Advanced Solid Tumor
Conditions
Keywords
PI3K,, Advanced solid tumor
Brief summary
In this study, BKM120 will be administered to adult patients with advanced solid tumors whose disease has progressed despite standard therapy or for whom no standard therapy exists. The trial will confirm the safety and tolerability and determine the maximum tolerated dose (MTD) of BKM120 in Japanese patients.
Interventions
DRUGBKM120
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients with histologically confirmed, advanced unresectable solid tumors who have progressed on (or not been able to tolerate) standard therapy or for whom no standard anticancer therapy exists. 2. At least one measurable or non-measurable lesion as defined by RECIST guidelines for solid tumors. 3. Age ≥ 20 years 4. Eastern Cooperative Oncology Group Performance Status (ECOG P.S.) of ≤ 2 5. Life expectancy of ≥ 12 weeks 6. Patients must have the laboratory values
Exclusion criteria
1. Patients with a history of primary central nervous system tumors or brain metastases or who have signs/symptoms attribute to brain metastases and have not been assessed with radiologic imaging to rule out the presence of brain metastases 2. Prior treatment with a PI3K inhibitor 3. Patients with any peripheral neuropathy ≥ CTCAE grade 2 4. Patients with unresolved diarrhea ≥ CTCAE grade 2 5. Women of child-bearing potential who are pregnant or breast feeding. Men or women of reproductive potential not to sign informed consent for birth control. Barrier contraceptives must be used throughout the trial and six months after the end of treatment. Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| establish Maximum tolerate dose (MTD) | every day up to first 4 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Safety assessed by type, frequency and severity of adverse events | Every week |
| Efficacy assessed by RECIST | Every 2 months |
| Establishment of a pharmacokinetic profile by collecting information on parameters including but not limited to Cmax, Tmax, T1/2 and AUC in plasma samples | Every 2 weeks up to first 4 weeks, then every odd cycle |
| Measurement of biomarkers for PI3K pathway in blood and tissue | First 4 weeks |
Countries
Japan
Outcome results
None listed