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Tests treatment safety and results for Myelofibrosis
Official title A Clinical Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics of TQ05105 Tablets in Subjects With Intermediate/High-risk Myelofibrosis
ClinicalTrials.gov ID: NCT07551427
What this study is testing
What is TQ05105 Tablets (Rovadicitinib Tablets)?
TQ05105 Tablets (Rovadicitinib Tablets) is an investigational medicine, being studied as a potential treatment for myelofibrosis.
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 is an open-label, single-arm, multi-center phase II study consisting of two cohorts. Cohort 1 evaluates the pharmacokinetics (PK) of TQ05105 in myelofibrosis participants with normal, mild, or moderate renal impairment to guide dosing.
- Phase 2: a mid-size study of how well it works
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
- Voluntary and signed informed consent, good compliance.
- Age ≥18 years (at time of signing informed consent); Eastern Cooperative Oncology Group performance status (ECOG PS) 0-2; life expectancy ≥24 weeks.
- Diagnosis of primary myelofibrosis (PMF) per World Health Organization (WHO) 2016, or post-polycythemia vera myelofibrosis (post-PV-MF) or...
- Intermediate or high risk per Dynamic International Prognostic Scoring System (DIPSS).
- Cohort 1: Renal function classified as normal, mild impairment, or moderate impairment. Cohort 2: Prior Janus kinase (JAK) inhibitor therapy with...
You likely can't join if
- Prior allogeneic stem cell transplantation, or autologous stem cell transplantation within 3 months before first dose, or planned stem cell...
- Prior treatment with 2 or more Janus kinase (JAK) inhibitors (except Cohort 1).
- Prior splenectomy or splenic radiotherapy within 6 months before first dose.
- Other malignancies within 3 years before first dose or currently present (exceptions per protocol).
- Factors affecting oral drug absorption.
- Non-hematologic toxicity from prior therapy not recovered to ≤ grade 1 (excluding hypertension and alopecia).
See the full eligibility criteria
- Voluntary and signed informed consent, good compliance.
- Age ≥18 years (at time of signing informed consent); Eastern Cooperative Oncology Group performance status (ECOG PS) 0-2; life expectancy ≥24 weeks.
- Diagnosis of primary myelofibrosis (PMF) per World Health Organization (WHO) 2016, or post-polycythemia vera myelofibrosis (post-PV-MF) or post-essential thrombocythemia myelofibrosis (post-ET-MF) per International...
- Intermediate or high risk per Dynamic International Prognostic Scoring System (DIPSS).
- Cohort 1: Renal function classified as normal, mild impairment, or moderate impairment. Cohort 2: Prior Janus kinase (JAK) inhibitor therapy with refractory, relapsed, or intolerant.
- Spleen enlargement (except Cohort 1).
- Peripheral blood and bone marrow blasts ≤10%.
- No growth factors, colony-stimulating factors, thrombopoietin, or platelet transfusion within 2 weeks before first dose; and routine blood parameters meet requirements within 7 days before first dose.
- Adequate major organ function within 7 days before first dose per protocol (renal function not restricted for Cohort 1).
- Agreement to use effective contraception during the study and for 6 months after; negative pregnancy test for females of childbearing potential; non-lactating.
- Prior allogeneic stem cell transplantation, or autologous stem cell transplantation within 3 months before first dose, or planned stem cell transplantation.
- Prior treatment with 2 or more Janus kinase (JAK) inhibitors (except Cohort 1).
- Prior splenectomy or splenic radiotherapy within 6 months before first dose.
- Other malignancies within 3 years before first dose or currently present (exceptions per protocol).
- Factors affecting oral drug absorption.
- Non-hematologic toxicity from prior therapy not recovered to ≤ grade 1 (excluding hypertension and alopecia).
- Major surgery or significant traumatic injury within 4 weeks before first dose.
- Congenital bleeding or coagulation disorders.
- Arterial/venous thrombosis event within 6 months before first dose.
- History of substance abuse or mental disorder.
- Active or uncontrolled severe infection.
- Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
- Grade ≥2 myocardial ischemia or infarction, arrhythmia, QT prolongation, or grade ≥2 congestive heart failure.
- Uncontrolled hypertension despite standard therapy.
- Renal failure requiring hemodialysis or peritoneal dialysis.
- Newly diagnosed pulmonary interstitial fibrosis or drug-related interstitial lung disease within 3 months before first dose.
- History of immunodeficiency or organ transplantation.
- Epilepsy requiring treatment.
- Use of protocol-prohibited myelofibrosis (MF) medications, immunomodulators, or immunosuppressants within specified time before first dose.
- Use of Chinese patent medicines with anti-tumor indications approved by National Medical Products Administration (NMPA) within 2 weeks before first dose.
- Uncontrolled pleural effusion, pericardial effusion, or ascites.
- Live attenuated vaccine within 4 weeks before first dose or planned during the study.
- Known hypersensitivity to study drug or excipients.
- Diagnosis of active autoimmune disease within 2 years before first dose.
- Participation in another treatment clinical trial with investigational drug within 4 weeks before first dose.
- Any condition that, in the investigator's judgment, seriously endangers subject safety or interferes with study completion.
The study team makes the final eligibility decision.
Where it's taking place
- Hefei, Anhui, China
- Fuzhou, Fujian, China
- Guangzhou, Guangdong, China
- Nanning, Guangxi, China
- Cangzhou, Hebei, China
- Chengde, Hebei, China
- Shijiazhuang, Hebei, China
- Xingtai, Hebei, China
- Zhengzhou, Henan, China
- Wuhan, Hubei, China
- Zhuzhou, Hunan, China
- Nanjin, Jiangsu, China
- Nanjing, Jiangsu, China
- Changchun, Jilin, China
- Shenyang, Liaoning, China
- Xi'an, Shaanxi, China
- Shanghai, Shanghai Municipality, China
- Changzhi, Shanxi, China
- Chengdu, Sichuan, China
- Tianjin, Tianjin Municipality, China
+ 2 more site(s).
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 listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to 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 Hefei, Anhui, China; Fuzhou, Fujian, China; Guangzhou, Guangdong, China; Nanning, Guangxi, China; Cangzhou, Hebei, China; Chengde, Hebei, China and 16 more location(s). 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.