Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Onureg+ Venetoclax · 1 trial · 1 indication
Dose-limiting toxicities according to CTCAE (common terminology criteria for adverses events) 5.0 occurring within the first cycle of treatment
Overall response measured after the first cycle of treatment according to modified IWG-MDS (International Working Group-Myelodysplastic Syndromes) 2006
| Arm | Type | Description |
|---|---|---|
| Onureg + Venetoclax | EXPERIMENTAL | Onureg (CC-486, oral azacitidine) will be administered orally at 200 or 300 mg once daily for 7 or 14 consecutive days, beginning on Day 1 of repeated 28-day cycles. Venetoclax will be administered orally at 400 mg once daily for 14 consecutive days on days 1 to 14, beginning on Day 1 of repeated 28-day cycles. Patients will be treated up to 4 cycles and for a maximum of 24 cycles. |
| Name | Type | Description |
|---|---|---|
| Onureg + Venetoclax | DRUG | Combination of Onureg and Venetoclax |
Inclusion Criteria: 1. Subjects must understand and voluntarily sign and date an ICF indicating the investigational nature of the study, approved by an independent EC/IRB, prior to the initiation of any screening or study-specific procedures. 2. Age ≥ 18 years at the date of signing the ICF. 3. Dia...
Onureg + Venetoclax is an investigational combination being studied for untreated myelodysplastic syndrome. It is a small molecule therapy in Phase 1 clinical development for patients with higher-risk disease who have not received prior treatment.
AbbVie Inc. (NYSE: ABBV) is developing Onureg + Venetoclax. The combination is being evaluated in a Phase 1 clinical trial for untreated myelodysplastic syndrome.
Onureg + Venetoclax is in Phase 1 clinical development. It is an investigational combination and has not been approved by the FDA. The therapy is being studied in a single active trial for untreated myelodysplastic syndrome.
Onureg + Venetoclax is being studied in NCT05782127, a Phase 1 trial titled "Oral Azacitidine Combined With Venetoclax in Previously Untreated Higher-risk Myelodysplastic Syndromes." The trial is active but not recruiting, with an enrollment of 36 participants in France.
Yes, Onureg + Venetoclax is also known as Onureg + Venetoclax. The combination refers to oral azacitidine (Onureg) plus venetoclax, as studied in the Phase 1 trial for untreated myelodysplastic syndrome.