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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04242199




Registration number
NCT04242199
Ethics application status
Date submitted
23/01/2020
Date registered
27/01/2020

Titles & IDs
Public title
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099280 in Participants With Advanced Solid Tumors
Scientific title
A Phase 1 Study Exploring the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099280 in Participants With Select Advanced Solid Tumors
Secondary ID [1] 0 0
INCB 99280-112
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Solid Tumor 0 0
MSI-H/dMMR Tumors 0 0
Cutaneous Squamous Cell Carcinoma 0 0
Urothelial Carcinoma 0 0
Cervical Cancer 0 0
HepatoCellular Carcinoma 0 0
Esophageal Squamous Cell Carcinoma 0 0
Merkel Cell Carcinoma 0 0
Small-cell Lung Cancer 0 0
Mesothelioma 0 0
PD-L1 Amplified Tumor (9p24.1) 0 0
Nasopharyngeal Carcinoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Malignant melanoma
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney
Cancer 0 0 0 0
Lung - Small cell
Cancer 0 0 0 0
Head and neck
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Oesophageal (gullet)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - INCB099280

Experimental: Cohort 1 - Participants with select solid tumors who are immunotherapy treatment-naive

Experimental: Cohort 2 - Participants with high microsatellite instability (MSI-H) or deficient mismatch repair (dMMR) tumors who are immunotherapy treatment-naïve.

Experimental: Cohort 3 - Participants with progression of any solid tumor treated with an approved anti-PD-1 monoclonal antibody therapy


Treatment: Drugs: INCB099280
INCB099280 administered orally in 25 mg or 100 mg tablets once daily or twice daily on each day of each 28-day cycle
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of treatment-emergent adverse events
Timepoint [1] 0 0
Up to approximately 25 months
Secondary outcome [1] 0 0
Cmax of INCB099280
Timepoint [1] 0 0
Up to approximately 3 months
Secondary outcome [2] 0 0
tmax of INCB099280
Timepoint [2] 0 0
Up to approximately 3 months
Secondary outcome [3] 0 0
Cmin of INCB099280
Timepoint [3] 0 0
Up to approximately 3 months
Secondary outcome [4] 0 0
AUC0-t of INCB099280
Timepoint [4] 0 0
Up to approximately 3 months
Secondary outcome [5] 0 0
t½ of INCB099280
Timepoint [5] 0 0
Up to approximately 3 months
Secondary outcome [6] 0 0
?z of INCB099280
Timepoint [6] 0 0
Up to approximately 3 months
Secondary outcome [7] 0 0
CL/F of INCB099280
Timepoint [7] 0 0
Up to approximately 3 months
Secondary outcome [8] 0 0
Vz/F of INCB099280
Timepoint [8] 0 0
Up to approximately 3 months

Eligibility
Key inclusion criteria
* Must have disease progression after treatment with available therapies that are known to confer clinical benefit or must be intolerant to or ineligible for standard treatment.
* Histologically confirmed advanced solid tumors (protocol-defined select solid tumors) with measurable lesions per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST v1.1) that are considered nonamenable to surgery or other curative treatments or procedures.
* Eastern Cooperative Oncology Group performance status score of 0 or 1.
* Life expectancy > 12 weeks.
* Willingness to avoid pregnancy or fathering children.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Laboratory values outside the Protocol-defined ranges.
* Clinically significant cardiac disease.
* History or presence of an electrocardiogram that, in the investigator's opinion, is clinically meaningful.
* Untreated brain or central nervous system (CNS) metastases or brain or CNS metastases that have progressed (eg, evidence of new or enlarging brain metastasis or new neurological symptoms attributable to brain or CNS metastases).
* Known additional malignancy that is progressing or requires active treatment.
* Has not recovered to = Grade 1 or baseline from toxic effects of prior therapy (including prior IO) and/or complications from prior surgical intervention before starting study treatment.
* Prior receipt of an anti-PD-L1 therapy.
* Treatment with anticancer medications or investigational drugs within protocol-defined intervals before the first administration of study drug.
* A 28-day washout for systemic antibiotics is required.
* Probiotic usage while on study and during screening is prohibited.
* Active infection requiring systemic therapy.
* Known history of Human Immunodeficiency Virus (HIV)
* Evidence of hepatitis B virus or hepatitis C virus infection or risk of reactivation.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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 1
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
4/09/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/10/2025
Actual
Sample size
Target
Accrual to date
Final
182
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
Chris Obrien Lifehouse - Camperdown
Recruitment hospital [2] 0 0
Austin Hospital - Heidelberg
Recruitment hospital [3] 0 0
Nucleus Network Pty Ltd - Melbourne
Recruitment hospital [4] 0 0
Linear Clinical Research - Nedlands
Recruitment postcode(s) [1] 0 0
02050 - Camperdown
Recruitment postcode(s) [2] 0 0
03084 - Heidelberg
Recruitment postcode(s) [3] 0 0
03004 - Melbourne
Recruitment postcode(s) [4] 0 0
06009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Massachusetts
Country [2] 0 0
United States of America
State/province [2] 0 0
Michigan
Country [3] 0 0
United States of America
State/province [3] 0 0
Pennsylvania
Country [4] 0 0
United States of America
State/province [4] 0 0
Texas
Country [5] 0 0
United States of America
State/province [5] 0 0
Washington
Country [6] 0 0
Belgium
State/province [6] 0 0
Brussels
Country [7] 0 0
Belgium
State/province [7] 0 0
Edegem
Country [8] 0 0
Belgium
State/province [8] 0 0
Ghent
Country [9] 0 0
Belgium
State/province [9] 0 0
Leuven
Country [10] 0 0
France
State/province [10] 0 0
Angers
Country [11] 0 0
France
State/province [11] 0 0
Bordeaux
Country [12] 0 0
France
State/province [12] 0 0
Marseille Cedex 5
Country [13] 0 0
France
State/province [13] 0 0
Rennes
Country [14] 0 0
France
State/province [14] 0 0
Villejuif
Country [15] 0 0
Japan
State/province [15] 0 0
Chiba
Country [16] 0 0
Japan
State/province [16] 0 0
Tokyo

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Incyte Corporation
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Incyte Medical Monitor
Address 0 0
Incyte Corporation
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)?
No
No/undecided IPD sharing reason/comment
There is no plan to share data


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/NCT04242199