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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03816163




Registration number
NCT03816163
Ethics application status
Date submitted
23/01/2019
Date registered
25/01/2019

Titles & IDs
Public title
A Study of Zolbetuximab (IMAB362) in Adults With Pancreatic Cancer
Scientific title
A Phase 2, Open-Label, Randomized Study to Assess the Efficacy and Safety of Zolbetuximab (IMAB362) in Combination With Nab-Paclitaxel and Gemcitabine (Nab-P + GEM) as First Line Treatment in Subjects With Claudin 18.2 (CLDN18.2) Positive, Metastatic Pancreatic Adenocarcinoma
Secondary ID [1] 0 0
2018-002551-15
Secondary ID [2] 0 0
8951-CL-5201
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pancreatic Cancer 0 0
Metastatic Pancreatic Cancer 0 0
Metastatic Pancreatic Adenocarcinoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Pancreatic

Intervention/exposure
Study type
Interventional(has expanded access)
Description of intervention(s) / exposure
Treatment: Drugs - zolbetuximab
Treatment: Drugs - nab-paclitaxel
Treatment: Drugs - gemcitabine

Experimental: zolbetuximab +nab-paclitaxel + gemcitabine - Participants will be treated with zolbetuximab in combination with nab-paclitaxel and gemcitabine for the phase 1 portion of the study to establish the recommended dose of zolbetuximab for the phase 2 portion. In the phase 2 portion, the participants will be treated with zolbetuximab at dose determined by the phase 1 portion of the study in combination with nab-paclitaxel and gemcitabine. Participants will be treated on continuous cycles until they no longer derive clinical benefit in the judgment of the treating physician, have unacceptable toxicity, undergo hematopoietic stem cell transplantation (HSCT), or meet one of the discontinuation criteria; whichever occurs first.

Active comparator: nab-paclitaxel + gemcitabine - Participants will be treated with nab-paclitaxel and gemcitabine. Participants will be treated on continuous cycles until they no longer derive clinical benefit in the judgment of the treating physician, have unacceptable toxicity, undergo hematopoietic stem cell transplantation (HSCT), or meet one of the discontinuation criteria; whichever occurs first.


Treatment: Drugs: zolbetuximab
Administered as an intravenous infusion.

Treatment: Drugs: nab-paclitaxel
Administered as an intravenous infusion

Treatment: Drugs: gemcitabine
Administered as an intravenous infusion
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Dose Limiting Toxicities (DLT) - (safety lead in)
Timepoint [1] 0 0
Up to 28 days
Primary outcome [2] 0 0
Overall Survival (OS)
Timepoint [2] 0 0
Up to 65 months
Primary outcome [3] 0 0
Safety assessed by Adverse Events (AEs)
Timepoint [3] 0 0
Up to 65 months
Primary outcome [4] 0 0
Safety assessed by incidence of serious adverse events (SAE)
Timepoint [4] 0 0
Up to 65 months
Primary outcome [5] 0 0
Safety assessed by incidence of treatment emergent adverse events (TEAE)
Timepoint [5] 0 0
Up to 65 months
Primary outcome [6] 0 0
Number of participants with laboratory value abnormalities and/or adverse events (AEs)
Timepoint [6] 0 0
Up to 65 months
Primary outcome [7] 0 0
Number of participants with vital sign abnormalities and /or adverse events (AEs)
Timepoint [7] 0 0
Up to 65 months
Primary outcome [8] 0 0
Number of participants with electrocardiograms (ECG) abnormalities and or adverse events
Timepoint [8] 0 0
Up to 65 months
Primary outcome [9] 0 0
Number of participants with Eastern Cooperative Oncology Group (ECOG) performance status abnormalities and or adverse events
Timepoint [9] 0 0
Up to 65 months
Secondary outcome [1] 0 0
Progression Free Survival (PFS)
Timepoint [1] 0 0
Up to 65 months
Secondary outcome [2] 0 0
Objective Response Rate (ORR)
Timepoint [2] 0 0
Up to 65 months
Secondary outcome [3] 0 0
Number of anti-drug antibody (ADA) Positive Participants
Timepoint [3] 0 0
Up to 65 months
Secondary outcome [4] 0 0
Disease Control Rate (DCR)
Timepoint [4] 0 0
Up to 65 months
Secondary outcome [5] 0 0
Duration Of Response (DOR)
Timepoint [5] 0 0
Up to 65 months
Secondary outcome [6] 0 0
Change in CA (Cancer Antigen) 19-9
Timepoint [6] 0 0
Baseline up to 65 months
Secondary outcome [7] 0 0
PK of zolbetuximab: Concentration Immediately Prior to Dosing (Ctrough)
Timepoint [7] 0 0
Up to 65 months
Secondary outcome [8] 0 0
PK of Nab-P: Area Under the Concentration-time Curve from the Time of Dosing Extrapolated to Time Infinity (AUCinf)
Timepoint [8] 0 0
Up to 30 days
Secondary outcome [9] 0 0
PK of Nab-P: Area Under the Concentration-time Curve from the Time of Dosing Until the Last Measurable Concentration (AUClast)
Timepoint [9] 0 0
Up to 30 days
Secondary outcome [10] 0 0
PK of Nab-P: Maximum Concentration (Cmax)
Timepoint [10] 0 0
Up to 30 days
Secondary outcome [11] 0 0
PK of Nab-P: Time of Maximum Concentration (Tmax)
Timepoint [11] 0 0
Up to 30 days
Secondary outcome [12] 0 0
PK of Nab-P: Terminal Elimination Half-life (T1/2)
Timepoint [12] 0 0
Up to 30 days
Secondary outcome [13] 0 0
PK of Nab-P: Clearance (CL)
Timepoint [13] 0 0
Up to 30 days
Secondary outcome [14] 0 0
PK of Nab-P: Volume of Distribution During the Terminal Phase (Vz)
Timepoint [14] 0 0
Up to 30 days
Secondary outcome [15] 0 0
PK of gemcitabine: Area Under the Concentration-time Curve from the Time of Dosing Extrapolated to Time Infinity (AUCinf)
Timepoint [15] 0 0
Up to 30 days
Secondary outcome [16] 0 0
PK of gemcitabine: Area Under the Concentration-time Curve from the Time of Dosing Until the Last Measurable Concentration (AUClast)
Timepoint [16] 0 0
Up to 30 days
Secondary outcome [17] 0 0
PK of gemcitabine: Maximum Concentration (Cmax)
Timepoint [17] 0 0
Up to 30 days
Secondary outcome [18] 0 0
PK of gemcitabine: Time of Maximum Concentration (Tmax)
Timepoint [18] 0 0
Up to 30 days
Secondary outcome [19] 0 0
PK of gemcitabine: Terminal Elimination Half-life (T1/2)
Timepoint [19] 0 0
Up to 30 days
Secondary outcome [20] 0 0
PK of gemcitabine: Clearance (CL)
Timepoint [20] 0 0
Up to 30 days
Secondary outcome [21] 0 0
PK of gemcitabine: Volume of Distribution During the Terminal Phase (Vz)
Timepoint [21] 0 0
Up to 30 days
Secondary outcome [22] 0 0
Health Related Quality of Life (HRQoL) measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC-QLQ-C30)
Timepoint [22] 0 0
Up to 65 months
Secondary outcome [23] 0 0
Health Related Quality of Life (HRQoL) measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Pancreatic Cancer Module (EORTC-QLQ-PAN-26)
Timepoint [23] 0 0
Up to 65 months
Secondary outcome [24] 0 0
Health Related Quality of Life (HRQoL) measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L)
Timepoint [24] 0 0
Up to 65 months
Secondary outcome [25] 0 0
Health Related Quality of Life (HRQoL) measured by the Patient Global Impression of Change (PGIC) scale
Timepoint [25] 0 0
Up to 65 months
Secondary outcome [26] 0 0
Health Related Quality of Life (HRQoL) measured by the Patient Global Impression of Severity (PGIS) Scale
Timepoint [26] 0 0
Up to 65 months
Secondary outcome [27] 0 0
Time to Improvement of pancreatic pain as measured by Quality-of-Life Questionnaire - Core Questionnaire (QLQ-C30)
Timepoint [27] 0 0
Up to 65 months
Secondary outcome [28] 0 0
Time to worsening of global health status (GHS)/quality of life (QoL) as measured by QLQ-C30
Timepoint [28] 0 0
Up to 65 months
Secondary outcome [29] 0 0
Time to Improvement of pancreatic pain as measured by Quality of Life Questionnaire - Pancreatic Cancer Module 26 (QLQ-PAN26)
Timepoint [29] 0 0
Up to 65 months
Secondary outcome [30] 0 0
Time to worsening of GHS/QoL as measured by QLQ-PAN26
Timepoint [30] 0 0
Up to 65 months
Secondary outcome [31] 0 0
Time to Improvement of pancreatic pain as measured by PGIS
Timepoint [31] 0 0
Up to 65 months
Secondary outcome [32] 0 0
Time to worsening of GHS/QoL as measured by PGIS
Timepoint [32] 0 0
Up to 65 months

Eligibility
Key inclusion criteria
* A female subject is eligible to participate if she is not pregnant or lactating and at least 1 of the following conditions applies:

* Not a woman of childbearing potential (WOCBP) OR
* WOCBP who agrees to follow the contraceptive guidance throughout the treatment period and for at least 6 months after the final study drug administration.
* Female subject must agree not to breastfeed starting at screening and throughout the study period, and for 6 months after the final study drug administration.
* Female subject must not donate ova starting at screening and throughout the study period, and for 6 months after the final study drug administration.
* A male subject with female partner(s) of child-bearing potential must agree to use contraception during the treatment period and for at least 6 months after the final study drug administration.
* A male subject must not donate sperm during the treatment period and for at least 6 months after the final study drug administration.
* Male subject with a pregnant or breastfeeding partner(s) must agree to remain abstinent or use a condom for the duration of the pregnancy or time partner is breastfeeding throughout the study period and for 6 months after the final study drug administration.
* Subject agrees not to participate in other interventional studies while receiving study drug in present study.
* Subject has histologically or cytologically confirmed adenocarcinoma of pancreas.
* Subjects must have metastatic pancreatic adenocarcinoma that has not been previously treated with chemotherapy.

* Prior treatment with fluorouracil (5-FU) or GEM administered as a radiation sensitizer during and up to 4 weeks after radiation therapy is allowed
* If a subject received adjuvant therapy, tumor recurrence or disease progression must have occurred at least 6 months after completing the last dose of the adjuvant therapy.
* Subjects whose disease progressed on prior treatment with Nab-P and GEM are not eligible.
* Subject has a measurable lesion(s) on at least 1 metastatic site based on RECIST 1.1 within 28 days prior to randomization. For subjects with only 1 measurable lesion and prior radiotherapy, the lesion must be outside the field of prior radiotherapy or must have documented progression following radiation therapy.
* Subject's tumor sample has CLDN18.2 expression in = 75% of tumor cells demonstrating moderate to strong membranous staining as determined by central immunohistochemistry (IHC) testing
* Subject has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Subject has predicted life expectancy = 12 weeks.
* Subject must meet all of the following criteria based on the laboratory tests that will be collected within 14 days prior to randomization. In case of multiple laboratory data within this period, the most recent data should be used.

* Hemoglobin = 9 g/dl (no transfusion within 14 days of start of study treatment)
* Absolute neutrophil count = 1.5 x 10^9/L
* Platelets = 100 x 10^9/L
* Albumin = 2.5 g/dL
* Total bilirubin = 1.5 x upper limit of normal (ULN)
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 2.5 x ULN without liver metastases (= 5 x ULN if liver metastases are present)
* Estimated creatinine clearance = 30 mL/min
* Prothrombin time/international normalized ratio (INR) and partial thromboplastin time = 1.5 x ULN (except for subjects receiving anticoagulation therapy)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Subject has received other investigational treatment within 28 days prior to randomization.
* Subject has received radiotherapy for metastatic pancreatic adenocarcinoma = 14 days prior to randomization and has not recovered from any related toxicity.
* Subject has received systemic immunosuppressive therapy, including systemic corticosteroids within 14 days prior to randomization. Subject using a physiologic replacement dose of hydrocortisone or its equivalent (defined as up to 30 mg per day of hydrocortisone or up to 10 mg per day of prednisone), receiving a single dose of systemic corticosteroids or receiving systemic corticosteroids as premedication for radiologic imaging contrast use are allowed.
* Subject has prior severe allergic reaction or intolerance to known ingredients of zolbetuximab or other monoclonal antibody, including humanized or chimeric antibodies.
* Subject has known immediate or delayed hypersensitivity, intolerance or contraindication to any component of study treatment.
* Subject has a known history of a positive test for human immunodeficiency virus infection or known active hepatitis B (positive HBs antigen [Ag]) or hepatitis C infection. NOTE: Screening for these infections should be conducted per local requirements.

1. For subjects who are negative for HBs Ag, but hepatitis B core antibody positive, a hepatitis B virus DNA test will be performed and if positive, the subject will be excluded.
2. Subjects with positive hepatitis C serology but negative hepatitis C virus RNA test results are eligible.
3. Subjects treated for hepatitis C with undetectable viral load results are eligible.
* Subject has a history of interstitial pneumonia or pulmonary fibrosis.
* Subject has pleural effusion or ascites = Grade 3.
* Subject has an active autoimmune disease that has required systemic treatment in the past 3 months prior to randomization.
* Subject has active infection requiring systemic therapy that has not completely resolved per investigator judgment within 7 days prior to randomization.
* Subject has significant cardiovascular disease, including:

* Congestive heart failure (defined as New York Heart Association Class III or IV), myocardial infarction, unstable angina, coronary angioplasty, coronary stenting, coronary artery bypass graft, cerebrovascular accident or hypertensive crisis within 6 months prior to randomization;
* History of clinically significant ventricular arrhythmias (i.e., sustained ventricular tachycardia, ventricular fibrillation or Torsades de Pointes);
* QTc interval > 450 msec for male subjects; QTc interval > 470 msec for female subjects;
* Cardiac arrhythmias requiring anti-arrhythmic medications (Subjects with rate controlled atrial fibrillation for > 1 month prior to randomization.)
* Subject has a history of central nervous system metastases and/or carcinomatous meningitis from pancreatic adenocarcinoma.
* Subject has known peripheral sensory neuropathy = Grade 2 unless the absence of deep tendon reflexes is the sole neurological abnormality.
* Subject has had a major surgical procedure = 28 days prior to randomization.
* Subject without complete recovery from a major surgical procedure = 14 days prior to randomization.
* Psychiatric illness or social situations that would preclude study compliance.
* Subject has another malignancy for which treatment is required.
* Subject has any concurrent disease, infection or co-morbid condition that interferes with the ability of the subject to participate in the study, which places the subject at undue risk or complicates the interpretation of data.

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
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
15/03/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/08/2026
Actual
Sample size
Target
Accrual to date
Final
393
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Site AU61008 - Gosford
Recruitment hospital [2] 0 0
Site AU61007 - Wollongong
Recruitment hospital [3] 0 0
Site AU61005 - Fitzroy
Recruitment hospital [4] 0 0
Site AU61006 - Warrnambool
Recruitment postcode(s) [1] 0 0
NSW 2250 - Gosford
Recruitment postcode(s) [2] 0 0
HVGM+3C - Wollongong
Recruitment postcode(s) [3] 0 0
5XRF+WX - Fitzroy
Recruitment postcode(s) [4] 0 0
VIC 3280 - Warrnambool
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Connecticut
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Kentucky
Country [7] 0 0
United States of America
State/province [7] 0 0
Louisiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Missouri
Country [9] 0 0
United States of America
State/province [9] 0 0
New Jersey
Country [10] 0 0
United States of America
State/province [10] 0 0
New York
Country [11] 0 0
United States of America
State/province [11] 0 0
North Carolina
Country [12] 0 0
United States of America
State/province [12] 0 0
Texas
Country [13] 0 0
United States of America
State/province [13] 0 0
Utah
Country [14] 0 0
United States of America
State/province [14] 0 0
Washington
Country [15] 0 0
Brazil
State/province [15] 0 0
Rio Grande Do Sul
Country [16] 0 0
Brazil
State/province [16] 0 0
Centro Passo Fundo
Country [17] 0 0
Brazil
State/province [17] 0 0
Santa Catarina
Country [18] 0 0
Brazil
State/province [18] 0 0
Sao Paulo
Country [19] 0 0
China
State/province [19] 0 0
Beijing
Country [20] 0 0
China
State/province [20] 0 0
Changchun
Country [21] 0 0
China
State/province [21] 0 0
Chongqing
Country [22] 0 0
China
State/province [22] 0 0
Guangdong
Country [23] 0 0
China
State/province [23] 0 0
Guangzhou
Country [24] 0 0
China
State/province [24] 0 0
Harbin
Country [25] 0 0
China
State/province [25] 0 0
Hubei
Country [26] 0 0
China
State/province [26] 0 0
Jiangsu
Country [27] 0 0
China
State/province [27] 0 0
Shan XI
Country [28] 0 0
China
State/province [28] 0 0
Shandong
Country [29] 0 0
China
State/province [29] 0 0
Shanghai
Country [30] 0 0
China
State/province [30] 0 0
Tianjin
Country [31] 0 0
China
State/province [31] 0 0
Xinjiang
Country [32] 0 0
China
State/province [32] 0 0
Zhejiang
Country [33] 0 0
China
State/province [33] 0 0
Zhengzhou
Country [34] 0 0
France
State/province [34] 0 0
Besancon Cedex
Country [35] 0 0
France
State/province [35] 0 0
Brest Cedex
Country [36] 0 0
France
State/province [36] 0 0
Cedex 5
Country [37] 0 0
France
State/province [37] 0 0
Cedex 9
Country [38] 0 0
France
State/province [38] 0 0
Herblain Cedex
Country [39] 0 0
France
State/province [39] 0 0
Loir-et-Cher
Country [40] 0 0
France
State/province [40] 0 0
Nancy Cedex
Country [41] 0 0
France
State/province [41] 0 0
Normandy
Country [42] 0 0
France
State/province [42] 0 0
Pessac
Country [43] 0 0
France
State/province [43] 0 0
Villejuif Cedex
Country [44] 0 0
France
State/province [44] 0 0
Bayonne Cedex
Country [45] 0 0
France
State/province [45] 0 0
Bordeaux
Country [46] 0 0
France
State/province [46] 0 0
Grenoble
Country [47] 0 0
France
State/province [47] 0 0
Nice Cedex 2
Country [48] 0 0
France
State/province [48] 0 0
Pierre Benite
Country [49] 0 0
France
State/province [49] 0 0
Plerin
Country [50] 0 0
France
State/province [50] 0 0
Pringy Cedex
Country [51] 0 0
France
State/province [51] 0 0
Roche-Sur-Yon
Country [52] 0 0
France
State/province [52] 0 0
Strasbourg
Country [53] 0 0
Ireland
State/province [53] 0 0
Dublin
Country [54] 0 0
Italy
State/province [54] 0 0
Milan
Country [55] 0 0
Italy
State/province [55] 0 0
Torino
Country [56] 0 0
Italy
State/province [56] 0 0
Cremona
Country [57] 0 0
Italy
State/province [57] 0 0
Lombardia
Country [58] 0 0
Italy
State/province [58] 0 0
Toscana
Country [59] 0 0
Italy
State/province [59] 0 0
Veneto
Country [60] 0 0
Japan
State/province [60] 0 0
Aichi
Country [61] 0 0
Japan
State/province [61] 0 0
Chiba
Country [62] 0 0
Japan
State/province [62] 0 0
Hokkaido
Country [63] 0 0
Japan
State/province [63] 0 0
Kanagawa
Country [64] 0 0
Japan
State/province [64] 0 0
Nara
Country [65] 0 0
Japan
State/province [65] 0 0
Tokyo
Country [66] 0 0
Japan
State/province [66] 0 0
Yamaguchi
Country [67] 0 0
Japan
State/province [67] 0 0
Fukuoka
Country [68] 0 0
Japan
State/province [68] 0 0
Osaka
Country [69] 0 0
Japan
State/province [69] 0 0
Wakayama
Country [70] 0 0
Korea, Republic of
State/province [70] 0 0
Gyeonggi-do
Country [71] 0 0
Korea, Republic of
State/province [71] 0 0
Daegu
Country [72] 0 0
Korea, Republic of
State/province [72] 0 0
Seoul
Country [73] 0 0
Mexico
State/province [73] 0 0
Distrito Federal
Country [74] 0 0
Mexico
State/province [74] 0 0
San Luis Potosi
Country [75] 0 0
Mexico
State/province [75] 0 0
Veracruz
Country [76] 0 0
Spain
State/province [76] 0 0
Barcelona
Country [77] 0 0
Spain
State/province [77] 0 0
Navarra
Country [78] 0 0
Spain
State/province [78] 0 0
Caceres
Country [79] 0 0
Spain
State/province [79] 0 0
Cordoba
Country [80] 0 0
Spain
State/province [80] 0 0
Lleida
Country [81] 0 0
Spain
State/province [81] 0 0
Madrid
Country [82] 0 0
Spain
State/province [82] 0 0
Malaga
Country [83] 0 0
Spain
State/province [83] 0 0
Santiago de Compostela
Country [84] 0 0
Taiwan
State/province [84] 0 0
New Taipei City
Country [85] 0 0
Taiwan
State/province [85] 0 0
Taichung City
Country [86] 0 0
Taiwan
State/province [86] 0 0
Taipei City
Country [87] 0 0
Turkey
State/province [87] 0 0
Ankara
Country [88] 0 0
Turkey
State/province [88] 0 0
Diyarbakir
Country [89] 0 0
Turkey
State/province [89] 0 0
Istanbul
Country [90] 0 0
Turkey
State/province [90] 0 0
Konya

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Astellas Pharma Global Development, Inc.
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Astellas Pharma Global Development
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?
Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
Available to whom?
Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.clinicaltrials.astellas.com/transparency/


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/NCT03816163