This study is being conducted to evaluate the safety and tolerability of INCB099280 in combination with axitinib and to assess the antitumor activity of INCB099280 in combination with axitinib. This study will only be open in the UK and EU.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
5
Administered as specified in the treatment arm description
Administered as specified in the treatment arm description
Addenbrookes Hospital
Cambridge, United Kingdom
Beatson West of Scotland Cancer Centrewester
Glasgow, United Kingdom
St Bartholomew'S Hospital
London, United Kingdom
Guys Hospital
London, United Kingdom
Part 1: Number of participants with Dose Limiting Toxicities (DLTs)
Dose-limiting toxicity will be defined as the occurrence of any of the toxicities as per protocol.
Time frame: Up to 21 days
Part 1: Number of participants with Treatment-emergent Adverse Events (TEAEs)
Defined as adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug.
Time frame: Up to 2 years and 90 days
Part 1: Number of participants with TEAEs leading to dose modification
Number of participants with TEAEs leading to a dose modification (treatment interruption, dose reduction, and permanent discontinuation of either study drug).
Time frame: Up to 2 years
Part 2: Objective response rate (ORR)
Defined as the percentage of participants with best overall response of complete response (CR) or partial response (PR), as determined by investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Time frame: Up to 2 years
Part 2: Number of participants with Treatment-emergent Adverse Events (TEAEs)
Defined as adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug.
Time frame: Up to 2 years and 90 days
Part 2: Number of participants with TEAEs leading to dose modification
Number of participants with TEAEs leading to a dose modification (treatment interruption, dose reduction, and permanent discontinuation of either study drug).
Time frame: Up to 2 years
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The Royal Marsden
London, United Kingdom
The Royal Marsden Nhs Foundation Trust - Sutton
Sutton, United Kingdom
Part 1: Objective response rate (ORR)
Defined as the percentage of participants with best overall response of complete response (CR) or partial response (PR), as determined by investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Time frame: Up to 2 years
Disease Control Rate (DCR)
Defined as the best overall response of CR, PR, or stable disease (SD) of at least 11 weeks from the start of treatment by investigator assessment per RECIST v1.1.
Time frame: Up to 2 years
Duration of Response (DOR)
Defined as the time from the first CR or PR until disease progression by investigator assessment per RECIST v1.1 or death from any cause, whichever occurs earlier.
Time frame: Up to 2 years
INCB099280 and axitinib plasma concentrations.
PK parameters will be calculated from the blood plasma concentrations of INCB099280 and axitinib using standard noncompartmental (model independent) PK methods.
Time frame: Up to 2 years