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

NCT00669097 | Completed Phase 1

• 1 other identifier: CTKI258A2106
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Solid Malignancies

Keywords

ADME; TKI258; RTKs inhibitor; PDGRF inhibitor; VEGFER inhibitor

Outcome Measures

Primary Outcomes (2)

• Cohort1: Find out about the routes and rates of excretion of TKI258 and its metabolites

  Day 15

• Cohort 2: Safety and Tolerability of TKI258

  Time to patient withdrawal due to disease progression or tolerability issues

Secondary Outcomes (3)

• Cohort 1: Safety and tolerability of TKI258

  Time to patient withdrawal due to disease progression or tolerability issues

• Cohort 1: Preliminary anti-tumor activity of TKI258

  Time to tumor progression

• Preliminary Anti-tumor activity of TKI258

  Time to tumor progression

Study Arms (1)

TKI258

EXPERIMENTAL

Drug: TKI258

Interventions

TKI258 DRUG

TKI258

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis Investigative Site

Amsterdam, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 23010851 DERIVED

Related Links

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

MeSH Terms

Interventions

4-amino-5-fluoro-3-(5-(4-methylpiperazin-1-yl)-1H-benzimidazol-2-yl)quinolin-2(1H)-one

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmeceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2008
• First Posted: April 29, 2008
• Study Start: April 1, 2008
• Primary Completion: January 1, 2010
• Last Updated: December 21, 2020

Record last verified: 2011-08

Locations

NL (1)