Study to allow patients with ALK+ malignancies to continue ceritinib treatment

Phase 1

• Conditions: on small cell lung cancer; MedDRA version: 21.1Level: PTClassification code 10061873Term: Non-small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2015-001922-40-IT
• Lead Sponsor: OVARTIS FARMA S.P.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-17
• Last Update Posted: 17 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 150

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? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 128
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 22

Exclusion Criteria

1. Patient has been permanently and prematurely 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 during dosing and for 3 months after stopping ceritinib treatment.
5. Sexually active males unless they use a condom during intercourse while taking drug and
for 3 months after stopping ceritinib and should not father a child for at least 3 months
after the last dose of treatment. A condom is required to be used also by vasectomized
men as well as during intercourse with a male partner in order to prevent delivery of the
drug via seminal fluid.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate long term safety data (SAEs and AEs);Secondary Objective: To evaluate clinical benefit as assessed by the investigator.;Primary end point(s): Frequency and severity of adverse events (AEs) and serious adverse events (SAEs);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 Outcome Measures

Name	Time	Method
Secondary end point(s): Proportion of patients with clinical benefit as assessed by the investigator at scheduled visits.;Timepoint(s) of evaluation of this end point: At every quarterly visit