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Pharmacokinetics (PK) of TKI258 in Cancer Patients With Normal and Impaired Hepatic Function

NCT ID: NCT01443481

Last Updated: 2020-12-21

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

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2014-10-31

Brief Summary

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This is a multi-center, open label study to assess pharmacokinetics (PK) of TKI258 at single-dose and steady state in adult cancer patients either with mild, moderate or severe hepatic impairment or with normal hepatic function. Hepatic function in study patients will be categorized as normal, mild, moderate or severe based upon pre-dose (Day 1) total bilirubin and AST/ALT levels. Starting dose of TKI258 will depend on total bilirubin and ALT/AST levels at baseline. Patients will be treated until disease progression (assessed by RECIST 1.1), unacceptable toxicity, death or discontinuation from the study treatment for any other reason.

Detailed Description

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Conditions

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Solid Tumors Hepatic Impairment

Keywords

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solid tumors hepatic impairment Child-Pugh classification pharmacokinetics PK RECIST 1.1

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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TKI258 normal hepatic function

TKI258 Capsule, @ 500 mg p.o. o.d. 5 days on/2 days off

Group Type EXPERIMENTAL

Dovitinib

Intervention Type DRUG

Starting dose to be determined based on the study outcome of the mild and moderate hepatic impairment groups

TKI258 mild hepatic impairment

TKI258 capsule @ 500 or 400 mg p.o. o.d. 5 days on/2 days off

Group Type EXPERIMENTAL

Dovitinib

Intervention Type DRUG

Starting dose to be determined based on the study outcome of the mild and moderate hepatic impairment groups

TKI258 moderate hepatic impairment

TKI258 capsule @ starting dose at 400 mg p.o. o.d. 5 days on/2 days off

Group Type EXPERIMENTAL

Dovitinib

Intervention Type DRUG

Starting dose to be determined based on the study outcome of the mild and moderate hepatic impairment groups

TKI258 severe hepatic impairment

TKI258 capsule Starting dose to be determined based on the study outcome of the mild and moderate hepatic impairment groups

Group Type EXPERIMENTAL

Dovitinib

Intervention Type DRUG

Starting dose to be determined based on the study outcome of the mild and moderate hepatic impairment groups

Interventions

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Dovitinib

Starting dose to be determined based on the study outcome of the mild and moderate hepatic impairment groups

Intervention Type DRUG

Other Intervention Names

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TKI258

Eligibility Criteria

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Inclusion Criteria

1. Patients with histologically or cytologically confirmed solid tumor, excluding breast cancer, that is either refractory to the standard therapy or has no available therapies.
2. ECOG performance status (PS) 0 or 1
3. Patients must have measurable and/or non-measurable lesion(s) as assessed by Computer Tomography (CT) Scan or Magnetic Resonance Imaging (MRI) per RECIST 1.1

Exclusion Criteria

1. Patients with known brain metastases.
2. Patients who have undergone major surgery ≤ 4 weeks prior to starting study treatment
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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University of California at Los Angeles Dept. of UCLA (4)

Los Angeles, California, United States

Site Status

Duke University Medical Center DUMC

Durham, North Carolina, United States

Site Status

Cancer Therapy & Research Center / UT Health Science Center SC

San Antonio, Texas, United States

Site Status

Novartis Investigative Site

Ghent, , Belgium

Site Status

Novartis Investigative Site

Frankfurt, , Germany

Site Status

Novartis Investigative Site

Hanover, , Germany

Site Status

Novartis Investigative Site

Milan, MI, Italy

Site Status

Novartis Investigative Site

Rozzano, MI, Italy

Site Status

Novartis Investigative Site

Verona, VR, Italy

Site Status

Novartis Investigative Site

Amsterdam, , Netherlands

Site Status

Novartis Investigative Site

Maastricht, , Netherlands

Site Status

Novartis Investigative Site

Singapore, , Singapore

Site Status

Countries

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United States Belgium Germany Italy Netherlands Singapore

Related Links

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https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=13906

Results for CTKI258A2124 from the Novartis Clinical Trials website

Other Identifiers

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2011-000103-41

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CTKI258A2124

Identifier Type: -

Identifier Source: org_study_id