BioinvestGPT

BioinvestGPT ApS · Research use only

NCT04067336 (Ziftomenib in Relapsed or Refractory Acute Myeloid Leukemia): BVCT ex-ante prediction vs. reported outcome

On 28 Nov 2023, BioinvestGPT's BVCT predicted technical success and commercial failure for this trial. The 30 Jan 2024 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically significant and commercially insufficient.

Clinical Trial

NCTID
NCT04067336
Acronym
KOMET-001
Drug Name
Ziftomenib
Drug MoA
Menin-MLL1 inhibitor
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Neoplasms
Indication
Relapsed or Refractory Acute Myeloid Leukemia
Human Patients
199
Sponsor
Kura Oncology
Phase
Phase 1 Phase 2

Prediction of , index 1347

Prospective Prediction
Prediction Index
1347
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit)
Technical Prediction
SUCCESS (statistically significant clinical benefit)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
63 days in advance
Readout Data Interpretation
65% ORR with 70% Top CR; non-superior to chemo’s 60%-70% CR.
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant and commercially insufficient
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

ClinicalTrials.gov record, retrieved 2026-09-24. Third-party data.

Official title
A Phase 1/2 First in Human Study of the Menin-MLL(KMT2A) Inhibitor KO-539 in Patients With Relapsed or Refractory Acute Myeloid Leukemia
Phase
Phase 1, Phase 2
Status
Active not recruiting
Enrollment
263
Lead sponsor
Kura Oncology, Inc.
Conditions
Advanced Malignant Neoplasm; Acute Myeloid Leukemia; Mixed Lineage Leukemia; Mixed Lineage Acute Leukemia; Acute Leukemia of Ambiguous Lineage; Mixed Phenotype Acute Leukemia; Acute Lymphoblastic Leukemia
Interventions
DRUG: Ziftomenib; DRUG: Midazolam; DRUG: Itraconazole
Design
Randomized · Parallel · None
Primary purpose
Treatment
Start
2019-09-12
Primary completion
2028-10-16
Completion
2028-10-16
Primary outcomes
  • Phase 1a: Maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) (Dose Limiting Toxicities (DLTs) will be evaluated during the first 28 days (1 cycle))
  • Phase 1b: Number of patients who experience Adverse Events (AEs) and Serious Adverse Events (SAEs) (During treatment and up to approximately 28 days after treatment discontinuation, or until immediately before the initiation of another anticancer therapy, whichever occurs first.)
  • Phase 1b: Minimum biologically effective dose (For at least 12 months following end of treatment)
  • Phase 1a, 1b, and 2: Evidence of anti-leukemia activity (For at least 12 months following end of treatment)
  • Sub-study 1: Time to observed maximum plasma concentration (Tmax) of ziftomenib and midazolam (Cycle 1 on Days 1 and 15 at predose and postdose)

NCT04067336 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

How to read these records: evidence · methodology · all trials