Informations générales (source: ClinicalTrials.gov)
A Phase I/II, Open-Label, Multicenter, Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Alectinib in Pediatric Participants With ALK Fusion-Positive Solid or CNS Tumors for Whom Prior Treatment Has Proven to be Ineffective or for Whom There is No Satisfactory Treatment Available
Interventional
Phase 1/Phase 2
Hoffmann-La Roche (Voir sur ClinicalTrials)
septembre 2021
juillet 2030
04 octobre 2024
This study will evaluate the safety, pharmacokinetics, and efficacy of alectinib in
children and adolescents with ALK fusion-positive solid or CNS tumors for whom prior
treatment has proven to be ineffective or for whom there is no satisfactory standard
treatment available.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT CURIE | 04/09/2024 13:49:43 | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Léon Bérard, Institut d?Hémato-Oncologie Pédiatrique - 69373 - Lyon - France | Contact (sur clinicalTrials) | ||||
| Hôpital de la Timone, Oncologie Pédiatrique - 13385 - Marseille - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria
- Histologically confirmed diagnosis of CNS or solid tumors with documented evidence
of ALK gene fusions as assessed centrally through the use of the investigational
F1CDx assay or based on pre-existing NGS test results
- Disease status: prior treatment proven to be ineffective (i.e. relapsed or
refractory), or for whom there is no satisfactory standard treatment available.
Disease should be measurable and evaluable as defined by Response Evaluation
Criteria in Solid Tumors (RECIST) v 1.1, or Response Assessment in Neuro-oncology
criteria (RANO) +/- bone marrow criteria for primary CNS tumors or International
Neuroblastoma Response Criteria (INRC)
- Available tumor tissue for submission to the Sponsor from active disease, obtained
subsequent to last anti-cancer therapy regiment administered and obtained prior to
study enrollment, or willingness to undergo a core or excisional biopsy sample
collection prior to enrollment
- For participants < 16 years old, Lansky Performance Status >/= 50%
- For participants >/= 16 years old, Karnofsky Performance Status >/= 50%
- Adequate bone marrow function as defined by the protocol within at least 28 days
prior to initiation of study drug
- Participant and/or caregiver willingness and ability to complete clinical outcome
assessments throughout the study using either electronic, paper, or interviewer
methods
- For females of childbearing potential: agreement to remain abstinent (refrain from
heterosexual intercourse) or use contraception, and agreement to refrain from
donating eggs, as defined by the protocol
- For males who are not surgically sterile: agreement to remain abstinent (refrain
from heterosexual intercourse) or use contraception, and agreement to refrain from
donating sperm, as defined by the protocol
Exclusion Criteria
- Medical history of: prior use of ALK inhibitors; diagnosis of Anaplastic Large Cell
Lymphoma (ALCL); any gastrointestinal disorder that may affect absorption of oral
medications, such as mal-absorption syndrome or status post-major bowel resection;
history of organ transplant; stem cell infusions as defined by the protocol
- Substance abuse within 12 months prior to screening
- Familial or personal history of congenital bone disorders, bone metabolism
alterations, or osteopenia
- Treatment with investigational therapy 28 days prior to initiation of study drug
- Liver or kidney disease as defined by the protocol
- National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events
(CTCAE) v5.0 grade >/=3 toxicities attributed to any prior therapy such as
radiotherapy (excluding alopecia), which have not shown improvement and are strictly
considered to interfere with alectinib
- Co-administration of anti-cancer therapies other than those administered in this
study
- Active hepatitis B or C virus (HBV, HBC), or known HIV-positivity or AIDS-related
illness
- Any clinically significant concomitant disease or condition that could interfere
with, or for which the treatment might interfere with, the conduct of the study or
the absorption of oral medications or that would, in the opinion of the Principal
Investigator, pose an unacceptable risk to the participant in this study
- Any psychological, familial, sociological, or geographical condition potentially
hampering compliance with the study protocol requirements and/or follow-up
procedures; such conditions should be discussed with the participant before trial
entry
- Planned procedure or surgery during the study except as permitted treatment as
defined by the protocol
- Infection considered by the investigator to be clinically uncontrolled or of
unacceptable risk to the participant upon induction of neutropenia, including
participants who are, or should be, on antimicrobial agents for the treatment as
active infection
- Pregnant or breastfeeding, or intending to become pregnant during the study or
within 3 months after the final dose of alectinib
- Histologically confirmed diagnosis of CNS or solid tumors with documented evidence
of ALK gene fusions as assessed centrally through the use of the investigational
F1CDx assay or based on pre-existing NGS test results
- Disease status: prior treatment proven to be ineffective (i.e. relapsed or
refractory), or for whom there is no satisfactory standard treatment available.
Disease should be measurable and evaluable as defined by Response Evaluation
Criteria in Solid Tumors (RECIST) v 1.1, or Response Assessment in Neuro-oncology
criteria (RANO) +/- bone marrow criteria for primary CNS tumors or International
Neuroblastoma Response Criteria (INRC)
- Available tumor tissue for submission to the Sponsor from active disease, obtained
subsequent to last anti-cancer therapy regiment administered and obtained prior to
study enrollment, or willingness to undergo a core or excisional biopsy sample
collection prior to enrollment
- For participants < 16 years old, Lansky Performance Status >/= 50%
- For participants >/= 16 years old, Karnofsky Performance Status >/= 50%
- Adequate bone marrow function as defined by the protocol within at least 28 days
prior to initiation of study drug
- Participant and/or caregiver willingness and ability to complete clinical outcome
assessments throughout the study using either electronic, paper, or interviewer
methods
- For females of childbearing potential: agreement to remain abstinent (refrain from
heterosexual intercourse) or use contraception, and agreement to refrain from
donating eggs, as defined by the protocol
- For males who are not surgically sterile: agreement to remain abstinent (refrain
from heterosexual intercourse) or use contraception, and agreement to refrain from
donating sperm, as defined by the protocol
Exclusion Criteria
- Medical history of: prior use of ALK inhibitors; diagnosis of Anaplastic Large Cell
Lymphoma (ALCL); any gastrointestinal disorder that may affect absorption of oral
medications, such as mal-absorption syndrome or status post-major bowel resection;
history of organ transplant; stem cell infusions as defined by the protocol
- Substance abuse within 12 months prior to screening
- Familial or personal history of congenital bone disorders, bone metabolism
alterations, or osteopenia
- Treatment with investigational therapy 28 days prior to initiation of study drug
- Liver or kidney disease as defined by the protocol
- National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events
(CTCAE) v5.0 grade >/=3 toxicities attributed to any prior therapy such as
radiotherapy (excluding alopecia), which have not shown improvement and are strictly
considered to interfere with alectinib
- Co-administration of anti-cancer therapies other than those administered in this
study
- Active hepatitis B or C virus (HBV, HBC), or known HIV-positivity or AIDS-related
illness
- Any clinically significant concomitant disease or condition that could interfere
with, or for which the treatment might interfere with, the conduct of the study or
the absorption of oral medications or that would, in the opinion of the Principal
Investigator, pose an unacceptable risk to the participant in this study
- Any psychological, familial, sociological, or geographical condition potentially
hampering compliance with the study protocol requirements and/or follow-up
procedures; such conditions should be discussed with the participant before trial
entry
- Planned procedure or surgery during the study except as permitted treatment as
defined by the protocol
- Infection considered by the investigator to be clinically uncontrolled or of
unacceptable risk to the participant upon induction of neutropenia, including
participants who are, or should be, on antimicrobial agents for the treatment as
active infection
- Pregnant or breastfeeding, or intending to become pregnant during the study or
within 3 months after the final dose of alectinib