Neoplasms
Conditions
Keywords
LCL161, Paclitaxel, Japanese patient, Neoplasms
Brief summary
This study will evaluate safety and tolerability to estimate the maximum tolerated dose and/or recommended dose of oral LCL161 in Japanese patients with advanced solid tumors.
Interventions
DRUGLCL161
Patients will receive oral LCL161 once a week until unacceptable toxicity, disease progression and/or withdrawal of consent.
DRUGPaclitaxel
Patients will receive weekly paclitaxel as intravenous infusion over 1 hour in combination with LCL161, from cycle 2 in dose escalation part or from the first cycle in dose expansion part, and will continue it until unacceptable toxicity, disease progression and/or withdrawal of consent.
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 a histologically or cytologically confirmed diagnosis of a solid tumor for which no further effective standard treatment is available. 2. ECOG performance status 0-1. 3. Patients must have recovered from all toxicities related to their previous treatment.
Exclusion criteria
1. Unresolved nausea, vomiting, diarrhea or peripheral neuropathy CTCAE grade \>1. 2. History of or current interstitial lung disease or autoimmune disease. 3. History of or current impaired cardiac function or clinically significant cardiac diseases. 4. Women of child-bearing potential, unless they are using highly effective methods of contraception. Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of dose limiting toxicities as a function of LCL161 during first cycle | First cycle (21 days) | — |
| Adverse events of oral LCL161 | From informed consent until 28 days after end of treatment (end of treatment visit occurs within 7 days after the determination of study discontinuation) | Type and frequency of adverse events of oral LCL161 when administered in combination with weekly paclitaxel |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events of oral LCL161 | From informed consent until 28 days after end of treatment (end of treatment visit occurs within 7 days after the determination of study discontinuation) | Type and frequency of adverse events of oral LCL161 |
| LCL161 plasma concentration and derived pharmacokinetic parameters | From first cycle and up to 3 cycle (each cycle is 21-day period) | — |
| Paclitaxel plasma concentration and derived pharmacokinetic parameters | From first cycle of combination and up to 2 cycle (each cycle is 21-day period) | — |
| Tumor response according to RECIST 1.1 | Every 2 cycles for first 8 cycles, then every 3 cycles and until end of treatment (each cycle is 21-day period and end of treatment visit occurs within 7 days after the determination of study discontinuation) | — |
Countries
Japan
Outcome results
None listed