Safety and Tolerability of Oral LCL161 in Japanese Adult Patients With Advanced Solid Tumors
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: LCL161 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. |
Drug: LCL161
Patients will receive oral LCL161 once a week until unacceptable toxicity, disease progression and/or withdrawal of consent.
Drug: Paclitaxel
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.
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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)]
Eligibility Criteria
Criteria
Inclusion criteria:
-
Patients with a histologically or cytologically confirmed diagnosis of a solid tumor for which no further effective standard treatment is available.
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ECOG performance status 0-1.
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Patients must have recovered from all toxicities related to their previous treatment.
Exclusion criteria:
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Unresolved nausea, vomiting, diarrhea or peripheral neuropathy CTCAE grade >1.
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History of or current interstitial lung disease or autoimmune disease.
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History of or current impaired cardiac function or clinically significant cardiac diseases.
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Women of child-bearing potential, unless they are using highly effective methods of contraception.
Other protocol-defined inclusion/exclusion criteria may apply.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Novartis Investigative Site | Nagoya-city | Aichi | Japan | 466-8560 |
| 2 | Novartis Investigative Site | Kobe-city | Hyogo | Japan | 650-0017 |
Sponsors and Collaborators
- Novartis Pharmaceuticals
Investigators
- Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- CLCL161A1102