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

Advanced Solid Malignancies Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00669097
• Other study ID #: CTKI258A2106
• Status: Completed
• Phase: Phase 1
• Start date: April 2008

Study information

• Verified date: August 2011
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Solid Malignancies
• Neoplasms

Intervention

Drug:
• TKI258

Locations

Country	Name	City	State
Netherlands	Novartis Investigative Site	Amsterdam

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cohort1: Find out about the routes and rates of excretion of TKI258 and its metabolites		Day 15
Primary	Cohort 2: Safety and Tolerability of TKI258		Time to patient withdrawal due to disease progression or tolerability issues
Secondary	Cohort 1: Safety and tolerability of TKI258		Time to patient withdrawal due to disease progression or tolerability issues
Secondary	Cohort 1: Preliminary anti-tumor activity of TKI258		Time to tumor progression
Secondary	Preliminary Anti-tumor activity of TKI258		Time to tumor progression

External Links

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