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

NCT ID: NCT00669097

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

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Brief Summary

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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

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Conditions

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Advanced Solid Malignancies

Keywords

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ADME TKI258 RTKs inhibitor PDGRF inhibitor VEGFER inhibitor

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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TKI258

Group Type EXPERIMENTAL

TKI258

Intervention Type DRUG

Interventions

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TKI258

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Aged ≥ 18 years
2. Patients with histologically confirmed solid tumor or lymphoma who are resistant/refractory to approved therapies or for whom no appropriate therapies are available.
3. WHO performance status ≤ 2
4. 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
5. Written informed consent to participate in the study

Exclusion Criteria

1. Primary Brain Tumors or symptomatic leptomeningeal metastases
2. Clinically significant cardiac impairment or unstable ischemic heart disease including a myocardial infarction within six months of study start
3. 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
4. Centrally located or squamous cell carcinoma of the lung
5. Proteinuria \> 1+ on dipstick testing
6. History of gastrointestinal malabsorption Surgery involving intestinal anastomosis within four weeks of study start.
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 Pharmeceuticals

Locations

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Novartis Investigative Site

Amsterdam, , Netherlands

Site Status

Countries

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Netherlands

References

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Dubbelman AC, Upthagrove A, Beijnen JH, Marchetti S, Tan E, Krone K, Anand S, Schellens JH. Disposition and metabolism of 14C-dovitinib (TKI258), an inhibitor of FGFR and VEGFR, after oral administration in patients with advanced solid tumors. Cancer Chemother Pharmacol. 2012 Nov;70(5):653-63. doi: 10.1007/s00280-012-1947-2. Epub 2012 Aug 22.

Reference Type DERIVED
PMID: 23010851 (View on PubMed)

Related Links

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https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=4883

Results for CTKI258A2106 can be found on the Novartis Clinical Trial Results Website

Other Identifiers

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CTKI258A2106

Identifier Type: -

Identifier Source: org_study_id