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This study evaluates TL-895, a potent, orally-available and highly selective irreversible tyrosine kinase inhibitor for the treatment of Myelofibrosis. Participants must have MF (PMF, Post PV MF, or Post ET MF) who are JAKi treatment-naïve or those who have a suboptimal response to ruxolitinib.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 1b - Dose Level 1 | Experimental | 150 mg of TL-895 will be administered orally, twice daily (BID) continuously starting on Day 1 in a 28-day cycle combined with the subject's pre-study stable dose of ruxolitinib. |
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| Phase 1b - Dose Level 2 | Experimental | 300 mg of TL-895 will be administered orally, twice daily (BID) continuously starting on Day 1 in a 28-day cycle combined with the subject's pre-study stable dose of ruxolitinib. |
|
| Phase 1b - Dose Level 3 | Experimental | 450 mg of TL-895 will be administered orally, twice daily (BID) continuously starting on Day 1 in a 28-day cycle combined with the subject's pre-study stable dose of ruxolitinib. |
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| Phase 2 - Cohort 1 JAKi treatment-naïve MF | Experimental | The RP2D of TL-895 as determined in Phase 1b will be administered orally, twice daily (BID) continuously starting on Day 1 in a 28-day cycle. The dose of ruxolitinib will be based on the subject's baseline platelet count. |
|
| Phase 2 - Cohort 2 suboptimal response to Ruxolitinib | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TL-895 | Drug | TL-895 is an experimental tyrosine kinase inhibitor anticancer drug taken by mouth. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1b - Recommended Phase 2 dose of TL-895 in combination with ruxolitinib | Dose-limiting toxicities (DLTs) will be used to establish the maximum-tolerated dose (MTD) of TL-895 in combination with ruxolitinib. The safety review committee (SRC) will determine the RP2D based on safety and efficacy data of the combination of TL-895 and ruxolitinib. | 28 days |
| Phase 2 - Spleen Volume Reduction (SVR) at Week 24 | The proportion of subjects achieving SVR of ≥35% at Week 24 by magnetic resonance imaging (MRI) or computed tomography (CT) scan. | 24 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1b - Spleen Volume Reduction (SVR) at Week 24 | The proportion of subjects achieving ≥35% SVR at Week 24 by MRI or CT scan. | 24 Weeks |
| Phase 1b - TSS reduction at Week 24 | The proportion of subjects achieving ≥50% reduction in TSS at Week 24 by Myelofibrosis Symptom Assessment Form (MFSAF) v4.0. |
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Inclusion Criteria:
Subjects with suboptimal response to ruxolitinib:
Exclusion Criteria:
Treatment-naive subjects:
Subjects with suboptimal response to ruxolitinib:
All subjects:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| John Mei | Contact | 650-542-0136 | jmei@teliospharma.com | |
| Nikki Stuart | Contact | nzona@teliospharma.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Recruiting | Birmingham | Alabama | 35294 | United States | |
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Phase 1b - Dose Escalation Design Phase 2 - Dose Expansion
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The RP2D of TL-895 as determined in Phase 1b will be administered orally, twice daily (BID) continuously starting on Day 1 in a 28-day cycle. The dose schedule will be the stable ruxolitinib dose schedule as the subject is currently taking prior to entry into the study. |
|
| Ruxolitinib | Drug | Ruxolitinib is an FDA-approved janus kinase inhibitor anticancer drug taken by mouth. |
|
|
| 24 Weeks |
| Phase 2 - TSS reduction at Week 24 | The proportion of subjects achieving ≥50% reduction in TSS at Week 24 by MFSAF v4.0. | 24 Weeks |
| DOR Spleen | Time from initial SVR of ≥ 35% by MRI/CT until the first occurrence of disease progression or death | 48 Months |
| Progression Free Survival | Time from first dose to progression or death from any cause. | 48 Month |
| Overall Survival | Time from first dose to death from any cause | 48 Months |
| Gabrail Cancer Center |
| Recruiting |
| Canton |
| Ohio |
| 44718 |
| United States |
| University of Cincinnati (UC) | Recruiting | Cincinnati | Ohio | 45267 | United States |
| The University of Texas MD Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
| CHU Angers | Recruiting | Angers | 49100 | France |
| AP-HM - Hôpital de la Timone | Recruiting | Marseille | 13005 | France |
| CHU de Nice - Hopital L'Archet II | Recruiting | Nice | 06200 | France |
| Hôpital Saint Louis - AP-HP | Recruiting | Paris | 75010 | France |
| Centre Hospitalier Lyon Sud | Recruiting | Pierre-Bénite | 69495 | France |
| Marien Hospital Duesseldorf | Recruiting | Düsseldorf | 40479 | Germany |
| Klinik fur Innere Medizin IV - Hamatologie/Onkologie, Universitatsklinikum Hall | Recruiting | Halle | 40479 | Germany |
| IRCCS Azienda Ospedaliero-Universitaria di Bologna - Policlinico di Sant'Orsola | Recruiting | Bologna | 40138 | Italy |
| Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano | Recruiting | Milan | 20122 | Italy |
| Azienda Ospedaliera di Perugia-Ospedale S. Maria della Misericordia | Recruiting | Perugia | 06129 | Italy |
| Pratia Onkologia Katowice | Recruiting | Katowice | 40-519 | Poland |
| Hospital Universitari Arnau de Vilanova | Recruiting | Lleida | 25198 | Spain |
| Hospital Universitario Ramon y Cajal | Recruiting | Madrid | 28034 | Spain |
| Hospital Universitario Virgen de la Victoria | Recruiting | Málaga | 29010 | Spain |
| Hospital Quironsalud de Zaragoza | Recruiting | Zaragoza | 50006 | Spain |
| ID | Term |
|---|---|
| D055728 | Primary Myelofibrosis |
| ID | Term |
|---|---|
| D009196 | Myeloproliferative Disorders |
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| C540383 | ruxolitinib |
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