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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)

Primary Purpose

Neoplasms, Colorectal Neoplasms, Melanoma

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Alectinib
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neoplasms focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Science 37, Inc
  • Science 37-Basem; Dept 004- Basem
  • Science 37-Beg; Dept 001 Dr. M. Beg
  • Science 37-Cannon; Dept 002-Cannon
  • Science 37-Kurzrock; Dept 005-Kurzrock
  • Science 37-Thomas; Dept 006-Thomas
  • Homebased Telemedicine
  • Homebased Telemedicine
  • Homebased Telemedicine
  • Homebased Telemedicine
  • Homebased Telemedicine
  • Homebased Telemedicine
  • Homebased Telemedicine
  • Homebased Telemedicine
  • Homebased Telemedicine
  • Homebased Telemedicine
  • Homebased Telemedicine
  • Homebased Telemedicine
  • Homebased Telemedicine
  • Homebased Telemedicine
  • Homebased Telemedicine
  • Homebased Telemedicine
  • Homebased Telemedicine
  • Homebased Telemedicine
  • Homebased Telemedicine
  • Homebased Telemedicine
  • Homebased Telemedicine
  • Homebased Telemedicine
  • Homebased Telemedicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ALK-positive Solid Tumors

Arm Description

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.

Outcomes

Primary Outcome Measures

Confirmed Objective Response Rate (ORR) as Determined by the Investigator Per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)

Secondary Outcome Measures

Confirmed ORR as Determined by Blinded Independent Center Review (BICR) Per RECIST v1.1
Duration of Response (DOR) as Determined by Both the Investigator and by BICR Per RECIST v1.1
Progression-Free Survival (PFS) as Determined by Both the Investigator and by BICR Per RECIST v1.1
Central Nervous System (CNS) ORR by BICR Per RECIST v1.1
CNS DOR by BICR Per RECIST v1.1
Overall Survival (OS)
Percentage of Participants With Adverse Events (AEs)
Percentage of Participants With Serious Adverse Events (SAEs)
Plasma Concentration of Alectinib
ORR in Participants With Primary CNS Tumors as Determined by Both BICR and the Investigator Per Response Assessment in Neuro-Oncology (RANO) Criteria
DOR in Participants With Primary CNS Tumors as Determined by Both BICR and the Investigator Per RANO Criteria
PFS in Participants With Primary CNS Tumors as Determined by Both BICR and the Investigator Per RANO Criteria
OS in Participants With Primary CNS Tumors

Full Information

First Posted
November 20, 2020
Last Updated
July 17, 2023
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT04644315
Brief Title
A Home-Based Approach Study to Evaluate the Efficacy and Safety of Alectinib in Locally-Advanced or Metastatic ALK-Positive Solid Tumors
Acronym
ALpha-T
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

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Terminated
Why Stopped
The data from this study is no longer needed.
Study Start Date
May 24, 2021 (Actual)
Primary Completion Date
May 16, 2022 (Actual)
Study Completion Date
May 16, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ALK-positive Solid Tumors
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Alectinib
Other Intervention Name(s)
Alecensa
Intervention Description
Participants will receive 600 mg oral alectinib BID until disease progression, unacceptable toxicity, withdrawal from treatment, or death.
Primary Outcome Measure Information:
Title
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
Approximately 1 year
Secondary Outcome Measure Information:
Title
Confirmed ORR as Determined by Blinded Independent Center Review (BICR) Per RECIST v1.1
Time Frame
0 days
Title
Duration of Response (DOR) as Determined by Both the Investigator and by BICR 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)
Title
Progression-Free Survival (PFS) as Determined by Both the Investigator and by BICR 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)
Title
Central Nervous System (CNS) ORR by BICR Per RECIST v1.1
Time Frame
Baseline up to 5 years
Title
CNS DOR by BICR 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)
Title
Overall Survival (OS)
Time Frame
From the first dose of study drug to death from any cause (up to 5 years)
Title
Percentage of Participants With Adverse Events (AEs)
Time Frame
Approximately 1 year
Title
Percentage of Participants With Serious Adverse Events (SAEs)
Time Frame
Approximately 1 year
Title
Plasma Concentration of Alectinib
Time Frame
Baseline up to 5 years
Title
ORR in Participants With Primary CNS Tumors as Determined by Both BICR and the Investigator Per Response Assessment in Neuro-Oncology (RANO) Criteria
Time Frame
Up to 5 years
Title
DOR in Participants With Primary CNS Tumors as Determined by Both BICR 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)
Title
PFS in Participants With Primary CNS Tumors as Determined by Both BICR 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)
Title
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
Science 37, Inc
City
Culver City
State/Province
California
ZIP/Postal Code
90230
Country
United States
Facility Name
Science 37-Basem; Dept 004- Basem
City
Culver City
State/Province
California
ZIP/Postal Code
90230
Country
United States
Facility Name
Science 37-Beg; Dept 001 Dr. M. Beg
City
Culver City
State/Province
California
ZIP/Postal Code
90230
Country
United States
Facility Name
Science 37-Cannon; Dept 002-Cannon
City
Culver City
State/Province
California
ZIP/Postal Code
90230
Country
United States
Facility Name
Science 37-Kurzrock; Dept 005-Kurzrock
City
Culver City
State/Province
California
ZIP/Postal Code
90230
Country
United States
Facility Name
Science 37-Thomas; Dept 006-Thomas
City
Culver City
State/Province
California
ZIP/Postal Code
90230
Country
United States
Facility Name
Homebased Telemedicine
City
Los Angeles
State/Province
California
ZIP/Postal Code
90013
Country
United States
Facility Name
Homebased Telemedicine
City
Sacramento
State/Province
California
ZIP/Postal Code
95814
Country
United States
Facility Name
Homebased Telemedicine
City
San Diego
State/Province
California
ZIP/Postal Code
92101
Country
United States
Facility Name
Homebased Telemedicine
City
San Francisco
State/Province
California
ZIP/Postal Code
94104
Country
United States
Facility Name
Homebased Telemedicine
City
San Jose
State/Province
California
ZIP/Postal Code
95110
Country
United States
Facility Name
Homebased Telemedicine
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32202
Country
United States
Facility Name
Homebased Telemedicine
City
Miami
State/Province
Florida
ZIP/Postal Code
33132
Country
United States
Facility Name
Homebased Telemedicine
City
Orlando
State/Province
Florida
ZIP/Postal Code
32801
Country
United States
Facility Name
Homebased Telemedicine
City
Tampa
State/Province
Florida
ZIP/Postal Code
33601
Country
United States
Facility Name
Homebased Telemedicine
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46802
Country
United States
Facility Name
Homebased Telemedicine
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Homebased Telemedicine
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55401
Country
United States
Facility Name
Homebased Telemedicine
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55155
Country
United States
Facility Name
Homebased Telemedicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63103
Country
United States
Facility Name
Homebased Telemedicine
City
Buffalo
State/Province
New York
ZIP/Postal Code
14202
Country
United States
Facility Name
Homebased Telemedicine
City
New York
State/Province
New York
ZIP/Postal Code
10038
Country
United States
Facility Name
Homebased Telemedicine
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19103
Country
United States
Facility Name
Homebased Telemedicine
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15282
Country
United States
Facility Name
Homebased Telemedicine
City
Austin
State/Province
Texas
ZIP/Postal Code
78701
Country
United States
Facility Name
Homebased Telemedicine
City
Dallas
State/Province
Texas
ZIP/Postal Code
75202
Country
United States
Facility Name
Homebased Telemedicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77002
Country
United States
Facility Name
Homebased Telemedicine
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23220
Country
United States
Facility Name
Homebased Telemedicine
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23451
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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).

Learn more about this trial

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

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