A post-trial access roll-over study to allow access to ribociclib (LEE011) for patients who are on ribociclib treatment in Novartis-sponsored study

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Novartis Pharma AG

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

19 Jul 2022 → ongoing

Decision date (initial)

2024-08-22

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Novartis Pharma AG -OMS ID: ORG-100003908

External identifiers

EU CT number

2024-514891-41-00

EudraCT number

2021-005184-42

ClinicalTrials.gov

NCT05161195

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Efficacy, Safety

To evaluate long-term safety as assessed by occurrence of adverse events of ribociclib as part of a combination regimen

Secondary objectives 1

1. To evaluate clinical benefit as assessed by the Investigator

Conditions and MedDRA coding

HR+, HER2- advanced or metastatic breast cancer

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Participant is currently participating in a Novartis sponsored global study (parent study), receiving treatment with ribociclib in combination with other drugs, and the parent study has fulfilled its primary objective(s).
2. Willingness and ability to comply with scheduled visits, treatment plans and any other study procedures.
3. Participant must have been receiving treatment with ribociclib for at least 6 cycles in the parent study.
4. Participant must have evidence of clinical benefit as determined by the Investigator.

Exclusion criteria 4

1. Permanent discontinuation of ribociclib in the parent study due to toxicity or disease progression, non-compliance to study procedures, withdrawal of consent or any other reason as stipulated in parent protocol.
2. Participants currently have unresolved toxicities for which ribociclib dosing has been interrupted in the parent study (participants meeting all other eligibility criteria may be enrolled once toxicities have resolved to allow ribociclib dosing to resume).
3. Local access to commercially available ribociclib and reimbursed (except for US enrolled participants from parent protocol CLEE011A2404 meeting all other eligibility criteria).
4. Women of child-bearing potential defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during the study treatment and for 21 days after stopping the treatment. Highly effective contraception methods include: a) Total abstinence b) Female sterilization c) Male partner sterilization d) Placement of an intrauterine device (IUD)

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. Frequency and severity of AEs/SAEs
2. Proportion of participants with clinical benefit as assessed by the Investigator

Investigational products

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

Test 5

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 5

Locations

5 EU/EEA countries · 7 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 45 files

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

Application history

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