BioinvestGPT

BioinvestGPT ApS · Research use only

NCT04905407 (Tamibarotene Venetoclax Azacitidine in Acute Myeloid Leukemia): BVCT ex-ante prediction vs. reported outcome

On 15 May 2024, BioinvestGPT's BVCT predicted technical failure and commercial failure for this trial. The 12 Aug 2024 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically insignificant and commercially insufficient.

Clinical Trial

NCTID
NCT04905407
Acronym
SELECT-AML-1
Drug Name
Tamibarotene Venetoclax Azacitidine
Drug MoA
RARalpha agonist
Drug Modality
synthetic retinoid
Drug Class
First-In-Class
Therapeutic Area
Neoplasms
Indication
Acute Myeloid Leukemia
Human Patients
95
Sponsor
Syros Pharmaceuticals
Phase
Phase 2

Prediction of , index 1625

Prospective Prediction
Prediction Index
1625
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient additive clinical benefit OS)
Technical Prediction
FAILURE (statistically insignificant additive clinical benefit in CR)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
89 days in advance
Readout Data Interpretation
CR/CRi achieved by tamibarotene + SoC vs 70% CR/CRi achieved by SoC; and trial terminated.
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically insignificant and commercially insufficient
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

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

Official title
Tamibarotene in Combination With Venetoclax and Azacitidine in Previously Untreated Adult Patients Selected for RARA-positive AML Who Are Ineligible for Standard Induction Therapy
Phase
Phase 2
Status
Terminated
Enrollment
66
Lead sponsor
Syros Pharmaceuticals
Conditions
Acute Myeloid Leukemia
Interventions
DRUG: Tamibarotene; DRUG: Venetoclax; DRUG: Azacitidine
Design
Randomized · Parallel · None
Primary purpose
Treatment
Start
2021-08-26
Primary completion
2024-08-12
Completion
2024-08-12
Results first posted
2025-02-24
Primary outcomes
  • Part 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs) (Up to 3 years)
  • Part 2: Complete Remission/Complete Remission With Incomplete Hematologic Recovery (CR/CRi) Rate (Up to 3 years)

NCT04905407 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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