Advanced Solid Tumors
Conditions
Keywords
HSP990, HSP90, Japan/Korea, Phase I, advanced solid tumors, dose escalation, maximum tolerated dose, MTD, Japanese paatients, Korean patients
Brief summary
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.
Interventions
DRUGHSP990
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients with advanced solid tumors (advanced cancer) 2. Patient's disease must be evaluable using the RECIST criteria 3. Patients must be 18 or older in Korea or 20 or older in Japan 4. Patients must be relatively healthy as measured by their performance status 5. Patients must have acceptable laboratory values as measured by blood tests 6. Patients must be able to swallow capsules 7. Patients must understand the study and give written permission to enter study
Exclusion criteria
1. Patients cannot have brain tumors 2. Patients cannot have had prior medicines that are similar to the study drug or an HDAC inhibitor medicine 3. Patients must not be classified as a poor or intermediate CYP2C9 metabolizer as measured using a sample of their blood 4. Patients must have recovered from all previous anti-cancer therapy 5. Patients must have finished taking their previous anti-cancer therapy before entering study 6. Patients must not have a severe disease at the time of study entry (for example: severe diarrhea, disease of the liver or kidney, other cancers, etc.) 7. Patients must have relatively good heart function Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| establish maximum tolerated dose (MTD) | 2.5 years |
Secondary
| Measure | Time frame |
|---|---|
| Measurement of biomarkers for HSP90 pathway in blood and tissue | 2.5 years |
| Safety by measuring occurrence of dose limiting toxicity (DLT) and other adverse events | 2.5 years |
| Efficacy by collecting data on response (complete response [CR], partial response [PR]) and stable disease (SD) | 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 | 2.5 years |
Countries
Japan
Outcome results
None listed