A Phase I Study of LEE011 in Asian Patients
1 other identifier
interventional
17
1 country
2
Brief Summary
This study will evaluate safety and tolerability to estimate the MTD and/or recommended dose for expansion.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started May 2013
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2013
CompletedFirst Submitted
Initial submission to the registry
July 1, 2013
CompletedFirst Posted
Study publicly available on registry
July 12, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2015
CompletedDecember 19, 2020
July 1, 2018
1.7 years
July 1, 2013
December 16, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Incidence of dose limiting toxicities (DLTs)
First cycle (28 days)
Maximum tolerated dose (MTD) and/or recomended dose (RD)
First cycle (28 days)
Secondary Outcomes (8)
Safety and Tolerability of LEE011
from informed consent till 28 days after end of treatment
PK parameters of LEE011
every week up to first 4 weeks, once a week in the subsequent 2 weeks
Best overall response
every 2 months until 28 days after end of treatment
Overall response rate
every 2 months until 28 days after end of treatment
Progression-free survival
every 2 months until 28 days after end of treatment
- +3 more secondary outcomes
Study Arms (1)
LEE011
EXPERIMENTALLEE011
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Novartis Investigative Site
Kashiwa, Chiba, Japan
Novartis Investigative Site
Chuo-ku, Tokyo, Japan
Related Publications (2)
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.
PMID: 29059492RESULTJi 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: 36800111DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 1, 2013
First Posted
July 12, 2013
Study Start
May 1, 2013
Primary Completion
January 1, 2015
Study Completion
January 1, 2015
Last Updated
December 19, 2020
Record last verified: 2018-07