Anaplastic lymphoma kinase (ALK)-positive or rearranged during transfection (RET)-positive cancer MedDRA version: 19.1 Level: PT Classification code 10029522 Term: Non-small cell lung cancer stage IV System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 19.1 Level: PT Classification code 10029521 Term: Non-small cell lung cancer stage IIIB System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and poly
Conditions
Interventions
Product Name: Alectinib
Product Code: RO5424802/F03
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: ALECTINIB
Current Sponsor code: RO5424802
Other descriptive name: ALK INHIBITOR
Concentratio
Sponsors
Roche Farma S.A.U. que realiza el ensayo en España y que actúa como representante de F.Hoffmann-La Roche Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Patients enrolled in a Roche-sponsored alectinib trial who are experiencing a clinical benefit from alectinib or crizotinib treatment at the time of discontinuation from the parent trial and for whom a switch to commercial supply is not feasible -Collected study termination data, including efficacy and safety data, as required by the parent study on the electronic Case Report Form -Ability and willingness to comply with the protocol, in the investigator's judgment -For women who are not postmenopausal (>=12 months of non-therapy-induced amenorrhea) or surgically sterile (absence of ovaries and/or uterus): agreement to remain abstinent or use single or combined contraceptive methods that result in a failure rate of =65 years) yes F.1.3.1 Number of subjects for this age range 72
Exclusion criteria
Exclusion criteria: -Evidence of lack of clinical benefit in parent trial during the screening phase of this rollover study -Permanent discontinuation of alectinib or crizotinib for any reason during the parent study or before first dose of study drug in the rollover study -Evidence of an adverse event for which the parent protocol stipulates permanent discontinuation -Pregnant or breastfeeding women -Ongoing serious adverse event that has not resolved to baseline level or Grade =1 prior to first dose of study treatment in the rollover study -Treatment interruption for more than 21 days due to an adverse event since the last administration of alectinib or crizotinib in the parent trial. Any ongoing adverse events that require temporary treatment interruption must be resolved to baseline grade or assessed as stable and not requiring further treatment interruption by the investigator -Administration of strong/potent cytochrome P450 (CYP) 3A inhibitors or inducers within 14 days prior to the first dose of treatment on this study and while on treatment with crizotinib -Any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol requirements and/or follow-up procedures; these conditions should be discussed with the patient before trial entry
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: •To provide continued treatment with alectinib or crizotinib as applicable to patients with ALK- or RET-positive cancer who were previously enrolled in any Roche-sponsored alectinib study and who are deriving continued clinical benefit from alectinib or crizotinib in the parent trial at the time of parent trial closure;Secondary Objective: •To assess long-term safety of alectinib therapy;Primary end point(s): -Not applicable;Timepoint(s) of evaluation of this end point: -Not applicable | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Incidence of serious and non-serious adverse events and adverse events of special interest 2. Selected safety laboratory test measurements 3. Number of Deaths occurring on study;Timepoint(s) of evaluation of this end point: 1-3. Throughout the study | — |
Countries
France, Italy, Korea, Republic of, Poland, Russian Federation, Spain, Taiwan
Contacts
Public ContactTrial Information Support Line-TISL
F. Hoffmann-La Roche Ltd.
Outcome results
None listed