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

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

NCT03194893•Hoffmann-La Roche

View on ClinicalTrials.gov

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

Age

All ages

Sex

ALL

Healthy Volunteers

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

Locations (29)

Chao Family Comprehensive Cancer Center

Orange, California, United States

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, United States

Centre Francois Baclesse

Caen, France

Centre Georges François Leclerc

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

Toulouse, France

Hopital Robert Schuman

Vantoux, France

Key Dates

Start Date

July 5, 2017

Primary Completion Date

May 30, 2026

Completion Date

May 30, 2026

Last Updated

February 20, 2026

Enrollment

200

ESTIMATED participants

Conditions

Neoplasms

Interventions

Alectinib

DRUG

Crizotinib

DRUG

Collection of Serum and Tissue Samples From Patients With Biopsy-Proved or Suspected Malignant Disease

NCT00026884

Malignant NeoplasmsHereditary Neoplastic Syndromes+3 more

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A Two-Part Phase 3 Study of Sofetabart Mipitecan (LY4170156) in Participants With Platinum-Resistant (Part A) and Platinum-Sensitive (Part B) Ovarian Cancer

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 20, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Collection of Serum and Tissue Samples From Patients With Biopsy-Proved or Suspected Malignant Disease

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