Safety, Tolerability, Pharmacokinetics, and Efficacy of AZD2811 Nanoparticles as Monotherapy or in Combination in Acute Myeloid Leukemia Participants.

PHASE1TerminatedINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

July 31, 2017

Primary Completion Date

March 25, 2021

Study Completion Date

March 25, 2021

Conditions
Acute Myeloid Leukaemia
Interventions
DRUG

AZD2811

AZD2811 will be administered by IV infusion with the specified dose level as reported in arms in 28-day cycles.

DRUG

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.

DRUG

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.

Trial Locations (11)

3004

Research Site, Melbourne

28204

Research Site, Charlotte

34232

Research Site, Sarasota

37203

Research Site, Nashville

44718

Research Site, Canton

48201

Research Site, Detroit

53226

Research Site, Milwaukee

73104

Research Site, Oklahoma City

75246

Research Site, Dallas

77030

Research Site, Houston

80218

Research Site, Denver

Sponsors

Lead Sponsor

All Listed Sponsors
lead

AstraZeneca

INDUSTRY