Absorption, Distribution, Metabolism and Excretion (ADME) Study of TKI258 in Patients With Advanced Solid Malignancies

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Novartis ( Novartis Pharmaceuticals )

ClinicalTrials.gov Identifier:

NCT00669097

First received: April 25, 2008

Last updated: August 31, 2011

Last verified: August 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

April 25, 2008

Last Updated Date

August 31, 2011

Start Date ^ICMJE

April 2008

Primary Completion Date

January 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Cohort1: Find out about the routes and rates of excretion of TKI258 and its metabolites [ Time Frame: Day 15 ] [ Designated as safety issue: No ]
Cohort 2: Safety and Tolerability of TKI258 [ Time Frame: Time to patient withdrawal due to disease progression or tolerability issues ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Find out about the routes and rates of excretion of TKI258 and its metabolites Time to disease progression

Change History

Complete list of historical versions of study NCT00669097 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Cohort 1: Safety and tolerability of TKI258 [ Time Frame: Time to patient withdrawal due to disease progression or tolerability issues ] [ Designated as safety issue: Yes ]
Cohort 1: Preliminary anti-tumor activity of TKI258 [ Time Frame: Time to tumor progression ] [ Designated as safety issue: No ]
Preliminary Anti-tumor activity of TKI258 [ Time Frame: Time to tumor progression ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Safety and tolerability of TKI258 Preliminary anti-tumor activity of TKI258

Current Other Outcome Measures ^ICMJE

Original Other Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Absorption, Distribution, Metabolism and Excretion (ADME) Study of TKI258 in Patients With Advanced Solid Malignancies

Official Title ^ICMJE

An Open-Label, Non-Randomized, Single-Center, Phase I Study to Determine the Absorption, Distribution, Metabolism and Excretion (ADME) of TKI258 After a Single Oral Administration of TKI258 500mg and to Assess the Preliminary Safety of TK258 400mg Once Daily in Patients With Advanced Solid Malignancies

Brief Summary

This is a phase l study to examine Absorption, Distribution, Metabolism and Excretion of TKI258. There are 2 cohorts. Cohort 1 (4 patients) will receive single radio-labeled 500mg dose of TKI258 followed after 15 days by daily dosing of 400mg TKI258. Cohort 2 (9 patients) will receive 400mg TKI258.

Detailed Description

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Advanced Solid Malignancies

Intervention ^ICMJE

Drug: TKI258

Study Arm (s)

Experimental: TKI258

Intervention: Drug: TKI258

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Primary Completion Date

January 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion criteria:

Aged ≥ 18 years
Patients with histologically confirmed solid tumor or lymphoma who are resistant/refractory to approved therapies or for whom no appropriate therapies are available.
WHO performance status ≤ 2
All previous treatment (including surgery and radiotherapy) must have been completed at least four weeks prior to study entry and any acute toxicities must have been resolved
Written informed consent to participate in the study

Exclusion criteria:

Primary Brain Tumors or symptomatic leptomeningeal metastases
Clinically significant cardiac impairment or unstable ischemic heart disease including a myocardial infarction within six months of study start
Fertile males not willing to use contraception or whose female partners are not using adequate contraceptive protection Pregnant or lactating women (all women of childbearing potential must have a negative pregnancy test (> 5 mIU/ml) before inclusion in the study; post-menopausal women must be amenorrheic for at least 12 months). Female patients must use adequate contraceptive protection
Centrally located or squamous cell carcinoma of the lung
Proteinuria > 1+ on dipstick testing
History of gastrointestinal malabsorption Surgery involving intestinal anastomosis within four weeks of study start.

Other protocol-defined inclusion/exclusion criteria may apply.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Netherlands

Administrative Information

NCT Number ^ICMJE

NCT00669097

Other Study ID Numbers ^ICMJE

CTKI258A2106

Has Data Monitoring Committee

Responsible Party

Novartis ( Novartis Pharmaceuticals )

Study Sponsor ^ICMJE

Novartis Pharmaceuticals

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Novartis Pharmaceuticals

Novartis Pharmeceuticals

Information Provided By

Novartis

Verification Date

August 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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