Phase 1/2 Study of Tasquinimod for Myelofibrosis
This study is looking at tasquinimod, either by itself or with ruxolitinib, to see if it can help people with primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis (post-PV MF), or post-essential thrombocytosis myelofibrosis (post-ET MF). You might be able to join if you are 18 or older and have myelofibrosis that hasn't responded well to other treatments like ruxolitinib, fedratinib, or pacritinib, or if you can't take those medicines. The main goal is to see how safe tasquinimod is and if it can reduce your symptoms and improve your condition. This study is currently unclear on its recruitment status and plans to enroll 33 participants.
- Study design
- This is an open-label Phase 1/2 study, meaning both you and your doctors will know which treatment you are receiving. It plans to enroll 33 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Safety and side effects will be measured throughout the study, which is expected to last an average of 1 year.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT06327100
Open Label Phase 1/2 Study of Tasquinimod in Patients With Primary Myelofibrosis (PMF), Post-Polycythemia Vera Myelofibrosis (Post-PV MF), or Post-Essential Thrombocytosis Myelofibrosis (Post-ET MF)
Recruiting
PHASE1Ages 18+InterventionalTreatmentM.D. Anderson Cancer CenterInvestigator-initiated
~33 participants
Updated 2026-05-26 on ClinicalTrials.gov
What's tested:RuxolitinibTasquinimod
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety and adverse events (AEs)
Measured over Through study completion; an average of 1 year.
Conditions
NCT06327100
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
MD Anderson Cancer Center
Houston, Texasstudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Lucia Masarova, MD · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center
Who to contact
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Eligibility criteria
Inclusion
Must be diagnosed with treatment requiring PMF or post ET/PV MF diagnosed according to the 2016 World Health Organization with intermediate -1, intermediate -2 or high-risk disease according to the DIPSS prognostic scoring system, or if with low risk disease then with symptomatic splenomegaly that is ≥ 5 cm below left costal margin by physical exam.
Peripheral or bone marrow blasts must be \< 10%
Participants must provide written informed consent.
Age 18 years or older. Because no dosing or adverse event data are currently available on the use of tasquinimod as monotherapy or in combination with ruxolitinib in patients \<18 years of age, children are excluded from this study.
Willing and able to comply with scheduled visits, treatment plan and laboratory tests.
Participant is able to swallow and retain oral medication.
ECOG performance status 0-2.
Required baseline laboratory status:
Absolute neutrophil count (ANC) ≥ 1.0 x 109/L (1000/mm3)
Serum direct bilirubin ≤ 1.0 x ULN (upper limit of normal)
AST (SGOT) or ALT (SGPT) \[if both measured, then this applies to both measurements\] ≤ 2.5 x ULN, except for participants with MF involvement of the liver who must have levels ≤ 5 x ULN
Glomerular Filtration Rate (GFR) of ≥ 30 ml/min based on Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation using serum or plasma creatinine or cystatin-C.
Treatment-related toxicities from prior therapies must have resolved to Grade ≤ 1.
Exclusion
For women of childbearing potential, a documented negative serum or urine pregnancy test within 14 days prior to the administration of study drug.
The effects of tasquinimod on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. (Refer to Pregnancy Assessment Policy MD Anderson Institutional Policy # CLN1114). This includes all female participants, between the onset of menses (as early as 8 years of age) and 55 years unless the patient presents with an applicable exclusionary factor which may be one of the following:
Postmenopausal (no menses in greater than or equal to 12 consecutive months).
History of hysterectomy or bilateral salpingo-oophorectomy.
Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).
History of bilateral tubal ligation or another surgical sterilization procedure.
Approved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy, Subject/Partner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 6 months after completion of tasquinimod administration.
Ability to understand and the willingness to sign a written informed consent document.
Any concurrent severe and/or uncontrolled medical conditions that could increase the participant's risk for toxicity while in the study or that could confound discrimination between disease- and study treatment-related toxicities.
Impaired cardiac function or clinically significant cardiac diseases, including any of the following:
History or presence of ventricular tachyarrhythmia.
Clinically significant resting bradycardia (\< 50 bpm).
Angina pectoris or acute myocardial infarction ≤ 3 months prior to starting study drug.
Other clinically significant heart disease (e.g., symptomatic congestive heart failure; uncontrolled arrhythmia or hypertension; history of labile hypertension or poor compliance with an antihypertensive regimen).
Participants who are currently receiving chronic (\> 14 days) treatment with corticosteroids at a dose ≥ 10 mg of prednisone (or its glucocorticoid equivalent) per day, or any other chronic immunosuppressive treatment that cannot be discontinued prior to starting study drug.
Treatment with chemotherapy (except hydroxyurea within 1 day prior to study treatment), immunomodulatory drug therapy (e.g. thalidomide, interferon-alpha), platelet-reducing therapy (e.g. anagrelide), immunosuppressive therapy, and erythropoetin use within 28 days prior to study treatment
Treatment with experimental therapy within the past 2 weeks or 5 half-lives, whichever is shorter
Treatment with tasquinimod at any time
Participants with impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of tasquinimod as per physician opinion
Participants with known or active (acute and chronic) Hepatitis A, B, or C; and Hepatitis B and C carriers, HIV. Participants are excluded regardless of detectability of viral load (lack of safety data).
Participants with clinically significant bacterial, fungal, parasitic or viral infection which require therapy
History of pancreatitis
History of malabsorption or other condition that would interfere with absorption of study drugs (e.g. ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, small bowel resection)
Systemic treatment within 14 days prior to the initiation of study treatment with any of the following moderate or strong inhibitor, or moderate or strong inducer of cytochrome P-3A4 (CYP3A4): imidazoles (e.g. ketoconazole), protease inhibitors (e.g. ritonavir), macrolides (e.g. erythromycin), rifampicin, rifabutin, phenytoin, carbamazepine, St. John's wort.
Need for ongoing therapy with any of the following drug substances of narrow therapeutic range that are metabolized mainly by CYP3A4: alfentanil, fentanyl, quinidine, astemizole, terfenadine, sirolimus, tacrolimus, cyclosporine, cisapride, and ergotamine
Need for ongoing therapy with any of the following drug substances of narrow therapeutic range metabolized mainly by CYP1A2: duloxetine, palonosetron, theophylline, tizanidine, and ondansetron.
Need for ongoing therapy with any of the following drug substances of narrow therapeutic range metabolized mainly by CYP2D6: Dosulepin, Flecainide, Sotalol, Pimozide, Procainamide, Clonidine, Desipramine, Clomipramine, Amitriptyline, Imipramine, Nortriptyline, Trimipramine, Amoxapine, Dronedarone, Phenytoin
Ongoing treatment with warfarin, unless the INR is \<=3.0.
Known hypersensitivity to tasquinimod or any excipients in the study treatments
Any other condition that would, in the Investigator's judgment, contraindicate subject's participation in the clinical study due to safety concerns or compliance with clinical study procedures
Prior inclusion in this study
Pregnant women are excluded from this study because tasquinimod is an agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with tasquinimod, breastfeeding should be discontinued if the mother is treated with tasquinimod. These potential risks may also apply to other agents used in this study.
What this trial measures
- Safety and adverse events (AEs)Through study completion; an average of 1 year.
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0