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
• Status: Terminated
• Phase: Phase 2
• 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
• 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

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)