Clinical trial NCT03194893: A Rollover Study of Alectinib in Patients With Anaplastic Lymphoma Kinase (ALK)-Positive or Rearranged During Transfection (RET)-Positive Cancer
Official title: A Multicenter, International, Rollover Study of Alectinib in Patients With Anaplastic Lymphoma Kinase (ALK)-Positive or Rearranged During Transfection (RET)-Positive Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Neoplasms
Keywords: Non-small cell lung cancer (NSCLC)
Anaplastic lymphoma kinase (ALK)
Rearranged during transfection (RET)
Alectinib
Crizotinib
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2017-06-21
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to provide continued treatment with alectinib or crizotinib as applicable to participants 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.


Eligibility criteria: Inclusion Criteria:

* Participants 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 (eCRF)
* 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 \< 1% per year during the treatment period and for at least 3 months after the last dose of study drug
* For men: agreement to remain abstinent or use a contraceptive method that results in a failure rate of \< 1% per year during the treatment period and for at least 3 months after the last dose of study drug.

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 participant before trial entry

Primary outcomes:
measure: Number of Patients with Serious Adverse Events (SAEs), Non-serious Adverse Events (non-SAEs) and Adverse Events of Special Interest
timeFrame: From first dose of study treatment and until the safety follow-up visit (4 weeks after the last dose of study treatment)
measure: Number of Patients With Clinically Significant Laboratory Values as per Protocol for Selected Safety Laboratory Parameters
timeFrame: From first dose of study treatment and until the safety follow-up visit (4 weeks after the last dose of study treatment)
Secondary outcomes:
measure: Number and Causes of Death Occurring on Study
timeFrame: From first dose of study treatment and until the safety follow-up visit (4 weeks after the last dose of study treatment)
Other outcomes:
Locations:
city: Orange
country: United States
facility: Chao Family Comprehensive Cancer Center
state: California
city: Boston
country: United States
facility: Massachusetts General Hospital Cancer Center
state: Massachusetts
city: Caen
country: France
facility: Centre Francois Baclesse
city: Dijon
country: France
facility: Centre Georges François Leclerc
city: Lille
country: France
facility: Centre Oscar Lambret
city: Lyon
country: France
facility: Centre Leon Berard
city: Pessac
country: France
facility: Groupe Hospitalier Sud - Hôpital Haut Lévêque
city: Rennes
country: France
facility: Hopital Pontchaillou - CHU de Rennes
city: Toulouse Cedex 9
country: France
facility: CHU de Toulouse - Hôpital Larrey
city: Vantoux
country: France
facility: Hopital Robert Schuman
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
city: Kowloon
country: Hong Kong
facility: Queen Elizabeth Hospital Department of Clinical Oncology
city: Aviano
country: Italy
facility: Irccs Centro Di Riferimento Oncologico (CRO)
state: Friuli-Venezia Giulia
city: Roma
country: Italy
facility: Azienda Ospedaliera San Camillo Forlanini - Unità Operativa Complessa di Pneumologia Oncologica 1
state: Lazio
city: Firenze
country: Italy
facility: Azienda Ospedaliero-Universitaria Careggi
state: Toscana
city: Perugia
country: Italy
facility: Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia
state: Umbria
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Gda?sk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne
city: Moscow
country: Russian Federation
facility: FSBSI "Russian Oncological Scientific Center n.a. N.N. Blokhin"
state: Moskovskaja Oblast
city: Moscow
country: Russian Federation
facility: University ?linic of headaches
state: Moskovskaja Oblast
city: Moscow
country: Russian Federation
facility: City Clinical Oncology Hospital
state: Moskovskaja Oblast
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Hospital Universitari Dexeus - Grupo Quironsalud
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Adana
country: Turkey
facility: Adana Ac?badem Hospital Oncology Department
city: Istanbul
country: Turkey
facility: Istanbul Uni Capa Medical Faculty
city: Izmir
country: Turkey
facility: Ege University Medical Faculty
city: S?hhiye, Ankara
country: Turkey
facility: Hacettepe Uni Medical Faculty Hospital
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: