First in Human Trial of TAS266 in Patients With Advanced Solid Tumors



Status:Completed
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:Any
Updated:11/18/2012
Start Date:June 2012
End Date:July 2013
Contact:Novartis Pharmaceuticals
Phone:+1(800)340-6843

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A Phase I, Open-label Dose Escalation Study With Safety Expansion of TAS266 Administered by IV Infusion to Patients With Advanced Solid Tumors


This study will assess safety, tolerability, maximum tolerated dose or recommended dose for
expansion of TAS266 administered by IV infusion to patients with advanced solid tumors.


Inclusion Criteria:

- Confirmed diagnosis of solid tumors

- 18 years or older

- ECOG performance status of 0, 1 or 2

- Adequate bone marrow, hepatic and renal function

- Obtained written informed consent

Exclusion Criteria:

- Patients with primary CNS tumor or CNS tumor involvement. However patients with CNS
metastases may be allowed if certain conditions are met.

- Major surgery within 4 weeks before study treatment

- Prior anaphylactic or other severe infusion reactions to human immunoglobulin or
antibody formulations

- Impaired cardiac functions

- Previous hepatitis viral infection such as hepatitis B or hepatitis C

- Diagnosis of HIV infection

- Pregnant or nursing (lactating) women

Other protocol-defined inclusion/exclusion criteria may apply
We found this trial at
4
sites
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San Antonio, TX
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Detroit, MI
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