Clinical trial · Interventional
Safety and Efficacy of LCL161 in Patients With Solid Tumors
A Phase I, Multi-center, Open-label, Dose-escalation Study of Oral LCL161 in Adult Patients With Advanced Solid Tumors
NCT01098838CI-TRIAL-00007734completedPhase 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)
The study will evaluate the safety of increasing doses of oral LCL161 in patients with solid tumors. It is primarily designed to evaluate the side effects and find the maximum tolerated dose of LCL161.
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 |
|---|---|---|---|
| Advanced Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| LCL161 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Weekly dosing of LCL161
- description
- by mouth (oral)
- interventionNames
- Drug: LCL161
- type
- EXPERIMENTAL
- label
- Comparison of LCL161
- description
- tablet versus liquid
- interventionNames
- Drug: LCL161
- type
- EXPERIMENTAL
- label
- Twice daily dosing of LCL161
- description
- by mouth for 4 days followed by a 3-day rest period every week
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Solid tumor * ECOG performance status 0-2 * Life expectancy greater than or equal to 12 weeks * Must meet certain blood laboratory values * Must meet criteria for time since the last dose of prior therapy * Must provide written informed consent to participate in this study Exclusion Criteria: * Active and/or symptomatic brain tumors or brain metastases. * Patients with unresolved nausea, vomiting, or diarrhea * Any ongoing severe and/or uncontrolled medical condition that could compromise participation in the study including heart, lung or inflammatory disease * Any disease that may significantly alter the absorption of the study drug (for example, ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or removal of small bowel) * Patients who are currently receiving treatment with steroids at a certain dose or other immunosuppressive treatment that cannot be stopped prior to starting study drug * Patients who are currently receiving treatment with certain medications * Patients who have received radiation therapy or have undergone major surgery within the last 4 weeks * Women of child-bearing potential who are pregnant or breast feeding. * Known diagnosis of human immunodeficiency virus (HIV) infection or chronic active hepatitis B or C * Patients unwilling or unable to follow the protocol Other protocol-defined inclusion/exclusion criteria may apply
References
Publications (1)
- DERIVEDInfante JR, Dees EC, Olszanski AJ, Dhuria SV, Sen S, Cameron S, Cohen RB. Phase I dose-escalation study of LCL161, an oral inhibitor of apoptosis proteins inhibitor, in patients with advanced solid tumors. J Clin Oncol. 2014 Oct 1;32(28):3103-10. doi: 10.1200/JCO.2013.52.3993. Epub 2014 Aug 11. PMID 25113756