Clinical trial NCT04644315: A Home-Based Approach Study to Evaluate the Efficacy and Safety of Alectinib in Locally-Advanced or Metastatic ALK-Positive Solid Tumors
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
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
Keywords: agnostic
ALK+
Alk-positive
ALK positive
ALK mutation
GI
breast
sarcoma
neuroendocrine
female reproductive
ALK
ALK fusions
ALK gene rearrangements
colorectal cancer
entrectinib
basket study
salivary gland cancers
primary brain tumors
melanoma
sarcomas
papillary thyroid cancer
renal cell cancer
pancreatic cancer
breast cancer
cholangiocarcinoma
head & neck cancers
ovarian cancer
anaplastic lymphoma kinase positive
solid tumors
ALK+ solid tumors
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2020-11-25
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility 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 \</= 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

Primary outcomes:
measure: Confirmed Objective Response Rate (ORR) as Determined by the Investigator Per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
timeFrame: Approximately 1 year
Secondary outcomes:
measure: Confirmed ORR as Determined by Blinded Independent Center Review (BICR) Per RECIST v1.1
timeFrame: 0 days
measure: Duration of Response (DOR) as Determined by Both the Investigator and by BICR Per RECIST v1.1
timeFrame: From first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first (up to 5 years)
measure: Progression-Free Survival (PFS) as Determined by Both the Investigator and by BICR Per RECIST v1.1
timeFrame: From first dose of alectinib to disease progression or death from any cause, whichever occurs first (up to 5 years)
measure: Central Nervous System (CNS) ORR by BICR Per RECIST v1.1
timeFrame: Baseline up to 5 years
measure: CNS DOR by BICR Per RECIST v1.1
timeFrame: From the first observation of CNS response to the first observation of CNS progression or death from any cause (up to 5 years)
measure: Overall Survival (OS)
timeFrame: From the first dose of study drug to death from any cause (up to 5 years)
measure: Percentage of Participants With Adverse Events (AEs)
timeFrame: Approximately 1 year
measure: Percentage of Participants With Serious Adverse Events (SAEs)
timeFrame: Approximately 1 year
measure: Plasma Concentration of Alectinib
timeFrame: Baseline up to 5 years
measure: ORR in Participants With Primary CNS Tumors as Determined by Both BICR and the Investigator Per Response Assessment in Neuro-Oncology (RANO) Criteria
timeFrame: Up to 5 years
measure: DOR in Participants With Primary CNS Tumors as Determined by Both BICR and the Investigator Per RANO Criteria
timeFrame: From first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first (up to 5 years)
measure: PFS in Participants With Primary CNS Tumors as Determined by Both BICR and the Investigator Per RANO Criteria
timeFrame: From first dose of alectinib to disease progression or death from any cause, whichever occurs first (up to 5 years)
measure: OS in Participants With Primary CNS Tumors
timeFrame: From the first dose of study drug to death from any cause (up to 5 years)
Other outcomes:
Locations:
city: Culver City
country: United States
facility: Science 37, Inc
state: California
city: Culver City
country: United States
facility: Science 37-Basem; Dept 004- Basem
state: California
city: Culver City
country: United States
facility: Science 37-Beg; Dept 001 Dr. M. Beg
state: California
city: Culver City
country: United States
facility: Science 37-Cannon; Dept 002-Cannon
state: California
city: Culver City
country: United States
facility: Science 37-Kurzrock; Dept 005-Kurzrock
state: California
city: Culver City
country: United States
facility: Science 37-Thomas; Dept 006-Thomas
state: California
city: Los Angeles
country: United States
facility: Homebased Telemedicine
state: California
city: Sacramento
country: United States
facility: Homebased Telemedicine
state: California
city: San Diego
country: United States
facility: Homebased Telemedicine
state: California
city: San Francisco
country: United States
facility: Homebased Telemedicine
state: California
city: San Jose
country: United States
facility: Homebased Telemedicine
state: California
city: Jacksonville
country: United States
facility: Homebased Telemedicine
state: Florida
city: Miami
country: United States
facility: Homebased Telemedicine
state: Florida
city: Orlando
country: United States
facility: Homebased Telemedicine
state: Florida
city: Tampa
country: United States
facility: Homebased Telemedicine
state: Florida
city: Fort Wayne
country: United States
facility: Homebased Telemedicine
state: Indiana
city: Indianapolis
country: United States
facility: Homebased Telemedicine
state: Indiana
city: Minneapolis
country: United States
facility: Homebased Telemedicine
state: Minnesota
city: Saint Paul
country: United States
facility: Homebased Telemedicine
state: Minnesota
city: Saint Louis
country: United States
facility: Homebased Telemedicine
state: Missouri
city: Buffalo
country: United States
facility: Homebased Telemedicine
state: New York
city: New York
country: United States
facility: Homebased Telemedicine
state: New York
city: Philadelphia
country: United States
facility: Homebased Telemedicine
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Homebased Telemedicine
state: Pennsylvania
city: Austin
country: United States
facility: Homebased Telemedicine
state: Texas
city: Dallas
country: United States
facility: Homebased Telemedicine
state: Texas
city: Houston
country: United States
facility: Homebased Telemedicine
state: Texas
city: Richmond
country: United States
facility: Homebased Telemedicine
state: Virginia
city: Virginia Beach
country: United States
facility: Homebased Telemedicine
state: Virginia
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: