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A Home-Based Approach Study to Evaluate the Efficacy and Safety of Alectinib in Locally-Advanced or Metastatic ALK-Positive Solid Tumors

NCT04644315 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2023-08-07

Study results available
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Summary

This study will evaluate the efficacy and safety of alectinib in participants with Anaplastic Lymphoma Kinase (ALK)-positive locally advanced or metastatic solid tumors other than lung cancer.

Conditions

  • Neoplasms
  • Colorectal Neoplasms
  • Melanoma
  • Pancreatic Neoplasms
  • Sarcoma
  • Ovarian Neoplasms
  • Brain Neoplasms
  • Thyroid Neoplasms
  • Neuroendocrine Tumors
  • Cholangiocarcinoma
  • Salivary Gland Neoplasms
  • Head and Neck Neoplasms
  • Thyroid Cancer, Papillary
  • Lymphoma, Large-Cell, Anaplastic
  • Neoplasms by Site
  • Respiratory Tract Neoplasms
  • Thoracic Neoplasms
  • Respiratory Tract Diseases
  • Carcinoma, Bronchogenic
  • Bronchial Neoplasms
  • Intestinal Neoplasms
  • Gastrointestinal Neoplasms
  • Digestive System Neoplasms
  • Digestive System Diseases
  • Gastrointestinal Diseases
  • Colonic Diseases
  • Intestinal Diseases
  • Central Nervous System

Interventions

DRUG

Alectinib

Participants will receive 600 mg oral alectinib BID until disease progression, unacceptable toxicity, withdrawal from treatment, or death.

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-24
Primary Completion
2022-05-16
Completion
2022-05-16
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04644315 on ClinicalTrials.gov