JOURNAL ONKOLOGIE – STUDIE

A Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Alectinib in Pediatric Participants With ALK Fusion-Positive Solid or CNS Tumors

Studien-Informationen Einschlusskriterien Studien-Rationale Geprüfte Regime

Rekrutierend

NCT-Nummer:
NCT04774718

Studienbeginn:
September 2021

Letztes Update:
22.04.2024

Wirkstoff:
Alectinib

Indikation (Clinical Trials):
Central Nervous System Neoplasms

Geschlecht:
Alle

Altersgruppe:
Kinder (0-17)

Phase:
-

Sponsor:
Hoffmann-La Roche

Collaborator:
-

Studienleiter

Clinical Trials
Study Director
Hoffmann-LaRoche

Kontakt

Reference Study ID Number: GO42286 https://forpatients.roche.com/
Kontakt:
Phone: 888-662-6728
E-Mail: global-roche-genentech-trials@gene.com» Kontaktdaten anzeigen

Studienlocations
(3 von 29)

Universitätsklinikum Heidelberg; KiTZ Hopp-Kindertumorzentrum
69120 Heidelberg
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps

Lucile Packard Children's Hospital; Division of Child Neurology
94304 Palo Alto
United StatesRekrutierend» Google-Maps

Johns Hopkins All Children's Hospital
33701 Saint Petersburg
United StatesRekrutierend» Google-Maps

University of Michigan, C.S. Mott Children's Hospital
48109 Ann Arbor
United StatesRekrutierend» Google-Maps

Memorial Sloan Kettering Cancer Center
11101 New York
United StatesAktiv, nicht rekrutierend» Google-Maps

Cincinnati Children's Hospital Medical Center
45229 Cincinnati
United StatesRekrutierend» Google-Maps

St. Jude Children'S Research Hospital
38105 Memphis
United StatesRekrutierend» Google-Maps

Sydney Children's Hospital
2031 Randwick
AustraliaAktiv, nicht rekrutierend» Google-Maps

Royal Children's Hospital
3052 Parkville
AustraliaRekrutierend» Google-Maps

The Hospital for Sick Children
M5G 1X8 Toronto
CanadaRekrutierend» Google-Maps

CHU Sainte-Justine
H3T 1C5 Montreal
CanadaRekrutierend» Google-Maps

Beijing Children's Hospital, Capital Medical University
100045 Beijing City
ChinaRekrutierend» Google-Maps

Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
200092 Shanghai
ChinaRekrutierend» Google-Maps

Rigshospitalet; Ny Medicin til Børn med Kræft
2100 København Ø
DenmarkRekrutierend» Google-Maps

Centre Léon Bérard, Institut d?Hémato-Oncologie Pédiatrique
69373 Lyon
FranceRekrutierend» Google-Maps

Hôpital de la Timone, Oncologie Pédiatrique
13385 Marseille
FranceRekrutierend» Google-Maps

Institut Curie - Centre de Lutte Contre le Cancer (CLCC) de Paris; Service d Oncologie Pediatrique
75248 Paris
FranceRekrutierend» Google-Maps

Istituto Giannina Gaslini-Ospedale Pediatrico IRCCS
16147 Genova
ItalyRekrutierend» Google-Maps

Istituto Nazionale Tumori di Milano; S.C. Oncologia Pediatrica
20133 Milano
ItalyRekrutierend» Google-Maps

Dipartimento di Scienze Pediatriche Adolescenza; Osp. Infantile Regina Margherita
10126 Torino
ItalyRekrutierend» Google-Maps

Seoul National University Hospital
03080 Seoul
Korea, Republic ofAktiv, nicht rekrutierend» Google-Maps

Asan Medical Center
05505 Seoul
Korea, Republic ofAktiv, nicht rekrutierend» Google-Maps

Samsung Medical Center
06351 Seoul
Korea, Republic ofRekrutierend» Google-Maps

Hospital Infantil Universitario Nino Jesus
28009 Madrid
SpainRekrutierend» Google-Maps

Hospital Universitari i Politecnic La Fe
46026 Valencia
SpainRekrutierend» Google-Maps

Great Ormond Street Hospital
WC1N 3JH London
United KingdomAktiv, nicht rekrutierend» Google-Maps

Royal Manchester Childrens Hospital
M13 9WL Manchester
United KingdomRekrutierend» Google-Maps

Great North Children's Hospital
NE1 4LP Newcastle upon Tyne
United KingdomRekrutierend» Google-Maps

Royal Marsden Hospital (Sutton)
SM2 5PT Sutton
United KingdomRekrutierend» Google-Maps

Alle anzeigen

Studien-Informationen

Brief Summary:

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.

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

1. Incidence of Participants with Dose-Limited Toxicities (DLTs) (Time Frame - Cycle 1 (cycle length = 28 days))

2. Percentage of Participants with Adverse Events (Time Frame - Up to 10 years)

3. Plasma Concentration of Alectinib (Time Frame - Up to 10 years)

4. Plasma Concentration of Alectinib Metabolite (M4) (Time Frame - Up to 10 years)

5. Confirmed Objective Response Rate (ORR): Defined as the Proportion of Participants with Complete Response (CR) or Partial Response (PR) on two Consecutive Occasions >/= 4 Weeks Apart, as Determined by Blinded Independent Central Review (BICR) (Time Frame - Up to 10 years)

Secondary outcome:

1. Confirmed ORR as Determined by the Investigator (Time Frame - Up to 10 years)

2. Duration of Response (DOR) as Determined by BICR and the Investigator (Time Frame - From the first occurrence of a documented objective response (CR or PR) to disease progression or death from any cause, whichever occurs first (up to 10 years))

3. Time to Response (TTR) as Determined by BICR and the Investigator (Time Frame - From the first dose of alectinib to the first documentation of objective response (CR or PR) (up to 10 years))

4. Clinical Benefit Rate (CBR) as Determined by BICR and the Investigator (Time Frame - 6 months after the first dose of alectinib)

5. Progression-Free Survival (PFS) as Determined by BICR and the Investigator (Time Frame - From the first dose of alectinib to the first occurrence of disease progression or death from any cause, whichever occurs first (up to 10 years))

6. Overall Survival (OS) (Time Frame - From the first dose of alectinib to the date of death due to any cause (up to 10 years))

Geprüfte Regime

Alectinib:
Participants will receive twice-daily alectinib capsules on Days 1-28 of each 28-day cycle

Quelle: ClinicalTrials.gov

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