A study for patients who have completed a prior global Novartis sponsored ceritinib (LDK378) study and are judged by the investigator to benefit from continued treatment.

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

Diseases [C] - Neoplasms [C04]

Trial duration

12 Jan 2016 → ongoing

Decision date (initial)

2024-06-14

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Novartis Pharma AG

External identifiers

EU CT number

2024-511040-58-00

EudraCT number

2015-001922-40

ClinicalTrials.gov

NCT02584933

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety

To evaluate long term safety data (SAEs and AEs ). Provide patients access to study drug after parent trials are concluded

Secondary objectives 1

1. To evaluate clinical benefit as assessed by the investigator.

Conditions and MedDRA coding

non small cell lung cancer

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Patient is currently receiving treatment with ceritinib within a Novartis-sponsored study which has fulfilled the requirements for the primary objective and, in the opinion of the Investigator, would benefit from continued treatment.
2. Patient has demonstrated compliance, as assessed by the investigator, with the parent study protocol requirements.
3. Wilingness and ability to comply with scheduled visits, treatment plans and any other study procedures.
4. Written informed consent obtained prior to enrolling in the roll-over study and receiving study medication. If consent cannot be expressed in writing, it must be formally documented and witnessed, ideally via an independent trusted witness.

Exclusion criteria 5

1. Patient has been permanently discontinued from ceritinib study treatment in the parent study due to any reason.
2. Patient currently has unresolved toxicities for which ceritinib dosing has been interrupted in the parent study. (Patients meeting all other eligibility criteria may be enrolled once toxicities have resolved to allow ceritinib dosing to resume.)
3. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive serum hCG laboratory test.
4. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception.
5. Sexually active males unless they use a condom during intercourse while taking drug and after stopping ceritinib and should not father a child in this period.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Frequency and severity of AEs/SAEs

Secondary endpoints 1

1. Proportion of patients with clinical benefit as assessed by the investigator at scheduled visits.

Investigational products

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

Test 1

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 7

Locations

6 EU/EEA countries · 10 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 20 files

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

Application history

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