18 and older, any sex, with Acute Myeloid Leukemia. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Summary of Best Modified Criteria Response Results, Bridged-to-Transplant (BTT) Participants, and Composite Remission Rates in Patients on Treatment With PLX3397 (Dose Expansion, Part 2).Primary· 1 year post dose
Complete remission (CR): Has bone marrow regenerating normal cells, achieve a morphologic leukemia-free state, Complete remission with incomplete platelet recovery (CRp): CR except for incomplete platelet recovery, Complete remission with incomplete recovery (CRi): CR except for incomplete hematological recovery with residual neutropenia, Partial response (PR): bone marrow generates normal hematopoietic cells, evidence of peripheral recovery with no or a few regenerating circulating blasts. Decrease of ≥50% of blasts in bone marrow aspirate, total marrow blasts between 5% -25%, Non-response (N
CR
Group
Value
95% CI
Part 2: 3000 mg/Day
1
CRp
Group
Value
95% CI
Part 2: 3000 mg/Day
1
CRi
Group
Value
95% CI
Part 2: 3000 mg/Day
4
PR
Group
Value
95% CI
Part 2: 3000 mg/Day
5
NR
Group
Value
95% CI
Part 2: 3000 mg/Day
45
Successful BTT patients
Group
Value
95% CI
Part 2: 3000 mg/Day
4
Successful BTT patient (CR, CRp, or CRi)
Group
Value
95% CI
Part 2: 3000 mg/Day
8
Summary of Time-to-Event Endpoints in Patients on Treatment With PLX3397 (Dose Expansion, Part 2)Primary· 1 year post dose
Median survival estimates were based on the Kaplan-Meier method. In the event disease progression/relapse or death was not documented prior to study termination, endpoints were censored at the date of last evaluable tumor assessment. Duration of remission, duration of complete remission, and disease-free survival, initial response was based on the modified response criteria. Duration of complete remission was defined as the number of days from the date of initial CR, CRp, or CRi response to the date of first documented disease relapse or death, whichever occurred first. Disease-free survival w
Duration of remission
Group
Value
95% CI
Part 2: 3000 mg/Day
91
43 – 337
Duration of complete remission
Group
Value
95% CI
Part 2: 3000 mg/Day
289
289 – 289
Progression-free survival
Group
Value
95% CI
Part 2: 3000 mg/Day
48
30 – 58
Disease-free survival
Group
Value
95% CI
Part 2: 3000 mg/Day
289
289 – 289
Overall survival
Group
Value
95% CI
Part 2: 3000 mg/Day
112
77 – 150
Number of Participants With On-treatment Best Modified Criteria Response Results of Partial Remission (PR) During Treatment With PLX3397 (Dose Expansion, Part 2)Secondary· 1 year post dose
Modified International Working Group Response Criteria for Acute Myeloid Leukemia defines Partial Remission (PR) as the following: Partial Remission (PR): Patients must have bone marrow regenerating normal hematopoietic cells with evidence of peripheral recovery with no (or only a few regenerating) circulating blasts and with a decrease of at least 50% in the percentage of blasts in the bone marrow aspirate with the total marrow blasts between 5% and 25%. In addition, patients do not need to be Red Blood Cell (RBC) or platelet transfusion independent.
Group
Value
95% CI
Part 2: 3000 mg/Day
5
Number of Participants With On-treatment Best Classic Criteria Response Results During Treatment With PLX3397 (Dose Expansion, Part 2)Secondary· 1 year post dose
Complete Remission (CR):
Bone marrow blasts \<5%; absence of blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count \>1.0 x 109/L (1000/μL); platelet count \>100 x 109/L (100000/μL); red cell transfusion independent
CR with incomplete recovery (CRi):
All CR criteria except for residual neutropenia (\<1.0 x 109/L) or thrombocytopenia
Partial Remission (PR):
All hematologic criteria of CR; decrease of bone marrow blast percentage to 5-25%; decrease of pretreatment bone marrow blast percentage by at least 50%.
CR
Group
Value
95% CI
Part 2: 3000 mg/Day
2
CRi
Group
Value
95% CI
Part 2: 3000 mg/Day
6
PR
Group
Value
95% CI
Part 2: 3000 mg/Day
2
NR
Group
Value
95% CI
Part 2: 3000 mg/Day
46
Number of Participants Reporting an Incidence of Adverse Events During Treatment With PLX3397 (Part 1, Dose Escalation and Part 2, Dose Expansion)Secondary· 1 year post dose
At least 1 AE
Group
Value
95% CI
Part 1: 800 mg/Day
3
Part 1: 1000 mg/Day
7
Part 1: 1200 mg/Day
3
Part 1: 1400 mg/Day
3
Part 1: 2000 mg/Day
3
Part 1: 3000 mg/Day
6
Part 1: 4000 mg/Day
5
Part 1: 5000 mg/Day
4
Part 2: 3000 mg/Day
56
At least 1 treatment-related AE
Group
Value
95% CI
Part 1: 800 mg/Day
2
Part 1: 1000 mg/Day
4
Part 1: 1200 mg/Day
3
Part 1: 1400 mg/Day
3
Part 1: 2000 mg/Day
3
Part 1: 3000 mg/Day
4
Part 1: 4000 mg/Day
4
Part 1: 5000 mg/Day
4
Part 2: 3000 mg/Day
49
AE that lead to change in drug administration
Group
Value
95% CI
Part 1: 800 mg/Day
0
Part 1: 1000 mg/Day
4
Part 1: 1200 mg/Day
2
Part 1: 1400 mg/Day
1
Part 1: 2000 mg/Day
2
Part 1: 3000 mg/Day
5
Part 1: 4000 mg/Day
4
Part 1: 5000 mg/Day
3
Part 2: 3000 mg/Day
28
At least 1 AE with CTCAE Grade >=3
Group
Value
95% CI
Part 1: 800 mg/Day
3
Part 1: 1000 mg/Day
7
Part 1: 1200 mg/Day
2
Part 1: 1400 mg/Day
3
Part 1: 2000 mg/Day
2
Part 1: 3000 mg/Day
5
Part 1: 4000 mg/Day
5
Part 1: 5000 mg/Day
4
Part 2: 3000 mg/Day
50
Serious Adverse Event (SAE)or other significant AE
Group
Value
95% CI
Part 1: 800 mg/Day
1
Part 1: 1000 mg/Day
5
Part 1: 1200 mg/Day
2
Part 1: 1400 mg/Day
1
Part 1: 2000 mg/Day
2
Part 1: 3000 mg/Day
5
Part 1: 4000 mg/Day
4
Part 1: 5000 mg/Day
4
Part 2: 3000 mg/Day
39
At least 1 treatment-related Serious Adverse Event
Group
Value
95% CI
Part 1: 800 mg/Day
0
Part 1: 1000 mg/Day
2
Part 1: 1200 mg/Day
0
Part 1: 1400 mg/Day
1
Part 1: 2000 mg/Day
1
Part 1: 3000 mg/Day
1
Part 1: 4000 mg/Day
0
Part 1: 5000 mg/Day
1
Part 2: 3000 mg/Day
10
AE resulting in death
Group
Value
95% CI
Part 1: 800 mg/Day
0
Part 1: 1000 mg/Day
0
Part 1: 1200 mg/Day
0
Part 1: 1400 mg/Day
0
Part 1: 2000 mg/Day
0
Part 1: 3000 mg/Day
3
Part 1: 4000 mg/Day
0
Part 1: 5000 mg/Day
0
Part 2: 3000 mg/Day
9
SAE leading to discontinuation of study drug
Group
Value
95% CI
Part 1: 800 mg/Day
0
Part 1: 1000 mg/Day
2
Part 1: 1200 mg/Day
0
Part 1: 1400 mg/Day
0
Part 1: 2000 mg/Day
0
Part 1: 3000 mg/Day
3
Part 1: 4000 mg/Day
2
Part 1: 5000 mg/Day
0
Part 2: 3000 mg/Day
9
Number of Participants Reporting an Incidence of Treatment-Related Treatment Emergent Adverse Events During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Secondary· 1 year post dose
Data reported are Treatment-Related Treatment Emergent Adverse Events that are ≥15% Occurrence in all patients.
At least 1 treatment-related AE
Group
Value
95% CI
Part 1: 800 mg/Day
2
Part 1: 1000 mg/Day
4
Part 1: 1200 mg/Day
3
Part 1: 1400 mg/Day
3
Part 1: 2000 mg/Day
3
Part 1: 3000 mg/Day
4
Part 1: 4000 mg/Day
4
Part 1: 5000 mg/Day
4
Part 2: 3000 mg/Day
49
Nausea
Group
Value
95% CI
Part 1: 800 mg/Day
2
Part 1: 1000 mg/Day
1
Part 1: 1200 mg/Day
2
Part 1: 1400 mg/Day
3
Part 1: 2000 mg/Day
0
Part 1: 3000 mg/Day
2
Part 1: 4000 mg/Day
1
Part 1: 5000 mg/Day
3
Part 2: 3000 mg/Day
21
Diarrhoea
Group
Value
95% CI
Part 1: 800 mg/Day
1
Part 1: 1000 mg/Day
1
Part 1: 1200 mg/Day
1
Part 1: 1400 mg/Day
1
Part 1: 2000 mg/Day
1
Part 1: 3000 mg/Day
0
Part 1: 4000 mg/Day
3
Part 1: 5000 mg/Day
1
Part 2: 3000 mg/Day
19
Vomiting
Group
Value
95% CI
Part 1: 800 mg/Day
0
Part 1: 1000 mg/Day
2
Part 1: 1200 mg/Day
1
Part 1: 1400 mg/Day
2
Part 1: 2000 mg/Day
0
Part 1: 3000 mg/Day
2
Part 1: 4000 mg/Day
1
Part 1: 5000 mg/Day
3
Part 2: 3000 mg/Day
15
Fatigue
Group
Value
95% CI
Part 1: 800 mg/Day
0
Part 1: 1000 mg/Day
1
Part 1: 1200 mg/Day
1
Part 1: 1400 mg/Day
1
Part 1: 2000 mg/Day
1
Part 1: 3000 mg/Day
2
Part 1: 4000 mg/Day
1
Part 1: 5000 mg/Day
2
Part 2: 3000 mg/Day
18
Decreased appetite
Group
Value
95% CI
Part 1: 800 mg/Day
1
Part 1: 1000 mg/Day
0
Part 1: 1200 mg/Day
0
Part 1: 1400 mg/Day
1
Part 1: 2000 mg/Day
1
Part 1: 3000 mg/Day
2
Part 1: 4000 mg/Day
1
Part 1: 5000 mg/Day
1
Part 2: 3000 mg/Day
16
Anaemia
Group
Value
95% CI
Part 1: 800 mg/Day
0
Part 1: 1000 mg/Day
1
Part 1: 1200 mg/Day
1
Part 1: 1400 mg/Day
1
Part 1: 2000 mg/Day
0
Part 1: 3000 mg/Day
0
Part 1: 4000 mg/Day
0
Part 1: 5000 mg/Day
2
Part 2: 3000 mg/Day
9
Aspartate aminotransferase increased
Group
Value
95% CI
Part 1: 800 mg/Day
0
Part 1: 1000 mg/Day
0
Part 1: 1200 mg/Day
0
Part 1: 1400 mg/Day
0
Part 1: 2000 mg/Day
1
Part 1: 3000 mg/Day
1
Part 1: 4000 mg/Day
1
Part 1: 5000 mg/Day
1
Part 2: 3000 mg/Day
10
Number of Participants Reporting a Treatment Emergent Adverse Events With a CTCAE Grade ≥3 During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Secondary· 1 year post dose
Data reported are Treatment Emergent Adverse Events with a CTCAE Grade ≥3 During Treatment that are ≥10% Occurrence in all patients.
At least 1 AE with CTCAE Grade ≥3
Group
Value
95% CI
Part 1: 800 mg/Day
3
Part 1: 1000 mg/Day
7
Part 1: 1200 mg/Day
2
Part 1: 1400 mg/Day
3
Part 1: 2000 mg/Day
2
Part 1: 3000 mg/Day
5
Part 1: 4000 mg/Day
5
Part 1: 5000 mg/Day
4
Part 2: 3000 mg/Day
50
Febrile neutropenia
Group
Value
95% CI
Part 1: 800 mg/Day
1
Part 1: 1000 mg/Day
5
Part 1: 1200 mg/Day
1
Part 1: 1400 mg/Day
3
Part 1: 2000 mg/Day
1
Part 1: 3000 mg/Day
1
Part 1: 4000 mg/Day
2
Part 1: 5000 mg/Day
2
Part 2: 3000 mg/Day
22
Anaemia
Group
Value
95% CI
Part 1: 800 mg/Day
0
Part 1: 1000 mg/Day
1
Part 1: 1200 mg/Day
0
Part 1: 1400 mg/Day
1
Part 1: 2000 mg/Day
1
Part 1: 3000 mg/Day
0
Part 1: 4000 mg/Day
2
Part 1: 5000 mg/Day
1
Part 2: 3000 mg/Day
9
Thrombocytopenia
Group
Value
95% CI
Part 1: 800 mg/Day
0
Part 1: 1000 mg/Day
1
Part 1: 1200 mg/Day
0
Part 1: 1400 mg/Day
1
Part 1: 2000 mg/Day
0
Part 1: 3000 mg/Day
0
Part 1: 4000 mg/Day
0
Part 1: 5000 mg/Day
3
Part 2: 3000 mg/Day
7
Sepsis
Group
Value
95% CI
Part 1: 800 mg/Day
0
Part 1: 1000 mg/Day
0
Part 1: 1200 mg/Day
1
Part 1: 1400 mg/Day
1
Part 1: 2000 mg/Day
0
Part 1: 3000 mg/Day
1
Part 1: 4000 mg/Day
0
Part 1: 5000 mg/Day
0
Part 2: 3000 mg/Day
10
Platelet count decreased
Group
Value
95% CI
Part 1: 800 mg/Day
0
Part 1: 1000 mg/Day
0
Part 1: 1200 mg/Day
0
Part 1: 1400 mg/Day
0
Part 1: 2000 mg/Day
1
Part 1: 3000 mg/Day
0
Part 1: 4000 mg/Day
1
Part 1: 5000 mg/Day
0
Part 2: 3000 mg/Day
10
Fatigue
Group
Value
95% CI
Part 1: 800 mg/Day
2
Part 1: 1000 mg/Day
0
Part 1: 1200 mg/Day
0
Part 1: 1400 mg/Day
1
Part 1: 2000 mg/Day
1
Part 1: 3000 mg/Day
1
Part 1: 4000 mg/Day
0
Part 1: 5000 mg/Day
1
Part 2: 3000 mg/Day
3
Number of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)Secondary· 1 year post dose
Anaemia
Group
Value
95% CI
Part 1: 800 mg/Day
0
Part 1: 1000 mg/Day
1
Part 1: 1200 mg/Day
1
Part 1: 1400 mg/Day
1
Part 1: 2000 mg/Day
1
Part 1: 3000 mg/Day
0
Part 1: 4000 mg/Day
2
Part 1: 5000 mg/Day
3
Part 2: 3000 mg/Day
15
Hypokalaemia
Group
Value
95% CI
Part 1: 800 mg/Day
1
Part 1: 1000 mg/Day
0
Part 1: 1200 mg/Day
1
Part 1: 1400 mg/Day
2
Part 1: 2000 mg/Day
0
Part 1: 3000 mg/Day
1
Part 1: 4000 mg/Day
2
Part 1: 5000 mg/Day
2
Part 2: 3000 mg/Day
13
Aspartate aminotransferase increased
Group
Value
95% CI
Part 1: 800 mg/Day
0
Part 1: 1000 mg/Day
1
Part 1: 1200 mg/Day
0
Part 1: 1400 mg/Day
0
Part 1: 2000 mg/Day
2
Part 1: 3000 mg/Day
1
Part 1: 4000 mg/Day
1
Part 1: 5000 mg/Day
1
Part 2: 3000 mg/Day
13
Thrombocytopenia
Group
Value
95% CI
Part 1: 800 mg/Day
0
Part 1: 1000 mg/Day
1
Part 1: 1200 mg/Day
0
Part 1: 1400 mg/Day
1
Part 1: 2000 mg/Day
0
Part 1: 3000 mg/Day
0
Part 1: 4000 mg/Day
1
Part 1: 5000 mg/Day
3
Part 2: 3000 mg/Day
9
Hypomagnesmia
Group
Value
95% CI
Part 1: 800 mg/Day
1
Part 1: 1000 mg/Day
0
Part 1: 1200 mg/Day
1
Part 1: 1400 mg/Day
1
Part 1: 2000 mg/Day
0
Part 1: 3000 mg/Day
0
Part 1: 4000 mg/Day
0
Part 1: 5000 mg/Day
2
Part 2: 3000 mg/Day
10
Hypocalcaemia
Group
Value
95% CI
Part 1: 800 mg/Day
1
Part 1: 1000 mg/Day
1
Part 1: 1200 mg/Day
0
Part 1: 1400 mg/Day
0
Part 1: 2000 mg/Day
1
Part 1: 3000 mg/Day
1
Part 1: 4000 mg/Day
1
Part 1: 5000 mg/Day
1
Part 2: 3000 mg/Day
8
Platelet count decreased
Group
Value
95% CI
Part 1: 800 mg/Day
0
Part 1: 1000 mg/Day
0
Part 1: 1200 mg/Day
0
Part 1: 1400 mg/Day
0
Part 1: 2000 mg/Day
1
Part 1: 3000 mg/Day
0
Part 1: 4000 mg/Day
1
Part 1: 5000 mg/Day
0
Part 2: 3000 mg/Day
12
Blood alkaline phosphatase increase
Group
Value
95% CI
Part 1: 800 mg/Day
0
Part 1: 1000 mg/Day
0
Part 1: 1200 mg/Day
0
Part 1: 1400 mg/Day
0
Part 1: 2000 mg/Day
1
Part 1: 3000 mg/Day
0
Part 1: 4000 mg/Day
1
Part 1: 5000 mg/Day
1
Part 2: 3000 mg/Day
10
A Summary of Time From Initial Dosing to First and Best Response, Modified Response Criteria in Patient Treated With PLX3397 (Dose Expansion, Part 2)Secondary· 1 year post dose
Time to First Response
Group
Value
95% CI
Part 2: 3000 mg/Day
29
26 – 30
Time to Best Response
Group
Value
95% CI
Part 2: 3000 mg/Day
30
26 – 55
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse event data were collected from after the first dose to 30 days after the last dose..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Part 1: 800 mg/Day
Serious: 1/3 (33%)
Deaths: 0/3
Part 1: 1000 mg/Day
Serious: 5/7 (71%)
Deaths: 0/7
Part 1: 1200 mg/Day
Serious: 2/3 (67%)
Deaths: 0/3
Part 1: 1400 mg/Day
Serious: 1/3 (33%)
Deaths: 0/3
Part 1: 2000 mg/Day
Serious: 2/3 (67%)
Deaths: 0/3
Part 1: 3000 mg/Day
Serious: 5/6 (83%)
Deaths: 0/6
Part 1: 4000 mg/Day
Serious: 4/5 (80%)
Deaths: 0/5
Part 1: 5000 mg/Day
Serious: 4/4 (100%)
Deaths: 1/4
Part 2: 3000 mg/Day
Serious: 39/56 (70%)
Deaths: 5/56
Serious adverse events (60 terms)
Reaction
System
Part 1: 800 mg/Day
Part 1: 1000 mg/Day
Part 1: 1200 mg/Day
Part 1: 1400 mg/Day
Part 1: 2000 mg/Day
Part 1: 3000 mg/Day
Part 1: 4000 mg/Day
Part 1: 5000 mg/Day
Part 2: 3000 mg/Day
Febrile neutropenia
Blood and lymphatic system disorders
—
—
—
—
—
—
—
—
—
Sepsis
Infections and infestations
—
—
—
—
—
—
—
—
—
Pneumonia
Infections and infestations
—
—
—
—
—
—
—
—
—
Cellulitis
Infections and infestations
—
—
—
—
—
—
—
—
—
Bacteraemia
Infections and infestations
—
—
—
—
—
—
—
—
—
Urinary tract infection
Infections and infestations
—
—
—
—
—
—
—
—
—
Gastrointestinal hemorrhage
Gastrointestinal disorders
—
—
—
—
—
—
—
—
—
Rash maculo-papular
Skin and subcutaneous tissue disorders
—
—
—
—
—
—
—
—
—
Device related infection
Infections and infestations
—
—
—
—
—
—
—
—
—
Respiratory failure
Respiratory, thoracic and mediastinal disorders
—
—
—
—
—
—
—
—
—
Pyrexia
General disorders
—
—
—
—
—
—
—
—
—
Atrial fibrillation
Cardiac disorders
—
—
—
—
—
—
—
—
—
Acute febrile neutrophilic dermatosis
Skin and subcutaneous tissue disorders
—
—
—
—
—
—
—
—
—
Thrombocytopenia
Blood and lymphatic system disorders
—
—
—
—
—
—
—
—
—
Bronchitis
Infections and infestations
—
—
—
—
—
—
—
—
—
Enterocolitis infectious
Infections and infestations
—
—
—
—
—
—
—
—
—
Fungaemia
Infections and infestations
—
—
—
—
—
—
—
—
—
Herpes zoster disseminated
Infections and infestations
—
—
—
—
—
—
—
—
—
Streptococcal bacteraemia
Infections and infestations
—
—
—
—
—
—
—
—
—
Haemoptysis
Respiratory, thoracic and mediastinal disorders
—
—
—
—
—
—
—
—
—
Pneumonitis
Respiratory, thoracic and mediastinal disorders
—
—
—
—
—
—
—
—
—
Respiratory distress
Respiratory, thoracic and mediastinal disorders
—
—
—
—
—
—
—
—
—
Acute myocardial infarction
Cardiac disorders
—
—
—
—
—
—
—
—
—
Mucosal inflammation
General disorders
—
—
—
—
—
—
—
—
—
Ejection fraction decreased
Investigations
—
—
—
—
—
—
—
—
—
Other adverse events (270 terms — click to expand)
The purpose of this study is to evaluate the safety of study drug PLX3397 at 3 dose levels (800 mg/day, 1000 mg/day, and 1200 mg/day) and explore the efficacy in patients with relapsed or refractory acute myeloid leukemia (AML). Additional dose levels beyond 1200 mg/day may be considered based on safety and efficacy observations.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT02975700 — A Study of PLX3397 in Patients With Unresectable or Metastatic KIT-mutated Melanoma
· NA
· completed
NCT02452424 — A Combination Clinical Study of PLX3397 and Pembrolizumab To Treat Advanced Melanoma and Other Solid Tumors
· Phase 1, PHASE2
· terminated
NCT01826448 — A Phase 1b Open Label, Dose Escalation Study of PLX3397 in Combination With Vemurafenib in V600-mutated BRAF Melanoma
· Phase 1
· terminated
NCT01790503 — A Phase 1b/2 Study of PLX3397 + Radiation Therapy + Temozolomide in Patients With Newly Diagnosed Glioblastoma
· Phase 1, PHASE2
· completed
NCT01596751 — Phase Ib/II Study of PLX 3397 and Eribulin in Patients With Metastatic Breast Cancer
· Phase 1, PHASE2
· completed
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Daiichi Sankyo
Last refreshed: 2 March 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01349049.