NeoplasmsPhase 3NCT03194893
A Rollover Study of Alectinib in Patients With Anaplastic Lymphoma Kinase (ALK)-Positive or Rearranged During Transfection (RET)-Positive Cancer
A Phase 3 study testing Alectinib and Crizotinib in people with Neoplasms, run by Hoffmann-La Roche at 29 sites in 9 countries.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Neoplasms
- What is being tested?
- Alectinib and Crizotinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 29 sitesin 9 countries
- Study dates
- 5 Jul 2017to 18 Sep 2025
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
29 sites in 9 countries.
29 sites in 9 countries
France8 sites
Centre Francois Baclesse
Caen, 14076
Centre Georges François Leclerc
Dijon, 21000
Centre Oscar Lambret
Lille, 59020
Centre Leon Berard
Lyon, 69008
Groupe Hospitalier Sud - Hôpital Haut Lévêque
Pessac, 33600
Hopital Pontchaillou - CHU de Rennes
Rennes, 35033
CHU de Toulouse - Hôpital Larrey
Toulouse, 31059
Hopital Robert Schuman
Vantoux, 57070
Italy4 sites
Irccs Centro Di Riferimento Oncologico (CRO)
Aviano, Friuli Venezia Giulia, 33081
Azienda Ospedaliero-Universitaria Careggi
Florence, Tuscany, 50139
Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia
Perugia, Umbria, 06132
Azienda Ospedaliera San Camillo Forlanini - Unità Operativa Complessa di Pneumologia Oncologica 1
Rome, Lazio, 00151
Turkey (Türkiye)4 sites
Adana Ac?badem Hospital Oncology Department
Adana, 01130
Istanbul Uni Capa Medical Faculty
Istanbul, 34093
Ege University Medical Faculty
Izmir, 35040
Hacettepe Uni Medical Faculty Hospital
S?hhiye, Ankara, 06100
Russia3 sites
FSBSI "Russian Oncological Scientific Center n.a. N.N. Blokhin"
Moscow, Moscow Oblast, 115478
University ?linic of headaches
Moscow, Moscow Oblast, 121467
City Clinical Oncology Hospital
Moscow, Moscow Oblast, 143423
Spain3 sites
Hospital del Mar
Barcelona, 08003
Hospital Universitari Dexeus - Grupo Quironsalud
Barcelona, 08028
Hospital Universitario La Paz
Madrid, 28046
United States2 sites
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114
Chao Family Comprehensive Cancer Center
Orange, California, 92868
Hong Kong2 sites
Queen Mary Hospital
Hong Kong
Queen Elizabeth Hospital Department of Clinical Oncology
Kowloon
South Korea2 sites
Seoul National University Hospital
Seoul, 03080
Samsung Medical Center
Seoul, 06351
About this study
Official title: A Multicenter, International, Rollover Study of Alectinib in Patients With Anaplastic Lymphoma Kinase (ALK)-Positive or Rearranged During Transfection (RET)-Positive Cancer
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.
- Conditions
- Neoplasms
- Being tested
- Alectinib, Crizotinib
- Keywords
- Non-small cell lung cancer (NSCLC), Anaplastic lymphoma kinase (ALK), Rearranged during transfection (RET), Alectinib, Crizotinib
- Medical subject headings
- Neoplasms, Carcinoma, Non-Small-Cell Lung, Multiple Endocrine Neoplasia Type 2a
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlectinibDrug
Alectinib capsules 600 mg twice a day (BID) orally until no further clinical benefit is to be expected, unacceptable toxicity, availability of commercial supply, withdrawal of consent, or death, whichever occurs first.
CrizotinibDrug
Crizotinib capsules 250 mg BID orally until no further clinical benefit is to be expected, unacceptable toxicity, availability of commercial supply, withdrawal of consent, or death, whichever occurs first.
| Study group | Role | What they receive |
|---|---|---|
| Alectinib | Experimental | Participants will receive alectinib at the same dose and schedule and according to the same administration guidelines as they received at the time of discontinuation from the parent trial. Receives: Drug: Alectinib |
| Crizotinib | Experimental | Participants will receive crizotinib at the same dose and schedule and according to the same administration guidelines as they received at the time of discontinuation from the parent trial. Receives: Drug: Crizotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI)
An AE is any untoward medical occurrence in a participant administered a study drug, regardless of causal relationship. A SAE is any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is a medically important event. AESI included drug induced liver injury that include an elevated alanine aminotransferase (ALT) or aspartate aminotransferase (AST) in combination with either an elevated bilirubin or clinical jaundice and suspected transmission of infectious agent via study drug.
Measured: From study initiation until 4 weeks after the last dose (up to approximately 8.19 years)
Secondary outcomes (1)
Number and Causes of Death on Study
Measured: Up to approximately 8.19 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2017
- Study start5 Jul 2017
- Primary completion18 Sep 2025
- Study completion18 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03194893
- Sponsor's protocol ID
- BO39694
- Other IDs
- 2017-000207-24, 2017
- Status last verified
- Sep 2026
- First submitted
- 20 Jun 2017
- Last updated
- 9 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing