Trial · NCT04865419
Study of AZD0466 Monotherapy or in Combination in Patients With Advanced Haematological Malignancies
NCT04865419, Phase 1, Terminated, AstraZeneca; results first posted 2025-06-15
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of AZD0466 Monotherapy or in Combination in Patients With Advanced Haematological Malignancies. Trials, record NCT04865419. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04865419
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of AZD0466 Monotherapy or in Combination in Patients With Advanced Haematological Malignancies
- NCT number
- NCT04865419
- Status
- Terminated
- Phases
- Phase 1
- Enrollment
- 46 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- Haematological Malignancies
- Interventions
- AZD0466, Voriconazole
- First posted
- 2021-04-29
- Last updated
- 2025-06-15
- Other registries' IDs
- eudract:2020-005106-25
- Results first posted
- 2025-06-15
- Limitations and caveats
- Trial terminated based on benefit-risk profile assessment. Due to early termination of the study, Module 1 Part A and Module 2 were conducted, Module 1 Part B was not started.
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [Module 1] | From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years) | The safety and tolerability of AZD0466 in participants with advanced haematological malignancies were assessed. |
| Primary | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [Module 2] | From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years) | The safety and tolerability of AZD0466 in participants with advanced haematological malignancies were assessed. |
| Primary | Number of Participants With Dose-limiting Toxicity (DLT) [Module 1] | upto 35 days | The safety and tolerability of AZD0466 in participants with advanced haematological malignancies were assessed. |
| Secondary | Module 1: Complete Response Rate | Day 1 until post treatment follow-up (28 days after last dose) (approximately 2.1 years) | Complete response rate (CR+CRi) is defined as the percentage of participants who have a complete remission (CR) or incomplete haematological response (CRi). |
| Secondary | Module 1: Time to Response (TTR) | Day 1 until post treatment follow-up (28 days after last dose) (Approximately 2.1 years) | Time to response is defined as the time from date of first dose until the date of first documented CR or CRi. |
| Secondary | Module 1: Duration of Response | Day 1 until post treatment follow-up (28 days after last dose) (approximately 2.1 years) | Duration of Response (DoR) will be defined as the time from the date of first documented response (CR+CRi) until date of documented progression, relapse or failure or death due to any cause. |
| Secondary | Module 1: Overall Survival | Day 1 until post treatment follow-up (28 days after last dose) and survival follow-up (every month after last dose) (approximately 2.1 years) | Overall survival (OS) is defined as time from date of first dose until the date of death due to any cause. |
| Secondary | Module 2: Area Under the Plasma Concentration-curve (AUC) of AZD4320 After Administration of AZD0466 Alone and in Combination With Voriconazole | Cycle 1 Days 1, 2, 3, 4, 8 and days 15, 16, 17, 18, 19, and Cycle 2 Day 1, Cycle 3 Day 1 and beyond (Cycle length 28-days) (approximately 2.1 years) | Assessment of AUC to evaluate the drug-drug interaction potential between AZD0466 and the azole antifungal voriconazole. For this outcome measure, pharmacokinetics (PK) analysis set was included which consisted of all dosed participants with reportable plasma concentrations and no important AEs or protocol deviations that may affect PK. |
| Secondary | Module 2: Maximum Observed Plasma (Peak) Drug Concentration (Cmax) of AZD4320 After Administration of AZD0466 Alone and in Combination With Voriconazole | Cycle 1: Days 1, 2, 3, 4, 8 and days 15, 16, 17, 18, 19, and Cycle 2 Day 1, Cycle 3 Day 1 and beyond (Cycle length 28-days) (approximately 2.1 years) | Assessment of Cmax to evaluate the drug-drug interaction potential between AZD0466 and the azole antifungal voriconazole. For this outcome measure, PK analysis set was included which consisted of all dosed participants with reportable plasma concentrations and no important AEs or protocol deviations that may affect PK. |
| Secondary | Module 1 and Module 2: Plasma Concentration of AZD4320 | Module 1: Cycle 1 Days 1-30 (Cycle length 21 days) to Cycle 3 Days 1-28, & beyond (Cycle length 28 days); Module 2: Cycle 1 Days 1-8, Days 15-19 (Cycle length 21 days), Cycle 2 Day 1, Cycle 3 Day 1 & beyond (Cycle length 28-days) (approximately 2.1 Years) | Assessment of AZD4320 to characterise the PK profile of AZD0466 following intravenous administration (via PK profiles of the active moiety AZD4320 in plasma). |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [Module 1] | From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years) | Safety analysis set consisted of all enrolled participants who received at least 1 dose of AZD0466. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [Module 2] | From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years) | Safety analysis set consisted of all enrolled participants who received at least 1 dose of AZD0466. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Dose-limiting Toxicity (DLT) [Module 1] | upto 35 days | DLT-evaluable set consisted of participants enrolled in the dose-escalation that have received at least 3 doses of AZD0466 at the target dose level (75% of target doses from Day 8 to Day 29 in Cycle 1) and have completed the safety follow-up through the DLT evaluation period or have experienced a DLT. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Module 1: Complete Response Rate | Day 1 until post treatment follow-up (28 days after last dose) (approximately 2.1 years) | Intention to treat (ITT) set consisted of all enrolled participants who received at least 1 dose of AZD0466. | Percentage of participants | NUMBER |
| SECONDARY | Module 1: Time to Response (TTR) | Day 1 until post treatment follow-up (28 days after last dose) (Approximately 2.1 years) | ITT set consisted of all enrolled participants who received at least 1 dose of AZD0466.~Since none of the participants had achieved CR or CRi, TTR could not be calculated. | ||
| SECONDARY | Module 1: Duration of Response | Day 1 until post treatment follow-up (28 days after last dose) (approximately 2.1 years) | ITT set consisted of all enrolled participants who received at least 1 dose of AZD0466.~Since none of the participants had achieved CR or CRi, DoR could not be calculated. | ||
| SECONDARY | Module 1: Overall Survival | Day 1 until post treatment follow-up (28 days after last dose) and survival follow-up (every month after last dose) (approximately 2.1 years) | ITT set consisted of all enrolled participants who received at least 1 dose of AZD0466. | Months | MEDIAN |
| SECONDARY | Module 2: Area Under the Plasma Concentration-curve (AUC) of AZD4320 After Administration of AZD0466 Alone and in Combination With Voriconazole | Cycle 1 Days 1, 2, 3, 4, 8 and days 15, 16, 17, 18, 19, and Cycle 2 Day 1, Cycle 3 Day 1 and beyond (Cycle length 28-days) (approximately 2.1 years) | It was pre-specified by the Study Protocol to only analyze dosed participants with at least 1 reportable plasma concentration and no important AEs or protocol deviations that may impact PK for this Outcome Measure.~Due to changes in target dose levels and protocol deviations affecting derivation of PK parameters, AUC could not be statistically assessed (summary statistics or inferential statistical comparisons), as no participant met pre-specified criteria for analysis. | hours*nanomole/liter (h*nmol/L) | GEOMETRIC_MEAN |
| SECONDARY | Module 2: Maximum Observed Plasma (Peak) Drug Concentration (Cmax) of AZD4320 After Administration of AZD0466 Alone and in Combination With Voriconazole | Cycle 1: Days 1, 2, 3, 4, 8 and days 15, 16, 17, 18, 19, and Cycle 2 Day 1, Cycle 3 Day 1 and beyond (Cycle length 28-days) (approximately 2.1 years) | It was pre-specified by the Study Protocol to only analyze dosed participants with at least 1 reportable plasma concentration and no important AEs or protocol deviations that may impact PK for this Outcome Measure.~Due to changes in target dose levels and protocol deviations affecting derivation of PK parameters, Cmax could not be statistically assessed (summary statistics or inferential statistical comparisons), as no participant met pre-specified criteria for analysis. | nanomole (nmol)/liter (L) | GEOMETRIC_MEAN |
| SECONDARY | Module 1 and Module 2: Plasma Concentration of AZD4320 | Module 1: Cycle 1 Days 1-30 (Cycle length 21 days) to Cycle 3 Days 1-28, & beyond (Cycle length 28 days); Module 2: Cycle 1 Days 1-8, Days 15-19 (Cycle length 21 days), Cycle 2 Day 1, Cycle 3 Day 1 & beyond (Cycle length 28-days) (approximately 2.1 Years) | PK set consisted of all dosed participants with reportable plasma concentrations and no important AEs or protocol deviations that may affect PK.~For PK concentration and parameter data, if there were \<3 values available at a time point or if the value was below the lower limit of quantification (BLQ), descriptive statistics were reported as 'Not calculable (NC)' or 'Not Available (NA)'. | nanomolar (nM) | GEOMETRIC_MEAN |
Source ClinicalTrials.gov
Results by group196
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [Module 1] | Module 1: AZD0466 Monotherapy- 300 mg | Any AE | 4 | Participants | |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [Module 1] | Module 1: AZD0466 Monotherapy- 600 mg | Any AE | 4 | Participants | |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [Module 1] | Module 1: AZD0466 Monotherapy- 1200 mg | Any AE | 6 | Participants | |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [Module 1] | Module 1: AZD0466 Monotherapy- 2400 mg | Any AE | 5 | Participants | |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [Module 1] | Module 1: AZD0466 Monotherapy- 3600 mg | Any AE | 9 | Participants | |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [Module 1] | Module 1: AZD0466 Monotherapy- 5400 mg | Any AE | 2 | Participants | |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [Module 1] | Module 1: AZD0466 Monotherapy- 300 mg | Any SAE | 4 | Participants | |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [Module 1] | Module 1: AZD0466 Monotherapy- 600 mg | Any SAE | 0 | Participants | |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [Module 1] | Module 1: AZD0466 Monotherapy- 1200 mg | Any SAE | 3 | Participants | |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [Module 1] | Module 1: AZD0466 Monotherapy- 2400 mg | Any SAE | 3 | Participants |
1 to 10 of 196Source ClinicalTrials.gov
See all 196 results by groupParticipant flow33
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Module 1: AZD0466 Monotherapy- 300 mg | 4 | |
| Overall Study | STARTED | Module 1: AZD0466 Monotherapy- 600 mg | 4 | |
| Overall Study | STARTED | Module 1: AZD0466 Monotherapy- 1200 mg | 7 | |
| Overall Study | STARTED | Module 1: AZD0466 Monotherapy- 2400 mg | 5 | |
| Overall Study | STARTED | Module 1: AZD0466 Monotherapy- 3600 mg | 10 | |
| Overall Study | STARTED | Module 1: AZD0466 Monotherapy- 5400 mg | 2 | |
| Overall Study | STARTED | Module 2: AZD0466 300 mg+ Voriconazole | 1 | |
| Overall Study | STARTED | Module 2: AZD0466 600 mg+ Voriconazole | 3 | |
| Overall Study | STARTED | Module 2: AZD0466 1200 mg+ Voriconazole | 4 | |
| Overall Study | STARTED | Module 2: AZD0466 2400 mg+ Voriconazole | 4 |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 participant flowAdverse events2,475
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Bacteraemia | Infections and infestations | Module 1: AZD0466 Monotherapy- 300 mg | 0 | 4 | |
| other | Bacteraemia | Infections and infestations | Module 1: AZD0466 Monotherapy- 600 mg | 0 | 4 | |
| other | Bacteraemia | Infections and infestations | Module 1: AZD0466 Monotherapy- 1200 mg | 1 | 7 | |
| other | Bacteraemia | Infections and infestations | Module 1: AZD0466 Monotherapy- 2400 mg | 0 | 5 | |
| other | Bacteraemia | Infections and infestations | Module 1: AZD0466 Monotherapy- 3600 mg | 0 | 10 | |
| other | Bacteraemia | Infections and infestations | Module 1: AZD0466 Monotherapy- 5400 mg | 0 | 2 | |
| other | Bacteraemia | Infections and infestations | Module 2: AZD0466 300 mg+ Voriconazole | 0 | 1 | |
| other | Bacteraemia | Infections and infestations | Module 2: AZD0466 600 mg+ Voriconazole | 1 | 3 | |
| other | Bacteraemia | Infections and infestations | Module 2: AZD0466 1200 mg+ Voriconazole | 0 | 4 | |
| other | Bacteraemia | Infections and infestations | Module 2: AZD0466 2400 mg+ Voriconazole | 0 | 4 |
1 to 10 of 2,475Source ClinicalTrials.gov
See all 2,475 adverse eventsAdverse event totals33
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Module 1: AZD0466 Monotherapy- 300 mg | 3 | 4 |
| Total, all-cause mortality | Module 1: AZD0466 Monotherapy- 600 mg | 1 | 4 |
| Total, all-cause mortality | Module 1: AZD0466 Monotherapy- 1200 mg | 4 | 7 |
| Total, all-cause mortality | Module 1: AZD0466 Monotherapy- 2400 mg | 2 | 5 |
| Total, all-cause mortality | Module 1: AZD0466 Monotherapy- 3600 mg | 5 | 10 |
| Total, all-cause mortality | Module 1: AZD0466 Monotherapy- 5400 mg | 2 | 2 |
| Total, all-cause mortality | Module 2: AZD0466 300 mg+ Voriconazole | 1 | 1 |
| Total, all-cause mortality | Module 2: AZD0466 600 mg+ Voriconazole | 1 | 3 |
| Total, all-cause mortality | Module 2: AZD0466 1200 mg+ Voriconazole | 2 | 4 |
| Total, all-cause mortality | Module 2: AZD0466 2400 mg+ Voriconazole | 2 | 4 |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04865419
GET https://conductscience.org/api/trials/v1/NCT04865419/results?page=2