Clinical trial · Interventional
Safety and Tolerability of Oral LCL161 in Japanese Adult Patients With Advanced Solid Tumors
A Phase I Study of Oral LCL161 in Japanese Adult Patients With Advanced Solid Tumors
NCT01968915CI-TRIAL-00048993completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| LCL161 | Drug | — | UNRESOLVED |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- LCL161
- description
- 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.
- interventionNames
- Drug: LCL161
- Drug: Paclitaxel
Primary outcomes (2)
- measure
- Frequency of dose limiting toxicities as a function of LCL161 during first cycle
- timeFrame
- First cycle (21 days)
- measure
- Adverse events of oral LCL161
- timeFrame
- From informed consent until 28 days after end of treatment (end of treatment visit occurs within 7 days after the determination of study discontinuation)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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/exclusion criteria may apply.
References
Publications (0)
Data not yet available
No reference posted for this study.