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This study will evaluate safety and tolerability to estimate the MTD and/or recommended dose for expansion.
This is a multi-center, open label, dose finding, phase I study of oral single agent LEE011, administered once daily.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LEE011 | Experimental | LEE011 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LEE011 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of dose limiting toxicities (DLTs) | First cycle (28 days) | |
| Maximum tolerated dose (MTD) and/or recomended dose (RD) | First cycle (28 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability of LEE011 | Assessed by incidence, duration and severity of adverse events and serious adverse events; changes in clinical laboratory values, vital signs and ECGs; tolerability of study drug (dose interruption, dose reduction) | from informed consent till 28 days after end of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Kashiwa | Chiba | Japan | |||
| Novartis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29059492 | Result | Doi 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. | |
| 42334791 | Derived | Ji 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 Jun 23. doi: 10.1007/s40262-026-01643-3. Online ahead of print. |
| Label | URL |
|---|---|
| Results for CLEE011X1101 can be found on the Novartis Clinical Trial Results Website | View source |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C000589651 | ribociclib |
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| PK parameters of LEE011 |
Concentration of LEE011 and PK parameters (e.g. Cmax and AUC) |
| every week up to first 4 weeks, once a week in the subsequent 2 weeks |
| Best overall response | To assess preliminaly anti-tumor activity based on RECIST | every 2 months until 28 days after end of treatment |
| Overall response rate | To assess preliminaly anti-tumor activity based on RECIST | every 2 months until 28 days after end of treatment |
| Progression-free survival | To assess preliminaly anti-tumor activity based on RECIST | every 2 months until 28 days after end of treatment |
| Disease control rate | To assess preliminaly anti-tumor activity based on RECIST | every 2 months until 28 days after end of treatment |
| Duration of response | To assess preliminaly anti-tumor activity based on RECIST | every 2 months until 28 days after end of treatment |
| Overall response | To assess preliminaly anti-tumor activity based on RECIST | every 2 months until 28 days after end of treatment |
| Chuo-ku |
| Tokyo |
| Japan |
| 36800111 | Derived | Ji 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. |