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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04686136




Registration number
NCT04686136
Ethics application status
Date submitted
21/12/2020
Date registered
28/12/2020

Titles & IDs
Public title
A Long-Term Safety and Tolerability Extension Study Evaluating Atogepant for the Prevention of Chronic or Episodic Migraine
Scientific title
A Phase 3, Multicenter, Open-Label 156-Week Extension Study To Evaluate The Long-Term Safety And Tolerability Of Oral Atogepant For The Prevention Of Migraine In Participants With Chronic Or Episodic Migraine
Secondary ID [1] 0 0
2020-002470-27
Secondary ID [2] 0 0
3101-312-002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lung Cancer 0 0
Episodic Migraine 0 0
Chronic Migraine 0 0
Neoplasms, Lung 0 0
Neoplasms, Pulmonary 0 0
Pulmonary Cancer 0 0
Pulmonary Neoplasms 0 0
Condition category
Condition code
Neurological 0 0 0 0
Other neurological disorders
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell
Cancer 0 0 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Atogepant 60 mg
Treatment: Drugs - JDQ443
Treatment: Drugs - TNO155
Treatment: Other - tislelizumab

Experimental: Atogepant 60 mg - Taken once daily

Experimental: Arm A - JDQ443

Experimental: Arm B - JDQ443 in combination with TNO155

Experimental: Arm C - JDQ443 in combination with tislelizumab

Experimental: Arm D - JDQ443 in combination with TNO155 and tislelizumab


Treatment: Drugs: Atogepant 60 mg
Tablets containing 60 mg of Atogepant

Treatment: Drugs: JDQ443
KRAS G12C inhibitor

Treatment: Drugs: TNO155
SHP2 inhibitor

Treatment: Other: tislelizumab
Anti PD1 antibody
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants with at Least 1 Treatment Emergent Adverse Event
Timepoint [1] 0 0
156 weeks
Primary outcome [2] 0 0
Dose Escalation: Incidence and severity of dose limiting toxicities (DLTs) during the first cycle of monotherapy or combination treatment
Timepoint [2] 0 0
21 days
Primary outcome [3] 0 0
Dose Escalation: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
Timepoint [3] 0 0
24 months
Primary outcome [4] 0 0
Dose Escalation: Frequency of dose interruptions and reductions, by treatment
Timepoint [4] 0 0
24 months
Primary outcome [5] 0 0
Dose Escalation: Dose intensity by treatment
Timepoint [5] 0 0
24 months
Primary outcome [6] 0 0
Dose Expansion: Overall response rate (ORR) per RECIST v1.1, by treatment
Timepoint [6] 0 0
24 months
Primary outcome [7] 0 0
Dose expansion: Overall intracranial response rate (OIRR) per mRANO-BM
Timepoint [7] 0 0
24 months
Primary outcome [8] 0 0
Dose expansion: Incidence and severity of AEs and SAEs
Timepoint [8] 0 0
24 months
Primary outcome [9] 0 0
Dose expansion: frequency of dose interruptions and reductions, by treatment
Timepoint [9] 0 0
24 months
Primary outcome [10] 0 0
Dose expansion: Dose intensity by treatment
Timepoint [10] 0 0
24 months
Primary outcome [11] 0 0
Dose expansion: ORR per RECIST 1.1 of JDQ443 single agent in patients with non-small cell lung cancer (JDQ443 dose randomization group only)
Timepoint [11] 0 0
24 months
Secondary outcome [1] 0 0
Percentage of Participants with Clinically Significant Laboratory Values (Chemistry, Hematology, Urinalysis) as assessed by the Investigator
Timepoint [1] 0 0
156 weeks
Secondary outcome [2] 0 0
Percentage of Participants with Clinically Significant Electrocardiograms (ECGs) Findings as assessed by the Investigator
Timepoint [2] 0 0
156 weeks
Secondary outcome [3] 0 0
Percentage of Participants with Clinically Significant Vital Sign Measurements as assessed by the Investigator
Timepoint [3] 0 0
156 weeks
Secondary outcome [4] 0 0
Columbia-Suicide Severity Rating Scale (C-SSRS) Assessing Suicidal Ideation and Behaviour using 5-Point Scales
Timepoint [4] 0 0
156 weeks
Secondary outcome [5] 0 0
Dose Escalation and Expansion: ORR per RECIST v1.1
Timepoint [5] 0 0
24 months
Secondary outcome [6] 0 0
Dose Escalation and Expansion: Best Overall Response (BOR) per RECIST v1.1
Timepoint [6] 0 0
24 months
Secondary outcome [7] 0 0
Dose Escalation and Expansion: Progression-free survival (PFS) per RECIST v1.1, Overall Survival (OS)
Timepoint [7] 0 0
24 months
Secondary outcome [8] 0 0
Dose Escalation and Expansion: Duration of Response (DOR) per RECIST v1.1
Timepoint [8] 0 0
24 months
Secondary outcome [9] 0 0
Dose Escalation and Expansion: Disease Control Rate (DCR) per RECIST v1.1
Timepoint [9] 0 0
24 months
Secondary outcome [10] 0 0
Dose Escalation and Expansion: Plasma or serum concentration vs time profiles (AUC) by treatment
Timepoint [10] 0 0
Up to 24 months
Secondary outcome [11] 0 0
Dose Escalation and Expansion: Plasma concentration (Cmax) by treatment
Timepoint [11] 0 0
Up to 24 months
Secondary outcome [12] 0 0
Dose Escalation and Expansion: Time to achieve Cmax (Tmax) by treatment
Timepoint [12] 0 0
Up to 24 months
Secondary outcome [13] 0 0
Dose Escalation and Expansion: Antidrug antibody (ADA) incidence by treatment
Timepoint [13] 0 0
Up to 24 months
Secondary outcome [14] 0 0
Dose Expansion: Dose intensity by treatment
Timepoint [14] 0 0
24 months
Secondary outcome [15] 0 0
Dose Expansion: Frequency of dose interruptions and reductions, by treatment
Timepoint [15] 0 0
24 months
Secondary outcome [16] 0 0
Dose Expansion: Incidence and severity of dose limiting toxicities (DLTs) during the first cycle of monotherapy or combination treatment
Timepoint [16] 0 0
21 days
Secondary outcome [17] 0 0
Dose Expansion: Incidence and severity of AEs and SAEs by treatment
Timepoint [17] 0 0
24 months
Secondary outcome [18] 0 0
Dose expansion: Intracranial disease control rate (IDCR) per mRANO-BM
Timepoint [18] 0 0
24 months
Secondary outcome [19] 0 0
Dose expansion: Best overall intracranial response (BOIR) per mRANO-BM
Timepoint [19] 0 0
24 months
Secondary outcome [20] 0 0
Dose expansion: Intracranial progression free survival (IPFS) per mRANO-BM
Timepoint [20] 0 0
24 months
Secondary outcome [21] 0 0
Dose expansion: Duration of intracranial response (DOIR) per mRANO-BM
Timepoint [21] 0 0
24 months

Eligibility
Key inclusion criteria
- Eligible participants who completed Visit 7, and Visit 8 if applicable, of Study 3101-303-002 or Study 3101-304-002 without significant protocol deviations and who did not experience an Adverse Event that may indicate an unacceptable safety risk.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Participants requiring any medication, diet, or nonpharmacological treatment on the list of prohibited concomitant medications or treatments that cannot be discontinued or switched to an allowable alternative.
* Participants with an ECG indicating clinically significant abnormalities at Visit 1.
* Participants with hypertension at Visit 1.
* Participants with a significant risk of self-harm, or of harm to others; participants who report suicidal ideation with intent, with or without a plan, since the last visit, must be excluded.
* Participants with clinically significant hematologic, endocrine, cardiovascular, pulmonary, renal, hepatic, gastrointestinal, or neurologic disease.

Study design
Purpose of the study
Treatment
Allocation to intervention
NA
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
19/02/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
8/10/2025
Actual
Sample size
Target
Accrual to date
Final
596
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Novartis Investigative Site - Melbourne
Recruitment postcode(s) [1] 0 0
3000 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Indiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Kansas
Country [8] 0 0
United States of America
State/province [8] 0 0
Louisiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Maryland
Country [10] 0 0
United States of America
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Massachusetts
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United States of America
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Minnesota
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United States of America
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Mississippi
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United States of America
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Missouri
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United States of America
State/province [14] 0 0
Nebraska
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United States of America
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New Mexico
Country [16] 0 0
United States of America
State/province [16] 0 0
New York
Country [17] 0 0
United States of America
State/province [17] 0 0
North Carolina
Country [18] 0 0
United States of America
State/province [18] 0 0
Ohio
Country [19] 0 0
United States of America
State/province [19] 0 0
Pennsylvania
Country [20] 0 0
United States of America
State/province [20] 0 0
Tennessee
Country [21] 0 0
United States of America
State/province [21] 0 0
Texas
Country [22] 0 0
United States of America
State/province [22] 0 0
Utah
Country [23] 0 0
United States of America
State/province [23] 0 0
Virginia
Country [24] 0 0
United States of America
State/province [24] 0 0
Washington
Country [25] 0 0
Canada
State/province [25] 0 0
Alberta
Country [26] 0 0
Canada
State/province [26] 0 0
British Columbia
Country [27] 0 0
Canada
State/province [27] 0 0
Ontario
Country [28] 0 0
Canada
State/province [28] 0 0
Quebec
Country [29] 0 0
Czechia
State/province [29] 0 0
Hradec Kralove
Country [30] 0 0
Czechia
State/province [30] 0 0
Kladno
Country [31] 0 0
Czechia
State/province [31] 0 0
Ostrava
Country [32] 0 0
Czechia
State/province [32] 0 0
Pardubice
Country [33] 0 0
Czechia
State/province [33] 0 0
Plzen
Country [34] 0 0
Czechia
State/province [34] 0 0
Prague 10
Country [35] 0 0
Czechia
State/province [35] 0 0
Prague
Country [36] 0 0
Czechia
State/province [36] 0 0
Praha
Country [37] 0 0
Czechia
State/province [37] 0 0
Rychnov nad Kneznou
Country [38] 0 0
Czechia
State/province [38] 0 0
Zlin
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Denmark
State/province [39] 0 0
Hovedstaden
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France
State/province [40] 0 0
Alpes-Maritimes
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France
State/province [41] 0 0
Bouches-du-Rhone
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France
State/province [42] 0 0
Bron
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France
State/province [43] 0 0
Clermont Ferrand
Country [44] 0 0
France
State/province [44] 0 0
Paris
Country [45] 0 0
France
State/province [45] 0 0
St-Priest-en-Jarez
Country [46] 0 0
Germany
State/province [46] 0 0
Niedersachsen
Country [47] 0 0
Germany
State/province [47] 0 0
Berlin
Country [48] 0 0
Germany
State/province [48] 0 0
Essen
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Germany
State/province [49] 0 0
Kassel
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Germany
State/province [50] 0 0
Kiel
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Germany
State/province [51] 0 0
Leipzig
Country [52] 0 0
Germany
State/province [52] 0 0
Ulm
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Germany
State/province [53] 0 0
Unterhaching
Country [54] 0 0
Germany
State/province [54] 0 0
Westerstede
Country [55] 0 0
Germany
State/province [55] 0 0
Wiesbaden
Country [56] 0 0
Hungary
State/province [56] 0 0
Heves
Country [57] 0 0
Hungary
State/province [57] 0 0
Somogy
Country [58] 0 0
Hungary
State/province [58] 0 0
Budapest
Country [59] 0 0
Italy
State/province [59] 0 0
L Aquila
Country [60] 0 0
Italy
State/province [60] 0 0
Roma
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Italy
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Florence
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Italy
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Milano
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Italy
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Pavia
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Korea, Republic of
State/province [64] 0 0
Gyeonggido
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Korea, Republic of
State/province [65] 0 0
Seoul Teugbyeolsi
Country [66] 0 0
Korea, Republic of
State/province [66] 0 0
Busan
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Korea, Republic of
State/province [67] 0 0
Seoul
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Korea, Republic of
State/province [68] 0 0
???
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Netherlands
State/province [69] 0 0
Nijmegen
Country [70] 0 0
Netherlands
State/province [70] 0 0
Terneuzen
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Poland
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Kujawsko-pomorskie
Country [72] 0 0
Poland
State/province [72] 0 0
Lubelskie
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Malopolskie
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Poland
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Pomorskie
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Poland
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Slaskie
Country [76] 0 0
Poland
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Wielkopolskie
Country [77] 0 0
Poland
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Zachodniopomorskie
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Poland
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Wroclaw
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Spain
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Navarra
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Spain
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Barcelona
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Spain
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Sevilla
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Spain
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Valladolid
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Taiwan
State/province [83] 0 0
Taipei
Country [84] 0 0
Taiwan
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Taichung City
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Taiwan
State/province [85] 0 0
Tainan City
Country [86] 0 0
Taiwan
State/province [86] 0 0
Taipei City
Country [87] 0 0
United Kingdom
State/province [87] 0 0
London
Country [88] 0 0
United States of America
State/province [88] 0 0
Oregon
Country [89] 0 0
Belgium
State/province [89] 0 0
Leuven
Country [90] 0 0
China
State/province [90] 0 0
Fujian
Country [91] 0 0
China
State/province [91] 0 0
Guangdong
Country [92] 0 0
China
State/province [92] 0 0
Jiangxi
Country [93] 0 0
China
State/province [93] 0 0
Beijing
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Denmark
State/province [94] 0 0
Copenhagen
Country [95] 0 0
France
State/province [95] 0 0
Lyon
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France
State/province [96] 0 0
Marseille
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France
State/province [97] 0 0
Villejuif
Country [98] 0 0
Germany
State/province [98] 0 0
Dresden
Country [99] 0 0
Germany
State/province [99] 0 0
Freiburg
Country [100] 0 0
Germany
State/province [100] 0 0
Koeln
Country [101] 0 0
Hong Kong
State/province [101] 0 0
Hong Kong
Country [102] 0 0
Italy
State/province [102] 0 0
BS
Country [103] 0 0
Italy
State/province [103] 0 0
MI
Country [104] 0 0
Japan
State/province [104] 0 0
Aichi
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Japan
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Chiba
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Japan
State/province [106] 0 0
Kanagawa
Country [107] 0 0
Japan
State/province [107] 0 0
Osaka
Country [108] 0 0
Japan
State/province [108] 0 0
Tokyo
Country [109] 0 0
Netherlands
State/province [109] 0 0
Amsterdam
Country [110] 0 0
Singapore
State/province [110] 0 0
Singapore
Country [111] 0 0
Spain
State/province [111] 0 0
Andalucia
Country [112] 0 0
Spain
State/province [112] 0 0
Catalunya
Country [113] 0 0
Spain
State/province [113] 0 0
Comunidad Valenciana
Country [114] 0 0
Spain
State/province [114] 0 0
Galicia
Country [115] 0 0
Spain
State/province [115] 0 0
Madrid
Country [116] 0 0
Taiwan
State/province [116] 0 0
Tainan
Country [117] 0 0
Mexico
State/province [117] 0 0
Ciudad de mexico
Country [118] 0 0
Netherlands
State/province [118] 0 0
Leiden
Country [119] 0 0
New Zealand
State/province [119] 0 0
Auckland
Country [120] 0 0
Norway
State/province [120] 0 0
Oslo
Country [121] 0 0
Russian Federation
State/province [121] 0 0
Moscow
Country [122] 0 0
Russian Federation
State/province [122] 0 0
Saint Petersburg
Country [123] 0 0
Russian Federation
State/province [123] 0 0
Tomsk
Country [124] 0 0
Turkey
State/province [124] 0 0
Istanbul
Country [125] 0 0
United Kingdom
State/province [125] 0 0
Birmingham
Country [126] 0 0
United Kingdom
State/province [126] 0 0
Glasgow

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AbbVie
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Nippon Shinyaku Co., Ltd.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
ABBVIE INC.
Address 0 0
AbbVie
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
Available to whom?
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://vivli.org/ourmember/abbvie/


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04686136