50
Participants
Start Date
July 31, 2017
Primary Completion Date
March 25, 2021
Study Completion Date
March 25, 2021
AZD2811
AZD2811 will be administered by IV infusion with the specified dose level as reported in arms in 28-day cycles.
Azacitidine
Azacitidine is supplied in vials of 25 mg/mL powder for suspension for injection. After reconstitution, each vial contains a maximum of 100 mg. Participants should be pre-medicated for nausea and vomiting according to institutional standards before receiving azacitidine. Participants will receive 75 mg/m² on Days 1 through 7 or for 5 consecutive weekdays with rest on the 2 weekend days, and azacitidine dosing the first 2 weekdays of the next week of each 28-day cycle.
Venetoclax
Venetoclax (VENCLEXTA®) is approved by the FDA for use in combination with azacitidine, or decitabine, or low-dose cytarabine for the treatment of newly-diagnosed AML in adults who are age 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy. Venetoclax is planned to be given at a dose of 100 mg orally (PO) on Day 1 and 200 mg (PO) on Days 2- 28 of each 28-day cycle or 100 mg orally (PO) on Day 1, 200 mg PO on Day 2, and 400 mg PO from Days 3 to 28 of each 28-day cycle. The third participant in Group 3 Arm A will only be enrolled after the first 2 participants will receive ≥2 weeks of treatment and have shown no evidence of toxicity observed to be compatible with a DLT.
Research Site, Melbourne
Research Site, Charlotte
Research Site, Sarasota
Research Site, Nashville
Research Site, Canton
Research Site, Detroit
Research Site, Milwaukee
Research Site, Oklahoma City
Research Site, Dallas
Research Site, Houston
Research Site, Denver
Lead Sponsor
AstraZeneca
INDUSTRY