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

Phase 2

Terminated

• Conditions: Melanoma; Pancreatic Neoplasms; Ovarian Neoplasms; Brain Neoplasms; Thyroid Neoplasms; Neuroendocrine Tumors; Salivary Gland Neoplasms; Digestive System Diseases; Neoplasms; Cholangiocarcinoma
• Interventions: Drug: Alectinib

• Registration Number: NCT04644315
• Lead Sponsor: Hoffmann-La Roche

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-11-20
• Study First Submitted QC: 2020-11-20
• Study First Posted: 2020-11-25
• Study Start: 2021-05-24
• Primary Completion: 2022-05-16
• Study Completion: 2022-05-16
• Results First Submitted: 2023-04-21
• Status Verified: 2023-07
• Results First Submitted QC: 2023-07-17
• Last Update Submitted: 2023-07-17
• Results First Posted: 2023-08-07
• Last Update Posted: 2023-08-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ALK-positive Solid Tumors	Alectinib	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Plasma Concentration of Alectinib	Baseline up to 5 years
Confirmed ORR as Determined by Blinded Independent Center Review (BICR) Per RECIST v1.1	0 days
Central Nervous System (CNS) ORR by BICR Per RECIST v1.1	Baseline up to 5 years
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)
Overall Survival (OS)	From the first dose of study drug to death from any cause (up to 5 years)
Percentage of Participants With Adverse Events (AEs)	Approximately 1 year
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)
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)
Percentage of Participants With Serious Adverse Events (SAEs)	Approximately 1 year
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
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)
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)
OS in Participants With Primary CNS Tumors	From the first dose of study drug to death from any cause (up to 5 years)

Trial Locations

Locations (7)

Science 37-Cannon; Dept 002-Cannon; 🇺🇸 Culver City, California, United States

Science 37-Basem; Dept 004- Basem; 🇺🇸 Culver City, California, United States

Science 37, Inc; 🇺🇸 Culver City, California, United States

Homebased Telemedicine; 🇺🇸 Virginia Beach, Virginia, United States

Science 37-Kurzrock; Dept 005-Kurzrock; 🇺🇸 Culver City, California, United States

Science 37-Beg; Dept 001 Dr. M. Beg; 🇺🇸 Culver City, California, United States

Science 37-Thomas; Dept 006-Thomas; 🇺🇸 Culver City, California, United States