A Phase 2/3 interventional study of KRT-232 and Best Available Therapy (BAT) in Primary Myelofibrosis (PMF), Post-Polycythemia Vera MF (Post-PV-MF) and Post-Essential Thrombocythemia MF (Post-ET-MF), sponsored by Kartos Therapeutics, Inc.. Recruiting at 191 sites in 28 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-04-28.
Sponsored by Kartos Therapeutics, Inc. (part of Ipsen) · Phase 2/3, Interventional, and Treatment
This study evaluates KRT-232, a novel oral small molecule inhibitor of MDM2, for the treatment of patients with myelofibrosis (MF) who no longer benefit from treatment with a JAK inhibitor. Inhibition of MDM2 is a novel mechanism of action in MF.
This study will be conducted in 2 phases. Phase 2 will determine the KRT-232 recommended dose and dosing schedule; Phase 3 will test KRT-232 vs Best Available Therapy (BAT). Patients in the Phase 3 part of the study will be randomized 2:1 to receive either KRT-232 (Arm 1) or BAT (Arm 2). The BAT administered will be determined by the treating physician, with the option to "cross-over" to KRT-232 treatment after 6 months of BAT or if the disease worsens at any time.
625 studies on the registry are indexed under Primary Myelofibrosis; 124 are open to participants now.
This study's planned enrollment of 385 is above the median of 43 across 489 interventional studies indexed under Primary Myelofibrosis.
Browse Primary Myelofibrosis studies →Kartos Therapeutics, Inc. is the lead sponsor of 16 studies on the registry; 7 are open to participants now.
First submitted before Kartos Therapeutics, Inc. became part of Ipsen.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CTCAE grade
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
KRT-232 120 mg by mouth once daily for Days 1-7, off treatment for Days 8-21 (21-day cycles)
Drug: KRT-232
KRT-232 240 mg by mouth once daily for Days 1-7, off treatment for Days 8-21 (21-day cycles)
Drug: KRT-232
KRT-232 240 mg by mouth once daily for Days 1-7, off treatment for Days 8-28 (28-day cycles)
Drug: KRT-232
KRT-232 240 mg by mouth once daily for Days 1-5, off treatment for Days 6-28 (28-day cycles)
Drug: KRT-232
KRT-232 240 mg by mouth once daily for Days 1-7, off treatment for Days 8-28 (28-day cycles)
Drug: KRT-232
Best available therapy at the discretion of the investigator, on a 28-day cycle.
Drug: Best Available Therapy (BAT)
KRT-232, administered by mouth
Best available therapy options include: 1. hydroxyurea 2. chemotherapy or 3. supportive care (including but not limited to corticosteroids and androgens; JAK inhibitors not allowed).
(Part A Only) Spleen Volume Reduction (SVR)
The proportion of subjects achieving a ≥ 35% spleen volume reduction (SVR) from Baseline to Week 24, as assessed by magnetic resonance imaging (MRI) or computed tomography (CT) scan
Time frame: 24 weeks
(Part B Only) Spleen Volume Reduction (SVR)
The proportion of subjects achieving SVR of ≥ 35% at Week 24 by MRI/CT scan (central review)
Time frame: 24 Weeks
(Part A only) Improvement in Total Symptom Score (TSS)
The proportion of subjects who have at least a 50% reduction from Baseline to Week 24 and Week 48 in the total symptom score as measured by the modified MPN-SAF v2.0
Time frame: 48 weeks
(Part B only) Improvement of Total Symptom Score (TSS)
The proportion of subjects who have at least a 50% reduction from Baseline to Week 24 in the total symptom score as measured by the MF-SAF v4.0
Time frame: 24 Weeks
(Part B only) Overall Survival (OS)
Time from randomization to death from any cause
Time frame: 48 months
(Part B only) Progression free survival (PFS)
Time from randomization to either first occurrence of disease progression or death due to any cause
Time frame: 48 months
(Part B Only) Overall Spleen Volume Reduction (SVR)
The proportion of subjects in each arm achieving SVR of ≥ 35% at any time by MRI/CT scan (central review)
Time frame: 48 months
(Part B Only) Spleen Response Duration
Time from initial SVR of ≥ 35% by MRI/CT (central review) until the first occurrence of disease progression
Time frame: 48 months
(Part B Only) Rate of conversion from RBC transfusion dependent to independent
The proportion of subjects who have RBC transfusion independence at week 24
Time frame: 24 weeks
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Showing the first 100 of 191 sites across 28 countries. Choose a country and city above to see the rest.
Started Jan 2019 (actual). Primary completion is estimated for Dec 2023, 59 months after the start.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: Navtemadlin