Long-Term Treatment and Follow up of Subjects Completing 24 Months of Treatment With Tesevatinib on Study KD019-101

Study Overview
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Brief Summary
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Subjects who received tesevatinib in Study KD019-101 and completed 24 months of treatment will continue on the dose of tesevatinib they were receiving at 24 months on the KD019-101 study.

Official Title
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Long-Term Treatment and Follow up of Subjects Completing 24 Months of Treatment With Tesevatinib on Study KD019-101 in Subjects With Autosomal Dominant Polycystic Kidney Disease

Conditions
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Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Intervention / Treatment
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* Drug: tesevatinib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The subject must have received 24 months of treatment with tesevatinib on study KD019-101. (Twenty-four months of study drug treatment includes days without treatment that were allowed by the KD019-101 protocol.) Sexually active subject (male and female) has agreed to use two forms of accepted methods of contraception during the course of the study and for 3 months after the last dose of study drug. Effective birth control includes (a) IUD plus one barrier method; (b) on stable doses of hormonal contraception for at least 3 months (eg, oral, injectable, implant, transdermal) plus one barrier method; or (c) 2 barrier methods. Effective barrier methods are male or female condoms, diaphragms, and spermicides (creams or gels that contain a chemical to kill sperm). Female subjects of childbearing potential have a negative pregnancy test at screening. Females of childbearing potential are defined as sexually mature women without prior hysterectomy or who have had any evidence of menses in the past 12 months. However, women who have been amenorrheic for 12 or more months are still considered to be of childbearing potential if the amenorrhea is possibly due to prior chemotherapy, anti-estrogens, or ovarian suppression.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 62 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Extension Study, participants to be followed at the dose of tesevatinib they were receiving in Study KD019-101.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 50mg Daily<br>One 50mg tesevatinib tablet per day | Drug: tesevatinib<br> <br> * Other names: XL647;|
| Experimental: 100mg Daily<br>Two 50mg tesevatinib tablets per day | Drug: tesevatinib<br> <br> * Other names: XL647;|
| Experimental: 150mg M/Th<br>Three 50mg tesevatinib tablets every Monday and Thursday. | Drug: tesevatinib<br> <br> * Other names: XL647;|
| Experimental: 150mg MWF<br>Three 50mg tesevatinib tablets every Monday, Wednesday and Friday. | Drug: tesevatinib<br> <br> * Other names: XL647;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Monitor Longitudinal Changes in Estimated Glomerular Filtration Rate | Monitor longitudinal changes in estimated glomerular filtration rate (eGFR) in subjects with ADPKD when treated with tesevatinib. | 37 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Monitor Longitudinal Changes in Total Kidney Volume | Monitor longitudinal changes from baseline in total kidney volume (TKV) in subjects with ADPKD when treated with tesevatinib. | 37 Months | 
| Number of Subjects Experiencing Adverse Events as a Measure of Safety and Tolerability | To evaluate the long term safety and tolerability of tesevatinib in subjects with ADPKD when treated with tesevatinib. | 37 Months |