Back to resultsA Rollover Study of Alectinib in Patients With Anaplastic Lymphoma Kinase (ALK)-Positive or Rearranged During Transfection (RET)-Positive Cancer
Primary Purpose
Neoplasms
Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Alectinib
Crizotinib
Sponsored by
About this trial
This is an interventional treatment trial for Neoplasms focused on measuring Non-small cell lung cancer (NSCLC), Anaplastic lymphoma kinase (ALK), Rearranged during transfection (RET), Alectinib, Crizotinib
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
Sites / Locations
- Chao Family Comprehensive Cancer Center; UC Irvine Medical CenterRecruiting
- Miami Cancer Institute of Baptist Health, Inc.
- Massachusetts General Hospital Cancer Center
- Guangdong General Hospital
- The First Affiliated Hospital of Guangzhou Medical University
- Shanghai Pulmonary Hospital
- Zhejiang Cancer Hospital
- Centre Francois Baclesse
- Centre Georges François Leclerc; Service Pharmacie, Bp 77980
- Centre Oscar Lambret
- Centre Leon Berard
- Groupe Hospitalier Sud - Hôpital Haut Lévêque
- Hopital Pontchaillou - CHU de Rennes
- CHU de Toulouse - Hôpital Larrey; Service de pneumologie et oncologie pneumologique
- Hopital Robert Schuman; Pneumologie
- Queen Mary Hospital; Dept. of Clinical Oncology
- Queen Elizabeth Hospital Department of Clinical Oncology
- Irccs Centro Di Riferimento Oncologico (CRO); Dipartimento Di Oncologia Medica
- Azienda Ospedaliera San Camillo Forlanini - Unità Operativa Complessa di Pneumologia Oncologica 1
- Irccs Istituto Europeo di Oncologia (IEO); Divisione di Oncologia
- Azienda Ospedaliero-Universitaria Careggi;S.C. Oncologia Medica 1
- Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia; Oncologia Medica
- Seoul National University Hospital
- Samsung Medical Center
- Uniwersyteckie Centrum Kliniczne; Klinika Onkologii i Radioterapii
- FSBSI "Russian Oncological Scientific Center n.a. N.N. Blokhin"
- University ?linic of headaches
- City Clinical Oncology Hospital
- Hospital del Mar; Servicio de Oncologia
- Hospital Universitari Dexeus - Grupo Quironsalud; Servicio de Oncologia Medica
- Hospital Universitario La Paz; Servicio de Oncologia
- Adana Ac?badem Hospital Oncology Department
- Istanbul Uni Capa Medical Faculty; Inst. of Oncology
- Ege University Medical Faculty; Chest DiseasesRecruiting
- Hacettepe Uni Medical Faculty Hospital; Oncology DeptRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Alectinib
Crizotinib
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Number of Patients with Serious Adverse Events (SAEs), Non-serious Adverse Events (non-SAEs) and Adverse Events of Special Interest
An AE is considered any unfavorable and unintended sign, symptom, or disease associated with use of study drug, whether or not considered related to study drug. Preexisting conditions that worsened during study and laboratory or clinical tests that resulted in a change in treatment or discontinuation from study drug is reported as adverse events. A SAE is any experience that suggests a significant hazard, contraindication, side effect that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant. Adverse events of special interest are cases of potential drug-induced liver injury that include an elevated alanine transaminase (ALT) or aspartate transaminase (AST) in combination with either an elevated bilirubin or clinical jaundice and suspected transmission of an infectious agent by study drug.
Number of Patients With Clinically Significant Laboratory Values as per Protocol for Selected Safety Laboratory Parameters
Selected safety laboratory parameters include alanine transaminase (ALT), aspartate transaminase (AST), total bilirubin, alkaline phosphatase (ALP), and blood creatine phosphokinase (CPK). Any treatment-emergent abnormal laboratory result accompanied by clinical symptoms or leading to a change in study medication or requiring a change in concomitant therapy is considered clinically significant.
Secondary Outcome Measures
Number and Causes of Death Occurring on Study
Once a patient has permanently discontinued study drug and completed the safety follow-up visit, no further survival data will be collected.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03194893
Brief Title
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
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 5, 2017 (Actual)
Primary Completion Date
June 12, 2024 (Anticipated)
Study Completion Date
June 12, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neoplasms
Keywords
Non-small cell lung cancer (NSCLC), Anaplastic lymphoma kinase (ALK), Rearranged during transfection (RET), Alectinib, Crizotinib
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Alectinib
Arm Type
Experimental
Arm Description
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.
Arm Title
Crizotinib
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Alectinib
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Crizotinib
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Patients with Serious Adverse Events (SAEs), Non-serious Adverse Events (non-SAEs) and Adverse Events of Special Interest
Description
An AE is considered any unfavorable and unintended sign, symptom, or disease associated with use of study drug, whether or not considered related to study drug. Preexisting conditions that worsened during study and laboratory or clinical tests that resulted in a change in treatment or discontinuation from study drug is reported as adverse events. A SAE is any experience that suggests a significant hazard, contraindication, side effect that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant. Adverse events of special interest are cases of potential drug-induced liver injury that include an elevated alanine transaminase (ALT) or aspartate transaminase (AST) in combination with either an elevated bilirubin or clinical jaundice and suspected transmission of an infectious agent by study drug.
Time Frame
From first dose of study treatment and until the safety follow-up visit (4 weeks after the last dose of study treatment)
Title
Number of Patients With Clinically Significant Laboratory Values as per Protocol for Selected Safety Laboratory Parameters
Description
Selected safety laboratory parameters include alanine transaminase (ALT), aspartate transaminase (AST), total bilirubin, alkaline phosphatase (ALP), and blood creatine phosphokinase (CPK). Any treatment-emergent abnormal laboratory result accompanied by clinical symptoms or leading to a change in study medication or requiring a change in concomitant therapy is considered clinically significant.
Time Frame
From first dose of study treatment and until the safety follow-up visit (4 weeks after the last dose of study treatment)
Secondary Outcome Measure Information:
Title
Number and Causes of Death Occurring on Study
Description
Once a patient has permanently discontinued study drug and completed the safety follow-up visit, no further survival data will be collected.
Time Frame
From first dose of study treatment and until the safety follow-up visit (4 weeks after the last dose of study treatment)
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Reference Study ID Number: BO39694 www.roche.com/about_roche/roche_worldwide.htm
Phone
+1 888-662-6728
Email
global-roche-genentech-trials@gene.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
Chao Family Comprehensive Cancer Center; UC Irvine Medical Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Individual Site Status
Recruiting
Facility Name
Miami Cancer Institute of Baptist Health, Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Individual Site Status
Completed
Facility Name
Massachusetts General Hospital Cancer Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Completed
Facility Name
Guangdong General Hospital
City
Guangzhou
ZIP/Postal Code
510080
Country
China
Individual Site Status
Withdrawn
Facility Name
The First Affiliated Hospital of Guangzhou Medical University
City
Guangzhou
ZIP/Postal Code
510120
Country
China
Individual Site Status
Withdrawn
Facility Name
Shanghai Pulmonary Hospital
City
Shanghai
ZIP/Postal Code
200433
Country
China
Individual Site Status
Withdrawn
Facility Name
Zhejiang Cancer Hospital
City
Zhejiang
ZIP/Postal Code
310022
Country
China
Individual Site Status
Withdrawn
Facility Name
Centre Francois Baclesse
City
Caen
ZIP/Postal Code
14076
Country
France
Individual Site Status
Completed
Facility Name
Centre Georges François Leclerc; Service Pharmacie, Bp 77980
City
Dijon
ZIP/Postal Code
21000
Country
France
Individual Site Status
Completed
Facility Name
Centre Oscar Lambret
City
Lille
ZIP/Postal Code
59020
Country
France
Individual Site Status
Completed
Facility Name
Centre Leon Berard
City
Lyon
ZIP/Postal Code
69008
Country
France
Individual Site Status
Completed
Facility Name
Groupe Hospitalier Sud - Hôpital Haut Lévêque
City
Pessac
ZIP/Postal Code
33600
Country
France
Individual Site Status
Completed
Facility Name
Hopital Pontchaillou - CHU de Rennes
City
Rennes
ZIP/Postal Code
35033
Country
France
Individual Site Status
Completed
Facility Name
CHU de Toulouse - Hôpital Larrey; Service de pneumologie et oncologie pneumologique
City
Toulouse cedex 9
ZIP/Postal Code
31100
Country
France
Individual Site Status
Completed
Facility Name
Hopital Robert Schuman; Pneumologie
City
Vantoux
ZIP/Postal Code
57070
Country
France
Individual Site Status
Completed
Facility Name
Queen Mary Hospital; Dept. of Clinical Oncology
City
Hong Kong
Country
Hong Kong
Individual Site Status
Completed
Facility Name
Queen Elizabeth Hospital Department of Clinical Oncology
City
Kowloon
Country
Hong Kong
Individual Site Status
Completed
Facility Name
Irccs Centro Di Riferimento Oncologico (CRO); Dipartimento Di Oncologia Medica
City
Aviano
State/Province
Friuli-Venezia Giulia
ZIP/Postal Code
33081
Country
Italy
Individual Site Status
Completed
Facility Name
Azienda Ospedaliera San Camillo Forlanini - Unità Operativa Complessa di Pneumologia Oncologica 1
City
Roma
State/Province
Lazio
ZIP/Postal Code
00151
Country
Italy
Individual Site Status
Completed
Facility Name
Irccs Istituto Europeo di Oncologia (IEO); Divisione di Oncologia
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20141
Country
Italy
Individual Site Status
Withdrawn
Facility Name
Azienda Ospedaliero-Universitaria Careggi;S.C. Oncologia Medica 1
City
Firenze
State/Province
Toscana
ZIP/Postal Code
50139
Country
Italy
Individual Site Status
Completed
Facility Name
Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia; Oncologia Medica
City
Perugia
State/Province
Umbria
ZIP/Postal Code
06156
Country
Italy
Individual Site Status
Completed
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Completed
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Completed
Facility Name
Uniwersyteckie Centrum Kliniczne; Klinika Onkologii i Radioterapii
City
Gda?sk
ZIP/Postal Code
80-214
Country
Poland
Individual Site Status
Completed
Facility Name
FSBSI "Russian Oncological Scientific Center n.a. N.N. Blokhin"
City
Moscow
State/Province
Moskovskaja Oblast
ZIP/Postal Code
115478
Country
Russian Federation
Individual Site Status
Completed
Facility Name
University ?linic of headaches
City
Moscow
State/Province
Moskovskaja Oblast
ZIP/Postal Code
121467
Country
Russian Federation
Individual Site Status
Completed
Facility Name
City Clinical Oncology Hospital
City
Moscow
State/Province
Moskovskaja Oblast
ZIP/Postal Code
143423
Country
Russian Federation
Individual Site Status
Completed
Facility Name
Hospital del Mar; Servicio de Oncologia
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Individual Site Status
Completed
Facility Name
Hospital Universitari Dexeus - Grupo Quironsalud; Servicio de Oncologia Medica
City
Barcelona
ZIP/Postal Code
08028
Country
Spain
Individual Site Status
Completed
Facility Name
Hospital Universitario La Paz; Servicio de Oncologia
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Individual Site Status
Completed
Facility Name
Adana Ac?badem Hospital Oncology Department
City
Adana
ZIP/Postal Code
01130
Country
Turkey
Individual Site Status
Completed
Facility Name
Istanbul Uni Capa Medical Faculty; Inst. of Oncology
City
Istanbul
ZIP/Postal Code
34093
Country
Turkey
Individual Site Status
Completed
Facility Name
Ege University Medical Faculty; Chest Diseases
City
Izmir
ZIP/Postal Code
35040
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Hacettepe Uni Medical Faculty Hospital; Oncology Dept
City
Sihhiye/Ankara
ZIP/Postal Code
06230
Country
Turkey
Individual Site Status
Recruiting
12. IPD Sharing Statement
Learn more about this trial
A Rollover Study of Alectinib in Patients With Anaplastic Lymphoma Kinase (ALK)-Positive or Rearranged During Transfection (RET)-Positive Cancer
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