Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
17 participants
INTERVENTIONAL
2013-05-31
2015-01-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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LEE011
LEE011
LEE011
Interventions
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LEE011
Eligibility Criteria
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Inclusion Criteria
* 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
* Patients with concurrent severe and/or uncontrolled concurrent medical conditions
* Known diagnosis of HIV or active viral hepatitis
* Pregnant or nursing (lactating) women
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
Kashiwa, Chiba, Japan
Novartis Investigative Site
Chuo-ku, Tokyo, Japan
Countries
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References
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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.
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.
Related Links
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Results for CLEE011X1101 can be found on the Novartis Clinical Trial Results Website
Other Identifiers
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CLEE011X1101
Identifier Type: -
Identifier Source: org_study_id