Study: NCT03217838

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: AZD2811
Description: AZD2811 will be administered by IV infusion with the specified dose level as reported in arms in 28-day cycles.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: AZD2811
Description: AZD2811 will be administered by IV infusion with the specified dose level as reported in arms in 28-day cycles.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: AZD2811
Description: AZD2811 will be administered by IV infusion with the specified dose level as reported in arms in 28-day cycles.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: AZD2811
Description: AZD2811 will be administered by IV infusion with the specified dose level as reported in arms in 28-day cycles.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: AZD2811
Description: AZD2811 will be administered by IV infusion with the specified dose level as reported in arms in 28-day cycles.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: AZD2811
Description: AZD2811 will be administered by IV infusion with the specified dose level as reported in arms in 28-day cycles.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: AZD2811
Description: AZD2811 will be administered by IV infusion with the specified dose level as reported in arms in 28-day cycles.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: AZD2811
Description: AZD2811 will be administered by IV infusion with the specified dose level as reported in arms in 28-day cycles.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: AZD2811
Description: AZD2811 will be administered by IV infusion with the specified dose level as reported in arms in 28-day cycles.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: AZD2811
Description: AZD2811 will be administered by IV infusion with the specified dose level as reported in arms in 28-day cycles.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: AZD2811
Description: AZD2811 will be administered by IV infusion with the specified dose level as reported in arms in 28-day cycles.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: AZD2811
Description: AZD2811 will be administered by IV infusion with the specified dose level as reported in arms in 28-day cycles.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: AZD2811
Description: AZD2811 will be administered by IV infusion with the specified dose level as reported in arms in 28-day cycles.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Azacitidine
Description: 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.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Azacitidine
Description: 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.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Azacitidine
Description: 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.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Azacitidine
Description: 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.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Venetoclax
Description: 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.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Venetoclax
Description: 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.