: Concentration Immediately Before Dosing (Ctrough) of Tesevatinib 150 mg | Ctrough was the plasma concentration observed at the time immediately before study drug administration. | 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 and '0' in the number analyzed field signifies that none of the participants were evaluable at the specified timepoint. Data for this OM was not planned to be collected and analyzed for Phase 2a SILK cohort participants. | Posted | Mean | Full Range | ng/mL | Bi-weekly: Pre-dose on Days 8, 11, 18 and 25; pre-dose on Months 2, 3, 4, 5 and 6; Tri-weekly: pre-dose on Days 3, 5, 8 and 12 |
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Phase 1b: From Baseline (Day 1) until 30 days after the last dose of study drug (i.e., up to 37 months) and Phase 2a: From Baseline (Day 1) until 30 days after the last dose of study drug (i.e., up to 29 months)
Reported AEs were AEs that developed or worsened or became serious from the first dose (Day 1) of the study drug until 30 days after the last dose of study drug. Analysis was performed on safety population.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Phase 1b: Cohort 1: Tesevatinib 50 mg Once Daily Dosing | Participants received tesevatinib 50 mg tablet orally QD for initial 28 days. After initial 28 days treatment, at the investigator's discretion, participants continued to receive tesevatinib for a total of 24 months (since treatment initiation) or until the development of unacceptable toxicity, noncompliance, or withdrawal of consent by the participant, or investigator decision (maximum duration: up to 36 months). | 0 | 24 | 1 | 24 | 24 | 24 |
| EG001 | Phase 1b: Cohort 2: Tesevatinib 100 mg Once Daily Dosing | Participants received tesevatinib 100 mg tablet orally QD for initial 28 days. After initial 28 days treatment, at the investigator's discretion, participants continued to receive tesevatinib for a total of 24 months (since treatment initiation) or until the development of unacceptable toxicity, noncompliance, or withdrawal of consent by the participant, or investigator decision (maximum exposure duration: up to 36 months). | 0 | 8 | 0 | 8 | 8 | 8 |
| EG002 | Phase 1b: Cohort 3: Tesevatinib 150 mg Once Daily Dosing | Participants received tesevatinib 150 mg tablet orally QD for initial 28 days. After initial 28 days treatment, at the investigator's discretion, participants continued to receive tesevatinib for a total of 24 months (since treatment initiation) or until the development of unacceptable toxicity, noncompliance, or withdrawal of consent by the participant, or investigator decision (maximum exposure duration: up to 36 months). | 0 | 5 | 0 | 5 | 5 | 5 |
| EG003 | Phase 2a: Cohort 4: Tesevatinib: Bi-weekly Dosing | Participants received tesevatinib 150 mg tablet orally bi-weekly in alternative dosing schedules on Monday and Thursday for initial 25 days. After initial 25 days treatment, at the investigator's discretion, participants continued to receive tesevatinib for a total of 24 months (since treatment initiation) or until the development of unacceptable toxicity, noncompliance, or withdrawal of consent by the participant, or investigator decision (maximum exposure duration: up to 28 months). | 0 | 10 | 1 | 10 | 10 | 10 |
| EG004 | Phase 2a: Cohort 5: Tesevatinib: Tri-weekly Dosing | Participants received tesevatinib 150 mg tablet orally tri-weekly in alternative dosing schedules on Monday, Wednesday and Friday for initial 26 days. After initial 26 days treatment, at the investigator's discretion, participants continued to receive tesevatinib for a total of 24 months (since treatment initiation) or until the development of unacceptable toxicity, noncompliance, or withdrawal of consent by the participant, or investigator decision (maximum exposure duration: up to 28 months). | 0 | 14 | 0 | 14 | 14 | 14 |
| EG005 | Phase 2a: SILK Cohort: Tesevatinib 50 mg Once Daily Dosing | Participants with ADPKD and Baseline eGFR >=35 mL/min/1.73 m^2 and <=80 mL/min/1.73 m^2, and htTKV >=1000 mL were enrolled and received tesevatinib 50 mg tablet orally QD for initial 28 days. After initial 28 days treatment, at the investigator's discretion, participants continued to receive tesevatinib for a total of 24 months (since treatment initiation) or until the development of unacceptable toxicity, noncompliance, or withdrawal of consent by the participant, or investigator decision (maximum exposure duration: up to 28 months). | 0 | 8 | 1 | 8 | 8 | 8 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Herpes zoster | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
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| Laceration | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA 19.0 | Systematic Assessment |
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| Suicidal ideation | Psychiatric disorders | MedDRA 19.0 | Systematic Assessment |
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| Angioedema | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Abdominal discomfort | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Food poisoning | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Abdominal distension | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Flatulence | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Haematochezia | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Inguinal hernia | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Umbilical hernia | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Abdominal pain lower | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Colitis ulcerative | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Dental caries | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Gastritis | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Haemorrhoidal haemorrhage | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Hiatus hernia | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Irritable bowel syndrome | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Pancreatic cyst | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Blood creatine phosphokinase increased | Investigations | MedDRA 19.0 | Systematic Assessment |
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| Blood creatinine increased | Investigations | MedDRA 19.0 | Systematic Assessment |
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| Alanine aminotransferase increased | Investigations | MedDRA 19.0 | Systematic Assessment |
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| Amylase increased | Investigations | MedDRA 19.0 | Systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | MedDRA 19.0 | Systematic Assessment |
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| Electrocardiogram QT prolonged | Investigations | MedDRA 19.0 | Systematic Assessment |
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| Blood bicarbonate decreased | Investigations | MedDRA 19.0 | Systematic Assessment |
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| Urine leukocyte esterase positive | Investigations | MedDRA 19.0 | Systematic Assessment |
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| Blood lactate dehydrogenase increased | Investigations | MedDRA 19.0 | Systematic Assessment |
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| Glomerular filtration rate decreased | Investigations | MedDRA 19.0 | Systematic Assessment |
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| Bacterial test positive | Investigations | MedDRA 19.0 | Systematic Assessment |
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| Blood glucose increased | Investigations | MedDRA 19.0 | Systematic Assessment |
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| Blood urine present | Investigations | MedDRA 19.0 | Systematic Assessment |
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| Cystatin C increased | Investigations | MedDRA 19.0 | Systematic Assessment |
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| Lipase increased | Investigations | MedDRA 19.0 | Systematic Assessment |
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| Lymphocyte count decreased | Investigations | MedDRA 19.0 | Systematic Assessment |
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| Monocyte count decreased | Investigations | MedDRA 19.0 | Systematic Assessment |
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| Neutrophil count decreased | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
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| Neutrophil count increased | Investigations | MedDRA 19.0 | Systematic Assessment |
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| Weight decreased | Investigations | MedDRA 19.0 | Systematic Assessment |
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| Weight increased | Investigations | MedDRA 19.0 | Systematic Assessment |
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| White blood cell count decreased | Investigations | MedDRA 19.0 | Systematic Assessment |
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| White blood cells urine positive | Investigations | MedDRA 19.0 | Systematic Assessment |
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| Blood bicarbonate increased | Investigations | MedDRA 19.0 | Systematic Assessment |
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| Blood bilirubin increased | Investigations | MedDRA 19.0 | Systematic Assessment |
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| Blood glucose decreased | Investigations | MedDRA 19.0 | Systematic Assessment |
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| Blood phosphorus decreased | Investigations | MedDRA 19.0 | Systematic Assessment |
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| Blood phosphorus increased | Investigations | MedDRA 19.0 | Systematic Assessment |
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| Blood potassium increased | Investigations | MedDRA 19.0 | Systematic Assessment |
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| Blood pressure increased | Investigations | MedDRA 19.0 | Systematic Assessment |
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| Electrocardiogram T wave amplitude decreased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Haematocrit increased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Heart rate increased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| International normalised ratio increased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Nitrite urine present | Investigations | MedDRA 19.0 | Systematic Assessment |
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| Protein total decreased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Red blood cells urine positive | Investigations | MedDRA 19.0 | Systematic Assessment |
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| Urinary sediment present | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Urine bilirubin increased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| White blood cell count increased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
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| Acne | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
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| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
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| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
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| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
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| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
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| Skin irritation | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
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| Dry skin | Investigations | MedDRA 19.0 | Systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
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| Rash papular | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
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| Urticaria | Investigations | MedDRA 19.0 | Systematic Assessment |
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| Rash erythematous | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
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| Seborrhoea | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
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| Influenza | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
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| Gastroenteritis viral | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
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| Pharyngitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
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| Conjunctivitis infective | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
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| Infectious mononucleosis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
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| Streptococcal infection | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
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| Acute sinusitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
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| Arthritis infective | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Eye infection | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Folliculitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Fungal infection | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Hordeolum | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Laryngitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Laryngitis viral | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Localised infection | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Periodontitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Pharyngitis streptococcal | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Rash pustular | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Plantar fasciitis | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Joint effusion | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Tenosynovitis | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Infusion site rash | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Disturbance in attention | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Memory impairment | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Muscle contractions involuntary | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Oropharyngeal discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Paranasal sinus hypersecretion | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Renal pain | Renal and urinary disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Renal cyst ruptured | Renal and urinary disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Urine abnormality | Renal and urinary disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Urine odour abnormal | Renal and urinary disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
| |
| Sunburn | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
| |
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
| |
| Traumatic haematoma | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
| |
| Heat stroke | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
| |
| Laceration | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
| |
| Post procedural constipation | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Vitamin C deficiency | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Vitamin D deficiency | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Mitral valve incompetence | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Ventricular extrasystoles | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Tricuspid valve incompetence | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Mitral valve disease | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Pulmonary valve incompetence | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Supraventricular extrasystoles | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Mood altered | Psychiatric disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Abnormal dreams | Psychiatric disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Depressed mood | Psychiatric disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Personality change | Psychiatric disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Increased tendency to bruise | Blood and lymphatic system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Thrombocytosis | Blood and lymphatic system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Cervical dysplasia | Reproductive system and breast disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Cystocele | Reproductive system and breast disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Fibrocystic breast disease | Reproductive system and breast disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Menometrorrhagia | Reproductive system and breast disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Polymenorrhoea | Reproductive system and breast disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Prostatic pain | Reproductive system and breast disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Rectocele | Reproductive system and breast disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Uterine spasm | Reproductive system and breast disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Deafness | Ear and labyrinth disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Ear congestion | Ear and labyrinth disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Vertigo positional | Ear and labyrinth disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Seasonal allergy | Immune system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Eye discharge | Eye disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Eye swelling | Eye disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Photophobia | Eye disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Visual acuity reduced | Eye disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Lipoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Systematic Assessment |
| |
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Systematic Assessment |
| |
| Hypertrophic cardiomyopathy | Congenital, familial and genetic disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Lymphocyte count increased | Investigations | MedDRA 19.0 | Systematic Assessment |
|
The Sponsor supports publication of clinical trial results but may request that investigators temporarily delay or alter publications in order to protect proprietary information. The Sponsor may also require that the results of multicenter studies be published only in their entirety and not as individual site data.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Trial Transparency Team | Kadmon, a Sanofi Company | 800-633-1610 | 6# | Contact-US@Sanofi.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 10, 2020 | Oct 12, 2022 | SAP_001.pdf |
| ID | Term |
|---|---|
| D016891 | Polycystic Kidney, Autosomal Dominant |
| ID | Term |
|---|---|
| D007690 | Polycystic Kidney Diseases |
| D052177 | Kidney Diseases, Cystic |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D000015 | Abnormalities, Multiple |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D000072661 | Ciliopathies |
| D030342 | Genetic Diseases, Inborn |
Not provided
Not provided
| ID | Term |
|---|---|
| C571826 | XL647 |
Not provided
Not provided
Not provided
| Unspecified reason |
|
| Male |
|
| White |
|
| Black or African American |
|
| Other |
|
| Title | Measurements |
|---|---|
|
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| Units | Counts |
|---|---|
| Participants |
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| Units | Counts |
|---|---|
| Participants |
|
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| OG002 | Phase 1b: Cohort 3: Tesevatinib 150 mg Once Daily Dosing | Participants received tesevatinib 150 mg tablet orally QD for initial 28 days. After initial 28 days treatment, at the investigator's discretion, participants continued to receive tesevatinib for a total of 24 months (since treatment initiation) or until the development of unacceptable toxicity, noncompliance, or withdrawal of consent by the participant, or investigator decision (maximum exposure duration: up to 36 months). |
|
|
Participants received tesevatinib 150 mg tablet orally bi-weekly in alternative dosing schedules on Monday and Thursday for initial 25 days. After initial 25 days treatment, at the investigator's discretion, participants continued to receive tesevatinib for a total of 24 months (since treatment initiation) or until the development of unacceptable toxicity, noncompliance, or withdrawal of consent by the participant, or investigator decision (maximum exposure duration: up to 28 months). |
| OG001 | Phase 2a: Cohort 5: Tesevatinib: Tri-weekly Dosing | Participants received tesevatinib 150 mg tablet orally tri-weekly in alternative dosing schedules on Monday, Wednesday and Friday for initial 26 days. After initial 26 days treatment, at the investigator's discretion, participants continued to receive tesevatinib for a total of 24 months (since treatment initiation) or until the development of unacceptable toxicity, noncompliance, or withdrawal of consent by the participant, or investigator decision (maximum exposure duration: up to 28 months). |
| OG002 | Phase 2a: SILK Cohort: Tesevatinib 50 mg Once Daily Dosing | Participants with ADPKD and Baseline eGFR >=35 mL/min/1.73 m^2 and <=80 mL/min/1.73 m^2, and htTKV >=1000 mL were enrolled and received tesevatinib 50 mg tablet orally QD for initial 28 days. After initial 28 days treatment, at the investigator's discretion, participants continued to receive tesevatinib for a total of 24 months (since treatment initiation) or until the development of unacceptable toxicity, noncompliance, or withdrawal of consent by the participant, or investigator decision (maximum exposure duration: up to 28 months). |
|
|
| OG002 | Phase 2a: SILK Cohort: Tesevatinib 50 mg Once Daily Dosing | Participants with ADPKD and Baseline eGFR >=35 mL/min/1.73 m^2 and <=80 mL/min/1.73 m^2, and htTKV >=1000 mL were enrolled and received tesevatinib 50 mg tablet orally QD for initial 28 days. After initial 28 days treatment, at the investigator's discretion, participants continued to receive tesevatinib for a total of 24 months (since treatment initiation) or until the development of unacceptable toxicity, noncompliance, or withdrawal of consent by the participant, or investigator decision (maximum exposure duration: up to 28 months). |
|
|
| OG002 | Phase 2a: SILK Cohort: Tesevatinib 50 mg Once Daily Dosing | Participants with ADPKD and Baseline eGFR >=35 mL/min/1.73 m^2 and <=80 mL/min/1.73 m^2, and htTKV >=1000 mL were enrolled and received tesevatinib 50 mg tablet orally QD for initial 28 days. After initial 28 days treatment, at the investigator's discretion, participants continued to receive tesevatinib for a total of 24 months (since treatment initiation) or until the development of unacceptable toxicity, noncompliance, or withdrawal of consent by the participant, or investigator decision (maximum exposure duration: up to 28 months). |
|
|
Participants received tesevatinib 150 mg tablet orally tri-weekly in alternative dosing schedules on Monday, Wednesday and Friday for initial 26 days. After initial 26 days treatment, at the investigator's discretion, participants continued to receive tesevatinib for a total of 24 months (since treatment initiation) or until the development of unacceptable toxicity, noncompliance, or withdrawal of consent by the participant, or investigator decision (maximum exposure duration: up to 28 months). |
| OG002 | Phase 2a: SILK Cohort: Tesevatinib 50 mg Once Daily Dosing | Participants with ADPKD and Baseline eGFR >=35 mL/min/1.73 m^2 and <=80 mL/min/1.73 m^2, and htTKV >=1000 mL were enrolled and received tesevatinib 50 mg tablet orally QD for initial 28 days. After initial 28 days treatment, at the investigator's discretion, participants continued to receive tesevatinib for a total of 24 months (since treatment initiation) or until the development of unacceptable toxicity, noncompliance, or withdrawal of consent by the participant, or investigator decision (maximum exposure duration: up to 28 months). |
|
|
| OG002 | Phase 2a: SILK Cohort: Tesevatinib 50 mg Once Daily Dosing | Participants with ADPKD and Baseline eGFR >=35 mL/min/1.73 m^2 and <=80 mL/min/1.73 m^2, and htTKV >=1000 mL were enrolled and received tesevatinib 50 mg tablet orally QD for initial 28 days. After initial 28 days treatment, at the investigator's discretion, participants continued to receive tesevatinib for a total of 24 months (since treatment initiation) or until the development of unacceptable toxicity, noncompliance, or withdrawal of consent by the participant, or investigator decision (maximum exposure duration: up to 28 months). |
|
|
|
|
|
|
Participants received tesevatinib 150 mg tablet orally tri-weekly in alternative dosing schedules on Monday, Wednesday and Friday for initial 26 days. After initial 26 days treatment, at the investigator's discretion, participants continued to receive tesevatinib for a total of 24 months (since treatment initiation) or until the development of unacceptable toxicity, noncompliance, or withdrawal of consent by the participant, or investigator decision (maximum exposure duration: up to 28 months).
|
|
Participants received tesevatinib 150 mg tablet orally tri-weekly in alternative dosing schedules on Monday, Wednesday and Friday for initial 26 days. After initial 26 days treatment, at the investigator's discretion, participants continued to receive tesevatinib for a total of 24 months (since treatment initiation) or until the development of unacceptable toxicity, noncompliance, or withdrawal of consent by the participant, or investigator decision (maximum exposure duration: up to 28 months).
|
|
Participants received tesevatinib 150 mg tablet orally tri-weekly in alternative dosing schedules on Monday, Wednesday and Friday for initial 26 days. After initial 26 days treatment, at the investigator's discretion, participants continued to receive tesevatinib for a total of 24 months (since treatment initiation) or until the development of unacceptable toxicity, noncompliance, or withdrawal of consent by the participant, or investigator decision (maximum exposure duration: up to 28 months). |
|
|
Participants received tesevatinib 150 mg tablet orally tri-weekly in alternative dosing schedules on Monday, Wednesday and Friday for initial 26 days. After initial 26 days treatment, at the investigator's discretion, participants continued to receive tesevatinib for a total of 24 months (since treatment initiation) or until the development of unacceptable toxicity, noncompliance, or withdrawal of consent by the participant, or investigator decision (maximum exposure duration: up to 28 months). |
|
|
|
|