Pharmacokinetics (PK) of TKI258 in Cancer Patients With Normal and Impaired Hepatic Function
| Status: | Completed |
|---|---|
| Conditions: | Cancer, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology, Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/7/2015 |
| Start Date: | November 2011 |
| End Date: | October 2014 |
| Contact: | Novartis Pharmaceuticals |
| Email: | trialsandresultsregistries@novartis.com |
| Phone: | 1-888-669-6682 |
A Multi-center, Open Label Study to Assess Pharmacokinetics of TKI258 in Adult Cancer Patients With Normal and Impaired Hepatic Function
This is a multi-center, open label study to assess pharmacokinetics (PK) of TKI258 at
single-dose and steady state in adult cancer patients either with mild, moderate or severe
hepatic impairment or with normal hepatic function. Hepatic function in study patients will
be categorized as normal, mild, moderate or severe based upon pre-dose (Day 1) total
bilirubin and AST/ALT levels. Starting dose of TKI258 will depend on total bilirubin and
ALT/AST levels at baseline. Patients will be treated until disease progression (assessed by
RECIST 1.1), unacceptable toxicity, death or discontinuation from the study treatment for
any other reason.
single-dose and steady state in adult cancer patients either with mild, moderate or severe
hepatic impairment or with normal hepatic function. Hepatic function in study patients will
be categorized as normal, mild, moderate or severe based upon pre-dose (Day 1) total
bilirubin and AST/ALT levels. Starting dose of TKI258 will depend on total bilirubin and
ALT/AST levels at baseline. Patients will be treated until disease progression (assessed by
RECIST 1.1), unacceptable toxicity, death or discontinuation from the study treatment for
any other reason.
Inclusion Criteria:
1. Patients with histologically or cytologically confirmed solid tumor, excluding breast
cancer, that is either refractory to the standard therapy or has no available
therapies.
2. ECOG performance status (PS) 0 or 1
3. Patients must have measurable and/or non-measurable lesion(s) as assessed by Computer
Tomography (CT) Scan or Magnetic Resonance Imaging (MRI) per RECIST 1.1
Exclusion Criteria:
1. Patients with known brain metastases.
2. Patients who have undergone major surgery ≤ 4 weeks prior to starting study
treatment
Other protocol-defined inclusion/exclusion criteria may apply
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