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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05888844
Registration number
NCT05888844
Ethics application status
Date submitted
24/05/2023
Date registered
5/06/2023
Titles & IDs
Public title
A Study to Evaluate INCB099280 in Participants With Advanced Cutaneous Squamous Cell Carcinoma
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Scientific title
A Phase 2 Study Evaluating INCB099280 in Participants With Advanced Squamous Cell Carcinoma
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Secondary ID [1]
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2022-502476-23-00
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Secondary ID [2]
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INCB 99280-212
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Cutaneous Squamous Cell Carcinoma
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Condition category
Condition code
Cancer
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Non melanoma skin cancer
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Cancer
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0
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Kidney
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - INCB099280
Experimental: Part 1: INCB099280 Dose 1 - Participants will receive INCB099280 dose 1 twice daily (BID) for up to 2 years.
Experimental: Part 1: INCB099280 Dose 2 - Participants will receive INCB099280 dose 2 twice daily (BID) for up to 2 years.
Experimental: Part 1: INCB099280 Dose 3 - Participants will receive INCB099280 dose 3 twice daily (BID) for up to 2 years.
Experimental: Part 2: INCB099280 Dose selected from Part 1 - Participants will receive INCB099280 dose selected from Part 1 twice daily (BID) for up to 2 years.
Treatment: Drugs: INCB099280
Administered as specified in the treatment arm description.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Objective response rate (ORR)
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Assessment method [1]
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Defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR), as determined by the blinded independent central review (BICR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or composite criteria for metastatic cSCC and per World Health Organization (WHO) criteria for locally advanced cSCC.
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Timepoint [1]
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Up to 2 years
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Primary outcome [2]
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Number of participants with Treatment-emergent Adverse Events (TEAEs)
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Assessment method [2]
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Defined as any Adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug up to 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurs first.
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Timepoint [2]
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Up to 2 years 3 months
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Primary outcome [3]
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Number of participants with TEAEs leading to dose modification or discontinuation
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Assessment method [3]
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Number of participants with TEAEs leading to dose modification or discontinuation.
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Timepoint [3]
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Up to 2 years
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Secondary outcome [1]
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Disease Control Rate (DCR)
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Assessment method [1]
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Defined as the percentage of participants with the best overall response of CR or PR, or stable disease (SD), after a minimum of 15 weeks following the initiation of study treatment as determined by the BICR per RECIST v1.1 or composite criteria for metastatic cSCC and WHO criteria for locally advanced cSCC.
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Timepoint [1]
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Up to 2 years
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Secondary outcome [2]
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Duration Of Response (DOR)
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Assessment method [2]
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Defined as the time from the earliest date of confirmed CR or PR to the earliest date of disease progression, as determined by the BICR according to RECIST v1.1 or composite criteria for metastatic cSCC and WHO criteria for locally advanced cSCC or death due to any cause if occurring sooner than progression.
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Timepoint [2]
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Up to 2 years
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Secondary outcome [3]
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Time to Response (TTR)
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Assessment method [3]
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Defined as the time from the date of first dose to the earliest date of confirmed CR or PR as determined by the BICR according to RECIST v1.1 or composite criteria for metastatic cSCC and WHO criteria for locally advanced cSCC.
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Timepoint [3]
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Up to 2 years
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Secondary outcome [4]
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Progression-free survival (PFS)
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Assessment method [4]
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Defined as the time from the date of first dose to the earliest date of disease progression as determined by the BICR according to RECIST v1.1 or composite criteria for metastatic cSCC and WHO criteria for locally advanced cSCC or death due to any cause if occurring sooner than progression.
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Timepoint [4]
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Up to 2 years
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Secondary outcome [5]
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Overall Survival (OS)
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Assessment method [5]
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Defined as the time from the date of first dose to death due to any cause.
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Timepoint [5]
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Up to 2 years
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Secondary outcome [6]
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INCB099280 pharmacokinetic (PK) in Plasma
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Assessment method [6]
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INCB099280 concentration in plasma
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Timepoint [6]
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Pre dose and 1, 2 and 6 hours post dose on Cycle 1 Day 1 and Cycle 2 Day 1. Pre dose every other cycle until Cycle 11 Day 1 (Cycle 3 Day 1, Cycle 5 Day 1, Cycle 7 Day 1, Cycle 9 Day 1 and Cycle 11 Day 1) (each cycle is 28 days)
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Eligibility
Key inclusion criteria
* Histopathological diagnosis of cSCC.
* Previously untreated or recurrent locally advanced (without nodal metastases) or metastatic (distant or regional metastasis) cSCC not amenable to curative surgery and/or radiotherapy.
* Measurable disease based on either radiographic imaging per RECIST 1.1 or WHO criteria.
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
* Life expectancy > 3 months.
* Willingness to avoid pregnancy or fathering children.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Known history of an additional malignancy.
* Central nervous system (CNS) metastases requiring treatment and/or leptomeningeal disease.
* Toxicity from prior therapy that has not recovered.
* Prior receipt of an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent; treatment with an immune modulator (eg, CTLA-4, GITR, LAG3, TIM3, OX40, ICOS, IL-2, 4-1BB, CAR-T cell).
* Received thoracic radiation within 6 months of the first dose of study treatment.
* Participation in another interventional clinical study while receiving INCB099280.
* Impaired cardiac function or clinically significant cardiac disease.
* History or evidence of interstitial lung disease including noninfectious pneumonitis.
* Presence of gastrointestinal conditions that may affect drug absorption.
* Any autoimmune disease requiring systemic treatment in the past 5 years.
* Diagnosis of primary immunodeficiency or receiving chronic systemic steroid therapy at a daily dose exceeding 10 mg of prednisone or equivalent.
* Active infection requiring systemic therapy.
* History of organ transplantation, including allogeneic stem cell transplantation.
* Receipt of systemic antibiotics within 28 days of first dose of study treatment.
* Probiotic usage is prohibited during screening and throughout the study treatment period.
* Received a live vaccine within 28 days of the planned start of study drug.
* Laboratory values outside the Protocol-defined ranges.
* Inadequate organ function.
Other protocol-defined Inclusion/Exclusion Criteria may apply.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
9/10/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
31/12/2026
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Actual
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Sample size
Target
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Accrual to date
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Final
63
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
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Recruitment hospital [1]
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Border Medical Oncology Research Unit - Albury
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Recruitment hospital [2]
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Townsville Cancer Centre - Townsville
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Recruitment hospital [3]
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Princess Alexandra Hospital Australia - Woolloongabba
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Recruitment hospital [4]
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Box Hill Hospital - Box Hill
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Recruitment hospital [5]
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Monash Medical Centre Clayton - Clayton
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Recruitment postcode(s) [1]
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02640 - Albury
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Recruitment postcode(s) [2]
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04814 - Townsville
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Recruitment postcode(s) [3]
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04102 - Woolloongabba
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Recruitment postcode(s) [4]
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03128 - Box Hill
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Recruitment postcode(s) [5]
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03168 - Clayton
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Recruitment outside Australia
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Brazil
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Barretos
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Ijui
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JAÚ
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Santa Cruz Do Sul
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Santo André
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Edirne
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Incyte Corporation
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
This study is being conducted to determine the safety, tolerability, and preliminary efficacy of INCB099280 in participants with advanced Cutaneous Squamous Cell Carcinoma.
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Trial website
https://clinicaltrials.gov/study/NCT05888844
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Incyte Medical Monitor
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Address
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Incyte Corporation
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Email
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Contact person for public queries
Name
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Incyte Corporation Call Center (US)
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Address
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Phone
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1.855.463.3463
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a 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. The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency
Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
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When will data be available (start and end dates)?
Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
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Available to whom?
Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://www.incyte.com/our-company/compliance-and-transparency
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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/NCT05888844