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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-510281-27-00 | Registry Identifier | EU CT Number | |
| 2022-003663-13 | EudraCT Number |
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This was a strategic business decision. There were no safety concerns contributing to this decision.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: Dose Escalation | Experimental | Up to 6 doses of INCB099280 administered twice daily (BID) in combination with axitinib BID will be evaluated to identify dose(s) for further evaluation in the dose expansion phase of the study. |
|
| Part 2: Dose Expansion | Experimental | On completion of Part 1, participants will be enrolled in 1 of 2 disease-specific cohorts: Cohort 1: Adults with clear-cell gynecological cancers with at least 50% clear-cell histology whose disease progressed on or following at least 1 prior line of systemic chemotherapy and are not candidates for curative surgery or (chemo)radiation. Cohort 2: Adults with rare histological subtype epithelial cancers of the gynecological tract whose disease progressed on or following at least 1 prior line of systemic chemotherapy and are not candidates for curative surgery or (chemo)radiation. One or two doses may be selected from Part 1 for each cohort in the Part 2 Expansion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| INCB099280 | Drug | Administered as specified in the treatment arm description |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Number of Participants With Dose-limiting Toxicities (DLTs) | Any adverse event that ws at least possibly related to study treatment and met protocol-specified criteria was classified as a DLT. For the purpose of dose finding, decisions on dose were based on DLTs observed during the first 21 days of treatment. | up to 3 weeks |
| Part 1: Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug related. An AE therefore could have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE was defined as an AE that was either reported for the first time or the worsening of a pre-existing event after the first dose of either study drug until 104 days after the last dose of study treatment or the start of new anticancer therapy. | up to approximately 1 year |
| Part 1: Number of Participants With TEAEs Leading to a Dosing Modification (Treatment Interruption, Dose Reduction, and Permanent Discontinuation of Either Study Drug) | An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug related. An AE therefore could have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE was defined as an AE that was either reported for the first time or the worsening of a pre-existing event after the first dose of either study drug until 104 days after the last dose of study treatment or the start of new anticancer therapy. | up to approximately 1 year |
| Part 2: Objective Response | Objective response was defined as the percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) by investigator assessment per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1). CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. |
| Measure | Description | Time Frame |
|---|---|---|
| Part 2: Number of Participants With Any TEAE | An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug related. An AE therefore could have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE was defined as an AE that was either reported for the first time or the worsening of a pre-existing event after the first dose of either study drug until 104 days after the last dose of study treatment or the start of new anticancer therapy. |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined Inclusion/Exclusion Criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Philomena Colucci | Incyte Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Addenbrookes Hospital | Cambridge | CB2 0QQ | United Kingdom | |||
| Beatson West of Scotland Cancer Centrewester |
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
Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
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.
This study was conducted at 3 study centers in the United Kingdom.
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| ID | Title | Description |
|---|---|---|
| FG000 | INCB099280 400 mg BID Plus Axitinib 5 mg BID | Participants received INCB099280 400 milligrams (mg) twice daily (BID) and axitinib 5 mg BID in consecutive 21-day cycles for up to 2 years as long as they were receiving benefit and did not meet any criteria for study withdrawal. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | INCB099280 400 mg BID Plus Axitinib 5 mg BID | Participants received INCB099280 400 milligrams (mg) twice daily (BID) and axitinib 5 mg BID in consecutive 21-day cycles for up to 2 years as long as they were receiving benefit and did not meet any criteria for study withdrawal. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Part 1: Number of Participants With Dose-limiting Toxicities (DLTs) | Any adverse event that ws at least possibly related to study treatment and met protocol-specified criteria was classified as a DLT. For the purpose of dose finding, decisions on dose were based on DLTs observed during the first 21 days of treatment. | DLT-Evaluable Population: all participants in Part 1 who had a DLT during the 3-week DLT observation period or received at least 75% of the planned doses of both INCB099280 and axitinib at the assigned dose. | Posted | Count of Participants | Participants | up to 3 weeks |
|
up to approximately 1 year
Adverse events have been reported for the Safety Population, comprised of all participants who received at least 1 dose of INCB099280 or axitinib.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | INCB099280 400 mg BID Plus Axitinib 5 mg BID | Participants received INCB099280 400 milligrams (mg) twice daily (BID) and axitinib 5 mg BID in consecutive 21-day cycles for up to 2 years as long as they were receiving benefit and did not meet any criteria for study withdrawal. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vision blurred | Eye disorders | MedDRA 27.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypoacusis | Ear and labyrinth disorders | MedDRA 27.0 | Systematic Assessment |
This study was terminated due to a strategic business decision. There were no safety concerns contributing to this decision. Part 2 of the study was not conducted.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Incyte Corporation | 1-855-463-3463 | medinfo@incyte.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 4, 2024 | Apr 7, 2026 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 25, 2025 | Apr 7, 2026 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D005185 | Fallopian Tube Neoplasms |
| D014594 | Uterine Neoplasms |
| D002583 | Uterine Cervical Neoplasms |
| D014846 | Vulvar Neoplasms |
| D014625 | Vaginal Neoplasms |
| D002288 | Adenocarcinoma, Mucinous |
| D002296 | Carcinosarcoma |
| D018284 | Cystadenocarcinoma, Serous |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
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| ID | Term |
|---|---|
| D000077784 | Axitinib |
| ID | Term |
|---|---|
| D001549 | Benzamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001565 | Benzoates |
| D000146 |
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The study consists of 2 parts. In the Part 1 dose-escalation, participants will be enrolled in up to 6 dose levels of INCB099280 administered in combination with axitinib. In the Part 2 dose expansion, participants will be enrolled into 1 of 2 disease-specific cohorts at the dose(s) identified in Part 1.
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| axitinib | Drug | Administered as specified in the treatment arm description |
|
| up to 2 years |
| up to 2 years |
| Part 2: Number of Participants With TEAEs Leading to a Dosing Modification (Treatment Interruption, Dose Reduction, and Permanent Discontinuation of Either Study Drug) | An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug related. An AE therefore could have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE was defined as an AE that was either reported for the first time or the worsening of a pre-existing event after the first dose of either study drug until 104 days after the last dose of study treatment or the start of new anticancer therapy. | up to 2 years |
| Part 1: Objective Response | Objective response was defined as the percentage of participants with a BOR of CR or PR by investigator assessment per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. | up to 335 days |
| Part 1: Disease Control | Disease control was defined as the percentage of participants with a BOR of CR, PR, or stable disease (SD) by investigator assessment per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion. SD: no change in target lesions to qualify for CR, PR, or PD. | up to 335 days |
| Part 1: Duration of Response (DOR) | DOR was 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 occurred earlier. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion. | up to 335 days |
| Part 1: INCB099280 and Axitinib Plasma Concentrations | Blood samples were collected for the analysis of INCB099280 and axitinib concentrations. Per Protocol, PK samples for axitinib were only to be analyzed in case of a concern that axitinib was not as active as expected. Due to the early termination of the study before readout, these samples were not analyzed. | Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, and Cycle 8 Day 1: before INCB099280 and axitinib dose. Cycle 1 Day 1 and Cycle 2 Day 1: 1, 2, and 4 hours after INCB099280 dose. End-of-trial visit: axitinib sample |
| Part 1: Cmax of INCB099280 When Administered With Axitinib | Cmax was defined as the maximum observed concentration of INCB099280. | Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, and Cycle 8 Day 1: before INCB099280 and axitinib dose. Cycle 1 Day 1 and Cycle 2 Day 1: 1, 2, and 4 hours after INCB099280 dose. End-of-trial visit: axitinib sample |
| Part 1: Tmax of INCB099280 When Administered With Axitinib | tmax was defined as the time to the maximum concentration of INCB099280. | Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, and Cycle 8 Day 1: before INCB099280 and axitinib dose. Cycle 1 Day 1 and Cycle 2 Day 1: 1, 2, and 4 hours after INCB099280 dose. End-of-trial visit: axitinib sample |
| Part 1: AUC0-4h of INCB099280 When Administered With Axitinib | AUC0-4h was defined as area under the steady-state plasma or serum concentration-time curve from 0 to 4 hours. | Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, and Cycle 8 Day 1: before INCB099280 and axitinib dose. Cycle 1 Day 1 and Cycle 2 Day 1: 1, 2, and 4 hours after INCB099280 dose. End-of-trial visit: axitinib sample |
| Part 1: Cmax,ss of INCB099280 When Administered With Axitinib | Cmax,ss was defined as the maximum observed concentration at steady state. | Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, and Cycle 8 Day 1: before INCB099280 and axitinib dose. Cycle 1 Day 1 and Cycle 2 Day 1: 1, 2, and 4 hours after INCB099280 dose. End-of-trial visit: axitinib sample |
| Part 1: Tmax,ss of INCB099280 When Administered With Axitinib | tmax,ss was defined as the time to the maximum concentration of INCB099280 at steady state. | Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, and Cycle 8 Day 1: before INCB099280 and axitinib dose. Cycle 1 Day 1 and Cycle 2 Day 1: 1, 2, and 4 hours after INCB099280 dose. End-of-trial visit: axitinib sample |
| Part 1: AUC0-12h of INCB099280 When Administered With Axitinib | AUC0-12h was defined as the area under the steady-state plasma or serum concentration-time curve from 0 to 12 hours. | Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, and Cycle 8 Day 1: before INCB099280 and axitinib dose. Cycle 1 Day 1 and Cycle 2 Day 1: 1, 2, and 4 hours after INCB099280 dose. End-of-trial visit: axitinib sample |
| Part 1: Cavg of INCB099280 When Administered With Axitinib | Cavg was defined as the average concentration of INCB099280. | Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, and Cycle 8 Day 1: before INCB099280 and axitinib dose. Cycle 1 Day 1 and Cycle 2 Day 1: 1, 2, and 4 hours after INCB099280 dose. End-of-trial visit: axitinib sample |
| Part 1: Ctau of INCB099280 When Administered With Axitinib | Ctau was defined as the concentration of INCB099280 at the end of a dose interval. | Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, and Cycle 8 Day 1: before INCB099280 and axitinib dose. Cycle 1 Day 1 and Cycle 2 Day 1: 1, 2, and 4 hours after INCB099280 dose. End-of-trial visit: axitinib sample |
| Part 1: t1/2 of INCB099280 When Administered With Axitinib | t1/2 was defined as the apparent terminal-phase disposition half life of INCB099280. | Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, and Cycle 8 Day 1: before INCB099280 and axitinib dose. Cycle 1 Day 1 and Cycle 2 Day 1: 1, 2, and 4 hours after INCB099280 dose. End-of-trial visit: axitinib sample |
| Part 1: CLss/F of INCB099280 When Administered With Axitinib | CLss/F was defined as the apparent oral dose clearance of INCB099280 at steady state. | Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, and Cycle 8 Day 1: before INCB099280 and axitinib dose. Cycle 1 Day 1 and Cycle 2 Day 1: 1, 2, and 4 hours after INCB099280 dose. End-of-trial visit: axitinib sample |
| Part 1: Vz/F of INCB099280 When Administered With Axitinib | Vz/F was defined as the apparent oral dose volume of distribution of INCB099280. | Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, and Cycle 8 Day 1: before INCB099280 and axitinib dose. Cycle 1 Day 1 and Cycle 2 Day 1: 1, 2, and 4 hours after INCB099280 dose. End-of-trial visit: axitinib sample |
| Glasgow |
| G12 0YN |
| United Kingdom |
| St Bartholomew'S Hospital | London | EC1A 7BE | United Kingdom |
| Guys Hospital | London | SE1 9RT | United Kingdom |
| The Royal Marsden | London | SW3 6JJ | United Kingdom |
| The Royal Marsden Nhs Foundation Trust - Sutton | Sutton | SM2 5PT | United Kingdom |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
| Primary | Part 1: Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug related. An AE therefore could have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE was defined as an AE that was either reported for the first time or the worsening of a pre-existing event after the first dose of either study drug until 104 days after the last dose of study treatment or the start of new anticancer therapy. | Safety Population: all participants who received at least 1 dose of INCB099280 or axitinib. Analysis in the Safety Population was based on the actual dose received regardless of assigned dose. | Posted | Count of Participants | Participants | up to approximately 1 year |
|
|
|
| Primary | Part 1: Number of Participants With TEAEs Leading to a Dosing Modification (Treatment Interruption, Dose Reduction, and Permanent Discontinuation of Either Study Drug) | An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug related. An AE therefore could have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE was defined as an AE that was either reported for the first time or the worsening of a pre-existing event after the first dose of either study drug until 104 days after the last dose of study treatment or the start of new anticancer therapy. | Safety Population | Posted | Count of Participants | Participants | up to approximately 1 year |
|
|
|
| Primary | Part 2: Objective Response | Objective response was defined as the percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) by investigator assessment per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1). CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. | Full Analysis Set: all participants who received at least 1 dose of INCB099280 or axitinib. Analysis in the FAS was based on assigned dose. Enrollment in this study was closed during Part 1 following the sponsor's decision to discontinue the INCB099280 development program for strategic reasons. There were no safety concerns that contributed to the decision. Part 2 of the study was not conducted. | Posted | up to 2 years |
|
|
| Secondary | Part 2: Number of Participants With Any TEAE | An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug related. An AE therefore could have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE was defined as an AE that was either reported for the first time or the worsening of a pre-existing event after the first dose of either study drug until 104 days after the last dose of study treatment or the start of new anticancer therapy. | Safety Population. Enrollment in this study was closed during Part 1 following the sponsor's decision to discontinue the INCB099280 development program for strategic reasons. There were no safety concerns that contributed to the decision. Part 2 of the study was not conducted. | Posted | up to 2 years |
|
|
| Secondary | Part 2: Number of Participants With TEAEs Leading to a Dosing Modification (Treatment Interruption, Dose Reduction, and Permanent Discontinuation of Either Study Drug) | An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug related. An AE therefore could have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE was defined as an AE that was either reported for the first time or the worsening of a pre-existing event after the first dose of either study drug until 104 days after the last dose of study treatment or the start of new anticancer therapy. | Safety Population. Enrollment in this study was closed during Part 1 following the sponsor's decision to discontinue the INCB099280 development program for strategic reasons. There were no safety concerns that contributed to the decision. Part 2 of the study was not conducted. | Posted | up to 2 years |
|
|
| Secondary | Part 1: Objective Response | Objective response was defined as the percentage of participants with a BOR of CR or PR by investigator assessment per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. | Full Analysis Set. Confidence intervals were calculated using the Clopper-Pearson method. | Posted | Number | 95% Confidence Interval | percentage of participants | up to 335 days |
|
|
|
| Secondary | Part 1: Disease Control | Disease control was defined as the percentage of participants with a BOR of CR, PR, or stable disease (SD) by investigator assessment per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion. SD: no change in target lesions to qualify for CR, PR, or PD. | Full Analysis Set. Confidence intervals were calculated using the Clopper-Pearson method. In order to have a best overall response of SD, overall response must have met the SD criteria at least once after a minimum of 5 weeks from the start of treatment. | Posted | Number | 95% Confidence Interval | percentage of participants | up to 335 days |
|
|
|
| Secondary | Part 1: Duration of Response (DOR) | DOR was 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 occurred earlier. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion. | Full Analysis Set. Only participants with a CR or PR were analyzed. | Posted | Median | 95% Confidence Interval | months | up to 335 days |
|
|
|
| Secondary | Part 1: INCB099280 and Axitinib Plasma Concentrations | Blood samples were collected for the analysis of INCB099280 and axitinib concentrations. Per Protocol, PK samples for axitinib were only to be analyzed in case of a concern that axitinib was not as active as expected. Due to the early termination of the study before readout, these samples were not analyzed. | Pharmacokinetic (PK)-Evaluable Population: all participants who received at least 1 dose of either INB099280 or axitinib and provided at least 1 postbaseline sample for PK analysis. Due to the expected limited number of PK samples from the 5 participants enrolled in this study, analysis of collected PK samples was not conducted, as pre-specified in the Statistical Analysis Plan. Collected samples will not be analyzed in the future. | Posted | Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, and Cycle 8 Day 1: before INCB099280 and axitinib dose. Cycle 1 Day 1 and Cycle 2 Day 1: 1, 2, and 4 hours after INCB099280 dose. End-of-trial visit: axitinib sample |
|
|
| Secondary | Part 1: Cmax of INCB099280 When Administered With Axitinib | Cmax was defined as the maximum observed concentration of INCB099280. | PK-Evaluable Population. Due to the expected limited number of PK samples from the 5 participants enrolled in this study, analysis of collected PK samples was not conducted, as pre-specified in the Statistical Analysis Plan. Collected samples will not be analyzed in the future. | Posted | Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, and Cycle 8 Day 1: before INCB099280 and axitinib dose. Cycle 1 Day 1 and Cycle 2 Day 1: 1, 2, and 4 hours after INCB099280 dose. End-of-trial visit: axitinib sample |
|
|
| Secondary | Part 1: Tmax of INCB099280 When Administered With Axitinib | tmax was defined as the time to the maximum concentration of INCB099280. | PK-Evaluable Population. Due to the expected limited number of PK samples from the 5 participants enrolled in this study, analysis of collected PK samples was not conducted, as pre-specified in the Statistical Analysis Plan. Collected samples will not be analyzed in the future. | Posted | Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, and Cycle 8 Day 1: before INCB099280 and axitinib dose. Cycle 1 Day 1 and Cycle 2 Day 1: 1, 2, and 4 hours after INCB099280 dose. End-of-trial visit: axitinib sample |
|
|
| Secondary | Part 1: AUC0-4h of INCB099280 When Administered With Axitinib | AUC0-4h was defined as area under the steady-state plasma or serum concentration-time curve from 0 to 4 hours. | PK-Evaluable Population. Due to the expected limited number of PK samples from the 5 participants enrolled in this study, analysis of collected PK samples was not conducted, as pre-specified in the Statistical Analysis Plan. Collected samples will not be analyzed in the future. | Posted | Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, and Cycle 8 Day 1: before INCB099280 and axitinib dose. Cycle 1 Day 1 and Cycle 2 Day 1: 1, 2, and 4 hours after INCB099280 dose. End-of-trial visit: axitinib sample |
|
|
| Secondary | Part 1: Cmax,ss of INCB099280 When Administered With Axitinib | Cmax,ss was defined as the maximum observed concentration at steady state. | PK-Evaluable Population. Due to the expected limited number of PK samples from the 5 participants enrolled in this study, analysis of collected PK samples was not conducted, as pre-specified in the Statistical Analysis Plan. Collected samples will not be analyzed in the future. | Posted | Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, and Cycle 8 Day 1: before INCB099280 and axitinib dose. Cycle 1 Day 1 and Cycle 2 Day 1: 1, 2, and 4 hours after INCB099280 dose. End-of-trial visit: axitinib sample |
|
|
| Secondary | Part 1: Tmax,ss of INCB099280 When Administered With Axitinib | tmax,ss was defined as the time to the maximum concentration of INCB099280 at steady state. | PK-Evaluable Population. Due to the expected limited number of PK samples from the 5 participants enrolled in this study, analysis of collected PK samples was not conducted, as pre-specified in the Statistical Analysis Plan. Collected samples will not be analyzed in the future. | Posted | Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, and Cycle 8 Day 1: before INCB099280 and axitinib dose. Cycle 1 Day 1 and Cycle 2 Day 1: 1, 2, and 4 hours after INCB099280 dose. End-of-trial visit: axitinib sample |
|
|
| Secondary | Part 1: AUC0-12h of INCB099280 When Administered With Axitinib | AUC0-12h was defined as the area under the steady-state plasma or serum concentration-time curve from 0 to 12 hours. | PK-Evaluable Population. Due to the expected limited number of PK samples from the 5 participants enrolled in this study, analysis of collected PK samples was not conducted, as pre-specified in the Statistical Analysis Plan. Collected samples will not be analyzed in the future. | Posted | Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, and Cycle 8 Day 1: before INCB099280 and axitinib dose. Cycle 1 Day 1 and Cycle 2 Day 1: 1, 2, and 4 hours after INCB099280 dose. End-of-trial visit: axitinib sample |
|
|
| Secondary | Part 1: Cavg of INCB099280 When Administered With Axitinib | Cavg was defined as the average concentration of INCB099280. | PK-Evaluable Population. Due to the expected limited number of PK samples from the 5 participants enrolled in this study, analysis of collected PK samples was not conducted, as pre-specified in the Statistical Analysis Plan. Collected samples will not be analyzed in the future. | Posted | Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, and Cycle 8 Day 1: before INCB099280 and axitinib dose. Cycle 1 Day 1 and Cycle 2 Day 1: 1, 2, and 4 hours after INCB099280 dose. End-of-trial visit: axitinib sample |
|
|
| Secondary | Part 1: Ctau of INCB099280 When Administered With Axitinib | Ctau was defined as the concentration of INCB099280 at the end of a dose interval. | PK-Evaluable Population. Due to the expected limited number of PK samples from the 5 participants enrolled in this study, analysis of collected PK samples was not conducted, as pre-specified in the Statistical Analysis Plan. Collected samples will not be analyzed in the future. | Posted | Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, and Cycle 8 Day 1: before INCB099280 and axitinib dose. Cycle 1 Day 1 and Cycle 2 Day 1: 1, 2, and 4 hours after INCB099280 dose. End-of-trial visit: axitinib sample |
|
|
| Secondary | Part 1: t1/2 of INCB099280 When Administered With Axitinib | t1/2 was defined as the apparent terminal-phase disposition half life of INCB099280. | PK-Evaluable Population. Due to the expected limited number of PK samples from the 5 participants enrolled in this study, analysis of collected PK samples was not conducted, as pre-specified in the Statistical Analysis Plan. Collected samples will not be analyzed in the future. | Posted | Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, and Cycle 8 Day 1: before INCB099280 and axitinib dose. Cycle 1 Day 1 and Cycle 2 Day 1: 1, 2, and 4 hours after INCB099280 dose. End-of-trial visit: axitinib sample |
|
|
| Secondary | Part 1: CLss/F of INCB099280 When Administered With Axitinib | CLss/F was defined as the apparent oral dose clearance of INCB099280 at steady state. | PK-Evaluable Population. Due to the expected limited number of PK samples from the 5 participants enrolled in this study, analysis of collected PK samples was not conducted, as pre-specified in the Statistical Analysis Plan. Collected samples will not be analyzed in the future. | Posted | Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, and Cycle 8 Day 1: before INCB099280 and axitinib dose. Cycle 1 Day 1 and Cycle 2 Day 1: 1, 2, and 4 hours after INCB099280 dose. End-of-trial visit: axitinib sample |
|
|
| Secondary | Part 1: Vz/F of INCB099280 When Administered With Axitinib | Vz/F was defined as the apparent oral dose volume of distribution of INCB099280. | PK-Evaluable Population. Due to the expected limited number of PK samples from the 5 participants enrolled in this study, analysis of collected PK samples was not conducted, as pre-specified in the Statistical Analysis Plan. Collected samples will not be analyzed in the future. | Posted | Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, and Cycle 8 Day 1: before INCB099280 and axitinib dose. Cycle 1 Day 1 and Cycle 2 Day 1: 1, 2, and 4 hours after INCB099280 dose. End-of-trial visit: axitinib sample |
|
|
| 0 |
| 5 |
| 1 |
| 5 |
| 5 |
| 5 |
| Diarrhoea | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
|
| Gastrointestinal pain | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 27.0 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 27.0 | Systematic Assessment |
|
| Hypertransaminasaemia | Hepatobiliary disorders | MedDRA 27.0 | Systematic Assessment |
|
| Catheter site infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
|
| Otitis media | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 27.0 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 27.0 | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA 27.0 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 27.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
|
| Posterior reversible encephalopathy syndrome | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 27.0 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
|
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
|
| Miliaria | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
|
| Skin plaque | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
|
Following the first publication, the Institution and/or Principal Investigator may publish data or results from the Study, provided, however, that the Institution and/or Principal Investigator submits the proposed publication to the Sponsor for review at least sixty (60) days prior to the date of the proposed publication. Sponsor may remove from the proposed publication any information that is considered confidential and/or proprietary other than Study data and results.
| D000291 |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D005184 | Fallopian Tube Diseases |
| D014591 | Uterine Diseases |
| D002577 | Uterine Cervical Diseases |
| D014845 | Vulvar Diseases |
| D014623 | Vaginal Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D018297 | Neoplasms, Cystic, Mucinous, and Serous |
| D018193 | Neoplasms, Complex and Mixed |
| D012509 | Sarcoma |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D003536 | Cystadenocarcinoma |
| Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D007191 | Indazoles |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| Title | Measurements |
|---|---|
|
| TEAE leading to dose reduction of axitinib |
|
| TEAE leading to discontinuation of axitinib |
|