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

Kadmon

Status and phase: Terminated; Phase 2

Conditions: Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Treatments: Drug: tesevatinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT02616055

KD019-207

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: All

Ages: 18 to 62 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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15 participants in 4 patient groups

50mg Daily

Experimental group

Description:

One 50mg tesevatinib tablet per day

Treatment:

Drug: tesevatinib

100mg Daily

Experimental group

Description:

Two 50mg tesevatinib tablets per day

Treatment:

Drug: tesevatinib

150mg M/Th

Experimental group

Description:

Three 50mg tesevatinib tablets every Monday and Thursday.

Treatment:

Drug: tesevatinib

150mg MWF

Experimental group

Description:

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

Treatment:

Drug: tesevatinib