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Clinical Trials List

Protocol NumberCLEE011X2X01B

NCT Number(ClinicalTrials.gov Identfier)NCT02934568

Active

2017-10-11 - 2022-06-30

Phase II

Terminated2

ICD-10C80.1

Malignant (primary) neoplasm, unspecified

ICD-9199.0

Disseminated malignant neoplasm

An Open-label, Multi-center Rollover Protocol for Patients Who Have Participated in a Novartis-sponsored Ribociclib (LEE011) Study and Are Continuing to Benefit From Ribociclib as Single Agent or in Combination With Other Investigational Treatments

Trial Applicant

NOVARTIS (TAIWAN) CO., LTD.
Sponsor

Novartis Pharmaceuticals
Trial scale

Multi-Regional Multi-Center
Update

2026/03/01

Investigators and Locations

Principal Investigator Shang-Yin Wu 無

National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Audit

None

Principal Investigator James Chih-Hsin Yang Division of Hematology & Oncology

National Taiwan University Hospital

Co-Principal Investigator

Jih-Hsiang Lee Division of Hematology & Oncology

The Actual Total Number of Participants Enrolled

0 Terminated

Audit

None

Condition/Disease

Advanced Solid Tumors

Objectives

Primary Objective(s) -To allow patients enrolled in a LEE011 Novartis-sponsored study continued access to study treatment after the study has reached its primary objective(s) or the study has been terminated for other reasons. Secondary Objectives -To collect safety data for ribociclib as single agent or in combination with other investigational treatments.

Test Drug

LEE011 / Ribociclib (LDK378) / Ceritinib (HDM201)

Active Ingredient

HDM201
LDK378
LEE011

Dosage Form

capsule
capsule
capsule

Dosage

50, 200
50, 150
10, 40, 100

Endpoints

Safety assessments
Regular collection of adverse events. SAEs reported to the Novartis safety database will be reviewed and reported as part of the regular pharmacovigilance activities. Hematology, Chemistry, Liver function testing, and ECG parameters will also be reviewed for safety. Dose administration of LEE011 and any combination partner will be collected.

Inclution Criteria

• Patient is currently enrolled in an eligible Novartis-sponsored ribociclib (LEE011) study and is receiving ribociclib as single agent or in combination with other investigational treatments.
• Patient is currently deriving clinical benefit from the study treatment, as determined by the investigator.
• Patient has demonstrated compliance, as assessed by the investigator, with the parent protocol requirements.

Exclusion Criteria

• Patients who have permanently discontinued from ribociclib (LEE011) in the parent protocol for any reason.
• Patients who do not meet parent protocol criteria to continue study treatment.

The Estimated Number of Participants

Taiwan

20 participants
Global

40 participants