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CompletedNCT00669097Updated Dec 21, 2020

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

A Phase 1 interventional study of TKI258 in Advanced Solid Malignancies, sponsored by Novartis Pharmaceuticals. Completed at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-12-21.

Sponsored by Novartis Pharmaceuticals · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
13
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Advanced Solid Malignancies

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Keywords

  • ADME
  • TKI258
  • RTKs inhibitor
  • PDGRF inhibitor
  • VEGFER inhibitor
03

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's enrollment of 13 is below the median of 50 across 7,253 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.

Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.

Other protocol-defined inclusion/exclusion criteria may apply.

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Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
13 participants (actual)

Study arms

  • Experimental
    TKI258

    Drug: TKI258

Interventions

  • DrugTKI258
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What researchers measure

Primary outcomes

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

    Time frame: Day 15

  2. Cohort 2: Safety and Tolerability of TKI258

    Time frame: Time to patient withdrawal due to disease progression or tolerability issues

Secondary outcomes

  1. Cohort 1: Safety and tolerability of TKI258

    Time frame: Time to patient withdrawal due to disease progression or tolerability issues

  2. Cohort 1: Preliminary anti-tumor activity of TKI258

    Time frame: Time to tumor progression

  3. Preliminary Anti-tumor activity of TKI258

    Time frame: Time to tumor progression

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Study locations

1 site
  • Novartis Investigative Site
    Amsterdam, Netherlands
08

References and documents

Publications

  • 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. PubMed 23010851 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 21, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00669097
Lead sponsor
Novartis Pharmaceuticals
Responsible party
Sponsor
First posted
Apr 29, 2008
Start date
Apr 2008
Primary completion
Jan 2010
Last update
Dec 21, 2020

Study contacts

Novartis Pharmaceuticals
study director · Novartis Pharmeceuticals
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2011. You cannot join it, but the record below documents what was studied.

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