NCT04644315|TerminatedPhase 2ResultsFDA Drug

Study Stopped

The data from this study is no longer needed.

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

ALpha-T

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

Hoffmann-La Roche ClinicalTrials.gov

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1 other identifier

BO41929

Study Type

interventional

Target

Locations

1 country

Sites

Timeline

RegisteredNov 2020

StartedMay 2021

CompletionMay 2022

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.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for phase_2

Timeline

Completed

Started May 2021

Shorter than P25 for phase_2

Geographic Reach

1 country

29 active sites

Status

terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

12 months study duration

First Submitted

Initial submission to the registry

November 20, 2020

Completed

5 days until next milestone

First Posted

Study publicly available on registry

November 25, 2020

Completed

6 months until next milestone

Study Start

First participant enrolled

May 24, 2021

Completed

12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 16, 2022

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 16, 2022

Completed

1.2 years until next milestone

Results Posted

Study results publicly available

August 7, 2023

Completed

Last Updated

August 7, 2023

Status Verified

July 1, 2023

Enrollment Period

12 months

First QC Date

November 20, 2020

Results QC Date

April 21, 2023

Last Update Submit

July 17, 2023

Conditions

Keywords

agnosticALK+Alk-positiveALK positiveALK mutationGIbreastsarcomaneuroendocrinefemale reproductiveALKALK fusionsALK gene rearrangementscolorectal cancerentrectinibbasket studysalivary gland cancersprimary brain tumorsmelanomasarcomaspapillary thyroid cancerrenal cell cancerpancreatic cancerbreast cancercholangiocarcinomahead & neck cancersovarian canceranaplastic lymphoma kinase positivesolid tumorsALK+ solid tumors

Outcome Measures

Primary Outcomes (1)

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 Outcomes (13)

Confirmed ORR as Determined by Blinded Independent Center Review (BICR) Per RECIST v1.1
0 days
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)
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)
+8 more secondary outcomes

Study Arms (1)

ALK-positive Solid Tumors

EXPERIMENTAL

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

Interventions

AlectinibDRUG

Participants will receive 600 mg oral alectinib BID until disease progression, unacceptable toxicity, withdrawal from treatment, or death.

Also known as: Alecensa

ALK-positive Solid Tumors

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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
+1 more criteria

You may not qualify if:

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

Contact the study team to confirm eligibility.