Study of AZD5991 Alone or in Combination With Venetoclax in Relapsed or Refractory Haematologic Malignancies.
- Conditions
- Relapsed or Refractory Acute Myeloid Leukemia (AML)
- Interventions
- Drug: AZD5991 + Venetoclax
- Registration Number
- NCT03218683
- Lead Sponsor
- AstraZeneca
- Brief Summary
This study is a multicenter, open-label, nonrandomized, sequential group, dose-escalation study to assess safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of ascending doses of AZD5991 in subjects with relapsed or refractory hematologic malignancies Part 1 of the study is monotherapy dose escalation. Closed November 2020 Part 2 of the study is monotherapy expansion groups for relapsed/refractory chronic lymphocytic leukaemia (CLL), AML/ myelodysplastic syndromes (MDS), and multiple myeloma (MM). Closed November 2020 Part 3 is a sequential, dose-escalation study of the combination of AZD5991 and venetoclax in subjects with relapsed/refractory AML
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 70
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description AZD5991 + venetoclax AZD5991 + Venetoclax Dose escalation - multiple dose levels Monotherapy AZD5991 AZD5991 Dose escalation - multiple dose levels Monotherapy AZD5991 expansion AZD5991 Dose expansion
- Primary Outcome Measures
Name Time Method maximum tolerated dose Minimum observation period is 28 days for the maximum dose cohort Dose limiting toxicities Minimum observation period is 28 days per cohort Incidence of Adverse Events At every treatment and follow up visit until disease progression. Expected to be for up to 12 months Number of subjects with adverse events as a measure of safety and tolerability including changes in vital signs, electrocardiograms (ECGs), safety and laboratory parameters
- Secondary Outcome Measures
Name Time Method Duration of response (DOR) From time of first dose until discontinuation of AZD5991 monotherapy and AZD5991+venetoclax expected to be for up to 12 months To assess the antitumor activity of AZD5991 monotherapy and AZD5991+venetoclax. Response will be evaluated every 8-12 weeks during treatment until progression.
Maximum observed plasma concentration of AZD5991 monotherapy and AZD5991+venetoclax Predose and through 24 hours postdose To assess the pharmacokinetics of AZD5991 monotherapy and AZD5991+venetoclax
Objective response rate (ORR) From time of first dose until discontinuation of AZD5991 monotherapy and AZD5991+venetoclax expected to be for up to 12 months To assess the antitumor activity of AZD5991 monotherapy and AZD5991+venetoclax. Response will be evaluated every 8-12 weeks during treatment until progression.
Area under the concentration-time curve for plasma concentrations of AZD5991 monotherapy and AZD5991+venetoclax Predose and through 24 hours postdose To assess the pharmacokinetics of AZD5991 monotherapy and AZD5991+venetoclax
Progression-free survival (PFS) From time of first dose until first observation of progression expected to be for up to 12 months To assess the antitumor activity of AZD5991 monotherapy and AZD5991+venetoclax. Response will be evaluated every 8-12 weeks during treatment until progression.
Complete remission rate (CRR) From time of first dose until discontinuation of AZD5991 monotherapy and AZD5991+venetoclax expected to be for up to 12 months To assess the antitumor activity of AZD5991 monotherapy and AZD5991+venetoclax. Response will be evaluated every 8-12 weeks during treatment until progression.
Trial Locations
- Locations (1)
Research Site
🇺🇸Houston, Texas, United States