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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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Histologically confirmed ALK-positive locally-advanced or metastatic solid tumor excluding lung cancer.
  • - ALK-positive tumor as per Foundation Medicine, Inc (FMI) next-generation sequencing (NGS) (NGS F1CDx, F1LCDx, or F1HEME) or per local accredited laboratory using validated NGS testing of tumor tissue or peripheral blood.
  • - No alternative effective standard therapy available, or standard therapy considered unsuitable or intolerable to the participant.
  • - Other cancer therapies are allowed, including investigational drugs, if any treatment-related toxicities (excluding alopecia) have resolved to grade
  • - Measurable disease at baseline as assessed by the Investigator per RECIST v1.1 or RANO criteria (for participants with primary CNS tumors) - Life expectancy of at least 12 weeks.
  • - Eastern cooperative oncology group (ECOG) performance status of 0-2.
  • - Adequate hemataologic, hepatic, and renal function.
  • - Participants with primary central nervous system (CNS) tumors are available.
  • - Participants with brain or leptomeningeal metastasis are allowed in the study if asymptomatic and if they meet additional criteria as defined by the protocol.
  • - Willingness to comply with study procedures.
  • - Willingness to comply with home-base approach and visits by Mobile Nurses.
  • - Ability to swallow alectinib capsules intact.
  • - Women of childbearing potential must test negative for pregnancy at screening and prior to the first dose of study drug.
  • - Women of childbearing potential must agree to remain abstinent or use contraceptive methods as defined by the protocol and refrain from donating eggs during the treatment period and for at least 90 days after the last dose of alectinib.
  • - Men must agree to remain abstinent or use contraceptive methods as defined by the protocol and refrain from donating sperm during the treatment period and for at least 90 days after the last dose of alectinib.

Exclusion Criteria:

  • - Pregnant or breastfeeding, or intending to become pregnant during the study or within 3 months after the final dose of alectinib.
  • - Lung Cancer.
  • - Patients with one of the following ALK point mutations: I1171X, G1202R, V1180L.
  • - Prior therapy with an ALK inhibitor.
  • - Liver disease as described in the protocol.
  • - Known HIV, hepatitis B, or hepatitis C (HCV) infection.
  • - Patients with symptomatic bradycardia.
  • - Patients with symptomatic or unstable brain metastasis; patients with primary CNS tumors are allowed.
  • - Malabsorption syndrome or any other condition that would interfere with enteral absorption.
  • - Incomplete recovery from any surgery prior to treatment.
  • - Any other malignancies within 5 years prior to enrollment, except for those described in the protocol.
  • - Any serious medical condition or abnormality in clinical laboratory tests that, in the Investigator's judgment, precludes the patient's safe participation in and completion of the study.
- History of hypersensitivity to any of the ingredients in the alectinib drug formulation

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04644315
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Hoffmann-La Roche
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Clinical Trials
Principal Investigator Affiliation Hoffmann-La Roche
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

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
Arms & Interventions

Arms

Experimental: ALK-positive Solid Tumors

Participants with locally advanced or metastatic ALK-positive tumors will receive alectinib twice daily (BID) until disease progression, unacceptable toxicity, death, or withdrawal from the study for any reason.

Interventions

Drug: - Alectinib

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Science 37, Inc, Culver City, California

Status

Active, not recruiting

Address

Science 37, Inc

Culver City, California, 90230

Science 37, Inc, Culver City, California

Status

Completed

Address

Science 37, Inc

Culver City, California, 90230

Science 37, Inc, Culver City, California

Status

Recruiting

Address

Science 37, Inc

Culver City, California, 90230

Homebased Telemedicine, Los Angeles, California

Status

Recruiting

Address

Homebased Telemedicine

Los Angeles, California, 90013

Homebased Telemedicine, Sacramento, California

Status

Recruiting

Address

Homebased Telemedicine

Sacramento, California, 95814

Homebased Telemedicine, San Diego, California

Status

Recruiting

Address

Homebased Telemedicine

San Diego, California, 92101

Homebased Telemedicine, San Francisco, California

Status

Recruiting

Address

Homebased Telemedicine

San Francisco, California, 94104

Homebased Telemedicine, San Jose, California

Status

Recruiting

Address

Homebased Telemedicine

San Jose, California, 95110

Homebased Telemedicine, Jacksonville, Florida

Status

Recruiting

Address

Homebased Telemedicine

Jacksonville, Florida, 32202

Homebased Telemedicine, Miami, Florida

Status

Recruiting

Address

Homebased Telemedicine

Miami, Florida, 33132

Homebased Telemedicine, Orlando, Florida

Status

Recruiting

Address

Homebased Telemedicine

Orlando, Florida, 32801

Homebased Telemedicine, Tampa, Florida

Status

Recruiting

Address

Homebased Telemedicine

Tampa, Florida, 33601

Homebased Telemedicine, Fort Wayne, Indiana

Status

Recruiting

Address

Homebased Telemedicine

Fort Wayne, Indiana, 46802

Homebased Telemedicine, Indianapolis, Indiana

Status

Recruiting

Address

Homebased Telemedicine

Indianapolis, Indiana, 46202

Homebased Telemedicine, Minneapolis, Minnesota

Status

Recruiting

Address

Homebased Telemedicine

Minneapolis, Minnesota, 55401

Homebased Telemedicine, Saint Paul, Minnesota

Status

Recruiting

Address

Homebased Telemedicine

Saint Paul, Minnesota, 55155

Homebased Telemedicine, Saint Louis, Missouri

Status

Recruiting

Address

Homebased Telemedicine

Saint Louis, Missouri, 63103

Homebased Telemedicine, Buffalo, New York

Status

Recruiting

Address

Homebased Telemedicine

Buffalo, New York, 14202

Homebased Telemedicine, New York, New York

Status

Recruiting

Address

Homebased Telemedicine

New York, New York, 10038

Homebased Telemedicine, Philadelphia, Pennsylvania

Status

Recruiting

Address

Homebased Telemedicine

Philadelphia, Pennsylvania, 19103

Homebased Telemedicine, Pittsburgh, Pennsylvania

Status

Recruiting

Address

Homebased Telemedicine

Pittsburgh, Pennsylvania, 15282

Homebased Telemedicine, Austin, Texas

Status

Recruiting

Address

Homebased Telemedicine

Austin, Texas, 78701

Homebased Telemedicine, Dallas, Texas

Status

Recruiting

Address

Homebased Telemedicine

Dallas, Texas, 75202

Homebased Telemedicine, Houston, Texas

Status

Recruiting

Address

Homebased Telemedicine

Houston, Texas, 77002

Homebased Telemedicine, Richmond, Virginia

Status

Recruiting

Address

Homebased Telemedicine

Richmond, Virginia, 23220

Homebased Telemedicine, Virginia Beach, Virginia

Status

Recruiting

Address

Homebased Telemedicine

Virginia Beach, Virginia, 23451