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

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ClinicalTrials.gov Identifier: NCT04644315
Recruitment Status : Recruiting
First Posted : November 25, 2020
Last Update Posted : April 1, 2021
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Description
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Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Solid Tumors Drug: Alectinib Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : April 1, 2021
Estimated Primary Completion Date : December 1, 2025
Estimated Study Completion Date : December 1, 2025

Resource links provided by the National Library of Medicine

Drug Information available for: Alectinib

Arms and Interventions
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Arm Intervention/treatment
Experimental: ALK-positive Solid Tumors
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.
 Drug: Alectinib
Participants will receive 600 mg oral alectinib BID until disease progression, unacceptable toxicity, withdrawal from treatment, or death.
Other Name: Alecensa


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. ORR as Determined by an Independent Review Facility per RECIST v1.1 [ Time Frame: From 28 days after initial response up to 5 years ]
  2. 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) ]
  3. 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) ]
  4. Central Nervous System (CNS) ORR per RECIST v1.1 [ Time Frame: Baseline up to 5 years ]
  5. 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) ]
  6. Overall Survival (OS) [ Time Frame: From the first dose of study drug to death from any cause (up to 5 years) ]
  7. Percentage of Participants with Adverse Events (AEs) [ Time Frame: Up to 5 years ]
  8. Percentage of Participants with Serious Adverse Events (SAEs) [ Time Frame: Up to 5 years ]
  9. Plasma Concentration of Alectinib [ Time Frame: At pre-defined intervals from baseline up to 5 years ]
  10. 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 ]
  11. 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) ]
  12. 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) ]
  13. 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) ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04644315


Contacts
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Contact: Reference Study ID Number: BO41929 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 global-roche-genentech-trials@gene.com

Locations
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United States, California
Science 37, Inc Recruiting
Culver City, California, United States, 90230
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
More Information
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT04644315    
Other Study ID Numbers: BO41929
First Posted: November 25, 2020    Key Record Dates
Last Update Posted: April 1, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hoffmann-La Roche:
Agnostic
Additional relevant MeSH terms:
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Neoplasms