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OpenTrials
Completed

NCT Number: NCT00669097

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novartis Investigative Site

Amsterdam, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

TKI258

Drug

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

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2010
First posted
Apr 29, 2008
Registry last updated
Dec 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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