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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


Phase 1
18 Years
N/A
Not Enrolling
Both
Advanced Solid Malignancies

Thank you

Trial Information

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

Inclusion Criteria


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.

Other protocol-defined inclusion/exclusion criteria may apply.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Outcome Time Frame:

Day 15

Safety Issue:

No

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmeceuticals

Authority:

Netherlands: Medicines Evaluation Board (MEB)

Study ID:

CTKI258A2106

NCT ID:

NCT00669097

Start Date:

April 2008

Completion Date:

Related Keywords:

  • Advanced Solid Malignancies
  • ADME
  • TKI258
  • RTKs inhibitor
  • PDGRF inhibitor
  • VEGFER inhibitor
  • Neoplasms

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