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

Conditions

• ALK Fusion-positive Solid or CNS Tumors

Eligibility Criteria

Sex

ALL

Age

N/A - 17 Years

Healthy Volunteers

Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date

Sep 14, 2021

Status verified

Jun 2026

Primary completion

Feb 28, 2032

Completion

Feb 28, 2032

Study Design

Enrollment

42 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: ALK-Fusion Positive
  Part 1 is a dose-confirmation phase to confirm the recommended phase 2 dose (RP2D). In Parts 2 and 3, participants will receive alectinib at the RP2D on Days 1-28 of each 28-day cycle

Primary Outcome Measure

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

Central Contacts

• Reference Study ID Number: GO42286 https://forpatients.roche.com/
  888-662-6728
  [email protected]
• Fastest response: use the inquiry form. No email attachments. https://www.gene.com/contact-us/submit-medical-inquiry

Locations (7)

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