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.

• Register: EUCTR
• Last refreshed on: 7 September 2020
• Main ID: EUCTR2015-001922-40-DE
• Date of registration: 01/10/2015
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharma Services AG
• Public title: 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.
• Scientific title: An open-label, multi-center, Phase IV, roll-over study in patients with ALK positive malignancies who have completed a prior Novartis-sponsored ceritinib (LDK378) study and are judged by the investigator to benefit from continued treatment with ceritinib.
• Date of first enrolment: 04/01/2016
• Target sample size: 150
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-001922-40
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes

Countries of recruitment

Australia, Belgium, Brazil, Bulgaria, China, Colombia, Czech Republic, France, Germany, Hong Kong, Italy, Japan, Korea, Republic of, Lebanon, Malaysia, New Zealand, Poland, Russian Federation, Singapore, Spain, Sweden, Taiwan, Thailand, United States

Contacts

• Name: Medizinischer Infoservice (MCC)
• Affiliation: Novartis Pharma GmbH

• Name: Medizinischer Infoservice (MCC)
• Affiliation: Novartis Pharma GmbH

Key inclusion & exclusion criteria

Inclusion criteria:
• 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.
• Patient has demonstrated compliance, as assessed by the investigator, with the parent study protocol requirements.
• Wilingness and ability to comply with scheduled visits, treatment plans and any other study procedures.
• 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.

Other protocol defined inclusion criteria may apply.
Are the trial subjects under 18? yes
Number of subjects for this age range: 6
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 90
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 19

Exclusion criteria:
• Patient has been permanently discontinued from ceritinib study treatment in the parent study due to any reason.
• 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.)
• 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.
• Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception.
• 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.

Other protocol defined exclusion criteria may apply.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

non small cell lung cancer
MedDRA version: 21.1 Level: PT Classification code 10061873 Term: Non-small cell lung cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Therapeutic area: Diseases [C] - Cancer [C04]

Intervention(s)

Trade Name: Zykadia 150 mg Hartkapseln
Product Code: LDK378, 150 mg (Studienware)
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: ceritinib
Current Sponsor code: LDK378
Other descriptive name: CERITINIB
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-

Trade Name: Zykadia 150 mg Hartkapseln
Product Code: LDK378, 150 mg (Handelsware)
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: ceritinib
Current Sponsor code: LDK378
Other descriptive name: CERITINIB
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-

Product Code: LDK378 (grey opaque)
Pharmaceutical Form: Capsule, hard
Other descriptive name: LDK378
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-

Product Code: LDK378 (pink opaque)
Pharmaceutical Form: Capsule, hard
Other descriptive name: LDK378
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-

Primary Outcome(s)

Main Objective: To allow continued treatment to patients receiving ceritinib in existing Novartis sponsored studies which have fulfilled the requirements for the primary objective, and in the opinion of the investigator, would benefit from continued treatment.

Timepoint(s) of evaluation of this end point: No stastitical analysis will be performed.

Primary end point(s): Number of patient recieving ceritinib

Secondary Objective: To collect safety data: adverse events (AEs) and serious adverse events (SAEs).

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: The assessment of safety will be based on the frequency of adverse events (AEs) and serious adverse events (SAEs)

Secondary end point(s): Frequency and nature of adverse events and serious adverse events

Secondary ID(s)

CLDK378A2X01B

Source(s) of Monetary Support

Novartis Pharma Services AG

Ethics review

Status: Approved
Approval date: 04/01/2016
Contact: