A Rollover Study of Alectinib in Patients With Anaplastic Lymphoma Kinase (ALK)-Positive or Rearranged During Transfection (RET)-Positive Cancer

Neoplasms Clinical Trial

Official title:

A Multicenter, International, Rollover Study of Alectinib in Patients With Anaplastic Lymphoma Kinase (ALK)-Positive or Rearranged During Transfection (RET)-Positive Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03194893
• Other study ID #: BO39694
• Secondary ID: 2017-000207-24
• Status: Recruiting
• Phase: Phase 3
• Start date: July 5, 2017
• Est. completion date: June 12, 2024

Study information

• Verified date: April 2024
• Source: Hoffmann-La Roche
• Contact: Reference Study ID Number: BO39694 www.roche.com/about_roche/roc
• Phone: +1 888-662-6728
• Email: global-roche-genentech-trials[@]gene.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 the time of parent trial closure.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: June 12, 2024
• Est. primary completion date: June 12, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Lymphoma
• Neoplasms

Intervention

Drug:
• Alectinib
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.
• Crizotinib
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.

Locations

Country	Name	City	State
China	Guangdong General Hospital	Guangzhou
China	The First Affiliated Hospital of Guangzhou Medical University	Guangzhou
China	Shanghai Pulmonary Hospital	Shanghai
China	Zhejiang Cancer Hospital	Zhejiang
France	Centre Francois Baclesse	Caen
France	Centre Georges François Leclerc; Service Pharmacie, Bp 77980	Dijon
France	Centre Oscar Lambret	Lille
France	Centre Leon Berard	Lyon
France	Groupe Hospitalier Sud - Hôpital Haut Lévêque	Pessac
France	Hopital Pontchaillou - CHU de Rennes	Rennes
France	CHU de Toulouse - Hôpital Larrey; Service de pneumologie et oncologie pneumologique	Toulouse cedex 9
France	Hopital Robert Schuman; Pneumologie	Vantoux
Hong Kong	Queen Mary Hospital; Dept. of Clinical Oncology	Hong Kong
Hong Kong	Queen Elizabeth Hospital Department of Clinical Oncology	Kowloon
Italy	Irccs Centro Di Riferimento Oncologico (CRO); Dipartimento Di Oncologia Medica	Aviano	Friuli-Venezia Giulia
Italy	Azienda Ospedaliero-Universitaria Careggi;S.C. Oncologia Medica 1	Firenze	Toscana
Italy	Irccs Istituto Europeo di Oncologia (IEO); Divisione di Oncologia	Milano	Lombardia
Italy	Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia; Oncologia Medica	Perugia	Umbria
Italy	Azienda Ospedaliera San Camillo Forlanini - Unità Operativa Complessa di Pneumologia Oncologica 1	Roma	Lazio
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Poland	Uniwersyteckie Centrum Kliniczne; Klinika Onkologii i Radioterapii	Gdansk
Russian Federation	City Clinical Oncology Hospital	Moscow	Moskovskaja Oblast
Russian Federation	FSBSI "Russian Oncological Scientific Center n.a. N.N. Blokhin"	Moscow	Moskovskaja Oblast
Russian Federation	University ?linic of headaches	Moscow	Moskovskaja Oblast
Spain	Hospital del Mar; Servicio de Oncologia	Barcelona
Spain	Hospital Universitari Dexeus - Grupo Quironsalud; Servicio de Oncologia Medica	Barcelona
Spain	Hospital Universitario La Paz; Servicio de Oncologia	Madrid
Turkey	Adana Ac?badem Hospital Oncology Department	Adana
Turkey	Istanbul Uni Capa Medical Faculty; Inst. of Oncology	Istanbul
Turkey	Ege University Medical Faculty; Chest Diseases	Izmir
Turkey	Hacettepe Uni Medical Faculty Hospital; Oncology Dept	Sihhiye/Ankara
United States	Massachusetts General Hospital Cancer Center	Boston	Massachusetts
United States	Miami Cancer Institute of Baptist Health, Inc.	Miami	Florida
United States	Chao Family Comprehensive Cancer Center; UC Irvine Medical Center	Orange	California

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  China,  France,  Hong Kong,  Italy,  Korea, Republic of,  Poland,  Russian Federation,  Spain,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	From first dose of study treatment and until the safety follow-up visit (4 weeks after the last dose of study treatment)
Primary	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.	From first dose of study treatment and until the safety follow-up visit (4 weeks after the last dose of study treatment)
Secondary	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.	From first dose of study treatment and until the safety follow-up visit (4 weeks after the last dose of study treatment)