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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00669097
First received: April 25, 2008
Last updated: August 31, 2011
Last verified: August 2011
  Purpose

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.


Condition Intervention Phase
Advanced Solid Malignancies
Drug: TKI258
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Cohort1: Find out about the routes and rates of excretion of TKI258 and its metabolites [ Time Frame: Day 15 ] [ Designated as safety issue: No ]
  • Cohort 2: Safety and Tolerability of TKI258 [ Time Frame: Time to patient withdrawal due to disease progression or tolerability issues ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Cohort 1: Safety and tolerability of TKI258 [ Time Frame: Time to patient withdrawal due to disease progression or tolerability issues ] [ Designated as safety issue: Yes ]
  • Cohort 1: Preliminary anti-tumor activity of TKI258 [ Time Frame: Time to tumor progression ] [ Designated as safety issue: No ]
  • Preliminary Anti-tumor activity of TKI258 [ Time Frame: Time to tumor progression ] [ Designated as safety issue: No ]

Enrollment: 13
Study Start Date: April 2008
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TKI258 Drug: TKI258

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00669097

Locations
Netherlands
Novartis Investigative Site
Amsterdam, Netherlands
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmeceuticals
  More Information

No publications provided by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00669097     History of Changes
Other Study ID Numbers: CTKI258A2106
Study First Received: April 25, 2008
Last Updated: August 31, 2011
Health Authority: Netherlands: Medicines Evaluation Board (MEB)

Keywords provided by Novartis:
ADME
TKI258
RTKs inhibitor
PDGRF inhibitor
VEGFER inhibitor

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on July 31, 2014