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NCT04644315 Clinical Trial

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

Melanoma Clinical Trial

— ALpha-T  

Official title:
A Phase II, Open-Label, Single Arm Decentralized Home-Based Approach Study to Evaluate the Efficacy and Safety of Alectinib in Locally-Advanced or Metastatic ALK-Positive Solid Tumors

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT04644315
Other study ID # BO41929
Secondary ID
Status Terminated
Phase Phase 2
First received
Last updated
Start date May 24, 2021
Est. completion date May 16, 2022

Study information
Verified date July 2023
Source Hoffmann-La Roche
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Terminated
Enrollment 1
Est. completion date May 16, 2022
Est. primary completion date May 16, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 </= 1 or to laboratory values as defined by the protocol - 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

Study Design

Related Conditions & MeSH terms

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

Intervention

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

Locations
Country Name City State
United States Homebased Telemedicine Austin Texas
United States Homebased Telemedicine Buffalo New York
United States Science 37, Inc Culver City California
United States Science 37-Basem; Dept 004- Basem Culver City California
United States Science 37-Beg; Dept 001 Dr. M. Beg Culver City California
United States Science 37-Cannon; Dept 002-Cannon Culver City California
United States Science 37-Kurzrock; Dept 005-Kurzrock Culver City California
United States Science 37-Thomas; Dept 006-Thomas Culver City California
United States Homebased Telemedicine Dallas Texas
United States Homebased Telemedicine Fort Wayne Indiana
United States Homebased Telemedicine Houston Texas
United States Homebased Telemedicine Indianapolis Indiana
United States Homebased Telemedicine Jacksonville Florida
United States Homebased Telemedicine Los Angeles California
United States Homebased Telemedicine Miami Florida
United States Homebased Telemedicine Minneapolis Minnesota
United States Homebased Telemedicine New York New York
United States Homebased Telemedicine Orlando Florida
United States Homebased Telemedicine Philadelphia Pennsylvania
United States Homebased Telemedicine Pittsburgh Pennsylvania
United States Homebased Telemedicine Richmond Virginia
United States Homebased Telemedicine Sacramento California
United States Homebased Telemedicine Saint Louis Missouri
United States Homebased Telemedicine Saint Paul Minnesota
United States Homebased Telemedicine San Diego California
United States Homebased Telemedicine San Francisco California
United States Homebased Telemedicine San Jose California
United States Homebased Telemedicine Tampa Florida
United States Homebased Telemedicine Virginia Beach Virginia

Sponsors (1)
Lead Sponsor Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Confirmed Objective Response Rate (ORR) as Determined by the Investigator Per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) Approximately 1 year
Secondary Confirmed ORR as Determined by Blinded Independent Center Review (BICR) Per RECIST v1.1 0 days
Secondary Duration of Response (DOR) as Determined by Both the Investigator and by BICR Per RECIST v1.1 From first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first (up to 5 years)
Secondary Progression-Free Survival (PFS) as Determined by Both the Investigator and by BICR Per RECIST v1.1 From first dose of alectinib to disease progression or death from any cause, whichever occurs first (up to 5 years)
Secondary Central Nervous System (CNS) ORR by BICR Per RECIST v1.1 Baseline up to 5 years
Secondary CNS DOR by BICR Per RECIST v1.1 From the first observation of CNS response to the first observation of CNS progression or death from any cause (up to 5 years)
Secondary Overall Survival (OS) From the first dose of study drug to death from any cause (up to 5 years)
Secondary Percentage of Participants With Adverse Events (AEs) Approximately 1 year
Secondary Percentage of Participants With Serious Adverse Events (SAEs) Approximately 1 year
Secondary Plasma Concentration of Alectinib Baseline up to 5 years
Secondary ORR in Participants With Primary CNS Tumors as Determined by Both BICR and the Investigator Per Response Assessment in Neuro-Oncology (RANO) Criteria Up to 5 years
Secondary DOR in Participants With Primary CNS Tumors as Determined by Both BICR and the Investigator Per RANO Criteria From first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first (up to 5 years)
Secondary PFS in Participants With Primary CNS Tumors as Determined by Both BICR and the Investigator Per RANO Criteria From first dose of alectinib to disease progression or death from any cause, whichever occurs first (up to 5 years)
Secondary OS in Participants With Primary CNS Tumors From the first dose of study drug to death from any cause (up to 5 years)
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