Clinical Trials /

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

NCT04644315

Description:

This study will evaluate the efficacy and safety of alectinib in patients with Anaplastic Lymphoma Kinase (ALK)-positive locally-advanced or metastatic solid tumors other than lung cancer and Cancer of Unknown Primary (CUP).

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: 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

Clinical Trial IDs

  • ORG STUDY ID: BO41929
  • NCT ID: NCT04644315

Conditions

  • Solid Tumors

Interventions

DrugSynonymsArms
AlectinibAlecensaALK-positive Solid Tumors

Purpose

This study will evaluate the efficacy and safety of alectinib in patients with Anaplastic Lymphoma Kinase (ALK)-positive locally-advanced or metastatic solid tumors other than lung cancer and Cancer of Unknown Primary (CUP).

Trial Arms

NameTypeDescriptionInterventions
ALK-positive Solid TumorsExperimentalParticipants 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.
  • Alectinib

Eligibility Criteria

        Inclusion Criteria:

          -  Histologically confirmed ALK-positive locally-advanced or metastatic solid tumor
             excluding lung cancer and cancer of unknown primary origin (CUP)

          -  ALK-positive tumor as per ALK-positive tumor as per Foundation Medicine, Inc (FMI)
             next-generation sequencing (NGS) (NGS F1CDx or F1LCDx) 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 or CUP

          -  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 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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Confirmed Objective Response Rate (ORR) as Determined by the Investigator per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
Time Frame:From 28 days after initial response up to 5 years
Safety Issue:
Description:

Secondary Outcome Measures

Measure:ORR as Determined by an Independent Review Facility per RECIST v1.1
Time Frame:From 28 days after initial response up to 5 years
Safety Issue:
Description:
Measure:Duration of Response (DOR) per RECIST v1.1
Time Frame:From first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first (up to 5 years)
Safety Issue:
Description:
Measure:Progression-Free Survival (PFS) per RECIST v1.1
Time Frame:From first dose of alectinib to disease progression or death from any cause, whichever occurs first (up to 5 years)
Safety Issue:
Description:
Measure:Central Nervous System (CNS) ORR per RECIST v1.1
Time Frame:Baseline up to 5 years
Safety Issue:
Description:
Measure:CNS DOR per RECIST v1.1
Time Frame:From the first observation of CNS response to the first observation of CNS progression or death from any cause (up to 5 years)
Safety Issue:
Description:
Measure:Overall Survival (OS)
Time Frame:From the first dose of study drug to death from any cause (up to 5 years)
Safety Issue:
Description:
Measure:Percentage of Participants with Adverse Events (AEs)
Time Frame:Up to 5 years
Safety Issue:
Description:
Measure:Percentage of Participants with Serious Adverse Events (SAEs)
Time Frame:Up to 5 years
Safety Issue:
Description:
Measure:Plasma Concentration of Alectinib
Time Frame:At pre-defined intervals from baseline up to 5 years
Safety Issue:
Description:
Measure:ORR in Participants with Primary CNS Tumors as Determined by both an Independent Review Facility and the Investigator per Response Assessment in Neuro-Oncology (RANO) Criteria
Time Frame:Up to 5 years
Safety Issue:
Description:
Measure:DOR in Participants with Primary CNS Tumors as Determined by both an Independent Review Facility and the Investigator per RANO Criteria
Time Frame:From first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first (up to 5 years)
Safety Issue:
Description:
Measure:PFS in Participants with Primary CNS Tumors as Determined by both an Independent Review Facility and the Investigator per RANO Criteria
Time Frame:From first dose of alectinib to disease progression or death from any cause, whichever occurs first (up to 5 years)
Safety Issue:
Description:
Measure:OS in Participants with Primary CNS Tumors
Time Frame:From the first dose of study drug to death from any cause (up to 5 years)
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Hoffmann-La Roche

Trial Keywords

  • Agnostic

Last Updated

April 1, 2021