This study is a phase I dose escalation, multi-center, open-label study of HSP990 administered orally once weekly in adult Japanese and Korea patients with advanced solid malignancies.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
17
Novartis Investigative Site
Nagoya, Aichi-ken, Japan
Novartis Investigative Site
Kashiwa, Chiba, Japan
establish maximum tolerated dose (MTD)
Time frame: 2.5 years
Safety by measuring occurrence of dose limiting toxicity (DLT) and other adverse events
Time frame: 2.5 years
Efficacy by collecting data on response (complete response [CR], partial response [PR]) and stable disease (SD)
Time frame: 2.5 years
Establishment of a pharmacokinetic profile by collecting information on parameters including but not limited to Cmax, Tmax, T1/2 and AUC in plasma samples
Time frame: 2.5 years
Measurement of biomarkers for HSP90 pathway in blood and tissue
Time frame: 2.5 years
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