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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04935359




Registration number
NCT04935359
Ethics application status
Date submitted
21/06/2021
Date registered
23/06/2021

Titles & IDs
Public title
Study of Efficacy and Safety of NIS793 in Combination With Standard of Care (SOC) Chemotherapy in First-line Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC) - daNIS-2
Scientific title
A Randomized, Double-blind, Phase III Study, Comparing NIS793 in Combination With Gemcitabine and Nab-paclitaxel Versus (vs.) Placebo Combined With Gemcitabine and Nab-paclitaxel for First Line Treatment of Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC) - daNIS-2
Secondary ID [1] 0 0
2021-000591-10
Secondary ID [2] 0 0
CNIS793B12301
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - NIS793
Treatment: Drugs - Nab-paclitaxel
Treatment: Drugs - Gemcitabine
Treatment: Drugs - Placebo

Experimental: Safety run-in part: NIS793+gemcitabine+nab-paclitaxel - In the safety run-in part, participants will receive a combination of NIS793, gemcitabine and nab-paclitaxel.

Experimental: Randomized part: NIS793+gemcitabine+nab-paclitaxel - Participants will receive a combination of NIS793, gemcitabine and nab-paclitaxel

Note: As of 07-Jul-2023, treatment with NIS793/placebo was stopped.

Placebo comparator: Randomized part: placebo+gemcitabine+nab-paclitaxel - Participants will receive a combination of placebo, gemcitabine and nab-paclitaxel

Note: As of 07-Jul-2023, treatment with NIS793/placebo was stopped.


Treatment: Drugs: NIS793
Concentrate for solution infusion (Liquid in Vial)

Treatment: Drugs: Nab-paclitaxel
Per locally approved formulation

Treatment: Drugs: Gemcitabine
Per locally approved formulation

Treatment: Drugs: Placebo
Dextrose 5% in water (D5W) solution for infusion
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety run-in part: Percentage of participants with dose limiting toxicities (DLTs) during the first cycle (4 weeks) of treatment.
Timepoint [1] 0 0
Up to 4 weeks
Primary outcome [2] 0 0
Randomized part: Overall survival (OS)
Timepoint [2] 0 0
From randomization up to death, assessed up to approximately 19 months
Secondary outcome [1] 0 0
Percentage of participants with Adverse Events (AEs)
Timepoint [1] 0 0
Up to approximately 19 months
Secondary outcome [2] 0 0
Percentage of participants with dose interruptions and dose reductions of NIS793 in combination with gemcitabine and nab-paclitaxel
Timepoint [2] 0 0
Up to approximately 19 months
Secondary outcome [3] 0 0
Dose intensity of NIS793 in combination with gemcitabine and nab-paclitaxel
Timepoint [3] 0 0
Up to approximately 19 months
Secondary outcome [4] 0 0
Progression-free survival (PFS) by investigator assessment per RECIST 1.1
Timepoint [4] 0 0
From enrollment (run-in part) or randomization (randomized part) up to disease progression or death, assessed up to approximately 19 months
Secondary outcome [5] 0 0
Overall response rate (ORR) by investigator assessment per RECIST 1.1
Timepoint [5] 0 0
Up to approximately 19 months
Secondary outcome [6] 0 0
Disease control rate (DCR) by investigator assessment per RECIST 1.1
Timepoint [6] 0 0
Up to approximately 19 months
Secondary outcome [7] 0 0
Time to response (TTR) by investigator assessment per RECIST 1.1
Timepoint [7] 0 0
From enrollment (run-in part) or randomization (randomized part) up to first documented response, assessed up to approximately 19 months
Secondary outcome [8] 0 0
Safety run-in part: Overall Survival (OS)
Timepoint [8] 0 0
From enrollment up to death, assessed up to approximately 19 months
Secondary outcome [9] 0 0
Maximum concentration (Cmax) of NIS793 in combination with gemcitabine and nab-paclitaxel
Timepoint [9] 0 0
From date of first study drug intake up to approximately 19 months
Secondary outcome [10] 0 0
Trough Concentration (Ctrough) of NIS793 in combination with gemcitabine and nab-paclitaxel
Timepoint [10] 0 0
From date of first study drug intake up to approximately 19 months
Secondary outcome [11] 0 0
Area under the curve from time zero to the last measurable concentration sampling time (AUClast) of NIS793 in combination with gemcitabine and nab-paclitaxel
Timepoint [11] 0 0
From date of first study drug intake up to approximately 19 months
Secondary outcome [12] 0 0
Area under the curve calculated to the end of a dosing interval (tau) at steady-state (AUCtau) of NIS793 in combination with gemcitabine and nab-paclitaxel
Timepoint [12] 0 0
From date of first study drug intake up to approximately 19 months
Secondary outcome [13] 0 0
Time to reach maximum concentration (Tmax) of NIS793 in combination with gemcitabine and nab-paclitaxel
Timepoint [13] 0 0
From date of first study drug intake up to approximately 19 months
Secondary outcome [14] 0 0
Randomized part: NIS793 serum concentration
Timepoint [14] 0 0
From date of first study drug intake up to approximately 19 months
Secondary outcome [15] 0 0
Randomized part: Anti-drug antibodies (ADA) against NIS793 prevalence at baseline
Timepoint [15] 0 0
Baseline
Secondary outcome [16] 0 0
Randomized part: ADA (anti-NIS793) incidence on treatment
Timepoint [16] 0 0
From date of first study drug intake up to approximately 19 months

Eligibility
Key inclusion criteria
* Applicable for both Safety run-in and Randomized part

* Participants aged =18 years with histologically or cytologically confirmed (based on local assessment and per local guidelines) mPDAC eligible for treatment in the first line setting and not amenable for potentially curative surgery
* Presence of at least one measurable lesion assessed by Computerized Tomography (CT) and/or Magnetic Resonance Imaging (MRI) according to RECIST 1.1
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
* Adequate organ function (assessed by central laboratory for eligibility)
* Participants must have recovered from treatment-related toxicities of prior anticancer therapies to grade = 1 (CTCAE v 5.0) at time of screening, except alopecia.

Main
Minimum age
18 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Applicable for both Safety run-in and Randomized part

* Previous systemic anti-cancer treatment for metastatic PDAC
* Pancreatic neuroendocrine (islet) or acinar tumors
* Participants with known status of microsatellite instability-high (MSI-H) or mismatch repair-deficient pancreatic cancer (if status is not already available, testing is not required at screening).
* Participant has not recovered from a major surgery performed prior to start of study treatment or has had a major surgery within 4 weeks prior to start of study treatment.
* Radiation therapy or brain radiotherapy = 4 weeks prior to start of study treatment (palliative radiotherapy to bone lesions allowed > 2 weeks prior to start of study treatment).
* Impaired cardiac function or clinically significant cardio-vascular disease
* Use of hematopoietic growth factors or transfusion support = 2 weeks prior to start of study treatment.
* Participant has conditions that are considered to have a high risk of clinically significant gastrointestinal tract bleeding or any other condition associated with or history of significant bleeding.
* Serious non-healing wounds.
* Pregnant or breast-feeding women
* Women of childbearing potential, unless willing to use highly effective contraception methods during treatment and after stopping study treatments as indicated
* Pre-existing peripheral neuropathy > grade 1 (CTCAE v5.0)

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 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/09/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
13/08/2024
Sample size
Target
Accrual to date
Final
511
Recruitment in Australia
Recruitment state(s)
SA,WA
Recruitment hospital [1] 0 0
Novartis Investigative Site - Adelaide
Recruitment hospital [2] 0 0
Novartis Investigative Site - Perth
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
6009 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arkansas
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
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Indiana
Country [5] 0 0
United States of America
State/province [5] 0 0
New York
Country [6] 0 0
United States of America
State/province [6] 0 0
Texas
Country [7] 0 0
United States of America
State/province [7] 0 0
Utah
Country [8] 0 0
United States of America
State/province [8] 0 0
Washington
Country [9] 0 0
Belgium
State/province [9] 0 0
Bonheiden
Country [10] 0 0
Belgium
State/province [10] 0 0
Bruxelles
Country [11] 0 0
Belgium
State/province [11] 0 0
Edegem
Country [12] 0 0
Belgium
State/province [12] 0 0
Leuven
Country [13] 0 0
Brazil
State/province [13] 0 0
Distrito Federal
Country [14] 0 0
Brazil
State/province [14] 0 0
Rio Grande Do Sul
Country [15] 0 0
Brazil
State/province [15] 0 0
RS
Country [16] 0 0
Brazil
State/province [16] 0 0
SP
Country [17] 0 0
Canada
State/province [17] 0 0
Ontario
Country [18] 0 0
Canada
State/province [18] 0 0
Quebec
Country [19] 0 0
China
State/province [19] 0 0
Guangdong
Country [20] 0 0
China
State/province [20] 0 0
Heilongjiang
Country [21] 0 0
China
State/province [21] 0 0
Jiangsu
Country [22] 0 0
China
State/province [22] 0 0
Liaoning
Country [23] 0 0
China
State/province [23] 0 0
Shandong
Country [24] 0 0
China
State/province [24] 0 0
Shanxi
Country [25] 0 0
China
State/province [25] 0 0
Sichuan
Country [26] 0 0
China
State/province [26] 0 0
Zhejiang
Country [27] 0 0
China
State/province [27] 0 0
Beijing
Country [28] 0 0
China
State/province [28] 0 0
Shanghai
Country [29] 0 0
China
State/province [29] 0 0
Tianjin
Country [30] 0 0
Czechia
State/province [30] 0 0
Czech Republic
Country [31] 0 0
Czechia
State/province [31] 0 0
CZE
Country [32] 0 0
Czechia
State/province [32] 0 0
Praha 4
Country [33] 0 0
Finland
State/province [33] 0 0
Helsinki
Country [34] 0 0
Finland
State/province [34] 0 0
Tampere
Country [35] 0 0
France
State/province [35] 0 0
Alpes Maritimes
Country [36] 0 0
France
State/province [36] 0 0
Avignon
Country [37] 0 0
France
State/province [37] 0 0
Besancon Cedex
Country [38] 0 0
France
State/province [38] 0 0
Creteil
Country [39] 0 0
France
State/province [39] 0 0
Lyon 08
Country [40] 0 0
France
State/province [40] 0 0
Marseille
Country [41] 0 0
France
State/province [41] 0 0
Montpellier
Country [42] 0 0
France
State/province [42] 0 0
Nantes Cedex 1
Country [43] 0 0
France
State/province [43] 0 0
Paris
Country [44] 0 0
Germany
State/province [44] 0 0
Berlin
Country [45] 0 0
Germany
State/province [45] 0 0
Bochum
Country [46] 0 0
Germany
State/province [46] 0 0
Essen
Country [47] 0 0
Germany
State/province [47] 0 0
Frankfurt
Country [48] 0 0
Germany
State/province [48] 0 0
Halle S
Country [49] 0 0
Germany
State/province [49] 0 0
Hamburg
Country [50] 0 0
Germany
State/province [50] 0 0
Ulm
Country [51] 0 0
Greece
State/province [51] 0 0
Thessaloniki
Country [52] 0 0
Hungary
State/province [52] 0 0
Budapest
Country [53] 0 0
Hungary
State/province [53] 0 0
Debrecen
Country [54] 0 0
Israel
State/province [54] 0 0
Jerusalem
Country [55] 0 0
Israel
State/province [55] 0 0
Ramat Gan
Country [56] 0 0
Israel
State/province [56] 0 0
Tel Aviv
Country [57] 0 0
Italy
State/province [57] 0 0
FI
Country [58] 0 0
Italy
State/province [58] 0 0
MI
Country [59] 0 0
Italy
State/province [59] 0 0
VR
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
Kanagawa
Country [63] 0 0
Japan
State/province [63] 0 0
Osaka
Country [64] 0 0
Japan
State/province [64] 0 0
Tokyo
Country [65] 0 0
Korea, Republic of
State/province [65] 0 0
Seocho Gu
Country [66] 0 0
Korea, Republic of
State/province [66] 0 0
Seoul
Country [67] 0 0
Netherlands
State/province [67] 0 0
Utrecht
Country [68] 0 0
Norway
State/province [68] 0 0
Oslo
Country [69] 0 0
Russian Federation
State/province [69] 0 0
Omsk
Country [70] 0 0
Russian Federation
State/province [70] 0 0
Pushkin Saint Petersburg
Country [71] 0 0
Singapore
State/province [71] 0 0
Singapore
Country [72] 0 0
Slovakia
State/province [72] 0 0
Slovak Republic
Country [73] 0 0
Slovakia
State/province [73] 0 0
Banska Bystrica
Country [74] 0 0
Slovakia
State/province [74] 0 0
Kosice
Country [75] 0 0
Spain
State/province [75] 0 0
Catalunya
Country [76] 0 0
Spain
State/province [76] 0 0
Galicia
Country [77] 0 0
Spain
State/province [77] 0 0
Madrid
Country [78] 0 0
Sweden
State/province [78] 0 0
Malmo
Country [79] 0 0
Sweden
State/province [79] 0 0
Umea
Country [80] 0 0
Switzerland
State/province [80] 0 0
Bellinzona
Country [81] 0 0
Switzerland
State/province [81] 0 0
Geneve 14
Country [82] 0 0
Switzerland
State/province [82] 0 0
St Gallen
Country [83] 0 0
Taiwan
State/province [83] 0 0
Taipei
Country [84] 0 0
Taiwan
State/province [84] 0 0
Taoyuan
Country [85] 0 0
Turkey
State/province [85] 0 0
Adana
Country [86] 0 0
Turkey
State/province [86] 0 0
Ankara
Country [87] 0 0
Turkey
State/province [87] 0 0
Istanbul
Country [88] 0 0
Turkey
State/province [88] 0 0
Izmir
Country [89] 0 0
United Kingdom
State/province [89] 0 0
Surrey
Country [90] 0 0
United Kingdom
State/province [90] 0 0
Cambridge
Country [91] 0 0
United Kingdom
State/province [91] 0 0
Liverpool
Country [92] 0 0
United Kingdom
State/province [92] 0 0
London
Country [93] 0 0
United Kingdom
State/province [93] 0 0
Oxford

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
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?
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


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/NCT04935359