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

NCT02616055 | Terminated Phase 2 DMC

• 1 other identifier: KD019-207
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 6

Brief Summary

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.

Conditions

Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Monitor Longitudinal Changes in Total Kidney Volume

  37 Months

• Number of Subjects Experiencing Adverse Events as a Measure of Safety and Tolerability

  37 Months

Study Arms (4)

50mg Daily

EXPERIMENTAL

One 50mg tesevatinib tablet per day

Drug: tesevatinib

100mg Daily

EXPERIMENTAL

Two 50mg tesevatinib tablets per day

Drug: tesevatinib

150mg M/Th

EXPERIMENTAL

Three 50mg tesevatinib tablets every Monday and Thursday.

Drug: tesevatinib

150mg MWF

EXPERIMENTAL

Three 50mg tesevatinib tablets every Monday, Wednesday and Friday.

Drug: tesevatinib

Interventions

tesevatinib DRUG

Also known as: KD019, XL647

100mg Daily; 150mg M/Th; 150mg MWF; 50mg Daily

Eligibility Criteria

• Age: 18 Years - 62 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

Sponsors & Collaborators

• Kadmon Corporation, LLC: lead

Study Sites (6)

UCLA Medical Center

Los Angeles, California, 90025, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

University of Virginia - Nephrology Clinical Research Center

Charlottesville, Virginia, 22908, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Polycystic Kidney, Autosomal Dominant

Interventions

XL647

Condition Hierarchy (Ancestors)

Polycystic Kidney Diseases; Kidney Diseases, Cystic; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Ciliopathies; Genetic Diseases, Inborn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: November 24, 2015
• First Posted: November 26, 2015
• Study Start: December 25, 2015
• Primary Completion: December 21, 2016
• Study Completion: December 21, 2016
• Last Updated: May 25, 2022

Record last verified: 2022-05

Locations

US (6)