Advanced Solid Tumors
Conditions
Keywords
Neoplasms
Brief summary
This study will evaluate safety and tolerability to estimate the MTD and/or recommended dose for expansion.
Detailed description
This is a multi-center, open label, dose finding, phase I study of oral single agent LEE011, administered once daily.
Interventions
DRUGLEE011
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
* Patient with a histologically confirmed diagnosis of a solid tumor * ECOG PS \<2 * Good organ function at screening visit * A sufficient interval mast have elapsed between the last dose of prior anti-cancer therapy
Exclusion criteria
* Impairment of GI function * Patients with concurrent severe and/or uncontrolled concurrent medical conditions * Known diagnosis of HIV or active viral hepatitis * Pregnant or nursing (lactating) women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of dose limiting toxicities (DLTs) | First cycle (28 days) |
| Maximum tolerated dose (MTD) and/or recomended dose (RD) | First cycle (28 days) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Best overall response | every 2 months until 28 days after end of treatment | To assess preliminaly anti-tumor activity based on RECIST |
| Overall response rate | every 2 months until 28 days after end of treatment | To assess preliminaly anti-tumor activity based on RECIST |
| Progression-free survival | every 2 months until 28 days after end of treatment | To assess preliminaly anti-tumor activity based on RECIST |
| Safety and Tolerability of LEE011 | from informed consent till 28 days after end of treatment | Assessed by incidence, duration and severity of adverse events and serious adverse events; changes in clinical laboratory values, vital signs and ECGs; tolerability of study drug (dose interruption, dose reduction) |
| Duration of response | every 2 months until 28 days after end of treatment | To assess preliminaly anti-tumor activity based on RECIST |
| Overall response | every 2 months until 28 days after end of treatment | To assess preliminaly anti-tumor activity based on RECIST |
| Disease control rate | every 2 months until 28 days after end of treatment | To assess preliminaly anti-tumor activity based on RECIST |
| PK parameters of LEE011 | every week up to first 4 weeks, once a week in the subsequent 2 weeks | Concentration of LEE011 and PK parameters (e.g. Cmax and AUC) |
Countries
Japan
Outcome results
None listed