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

Phase 1

Recruiting

• Conditions: ALK fusion-positive extracranial solid or primary CNS tumors who have progressed following prior treatment or who have no satisfactory treatment available; MedDRA version: 20.0Level: LLTClassification code: 10025648Term: Malignant mast cell tumors unspecified site extranodal and solid organ sites Class: 10029104; Therapeutic area: Diseases [C] - Neoplasms [C04]

• Registration Number: CTIS2023-504084-17-00
• Lead Sponsor: F. Hoffmann-La Roche AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-06-06
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 55

Inclusion Criteria

Age at study entry <18 years old, 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, Participants with prior treatment proven to be ineffective (relapsed or refractory), or for whom there is no satisfactory treatment available, Participants with tumor tissue availability for submission to the Sponsor from active disease, obtained subsequent to last anti-cancer therapy regimen administered and obtained prior to study enrollment (preferred option), or willing to undergo a core or excisional biopsy sample collection prior to enrollment, Adequate performance status (for participants < 16 years old: Lansky Performance Status should be >= 50% and for participants >= 16 years old: Karnofsky Performance Status should be >= 50%), Participants with adequate end-organ function

Exclusion Criteria

Medical history of prior use of ALK inhibitors, diagnosis of Anaplastic Large Cell Lymphoma (ALCL), any gastrointestinal (GI) disorder that may affect absorption of oral medications, organ transplant, recent stem cell infusions (with or without traumatic brain injury), hypersensitivity to any of the additives in the alectinib drug formulation, substance abuse within 12 months prior to screening, congenital bone disorders, bone metabolism alterations or osteopenia (familial or personal history), treatment with investigational therapy 28 days prior to initiation of study drug, Liver disease as evidenced by abnormal levels of ALT or AST and Bilirubin, Abnormal levels of creatinine or glomerular filtration rate (GFR), 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, Infection considered by the investigator to be clinically uncontrolled or of unacceptable risk to the participant upon induction of neutropenia

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified