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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-25

Study Completion Date

2016-12-21

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.

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Detailed Description

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Conditions

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Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Extension Study, participants to be followed at the dose of tesevatinib they were receiving in Study KD019-101.

Primary Study Purpose

TREATMENT

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tesevatinib

Intervention Type DRUG

Other Intervention Names

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KD019 XL647

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

62 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No