Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LCL161 | Experimental | Dose escalation part: Eligible patients will start to receive oral LCL161 once a week and will receive weekly paclitaxel, at 80 mg/m2 intravenous infusion over 1 hour, in combination with LCL161 from cycle 2. Dose expansion part: Eligible patients will receive oral LCL161 at the maximum tolerated dose and/or recommended dose in combination with weekly paclitaxel, at 80 mg/m2 intravenous infusion over 1 hour from cycle 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LCL161 | Drug | Patients will receive oral LCL161 once a week until unacceptable toxicity, disease progression and/or withdrawal of consent. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of dose limiting toxicities as a function of LCL161 during first cycle | First cycle (21 days) | |
| Adverse events of oral LCL161 | Type and frequency of adverse events of oral LCL161 when administered in combination with weekly paclitaxel | From informed consent until 28 days after end of treatment (end of treatment visit occurs within 7 days after the determination of study discontinuation) |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events of oral LCL161 | Type and frequency of 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) |
| LCL161 plasma concentration and derived pharmacokinetic parameters |
Not provided
Inclusion criteria:
Exclusion criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Nagoya | Aichi-ken | 466-8560 | Japan | ||
| Novartis Investigative Site |
Not provided
| Label | URL |
|---|---|
| Results for CLCL161A1102 can be found on the Novartis Clinical Trial Results Website | View source |
Not provided
Not provided
| ID | Term |
|---|---|
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| C574246 | LCL161 |
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Paclitaxel | Drug | 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. |
|
| 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) |
| Kobe |
| Hyōgo |
| 650-0017 |
| Japan |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |