Clinical trial · Interventional
A Phase I Study of LEE011 in Asian Patients
A Phase I Study of LEE011 in Asian Patients With Advanced Solid Tumors
NCT01898845CI-TRIAL-00048973completedPhase 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 MTD and/or recommended dose for expansion.
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 |
|---|---|---|---|
| LEE011 | Drug | Ribociclib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- LEE011
- description
- LEE011
- interventionNames
- Drug: LEE011
Primary outcomes (2)
- measure
- Incidence of dose limiting toxicities (DLTs)
- timeFrame
- First cycle (28 days)
- measure
- Maximum tolerated dose (MTD) and/or recomended dose (RD)
- timeFrame
- First cycle (28 days)
Secondary outcomes (8)
- measure
- Safety and Tolerability of LEE011
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patient with a histologically confirmed diagnosis of a solid tumor * ECOG PS \<2 * Good organ function at screening visit * A sufficient interval mast have elapsed between the last dose of prior anti-cancer therapy Exclusion Criteria: * Impairment of GI function * Patients with concurrent severe and/or uncontrolled concurrent medical conditions * Known diagnosis of HIV or active viral hepatitis * Pregnant or nursing (lactating) women
References
Publications (3)
- RESULTDoi T, Hewes B, Kakizume T, Tajima T, Ishikawa N, Yamada Y. Phase I study of single-agent ribociclib in Japanese patients with advanced solid tumors. Cancer Sci. 2018 Jan;109(1):193-198. doi: 10.1111/cas.13428. Epub 2017 Nov 12. PMID 29059492
- DERIVEDJi Y, Wang C, Combes FP, Ho YY, Fasching PA, Untch M, Zarate JP, Crown J. Quantitative Pharmacology Justifying Ribociclib Dose in Early Breast Cancer. Clin Pharmacokinet. 2026 Aug;65(8):1217-1228. doi: 10.1007/s40262-026-01643-3. Epub 2026 Jun 23. PMID 42334791
- DERIVEDJi Y, Yartsev V, Quinlan M, Serra P, Wang Y, Chakraborty A, Miller M. Justifying Ribociclib Dose in Patients with Advanced Breast Cancer with Renal Impairment Based on PK, Safety, and Efficacy Data: An Innovative Approach Integrating Data from a Dedicated Renal Impairment Study and Oncology Clinical Trials. Clin Pharmacokinet. 2023 Mar;62(3):493-504. doi: 10.1007/s40262-022-01206-2. Epub 2023 Feb 17. PMID 36800111