Clinical trial · Interventional
A Study of TQ05105 Tablets in Subjects With Myeloproliferative Neoplasms
A Single-group, Open-label, Multicenter, Phase I Study of TQ05105 Tablets in Subjects With Myeloproliferative Neoplasms
NCT04339400CI-TRIAL-00113514completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
TQ05105 is a JAK2 inhibitors and can be used to treat JAK2 target-related diseases. The activation of the JAK/STAT pathway is related to abnormal proliferation, obstruction of apoptosis, and differentiation disorder of leukemia cells which is caused by genetic abnormalities and viral infection.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Myeloproliferative Neoplasms | Myeloproliferative Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TQ05105 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- TQ05105 Tablet
- description
- TQ05105 tablet 5mg administered orally once. Then TQ05105 tablet administered orally, twice daily in 28-day cycle after 3 days of first administration.
- interventionNames
- Drug: TQ05105
Primary outcomes (2)
- measure
- Dose Limiting Toxicity(DLT)
- timeFrame
- Baseline up to 28 days
- description
- DLT defined as any of the events occurring during the study related to drugs.
- measure
- Maximal tolerance dose (MTD)
- timeFrame
- Baseline up to 28 days
- description
- MTD defined as the highest dose level at which less than or equal to 2 of 6 subjects experience dose limiting toxicity (DLT).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 1.18 years and older; Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 3; Life expectancy ≥ 3 months. 2\. Diagnosed as Primary Myelofibrosis(PMF), Polycythemia Vera(PV), Essential Thrombocythemia(ET), Post-Polycythemia Vera Myelofibrosis (PPV-MF) or Post- Essential Thrombocythemia Myelofibrosis (PET-MF). 3\. Myelofibrosis at intermediate risk -1 and above according to Dynamic International Prognostic Scoring System(DIPSS); PV or ET were resistant or intolerant to hydroxyurea and/or interferon therapy. 4\. Adequate hematology laboratory index. 5.The most prominent part of the spleen ≥ 5cm to the lower edge of the ribs. 6.Bone marrow blasts and peripheral blood blasts \<20%. 7. Appropriate liver and kidney functions. 8.The main blood coagulation function is appropriate. 9. Those who have used other MPN treatment drugs before first dose need to stop exceed 2 weeks. Those who have received major surgery before first dose need to exceed 4 weeks. 10.No pregnant or breastfeeding women, and a negative pregnancy test. 11.Understood and signed an informed consent form. Exclusion Criteria: * 1\. Has diagnosed and/or treated additional malignancy within 5 years prior to randomization. With exception of non-melanoma, skin cancer, and carcinoma in situ. 2\. Has participated in other anticancer drug clinical trials within 4 weeks. 3. Has multiple factors affecting oral medication. 4. Has drug abuse history that unable to abstain from or mental disorders. 5. Has active hepatitis B or C, or immunodeficiency. 6. Has immunodeficiency. 7. Has arteriovenous thrombosis events within 4 weeks. 8. Has received long-term and large-dose glucocorticoids or other immunosuppressive drugs within 28 days before signed the informed consent form. 9\. Has serious systemic infections. 10. Has uncontrolled cardiovascular disease. 11. Has uncontrolled hypertension. 12. Has serious systemic infections. 13. According to the judgement of the researchers, there are other factors that subjects are not suitable for the study.
References
Publications (0)
Data not yet available
No reference posted for this study.