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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-004967-35 | EudraCT Number |
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The purpose of this study is to evaluate the safety and tolerability, pharmacokinetics, pharmacodynamics, and early clinical activity of INCB099280 in participants with select solid tumors
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | Participants with select solid tumors who are immunotherapy treatment-naive |
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| Cohort 2 | Experimental | Participants with high microsatellite instability (MSI-H) or deficient mismatch repair (dMMR) tumors who are immunotherapy treatment-naïve. |
|
| Cohort 3 | Experimental | Participants with progression of any solid tumor treated with an approved anti-PD-1 monoclonal antibody therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| INCB099280 | Drug | INCB099280 administered orally in 25 mg or 100 mg tablets once daily or twice daily on each day of each 28-day cycle |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of treatment-emergent adverse events | 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 30 days after last dose of study drug. | Up to approximately 25 months |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax of INCB099280 | Maximum observed plasma concentration | Up to approximately 3 months |
| tmax of INCB099280 | Time to maximum plasma concentration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Incyte Medical Monitor | Incyte Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | United States | ||
| Henry Ford Hospital |
There is no plan to share data
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The study consists of 2 parts. Part 1 is a dose-escalation design to identify the maximum tolerant dose and/or pharmacologically active dose for INCB099280. Part 2 is an expansion at 1 or more dose levels to further explore safety, preliminary efficacy, pharmacokinetic, and pharmacodynamic effects.
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| Up to approximately 3 months |
| Cmin of INCB099280 | Minimum observed plasma concentration over the dose interval | Up to approximately 3 months |
| AUC0-t of INCB099280 | Area under the plasma concentration-time curve from time = 0 to the last measurable concentration at time = t | Up to approximately 3 months |
| t½ of INCB099280 | Apparent terminal-phase disposition half-life | Up to approximately 3 months |
| λz of INCB099280 | Terminal elimination rate constant | Up to approximately 3 months |
| CL/F of INCB099280 | Oral dose clearance | Up to approximately 3 months |
| Vz/F of INCB099280 | Apparent oral dose volume of distribution | Up to approximately 3 months |
| Detroit |
| Michigan |
| 48202 |
| United States |
| Upmc Cancercenter | Pittsburgh | Pennsylvania | 15232 | United States |
| Md Anderson Cancer Center | Houston | Texas | 77030 | United States |
| University of Washington | Seattle | Washington | 98195 | United States |
| Chris Obrien Lifehouse | Camperdown | New South Wales | 02050 | Australia |
| Austin Hospital | Heidelberg | Victoria | 03084 | Australia |
| Nucleus Network Pty Ltd | Melbourne | Victoria | 03004 | Australia |
| Linear Clinical Research | Nedlands | Western Australia | 06009 | Australia |
| Cliniques Universitaires Ucl Saint-Luc | Brussels | 01200 | Belgium |
| Institut Jules Bordet Clinical Trials Conduct Unit | Brussels | B-1070 | Belgium |
| Universitair Ziekenhuis Antwerpen (Uza) | Edegem | 02650 | Belgium |
| Ghent University Hospital | Ghent | 09000 | Belgium |
| Universitaire Ziekenhuis Leuven - Gasthuisberg | Leuven | 03000 | Belgium |
| Institut de Cancerologie de L Ouest - Site Paul Papin | Angers | 49000 | France |
| Institut Bergonie | Bordeaux | 33076 | France |
| Chu Hopital de La Timone | Marseille | 13385 | France |
| Centre Eugene Marquis | Rennes | 35042 | France |
| Institut Gustave Roussy | Villejuif | 94800 | France |
| National Cancer Center Hospital East | Chiba | 277-8577 | Japan |
| National Cancer Center Hospital | Tokyo | 104-0045 | Japan |
| ID | Term |
|---|---|
| D002295 | Carcinoma, Transitional Cell |
| D002583 | Uterine Cervical Neoplasms |
| D006528 | Carcinoma, Hepatocellular |
| D000077277 | Esophageal Squamous Cell Carcinoma |
| D015266 | Carcinoma, Merkel Cell |
| D055752 | Small Cell Lung Carcinoma |
| D008654 | Mesothelioma |
| D000077274 | Nasopharyngeal Carcinoma |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D000230 | Adenocarcinoma |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| D002294 | Carcinoma, Squamous Cell |
| D018307 | Neoplasms, Squamous Cell |
| D004938 | Esophageal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D027601 | Polyomavirus Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D014412 | Tumor Virus Infections |
| D018278 | Carcinoma, Neuroendocrine |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009380 | Neoplasms, Nerve Tissue |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000236 | Adenoma |
| D018301 | Neoplasms, Mesothelial |
| D009303 | Nasopharyngeal Neoplasms |
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D009302 | Nasopharyngeal Diseases |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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