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

Overview

Sponsor-declared trial summary

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

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.

Secondary objectives 1

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

1. 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.
2. Patient is currently deriving clinical benefit from the study treatment, as determined by the investigator.
3. Patient has demonstrated compliance, as assessed by the investigator, with the parent protocol requirements.

Exclusion criteria 2

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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

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

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 4

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

Locations

2 EU/EEA countries · 2 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 7 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

5 submissions — initial application plus substantial / non-substantial modifications