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

Start 8 Mar 2017 · Status Ongoing, recruitment ended · 2 EU/EEA countries · 2 sites · Protocol CLEE011X2X01B

Overview

Sponsor-declared trial summary

Phase Phase I and Phase II (Integrated) - Other

Status Ongoing, recruitment ended

Participants planned 5

Countries 2

Sites 2

Different types of advanced cancer

To allow patients enrolled in a ribociclib (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.

Key facts

Sponsor: Novartis Pharma AG
Participant type: Pediatric, Patients
Age range: 0-17 years, 18-64 years, 65+ years
Gender: Male and Female
Therapeutic area: Not possible to specify
Trial duration: 8 Mar 2017 → ongoing
Decision date (initial): 2025-08-27
Transition trial: Yes
Low-intervention: No
Rare-disease indication: No
Vulnerable population: Yes
Funding sources: Novartis Pharma Services AG

External identifiers

EU CT number: 2024-511125-61-00
EudraCT number: 2016-000293-37
WHO UTN: U1111-1321-9119
ClinicalTrials.gov: NCT02934568

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Others, Safety

Secondary objectives 1

To collect safety data for ribociclib as single agent or in combination with other investigational treatments.

Conditions and MedDRA coding

Different types of advanced cancer

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

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 2

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.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

Number of patients receiving ribociclib as single agent or in combination with other investigational treatments under the rollover study, duration of exposure

Secondary endpoints 1

Frequency and nature of adverse events (AEs), serious adverse events (SAE) and liver function tests

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 5

EGF816

PRD10985320 · Product

Active substance: Nazartinib
Substance synonyms: EGF816
Pharmaceutical form: CAPSULE, HARD
Route of administration: ORAL
Authorisation status: Not Authorised
MA holder: NOVARTIS PHARMA AG
Paediatric formulation: No
Orphan designation: No

EGF816

PRD10985319 · Product

Active substance: Nazartinib
Substance synonyms: EGF816
Pharmaceutical form: CAPSULE, HARD
Route of administration: ORAL
Authorisation status: Not Authorised
MA holder: NOVARTIS PHARMA AG
Paediatric formulation: No
Orphan designation: No

Kisqali 200 mg film-coated tablets

PRD5341580 · Product

Active substance: Ribociclib
Substance synonyms: LEE011
Pharmaceutical form: FILM-COATED TABLET
Route of administration: ORAL
Authorisation status: Authorised
ATC code: L01EF02 — -
Marketing authorisation: EU/1/17/1221/012
MA holder: NOVARTIS EUROPHARM LIMITED
MA country: Liechtenstein
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: Yes
Modification description: LEE011 200 mg film-coated tablet is maintained at storage condition ‘Do not store above 25°C’ while the registered storage condition for the current EU centrally authorized marketed product is “This medicinal product does not require any special temperature storage condition. Store in the original package in order to protect from moisture”.

LEE011

PRD4410407 · Product

Active substance: Ribociclib
Pharmaceutical form: FILM-COATED TABLET
Route of administration: ORAL
Authorisation status: Not Authorised
MA holder: NOVARTIS PHARMA AG
Paediatric formulation: No
Orphan designation: No

LEE011

PRD198877 · Product

Active substance: Ribociclib
Pharmaceutical form: CAPSULE, HARD
Route of administration: ORAL
Authorisation status: Not Authorised
MA holder: NOVARTIS PHARMA AG
Paediatric formulation: No
Orphan designation: No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Novartis Pharma AG

Sponsor organisation: Novartis Pharma AG
Address: Lichtstrasse 35
City: Basel
Postcode: 4056
Country: Switzerland

Scientific contact point

Organisation: Novartis Pharma AG
Contact name: Novartis Pharma Arzneimittel GmbH

Public contact point

Organisation: Novartis Pharma AG
Contact name: Novartis Pharma Arzneimittel GmbH

Third parties 4

Organisation	City, country	Duties
IQVIA Limited ORG-100008655	Reading, United Kingdom	Code 10
Syneos Health Inc. ORG-100008382	Morrisville, United States	On site monitoring
Parexel International (IRL) Limited ORG-100022780	Dublin 2, Ireland	Code 12
Icon Clinical Research Limited ORG-100008322	Dublin 18, Ireland	On site monitoring

Locations

2 EU/EEA countries · 2 investigational sites

By country

Country	MS status	Planned subjects	Sites
Germany	Ongoing, recruitment ended	1	1
Spain	Ongoing, recruitment ended	1	1
Rest of world Singapore, United States, Taiwan	—	3	—

Investigational sites

Germany

1 site · Ongoing, recruitment ended

University Hospital Cologne AöR

#1200: Klinik I fuer Innere Medizin, Kerpener Strasse 62, Lindenthal, Cologne

Spain