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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06450197




Registration number
NCT06450197
Ethics application status
Date submitted
8/05/2024
Date registered
10/06/2024
Date last updated
10/06/2024

Titles & IDs
Public title
Phase IIa Study Evaluating AZD7798 in Crohn's Disease
Scientific title
A Double-blind, Placebo-controlled Phase IIa Study to Evaluate the Efficacy and Safety of AZD7798 in Patients With Moderate to Severe Crohn's Disease
Secondary ID [1] 0 0
D9690C00005
Universal Trial Number (UTN)
Trial acronym
AMALTHEA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Moderate to Severe Crohn's Disease 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Crohn's disease
Diet and Nutrition 0 0 0 0
Obesity
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders
Diet and Nutrition 0 0 0 0
Other diet and nutrition disorders
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - AZD7798
Other interventions - Placebo

Experimental: AZD7798 - AZD7798

Placebo comparator: Placebo - Placebo


Treatment: Drugs: AZD7798
AZD7798

Other interventions: Placebo
Placebo
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
A Composite Endpoint of Normalization or Clinically Significant Improvement in At Least 2 Predefined Weight-Related Comorbidities Present at Screening Without Development of New Predefined Comorbidity or Worsening of Existing Predefined Comorbidity
Timepoint [1] 0 0
Baseline, Week 72
Primary outcome [2] 0 0
CDAI remission
Timepoint [2] 0 0
Week 12
Primary outcome [3] 0 0
5-year rate of any axillary recurrence
Timepoint [3] 0 0
5 years
Primary outcome [4] 0 0
5-year rate of isolated axillary recurrence
Timepoint [4] 0 0
5 years
Primary outcome [5] 0 0
Comparison of 5-year rate of axillary recurrence in patients treated with and without axillary dissection
Timepoint [5] 0 0
5 years
Primary outcome [6] 0 0
Number of Participants with Primary Adverse Events (PAEs)
Timepoint [6] 0 0
7 days post-procedure
Primary outcome [7] 0 0
Number of Participants Reporting Freedom from Documented (Symptomatic and Asymptomatic) Atrial Tachyarrhythmia (Atrial Fibrillation [AF], Atrial Tachycardia [AT] or Atrial Flutter [AFL] of Unknown Origin) Episodes
Timepoint [7] 0 0
Day 91 to Day 365 post-procedure
Secondary outcome [1] 0 0
Endoscopic response
Timepoint [1] 0 0
Week 12
Secondary outcome [2] 0 0
Endoscopic remission
Timepoint [2] 0 0
Week 12
Secondary outcome [3] 0 0
Endoscopic score change from baseline
Timepoint [3] 0 0
Week 12
Secondary outcome [4] 0 0
CDAI response
Timepoint [4] 0 0
Week 12
Secondary outcome [5] 0 0
CDAI score change from baseline
Timepoint [5] 0 0
Week 12
Secondary outcome [6] 0 0
Symptomatic remission
Timepoint [6] 0 0
Week 12
Secondary outcome [7] 0 0
Serum AZD7798 concentration
Timepoint [7] 0 0
Up to 85 days
Secondary outcome [8] 0 0
Incidence of anti-drug antibody response
Timepoint [8] 0 0
Up to 36 weeks
Secondary outcome [9] 0 0
Titre of anti-drug antibody response
Timepoint [9] 0 0
Up to 36 weeks
Secondary outcome [10] 0 0
Percentage of Participants Who Achieve BMI Reduction of = 5%
Timepoint [10] 0 0
Week 72
Secondary outcome [11] 0 0
Percentage of Participants Who Achieve BMI Reduction of = 10%
Timepoint [11] 0 0
Week 72
Secondary outcome [12] 0 0
Percentage of Participants Who Achieve BMI Reduction of = 15%
Timepoint [12] 0 0
Week 72
Secondary outcome [13] 0 0
Percentage of Participants Who Achieve BMI Reduction of = 20%
Timepoint [13] 0 0
Week 72
Secondary outcome [14] 0 0
Change from Baseline in Hemoglobin A1c (HbA1c)
Timepoint [14] 0 0
Baseline, Week 72
Secondary outcome [15] 0 0
Percent Change from Baseline in Triglycerides
Timepoint [15] 0 0
Baseline, Week 72
Secondary outcome [16] 0 0
Change from Baseline in Systolic Blood Pressure (SBP)
Timepoint [16] 0 0
Baseline, Week 72
Secondary outcome [17] 0 0
Change from Baseline in Peripheral Apnea-Hypopnea Index (pAHI)
Timepoint [17] 0 0
Baseline, Week 72
Secondary outcome [18] 0 0
Percent Change from Baseline in Total Body Fat Mass as Determined by Dual energy X-ray Absorptiometry (DXA)
Timepoint [18] 0 0
Baseline, Week 72
Secondary outcome [19] 0 0
Change from Baseline in Diastolic Blood Pressure (DBP)
Timepoint [19] 0 0
Baseline, Week 72
Secondary outcome [20] 0 0
Percent Change from Baseline in Body Weight
Timepoint [20] 0 0
Baseline, Week 72
Secondary outcome [21] 0 0
Change from Baseline in Waist Circumference
Timepoint [21] 0 0
Baseline, Week 72
Secondary outcome [22] 0 0
Proportion of patients with additional micro- and macrometastases removed by axillary lymph node dissection
Timepoint [22] 0 0
5 years
Secondary outcome [23] 0 0
5-year rates of locoregional and any invasive recurrence
Timepoint [23] 0 0
5 years
Secondary outcome [24] 0 0
Comparison of 5-year rate of locoregional and any invasive recurrence in patients treated with and without axillary lymph node dissection
Timepoint [24] 0 0
5 years
Secondary outcome [25] 0 0
Part 1 and 2: Change from baseline in blood pressure [millimetres of mercury (mmHg)]
Timepoint [25] 0 0
Baseline (Day -1) and up to approximately 31 months
Secondary outcome [26] 0 0
Part 1 and 2: Change from baseline in weight [kilogram (kg)]
Timepoint [26] 0 0
Baseline (Day -1) and up to approximately 31 months
Secondary outcome [27] 0 0
Part 1 and 2: Change from baseline in white blood cell count (cells per microliter)
Timepoint [27] 0 0
Baseline (Day -1) and up to approximately 31 months
Secondary outcome [28] 0 0
Part 1 and 2: Change from baseline in hemoglobin (grams per deciliter)
Timepoint [28] 0 0
Baseline (Day -1) and up to approximately 31 months
Secondary outcome [29] 0 0
Part 1 and 2: Change from Baseline in Platelet count (cells per microliter)
Timepoint [29] 0 0
Baseline (Day -1) and up to approximately 31 months
Secondary outcome [30] 0 0
Part 1 and 2: Change from Baseline in Red Blood Cell Count (RBC) (million cells per microliter)
Timepoint [30] 0 0
Baseline (Day -1) and up to approximately 31 months
Secondary outcome [31] 0 0
Part 1 and 2: Change from Baseline in haematocrit (Proportion of red blood cells in blood)
Timepoint [31] 0 0
Baseline (Day -1) and up to approximately 31 months
Secondary outcome [32] 0 0
Part 1 and 2: Change from Baseline in Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils (giga cells per litre)
Timepoint [32] 0 0
Baseline (Day -1) and up to approximately 31 months
Secondary outcome [33] 0 0
Part 1 and 2: Change from Baseline in Glucose (fasting), Blood Urea Nitrogen (BUN), Creatinine, Sodium, Potassium, Calcium, Chloride, Magnesium Direct Bilirubin and Total Bilirubin (milligrams per decilitre)
Timepoint [33] 0 0
Baseline (Day -1) and up to approximately 31 months
Secondary outcome [34] 0 0
Part 1 and 2: Change from Baseline in AST/SGOT, ALT/ SGPT, ALP and CPK (International Units per litre)
Timepoint [34] 0 0
Baseline (Day -1) and up to approximately 31 months
Secondary outcome [35] 0 0
Part 1 and 2: Change from baseline in Total Protein and Albumin (Grams per deciliter)
Timepoint [35] 0 0
Baseline (Day -1) and up to approximately 31 months
Secondary outcome [36] 0 0
Part 1 and 2: Change from baseline in Amylase and Lipase (Units per liter)
Timepoint [36] 0 0
Baseline (Day -1) and up to approximately 31 months
Secondary outcome [37] 0 0
Part 1 and 2: Change from baseline in Creatinine clearance (milliliter per minute)
Timepoint [37] 0 0
Baseline (Day -1) and up to approximately 31 months
Secondary outcome [38] 0 0
Part 1 and 2: Change from baseline in Activated Partial Thromboplastin Time (aPTT), Prothrombin Time (PT) and Thrombin time (seconds)
Timepoint [38] 0 0
Baseline (Day -1) and up to approximately 31 months
Secondary outcome [39] 0 0
Part 1 and 2: Change from baseline in fibrinogen (milligrams per deciliter)
Timepoint [39] 0 0
Baseline (Day -1) and up to approximately 31 months
Secondary outcome [40] 0 0
Part 1 and 2: Change from baseline in liver panel parameter: International Normalized Ratio (INR)
Timepoint [40] 0 0
Baseline (Day -1) and up to approximately 31 months
Secondary outcome [41] 0 0
Part 1 and 2: Change from baseline in routine urine tests: Leukocyte esterase
Timepoint [41] 0 0
Baseline (Day -1) and up to approximately 31 months
Secondary outcome [42] 0 0
Part 1 and 2: Change from baseline in routine urine tests: Occult blood (10^9 Cells Per Liter)
Timepoint [42] 0 0
Baseline (Day -1) and up to approximately 31 months
Secondary outcome [43] 0 0
Part 1 and 2: Change from baseline in routine urine tests: potential of hydrogen (pH) value
Timepoint [43] 0 0
Baseline (Day -1) and up to approximately 31 months
Secondary outcome [44] 0 0
Part 1 and 2: Change from baseline in routine urine tests: Protein and bilirubin (Grams Per Liter)
Timepoint [44] 0 0
Baseline (Day -1) and up to approximately 31 months
Secondary outcome [45] 0 0
Part 1 and 2: Change From Baseline in routine urine tests: Specific Gravity (Ratio)
Timepoint [45] 0 0
Baseline (Day -1) and up to approximately 31 months
Secondary outcome [46] 0 0
Part 1 and 2: Change from baseline in CA-125 tumor marker [units per milliliter (U/mL)]
Timepoint [46] 0 0
Baseline (Day -1) and up to approximately 31 months
Secondary outcome [47] 0 0
Part 1 and 2: Change from baseline in Electrocardiogram (ECG) readings [milliseconds (msec)]
Timepoint [47] 0 0
Baseline (Day -1) and up to approximately 31 months
Secondary outcome [48] 0 0
Part 1 and 2: Change from baseline in Left ventricular ejection fraction (LVEF) [Percentage]
Timepoint [48] 0 0
Baseline (Day -1) and up to approximately 31 months
Secondary outcome [49] 0 0
Part 1 and 2: Change from baseline in Eastern Cooperative Oncology Group Performance Scale (ECOG PS) score
Timepoint [49] 0 0
Baseline (Day -1) and up to approximately 31 months
Secondary outcome [50] 0 0
Part 2: Overall Survival (OS)
Timepoint [50] 0 0
Up to approximately 31 months
Secondary outcome [51] 0 0
Change from Baseline in Atrial Fibrillation Effect on Quality of Life (AFEQT) Total Score
Timepoint [51] 0 0
Baseline, Month 12
Secondary outcome [52] 0 0
Percent Time <54 mg/dL, overall
Timepoint [52] 0 0
3 days
Secondary outcome [53] 0 0
Percent Time <54 mg/dL, daytime
Timepoint [53] 0 0
3 days
Secondary outcome [54] 0 0
Percent Time <54 mg/dL, nighttime
Timepoint [54] 0 0
3 days
Secondary outcome [55] 0 0
Percent Time in Range 70 - 180 mg/dL, overall
Timepoint [55] 0 0
3 days
Secondary outcome [56] 0 0
Percent Time in Range 70 - 180 mg/dL, daytime
Timepoint [56] 0 0
3 days
Secondary outcome [57] 0 0
Percent Time in Range 70 - 180 mg/dL, nighttime
Timepoint [57] 0 0
3 days
Secondary outcome [58] 0 0
Percent Time in Range 70 - 140 mg/dL, overall
Timepoint [58] 0 0
3 days
Secondary outcome [59] 0 0
Percent Time in Range 70 - 140 mg/dL, daytime
Timepoint [59] 0 0
3 days
Secondary outcome [60] 0 0
Nighttime Percent between 70-140 mg/dL, nighttime
Timepoint [60] 0 0
3 days
Secondary outcome [61] 0 0
Percent Time >180 mg/dL, overall
Timepoint [61] 0 0
3 days
Secondary outcome [62] 0 0
Percent Time >180 mg/dL, daytime
Timepoint [62] 0 0
3 days
Secondary outcome [63] 0 0
Percent Time >180 mg/dL, nighttime
Timepoint [63] 0 0
3 days
Secondary outcome [64] 0 0
Percent Time >250 mg/dL, overall
Timepoint [64] 0 0
3 days
Secondary outcome [65] 0 0
Daytime Percent time >250 mg/dL, daytime
Timepoint [65] 0 0
3 days
Secondary outcome [66] 0 0
Nighttime Percent time >250 mg/dL, nighttime
Timepoint [66] 0 0
3 days
Secondary outcome [67] 0 0
Mean glucose (mg/dL), overall
Timepoint [67] 0 0
3 days
Secondary outcome [68] 0 0
Mean glucose (mg/dL), daytime
Timepoint [68] 0 0
3 days
Secondary outcome [69] 0 0
Mean glucose (mg/dL), nighttime
Timepoint [69] 0 0
3 days
Secondary outcome [70] 0 0
Glycemic Variability as assessed by Coefficient of Variation (%), overall
Timepoint [70] 0 0
3 days
Secondary outcome [71] 0 0
Glycemic Variability as assessed by Coefficient of Variation (%), daytime
Timepoint [71] 0 0
3 days

Eligibility
Key inclusion criteria
1. 18 to 80 years of age.
2. Diagnosis of Crohn's disease established with verifiable clinical, imaging, endoscopic and/or histopathologic evidence.
3. Moderate to severe active Crohn's disease.
4. Ileal/ileocecal (L1), colonic (L2), or ileocolonic (L3) disease, as classified based on the localisation of active inflammation.
5. Capable of giving signed informed consent.
6. A history of at least one of:

1. Intolerance or inadequate response to conventional treatment (oral corticosteroid, azathioprine, 6-mercaptopurine, or methotrexate), biologics, or other approved advanced therapy (eg, JAK inhibitors) OR
2. Corticosteroid dependency (defined as inability to taper below budesonide 6 mg/day or prednisolone 10 mg/day without recurrent active disease) for the treatment of Crohn's disease.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Evidence, or clinical suspicion, of other forms of IBD or concomitant additional active gastrointestinal luminal inflammatory diseases.
2. Known symptomatic strictures or bowel stenoses or strictures preventing passage of endoscope throughout the colon.
3. Any complications of Crohn's disease where surgery is anticipated or planned prior to end of study treatment.
4. Evidence of extensive prior gastrointestinal surgical interventions.
5. Within 3 months prior to screening endoscopy visit:

1. History of toxic megacolon
2. Diagnosis of peritonitis or need for treatment of peritonitis
3. Bowel perforation or evidence of obstruction.
6. Undrained fistula or abscess, including intrabdominal abscesses.
7. Ongoing or expected nutritional dependency on total enteral or parenteral nutrition during study.
8. Evidence of an increased risk of colorectal cancer.
9. Symptomatic oral Crohn's disease within one year.
10. Any of the following treatments within the specified time period prior to screening endoscopy visit

1. An anti-TNF biologic within 8 weeks prior to screening endoscopy visit
2. Any biologic targeting immune response other than an anti-TNF within 12 weeks prior to screening endoscopy visit
3. Other advanced small molecule treatments for Crohn's disease within 4 weeks prior to screening endoscopy visit
4. Cyclosporine, mycophenolate mofetil, sirolimus (rapamycin), thalidomide, or tacrolimus (FK-506) within 4 weeks prior to screening endoscopy visit
5. Treatment with apheresis within 4 weeks prior to screening endoscopy visit
6. Administration of any live vaccine within 4 weeks prior to screening endoscopy visit to end of study
7. Faecal microbiota transplantation within 4 weeks prior to screening endoscopy visit
8. Lymphocyte-depleting treatment within 12 months prior to screening endoscopy visit
9. Any previous exposure to AZD7798.
11. Any changes in dosing of the following medications prior to screening endoscopy visit as outlined:

1. 5-aminosalicylates within 2 weeks
2. Oral corticosteroids within 2 weeks:

(i) Prednisolone (ii) Budesonide (c) Immunomodulators within 4 weeks (d) Antibiotic therapy for the treatment of Crohn's disease (e) Probiotics within 2 weeks.
12. Known or suspected history of chronic use of nonsteroidal anti-inflammatory drugs.
13. Evidence of recent or currently active infection, including use of IV or oral antibiotics for documented infection within 30 days prior to screening endoscopy visit.
14. Evidence of chronic HBV or HCV.
15. History of TB (active or latent) unless an appropriate course of treatment has been completed.
16. Positive diagnostic TB test at screening.
17. History of serious opportunistic infection within 12 months prior to screening endoscopy visit.
18. CMV colitis within previous 12 months prior to screening endoscopy visit.
19. Positive C. difficile toxin stool test at screening.
20. Symptomatic herpes zoster infection within 3 months prior to screening endoscopy.
21. Any identified immunodeficiency.
22. Abnormal laboratory results at screening suggesting participation may be unsafe, which will prevent the patient from completing the study, or will interfere with the interpretation of the study results.
23. Reproduction:

1. Pregnant and breastfeeding patients, or those planning to breastfeed during the study
2. FOCBP unless completely abstinent or using a highly effective contraception and barrier method of contraception.
24. Prolonged QTcF interval.
25. Clinically significant cardiovascular conditions.
26. Current malignancy or history of malignancy.
27. Current significant major or unstable respiratory disease, heart disease, cerebrovascular disease, haematological disease, hepatic disease, renal disease, gastrointestinal disease or other major disease other than active Crohn's disease.
28. Current enrolment in another interventional study or treatment with any investigational drug within 4 months prior to screening endoscopy visit.
29. Unstable lifestyle factors.
30. Patients committed to an institution by virtue of an order issued either by the judicial or the administrative authorities.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
17/06/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
21/05/2027
Actual
Sample size
Target
192
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA
Recruitment hospital [1] 0 0
Research Site - South Brisbane
Recruitment hospital [2] 0 0
Hunter Medical Research Institute - Newcastle
Recruitment hospital [3] 0 0
University of Sydney - Charles Perkins Centre - Sydney
Recruitment hospital [4] 0 0
The Children's Hospital at Westmead - Westmead
Recruitment hospital [5] 0 0
Cornerstone Dermatology - Coorparoo
Recruitment hospital [6] 0 0
Nightingale Research - Adelaide
Recruitment hospital [7] 0 0
Perth Children's Hospital - Perth
Recruitment hospital [8] 0 0
Chris O'Brien Lifehouse - Camperdown
Recruitment hospital [9] 0 0
University of Sydney - Camperdown
Recruitment hospital [10] 0 0
GSK Investigational Site - Blacktown
Recruitment hospital [11] 0 0
GSK Investigational Site - Sydney
Recruitment hospital [12] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [13] 0 0
Canberra Heart Rhythm - Garran
Recruitment postcode(s) [1] 0 0
QLD 4101 - South Brisbane
Recruitment postcode(s) [2] 0 0
2305 - Newcastle
Recruitment postcode(s) [3] 0 0
2006 - Sydney
Recruitment postcode(s) [4] 0 0
2145 - Westmead
Recruitment postcode(s) [5] 0 0
4151 - Coorparoo
Recruitment postcode(s) [6] 0 0
5000 - Adelaide
Recruitment postcode(s) [7] 0 0
6009 - Perth
Recruitment postcode(s) [8] 0 0
NSW 2050 - Camperdown
Recruitment postcode(s) [9] 0 0
2148 - Blacktown
Recruitment postcode(s) [10] 0 0
2109 - Sydney
Recruitment postcode(s) [11] 0 0
2605 - Garran
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Michigan
Country [2] 0 0
United States of America
State/province [2] 0 0
Texas
Country [3] 0 0
Argentina
State/province [3] 0 0
Buenos Aires
Country [4] 0 0
Austria
State/province [4] 0 0
Klagenfurt am Wörthersee
Country [5] 0 0
Brazil
State/province [5] 0 0
Campinas
Country [6] 0 0
Brazil
State/province [6] 0 0
Curitiba
Country [7] 0 0
Brazil
State/province [7] 0 0
Jaú
Country [8] 0 0
Brazil
State/province [8] 0 0
Porto Alegre
Country [9] 0 0
Brazil
State/province [9] 0 0
Santo Andre
Country [10] 0 0
Brazil
State/province [10] 0 0
São Paulo
Country [11] 0 0
Bulgaria
State/province [11] 0 0
Sofia
Country [12] 0 0
Chile
State/province [12] 0 0
Santiago
Country [13] 0 0
Chile
State/province [13] 0 0
Talcahuano
Country [14] 0 0
Chile
State/province [14] 0 0
Viña del Mar
Country [15] 0 0
Germany
State/province [15] 0 0
Berlin
Country [16] 0 0
Germany
State/province [16] 0 0
Kiel
Country [17] 0 0
Germany
State/province [17] 0 0
Ulm
Country [18] 0 0
Italy
State/province [18] 0 0
Milano
Country [19] 0 0
Japan
State/province [19] 0 0
Chiba-shi
Country [20] 0 0
Japan
State/province [20] 0 0
Hamamatsu-shi
Country [21] 0 0
Japan
State/province [21] 0 0
Kashiwa-shi
Country [22] 0 0
Japan
State/province [22] 0 0
Kure-shi
Country [23] 0 0
Japan
State/province [23] 0 0
Osaka-shi
Country [24] 0 0
Japan
State/province [24] 0 0
Shinjuku-ku
Country [25] 0 0
Malaysia
State/province [25] 0 0
Johor Bahru
Country [26] 0 0
Malaysia
State/province [26] 0 0
Kota Bharu
Country [27] 0 0
Malaysia
State/province [27] 0 0
Kota Kinabalu
Country [28] 0 0
Malaysia
State/province [28] 0 0
Kuala Lumpur
Country [29] 0 0
Malaysia
State/province [29] 0 0
Kuching
Country [30] 0 0
Mexico
State/province [30] 0 0
Mexico City
Country [31] 0 0
Romania
State/province [31] 0 0
Bucharest
Country [32] 0 0
Romania
State/province [32] 0 0
Cluj Napoca
Country [33] 0 0
Romania
State/province [33] 0 0
Timisoara
Country [34] 0 0
Slovakia
State/province [34] 0 0
Kosice
Country [35] 0 0
Slovakia
State/province [35] 0 0
Nitra
Country [36] 0 0
Slovakia
State/province [36] 0 0
Presov
Country [37] 0 0
Slovakia
State/province [37] 0 0
Trnava
Country [38] 0 0
South Africa
State/province [38] 0 0
Cape Town
Country [39] 0 0
South Africa
State/province [39] 0 0
Milnerton
Country [40] 0 0
South Africa
State/province [40] 0 0
Plumstead
Country [41] 0 0
Spain
State/province [41] 0 0
Madrid
Country [42] 0 0
Spain
State/province [42] 0 0
Sevilla
Country [43] 0 0
Sweden
State/province [43] 0 0
Linköping
Country [44] 0 0
Sweden
State/province [44] 0 0
Stockholm
Country [45] 0 0
Taiwan
State/province [45] 0 0
Kaohsiung
Country [46] 0 0
Taiwan
State/province [46] 0 0
New Taipei City
Country [47] 0 0
Taiwan
State/province [47] 0 0
Taichung
Country [48] 0 0
Taiwan
State/province [48] 0 0
Taipei
Country [49] 0 0
Taiwan
State/province [49] 0 0
Taoyuan
Country [50] 0 0
Turkey
State/province [50] 0 0
Ankara
Country [51] 0 0
Turkey
State/province [51] 0 0
Antalya
Country [52] 0 0
Turkey
State/province [52] 0 0
Bursa
Country [53] 0 0
Turkey
State/province [53] 0 0
Istanbul
Country [54] 0 0
Turkey
State/province [54] 0 0
Izmir
Country [55] 0 0
Turkey
State/province [55] 0 0
Izmit
Country [56] 0 0
Turkey
State/province [56] 0 0
Malatya
Country [57] 0 0
Ukraine
State/province [57] 0 0
Chernivts?
Country [58] 0 0
Ukraine
State/province [58] 0 0
Kiev
Country [59] 0 0
Ukraine
State/province [59] 0 0
Kyiv
Country [60] 0 0
Ukraine
State/province [60] 0 0
Ternopil
Country [61] 0 0
Ukraine
State/province [61] 0 0
Vinnytsia
Country [62] 0 0
Vietnam
State/province [62] 0 0
Hanoi
Country [63] 0 0
Vietnam
State/province [63] 0 0
Ho Chi Minh city
Country [64] 0 0
Vietnam
State/province [64] 0 0
Ho Chi Minh
Country [65] 0 0
United States of America
State/province [65] 0 0
California
Country [66] 0 0
United States of America
State/province [66] 0 0
Delaware
Country [67] 0 0
United States of America
State/province [67] 0 0
Illinois
Country [68] 0 0
United States of America
State/province [68] 0 0
Indiana
Country [69] 0 0
United States of America
State/province [69] 0 0
New York
Country [70] 0 0
United States of America
State/province [70] 0 0
Utah
Country [71] 0 0
Argentina
State/province [71] 0 0
Ciudad Autónoma De Buenos Aires
Country [72] 0 0
Argentina
State/province [72] 0 0
Tucumán
Country [73] 0 0
Canada
State/province [73] 0 0
Alberta
Country [74] 0 0
Canada
State/province [74] 0 0
Ontario
Country [75] 0 0
Canada
State/province [75] 0 0
Quebec
Country [76] 0 0
France
State/province [76] 0 0
Bouches-du-Rhône
Country [77] 0 0
France
State/province [77] 0 0
Haute-Garonne
Country [78] 0 0
France
State/province [78] 0 0
Maine-et-Loire
Country [79] 0 0
France
State/province [79] 0 0
Nord-Pas-de-Calais
Country [80] 0 0
France
State/province [80] 0 0
Rhône
Country [81] 0 0
France
State/province [81] 0 0
Paris
Country [82] 0 0
Germany
State/province [82] 0 0
Baden-Württemberg
Country [83] 0 0
Germany
State/province [83] 0 0
Nordrhein-Westfalen
Country [84] 0 0
Germany
State/province [84] 0 0
Sachsen
Country [85] 0 0
Israel
State/province [85] 0 0
HaDarom
Country [86] 0 0
Israel
State/province [86] 0 0
HaMerkaz
Country [87] 0 0
Israel
State/province [87] 0 0
HaTsafon
Country [88] 0 0
Israel
State/province [88] 0 0
Yerushalayim
Country [89] 0 0
Israel
State/province [89] 0 0
?eifa
Country [90] 0 0
Mexico
State/province [90] 0 0
Jalisco
Country [91] 0 0
Mexico
State/province [91] 0 0
Nuevo León
Country [92] 0 0
Mexico
State/province [92] 0 0
Aguascalientes
Country [93] 0 0
Mexico
State/province [93] 0 0
Puebla
Country [94] 0 0
Puerto Rico
State/province [94] 0 0
San Juan
Country [95] 0 0
Spain
State/province [95] 0 0
Andalucía
Country [96] 0 0
Spain
State/province [96] 0 0
Barcelona [Barcelona]
Country [97] 0 0
Spain
State/province [97] 0 0
Madrid, Comunidad De
Country [98] 0 0
Spain
State/province [98] 0 0
Málaga
Country [99] 0 0
Spain
State/province [99] 0 0
València
Country [100] 0 0
Taiwan
State/province [100] 0 0
Tainan
Country [101] 0 0
United Kingdom
State/province [101] 0 0
Cambridgeshire
Country [102] 0 0
United Kingdom
State/province [102] 0 0
England
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United Kingdom
State/province [103] 0 0
Hampshire
Country [104] 0 0
United Kingdom
State/province [104] 0 0
London, City Of
Country [105] 0 0
United Kingdom
State/province [105] 0 0
Leeds
Country [106] 0 0
United Kingdom
State/province [106] 0 0
Liverpool
Country [107] 0 0
United Kingdom
State/province [107] 0 0
Sheffield
Country [108] 0 0
United States of America
State/province [108] 0 0
Arizona
Country [109] 0 0
United States of America
State/province [109] 0 0
Florida
Country [110] 0 0
United States of America
State/province [110] 0 0
Massachusetts
Country [111] 0 0
United States of America
State/province [111] 0 0
Minnesota
Country [112] 0 0
United States of America
State/province [112] 0 0
North Carolina
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United States of America
State/province [113] 0 0
Pennsylvania
Country [114] 0 0
United States of America
State/province [114] 0 0
Washington
Country [115] 0 0
Argentina
State/province [115] 0 0
Quilmes
Country [116] 0 0
Austria
State/province [116] 0 0
Linz
Country [117] 0 0
Austria
State/province [117] 0 0
Wien
Country [118] 0 0
Brazil
State/province [118] 0 0
Goiânia
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Canada
State/province [119] 0 0
Montréal
Country [120] 0 0
Chile
State/province [120] 0 0
Providencia
Country [121] 0 0
Chile
State/province [121] 0 0
Vitacura
Country [122] 0 0
Croatia
State/province [122] 0 0
Rijeka
Country [123] 0 0
Cyprus
State/province [123] 0 0
Nicosia
Country [124] 0 0
Egypt
State/province [124] 0 0
Mansoura
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Germany
State/province [125] 0 0
Augsburg
Country [126] 0 0
Germany
State/province [126] 0 0
Düsseldorf
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Germany
State/province [127] 0 0
Essen
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Germany
State/province [128] 0 0
Heidelberg
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Germany
State/province [129] 0 0
Lübeck
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Greece
State/province [130] 0 0
Heraklion
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Greece
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Marousi
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Greece
State/province [132] 0 0
Patras
Country [133] 0 0
Greece
State/province [133] 0 0
Thessaloniki
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Israel
State/province [134] 0 0
Ramat Gan
Country [135] 0 0
Italy
State/province [135] 0 0
Milan
Country [136] 0 0
Italy
State/province [136] 0 0
Napoli
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Italy
State/province [137] 0 0
Padova
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Italy
State/province [138] 0 0
Pavia
Country [139] 0 0
Italy
State/province [139] 0 0
Roma
Country [140] 0 0
Italy
State/province [140] 0 0
Trento
Country [141] 0 0
Korea, Republic of
State/province [141] 0 0
Seoul
Country [142] 0 0
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State/province [142] 0 0
Riga
Country [143] 0 0
Lithuania
State/province [143] 0 0
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Amsterdam
Country [145] 0 0
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State/province [145] 0 0
Oslo
Country [146] 0 0
Pakistan
State/province [146] 0 0
Karachi
Country [147] 0 0
Peru
State/province [147] 0 0
La Victoria
Country [148] 0 0
Peru
State/province [148] 0 0
Surquillo
Country [149] 0 0
Poland
State/province [149] 0 0
Zielona Gora
Country [150] 0 0
Portugal
State/province [150] 0 0
Lisboa
Country [151] 0 0
Portugal
State/province [151] 0 0
Setúbal
Country [152] 0 0
Russian Federation
State/province [152] 0 0
Saint Petersburg
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Slovakia
State/province [153] 0 0
Banská Bystrica
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Slovakia
State/province [154] 0 0
Bratislava
Country [155] 0 0
Slovenia
State/province [155] 0 0
Ljubljana
Country [156] 0 0
Spain
State/province [156] 0 0
Barcelona
Country [157] 0 0
Sweden
State/province [157] 0 0
Uppsala
Country [158] 0 0
Switzerland
State/province [158] 0 0
Baden
Country [159] 0 0
Switzerland
State/province [159] 0 0
Basel
Country [160] 0 0
Switzerland
State/province [160] 0 0
Bellinzona
Country [161] 0 0
Switzerland
State/province [161] 0 0
Bern
Country [162] 0 0
Switzerland
State/province [162] 0 0
Lugano
Country [163] 0 0
Switzerland
State/province [163] 0 0
Luzern
Country [164] 0 0
Switzerland
State/province [164] 0 0
St. Gallen
Country [165] 0 0
Switzerland
State/province [165] 0 0
Winterthur
Country [166] 0 0
Switzerland
State/province [166] 0 0
Zürich
Country [167] 0 0
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State/province [167] 0 0
Dushanbe
Country [168] 0 0
Turkey
State/province [168] 0 0
Fatih
Country [169] 0 0
Turkey
State/province [169] 0 0
Zonguldak
Country [170] 0 0
United Arab Emirates
State/province [170] 0 0
Dubai
Country [171] 0 0
United Kingdom
State/province [171] 0 0
Cambridge
Country [172] 0 0
United Kingdom
State/province [172] 0 0
Glasgow
Country [173] 0 0
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State/province [173] 0 0
Helsinki
Country [174] 0 0
United States of America
State/province [174] 0 0
Colorado
Country [175] 0 0
United States of America
State/province [175] 0 0
Connecticut
Country [176] 0 0
United States of America
State/province [176] 0 0
Georgia
Country [177] 0 0
United States of America
State/province [177] 0 0
Maryland
Country [178] 0 0
United States of America
State/province [178] 0 0
New Jersey
Country [179] 0 0
United States of America
State/province [179] 0 0
New Mexico
Country [180] 0 0
United States of America
State/province [180] 0 0
Ohio
Country [181] 0 0
United States of America
State/province [181] 0 0
Virginia

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Memorial Sloan Kettering Cancer Center
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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
AstraZeneca Clinical Study Information Center
Address 0 0
Country 0 0
Phone 0 0
1-877-240-9479
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

No information has been provided regarding IPD availability


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/NCT06450197