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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-502514-86-00 | Registry Identifier | EU CT Number |
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This study is being conducted to evaluate the safety, tolerability, and dose-limiting toxicity (DLT) and determine the maximum tolerated dose (MTD) and/or recommended dose(s) for expansion (RDE) of INCA033989 administered as a monotherapy or in combination with ruxolitinib in participants with myeloproliferative neoplasms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1a Dose Escalation Cohort Disease Group A - with MF | Experimental | INCA033989 will be administered at a protocol defined starting regimen in 28-day cycles as monotherapy to identify the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE[s]). Participants with myelofibrosis (MF) will enroll in this group. |
|
| Part 1a Dose Escalation Cohort Disease Group A - with ET | Experimental | INCA033989 will be administered at a protocol defined starting regimen in 28-day cycles as monotherapy to identify the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE[s]). Participants with with essential thrombocythemia (ET) will enroll in this group. |
|
| Part 1a: Dose Escalation Cohort Disease Group B - with TGB-MF SubOpt R | Experimental | INCA033989 will be administered at a protocol defined starting regimen in 28- day cycles and will allow for the evaluation of INCA033989 in combination with ruxolitinib to identify the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE[s]). Participants with myelofibrosis (MF) exhibiting suboptimal response (SubOpt R) will enroll in this group. |
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| Part 1b: Dose Expansion - with MF | Experimental | INCA033989 will be administered as monotherapy at the RDE(s) identified during Part 1a. Participants with treatment group A (TGA) myelofibrosis MF will enroll in this group. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| INCA033989 | Drug | INCA033989 will be administered at protocol defined dose. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 28 days |
| 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 monotherapy and in combination with ruxolitinib | Up to 3 years and 60 days |
| Number of participants with TEAEs leading to dose modification or discontinuation | Number of participants with TEAEs leading to dose modification or discontinuation. | Up to 3 years and 60 days |
| Measure | Description | Time Frame |
|---|---|---|
| Participants with MF: Response using the revised IWG-MRT and ELN response criteria for MF | Defined as the percentage of participants with Response using the revised IWG-MRT and ELN response criteria. | Up to 3 years and 60 days |
| Participants With MF: Percentage of participants achieving spleen volume reduction as defined in the protocol |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined Inclusion/Exclusion Criteria may apply.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Incyte Corporation Call Center (US) | Contact | 1.855.463.3463 | medinfo@incyte.com | |
| Incyte Corporation Call Center (ex-US) | Contact | +800 00027423 | eumedinfo@incyte.com |
| Name | Affiliation | Role |
|---|---|---|
| Incyte Medical Monitor | Incyte Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Brisbane and Women'S Hospital | Recruiting | Herston | Queensland | 04029 | Australia | |
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| Label | URL |
|---|---|
| A Study to Evaluate INCA033989 Administered as a Monotherapy or in Combination With Ruxolitinib in Participants With Myeloproliferative Neoplasms | View source |
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| Part 1b: Dose Expansion - with TGB-MF SubOpt R | Experimental | INCA033989 will be administered as an add-on therapy in combination with ruxolitinibat at the RDE(s) identified during Part 1a. Participants with treatment Group B (TGB) MF SubOpt R will enroll in this group. |
|
| Part 1b: Dose Expansion - with ET | Experimental | INCA033989 will be administered as monotherapy at the RDE(s) identified during Part 1a. Participants with treatment group A (TGA) essential thrombocythemia (ET) will enroll in this group. |
|
| Part 1c: Dose Expansion | Experimental | INCA033989 will be administered at the dose level found to exhibit an overall positive benefit/risk as monotherapy or as combination therapy with Ruxolitinib. Participants with myelofibrosis (MF) will enroll in this group. The participants enrolled in the monotherapy arm will be offered the option to crossover to combination therapy with ruxolitinib if a suboptimal response to monotherapy is observed after 12 weeks. |
|
| Ruxolitinib | Drug | Rux will be administered according to Prescribing Information/SmPC. |
|
|
Defined as percentage of participants with a protocol defined Spleen Volume Reduction. |
| Up to 3 years and 60 days |
| Participants with MF with symptomatic anemia: Anemia Response | For non transfusion-dependent (TD) participants: An Hb increase relative to baseline as defined in the protocol if non-TD at baseline. For TD participants: Achieving transfusion independency (TI) as defined in the protocol. | Up to 3 years and 60 days |
| Participants With ET: Response Rate | Defined as the proportion of participants with Complete Response or Partial Response when treated with study drug. | Up to 3 years and 60 days |
| Participants With ET: Mean change from baseline of total symptom score (TSS) | Mean change of TSS from baseline. | Up to 3 years and 60 days |
| Mean change in disease-related allele burden | Mean change in disease-related allele burden. | Up to 3 years and 60 days |
| Pharmacokinetics Parameter: Cmax of INCA33989 | Defined as maximum observed plasma concentration of INCA33989. | Up to 3 years and 60 days |
| Pharmacokinetics Parameter: Tmax of INCA033989 | Defined as the time to reach the maximum plasma concentration of INCA33989. | Up to 3 years and 60 days |
| Pharmacokinetics Parameter: Cmin of INCA33989 | Defined as the minimum observed plasma concentration of INCA33989. | Up to 3 years and 60 days |
| Pharmacokinetics Parameter: AUC(0-t) of INCA33989 | Defined as the area under the concentration-time curve up to the last measurable concentration of INCA33989. | Up to 3 years and 60 days |
| Pharmacokinetics Parameter: AUC 0-∞ of INCA33989 | Defined as the area under the concentration-time curve from 0 to infinity of INCA33989. | Up to 3 years and 60 days |
| Pharmacokinetics Parameter: CL/F of INCA33989 | Defined as the apparent oral dose clearance of INCA33989. | Up to 3 years and 60 days |
| Pharmacokinetics Parameter: Vz/F of INCA33989 | Defined as the apparent oral dose volume of distribution of INCA33989. | Up to 3 years and 60 days |
| Pharmacokinetics Parameter: t1/2 of INCA33989 | Defined as the apparent terminal phase disposition half-life of INCA33989. | Up to 3 years and 60 days |
| Royal Adelaide Hospital |
| Recruiting |
| Adelaide |
| South Australia |
| 05000 |
| Australia |
| Peter Maccallum Cancer Centre | Recruiting | Melbourne | Victoria | 03000 | Australia |
| The Alfred Hospital | Recruiting | Melbourne | Victoria | 03004 | Australia |
| Princess Margaret Cancer Center | Recruiting | Toronto | Ontario | M5G 2M9 | Canada |
| Hopital Maisonneuve-Rosemont, Montreal, Qc | Recruiting | Montreal | Quebec | H1T 2M4 | Canada |
| Odense University Hospital | Withdrawn | Odense C | 05000 | Denmark |
| Sjaellands Universitetshospital | Recruiting | Roskilde | 04000 | Denmark |
| Vejle Hospital | Recruiting | Vejle | 07100 | Denmark |
| Institut Bergonie | Recruiting | Bordeaux | 33076 | France |
| Chu Nimes | Recruiting | Nîmes | 30029 | France |
| Hospital Saint Louis | Recruiting | Paris | 75010 | France |
| Institut Gustave Roussy | Recruiting | Villejuif | 94805 | France |
| University Medical Center Rwth Aachen | Recruiting | Aachen | 52074 | Germany |
| Universitatsklinikum Halle (Saale) | Recruiting | Halle | 06120 | Germany |
| Universitätsklinikum Ulm | Recruiting | Ulm | 89081 | Germany |
| Aou Policlinico S. Orsola-Malpighi | Recruiting | Bologna | 40138 | Italy |
| Azienda Ospedaliero-Universitaria Careggi (Aouc) | Recruiting | Florence | 50134 | Italy |
| Fondazione Irccs Ca Granda Ospedale Maggiore | Recruiting | Milan | 20122 | Italy |
| National Cancer Center Hospital East | Recruiting | Chiba-ken | 277-0882 | Japan |
| Kagoshima University Hospital | Recruiting | Kagoshima | 890-8520 | Japan |
| Osaka Metropolitan University Hospital | Recruiting | Osaka | 545-8586 | Japan |
| Nippon Medical School Hospital | Recruiting | Tokyo | 113-8603 | Japan |
| Mie University Hospital | Recruiting | Tsu | 514-0001 | Japan |
| Hospital Universitario 12 de Octubre | Recruiting | Madrid | 28041 | Spain |
| Hospital Universitari I Politecnic La Fe | Recruiting | Valencia | 46026 | Spain |
| Guys and St Thomas Nhs Foundation Trust | Recruiting | London | SE1 9RT | United Kingdom |
| The Christie Nhs Foundation Trust Uk | Recruiting | Manchester | M20 4BV | United Kingdom |
| University of Oxford | Recruiting | Oxford | OX3 7LE | United Kingdom |
| ID | Term |
|---|---|
| D009196 | Myeloproliferative Disorders |
| D055728 | Primary Myelofibrosis |
| D013920 | Thrombocythemia, Essential |
| ID | Term |
|---|---|
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D001778 | Blood Coagulation Disorders |
| D013922 | Thrombocytosis |
| D001791 | Blood Platelet Disorders |
| D006474 | Hemorrhagic Disorders |
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| ID | Term |
|---|---|
| C540383 | ruxolitinib |
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