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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
Date last updated
17/04/2024

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
Not applicable
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
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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
This study will evaluate the Long-Term Safety and Tolerability of Atogepant 60 mg daily for the Prevention of Migraine in Participants with Chronic or Episodic Migraine
Trial website
https://clinicaltrials.gov/study/NCT04686136
Trial related presentations / publications
Lorthiois E, Gerspacher M, Beyer KS, Vaupel A, Leblanc C, Stringer R, Weiss A, Wilcken R, Guthy DA, Lingel A, Bomio-Confaglia C, Machauer R, Rigollier P, Ottl J, Arz D, Bernet P, Desjonqueres G, Dussauge S, Kazic-Legueux M, Lozac'h MA, Mura C, Sorge M, Todorov M, Warin N, Zink F, Voshol H, Zecri FJ, Sedrani RC, Ostermann N, Brachmann SM, Cotesta S. JDQ443, a Structurally Novel, Pyrazole-Based, Covalent Inhibitor of KRASG12C for the Treatment of Solid Tumors. J Med Chem. 2022 Dec 22;65(24):16173-16203. doi: 10.1021/acs.jmedchem.2c01438. Epub 2022 Nov 18.
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04686136