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Tests treatment safety and results for Essential Thrombocythemia (ET)
Official title Phase 1/ Phase 2 Study to Assess Safety and Efficacy of Orally Administered JBI-802 in Subjects With Myeloproliferative Neoplasms (MPN) and Myelodysplastic/Myeloproliferative Neoplasms (MDS/MPN) With Thrombocytosis
ClinicalTrials.gov ID: NCT07612280
What this study is testing
What is JBI-802?
JBI-802 is an investigational medicine, given as an once-weekly pill taken by mouth, being studied as a potential treatment for essential thrombocythemia (et).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study aims to assess the safety and efficacy of orally administered JBI-802 in subjects with Myeloproliferative Neoplasms (MPN) and Myelodysplastic/ Myeloproliferative Neoplasms (MDS/MPN) with Thrombocytosis. Who is it for?
- Phase 2: a mid-size study of how well it works
- Time commitment: about 2 years
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- \- Male or female people aged ≥18 years at the time of screening visit. For Dose Escalation Phase: people diagnosed with any one of the following:
- Subject with diagnosis of Essential Thrombocythemia (ET) per World Health Organization (WHO) diagnostic criteria for myeloproliferative neoplasms .
- Subject requires treatment in order to lower platelet count based on subject age over 60 or history of thrombosis.
- Subject with Morphologically confirmed diagnosis of MDS/MPN neoplasms, excluding Juvenile Myelomonocytic Leukaemia (JMML), CMML and aCML (Atypical...
- Subject with Myelodysplastic/myeloproliferative neoplasm, (unclassifiable (MDS/MPN-UC) and MDS/MPN-RS-T). For Dose Expansion Phase people diagnosed...
You likely can't join if
- 1\. Subject who is treated with systemic anticancer therapy or biological therapy or an investigational agent within 2 weeks or 5 half-lives...
- For MF subject who come off JAK2 antagonists or hydroxyurea, shorter washout is permitted as these subject progress quickly after treatment...
- Subject who is in need of immediate cytoreduction should be excluded 2. Subject who has undergone autologous/allogeneic Haematopoietic Stem Cell...
- Patient with previous cancers can be included to the study provided they are in remission at the time of screening and enrolment.
- Patient with localized skin cancer can also be included for screening and enrollment. 10\. Subject with live vaccines within 30 days prior to the...
See the full eligibility criteria
- \- Male or female people aged ≥18 years at the time of screening visit. For Dose Escalation Phase: people diagnosed with any one of the following:
- Subject with diagnosis of Essential Thrombocythemia (ET) per World Health Organization (WHO) diagnostic criteria for myeloproliferative neoplasms .
- Subject requires treatment in order to lower platelet count based on subject age over 60 or history of thrombosis.
- Subject with Morphologically confirmed diagnosis of MDS/MPN neoplasms, excluding Juvenile Myelomonocytic Leukaemia (JMML), CMML and aCML (Atypical Chronic Myeloid Leukaemia), in accordance with WHO 2016 revised...
- Subject with Myelodysplastic/myeloproliferative neoplasm, (unclassifiable (MDS/MPN-UC) and MDS/MPN-RS-T). For Dose Expansion Phase people diagnosed with any one of the following:
- Subject with diagnosis of Essential Thrombocythemia (ET) per WHO diagnostic criteria for myeloproliferative neoplasms which requires treatment in order to lower platelet count based on subject age over 60 or history of...
- Subject with diagnosis of Polycythemia Vera (PV) per WHO diagnostic criteria that is relapsed and/or refractory or intolerant to standard of care and that, in the opinion of the Investigator, people who have no...
- MDS/MPN (MDS/MPN-RS-T, MDS/MPN unclassifiable and CMML people providing the marrow blast count is ≤5%.). 2. Subject must have disease that failed at least one standard therapy or being intolerant to standard of care. 3...
- Hb ≥ 9 g/dL, if subject is transfused to meet this criterion, transfusion must be completed ≥ 14 days prior to first dose.
- Absolute neutrophil count ≥ 1500 × 109/L
- Absolute neutrophil count ≥ 1000 × 109/L, if significant marrow infiltration
- Platelet count ≥ 450 × 109/L for dose finding
- Platelet count ≥ 100 × 109/L for expansion cohort at RP2D, if subject is transfused to meet this criterion, transfusion must be completed ≥14 days prior to first dose
- Total bilirubin ≤ 1.5 × ULN. people with Gilbert's syndrome may be enrolled with up to 3.0 × ULN
- Aspartate transaminase (AST) and Alanine transaminase (ALT) ≤ 2.5 × ULN (unless liver metastases are present then up to 5 × ULN is allowed)
- Calculated creatinine clearance (CrCL) ≥ 30 mL/min (Cockcroft- Gault formula) (Refer Appendix IV)
- Prothrombin Time (PT) or Activated Partial Thromboplastin Time (aPTT) ≤ 1.5 × ULN, if subject is not anticoagulated (Note: If subject is on anticoagulants, the subject must be on a stable dose for at least 2 weeks prior...
- 1\. Subject who is treated with systemic anticancer therapy or biological therapy or an investigational agent within 2 weeks or 5 half-lives, whichever is shorter, prior to start of study drug treatment.
- For MF subject who come off JAK2 antagonists or hydroxyurea, shorter washout is permitted as these subject progress quickly after treatment discontinuation and remain eligible (steroids must be stop at least 7 day...
- Subject who is in need of immediate cytoreduction should be excluded 2. Subject who has undergone autologous/allogeneic Haematopoietic Stem Cell Transplantation (HSCT) therapy within 60 days of the first dose of study...
- Patient with previous cancers can be included to the study provided they are in remission at the time of screening and enrolment.
- Patient with localized skin cancer can also be included for screening and enrollment. 10\. Subject with live vaccines within 30 days prior to the first dose of JBI-802. 11\. people who receive Glucocorticoids for any...
The study team makes the final eligibility decision.
Where it's taking place
- Sydney, New South Wales, Australia
- Adelaide, South Australia, Australia
- Melbourne, Victoria, Australia
- Perth, Western Australia, Australia
- Nedlands, Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 2 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Sydney, New South Wales, Australia; Adelaide, South Australia, Australia; Melbourne, Victoria, Australia; Perth, Western Australia, Australia; Nedlands, Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.