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NCT04797780 (Tamibarotene in Myelodysplastic Syndrome with RARA gene overexpression): 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 Nov 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
NCT04797780
Acronym
SELECT MDS-1
Drug Name
Tamibarotene
Drug MoA
RARalpha agonist
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Neoplasms
Indication
Myelodysplastic Syndrome with RARA gene overexpression
Human Patients
550
Sponsor
Syros Pharmaceuticals
Phase
Phase 3

Prediction of , index 1624

Prospective Prediction
Prediction Index
1624
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
181 days in advance
Readout Data Interpretation
Tamibarotene failed to achieve additional benefit in CR as the primary efficacy endpoint
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
A Randomized, Double-blind, Placebo-controlled Phase 3 Study of Tamibarotene Plus Azacitidine Versus Placebo Plus Azacitidine in Newly Diagnosed, Adult Patients Selected for RARA-positive Higher-risk Myelodysplastic Syndrome (SELECT MDS-1)
Phase
Phase 3
Status
Terminated
Enrollment
246
Lead sponsor
Syros Pharmaceuticals
Conditions
Myelodysplastic Syndromes
Interventions
DRUG: Tamibarotene; DRUG: Placebo; DRUG: Azacitidine
Design
Randomized · Parallel · Quadruple
Primary purpose
Treatment
Start
2021-02-08
Primary completion
2024-11-13
Completion
2024-11-13
Results first posted
2025-04-10
Primary outcomes
  • Percentage of Participants With Complete Remission (CR) (Up to 45 months)

NCT04797780 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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