Haematological MalignanciesPhase 1NCT04865419
Study of AZD0466 Monotherapy or in Combination in Patients With Advanced Haematological Malignancies
A Phase 1 study testing AZD0466 and Voriconazole in people with Haematological Malignancies, run by AstraZeneca at 15 sites in 6 countries.
Trial summary
The purpose of the study is to the evaluate safety, tolerability, pharmacokinetics (PK), and efficacy of AZD0466 as monotherapy in partciapants with advanced haematological malignancies and also to assess drug-drug interaction (DDI) potential between AZD0466 and the azole antifungal voriconazole. Read more about this study
- Who is it for?
- Ages 18 to 130 years
- Conditions the study is for
- Haematological Malignancies
- What is being tested?
- AZD0466 and Voriconazole
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 15 sitesin 6 countries
- Study dates
- 11 Jun 2021to 8 Aug 2023
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 130 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of acute myeloid leukaemia (AML) or acute lymphoblastic leukaemia (ALL), or intermediate or higher risk myelodysplastic syndrome (MDS; Part A only), which is histologically proven based on criteria established by the World Health Organization (WHO) as documented by medical records. for which there are limited treatment options known to provide clinical benefit.
- Eastern cooperative oncology group performance status ≤2. Performance status must not have deteriorated by ≥2 levels within 2 weeks after providing informed consent.
- Predicted life expectancy ≥8 weeks.
- Adequate organ function at screening as per the protocol defined criteria.
- Adequate cardiac function as demonstrated by LVEF > 50% on screening cardiac multigated acquisition, magnetic resonance image or echocardiogram.
- Willing and able to participate in all required study evaluations and procedures including receiving IV administration of study treatment and admission to the hospital, when required, for administration of study treatment and monitoring.
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- For inclusion in the genetic component of the study, participants must fulfil protocol defined criteria.
- White blood cell count must be <10 x 10^9/L prior to the first dose in Cycle 1, Day 1. Treatment with hydroxyurea during screening and Cycle 1 to control white blood cell count is permitted.
- Women of childbearing potential and men should use protocol defined contraceptive measures.
Who cannot join
- Unresolved toxicity from prior anticancer therapy of Common Terminology Criteria for Adverse Events Grade ≥2. Participants with Grade 2 neuropathy or Grade 2 alopecia are eligible.
- Active idiopathic thrombocytopenic purpura.
- Stem cell transplant < 100 days prior to the first dose of study treatment.
- Immunosuppression for graft versus host disease (GVHD) or GVHD prophylaxis within 4 weeks prior to the first dose of study treatment.
- Active central nervous system (CNS) leukaemia/leptomeningeal disease/spinal cord compression. Participants who have a history of CNS leukaemia must be free of CNS leukaemia for >30 days prior to the first dose of study treatment, and the most recent 2 lumbar punctures must be negative for leukaemic cells, to be eligible.
- Known uncontrolled infection with cytomegalovirus (CMV) infection (positive CMV Immunoglobulin M (IgM) and/or positive polymerase chain reaction (PCR) result).
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- Active infection including human immunodeficiency virus, Hepatitis B, Hepatitis C, or severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2).
- As judged by the Investigator: any evidence of severe or uncontrolled systemic diseases, (eg, severe hepatic impairment, interstitial lung disease [bilateral, diffuse, parenchymal lung disease]); current unstable or uncompensated respiratory or cardiac conditions; Uncontrolled hypertension; history of, or active, bleeding diatheses (eg, haemophilia or von Willebrand disease); uncontrolled active systemic fungal, bacterial, or other infection.
- Any of the given cardiac criteria: history of myocarditis within one year of study entry, or heart failure New York Heart Association Functional Classification Class 3 or 4; mean resting corrected QT interval (QTcF) ≥470 msec obtained from 3 electrocardiogram (ECGs), in the absence of a cardiac pacemaker; abnormalities in rhythm, conduction or morphology of resting ECG; any factors that increase the risk of QTc prolongation or risk of arrhythmic events such congenital long QT syndrome, family history of long QT syndrome, or unexplained sudden death under 40 years of age.
- History of another life-threatening malignancy ≤2 years prior to first dose of study treatment. The following are permitted: myelodysplastic syndrome or myeloproliferative neoplasm (including chronic myelomonocytic leukaemia [CMML]); malignancy treated with curative intent and with no evidence of active disease present for more than 2 years before screening and considered to be at low risk of recurrence by the treating physician; adequately treated lentigo malignant melanoma without current evidence of disease or adequately controlled non-melanomatous skin cancer; adequately treated carcinoma in situ without current evidence of disease.
- Any of the mentioned procedures or conditions currently or in the 6 months prior to the first dose of study treatment: coronary artery bypass graft; angioplasty; vascular stent; myocardial infarction; angina pectoris; haemorrhagic or thrombotic stroke, including transient ischaemic attacks or any other CNS bleeding.
- Treatment with any of the mentioned therapy: radiotherapy less than 3 weeks prior to first study treatment; chemotherapy within ≤14 days or 5 half-lives prior to the first dose of study treatment. Treatment with high-dose steroids for primary malignancy control is permitted but must be discontinued at least 2 days prior to the first dose of study treatment. Treatment with hydroxyurea is permitted; immunotherapies and cellular therapies within 4 weeks prior to the first dose of study treatment; investigational drugs within ≤14 days or 5 half-lives (whichever is shorter) prior to the first dose of study treatment; major surgery (excluding placement of vascular access) ≤21 days, or minor surgical procedures ≤7 days, prior to the first dose of study treatment. No waiting is required mentioned implantable port or catheter placement; prescription or non-prescription drugs or other products known to be sensitive substrates of BCRP, OCT2, OAT3, OATP1B1, OATP1B3, CYP2B6, CYP2C8, CYP2C9 or CYP2D6, or reversible moderate or strong CYP3A inhibitors, which cannot be discontinued within 5 half-lives prior to the first dose of study treatment and withheld throughout the study until 14 days after the last dose of AZD0466; moderate or strong mechanism-based inhibitors or inducers of CYP3A4 which cannot be discontinued within 5 half-lives plus of the specific drug 12 days of the drug prior to the first dose of study treatment and withheld until 14 days after the last dose of AZD0466; concurrent anti-coagulation therapy, including aspirin and heparin, which cannot be stopped; medications with known risk of Torsades de Pointes which cannot be discontinued within 5 half-lives of the first dose of study treatment and withheld until 14 days after the last dose of AZD0466; IV anti infection treatment within 14 days before first dose of study treatment.
- History of hypersensitivity to polyethylene glycol (PEG), PEGylated products or drugs with a similar chemical structure or class to AZD0466 or other BH3 mimetic.
- Module 2:
- Patients for whom treatment with voriconazole is contraindicated per the local prescribing information must not enter the study.
Trial locations and contacts
15 sites in 6 countries.
15 sites in 6 countries
United States5 sites
Research Site
Chicago, Illinois, 60611
Research Site
Columbus, Ohio, 43210
Research Site
Duarte, California, 91010
Research Site
Houston, Texas, 77030
Research Site
Jacksonville, Florida, 32224
Germany3 sites
Research Site
Aachen, 52074
Research Site
Heidelberg, 69120
Research Site
Kiel, 24105
Italy3 sites
Research Site
Bologna, 40138
Research Site
Meldola, 47014
Research Site
Rozzano, 20089
About this study
Official title: A Modular Phase I/II, Open-Label, Multi-Centre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of AZD0466 Monotherapy or in Combination in Patients With Advanced Haematological Malignancies
The purpose of the study is to the evaluate safety, tolerability, pharmacokinetics (PK), and efficacy of AZD0466 as monotherapy in partciapants with advanced haematological malignancies and also to assess drug-drug interaction (DDI) potential between AZD0466 and the azole antifungal voriconazole.
Read the detailed description
The study consists of 2 individual modules as: Module 1 (AZD0466 monotherapy), and Module 2 (DDI study of AZD0466 with voriconazole).
Eligible participants will be assigned to study treatments across Modules 1 and 2.
- Module 1: AZD0466 monotherapy will include 2 parts- Part A dose escalation cohorts and Part B dose expansion cohorts. Initiation of Part B will depend on the evaluation of safety, tolerability, and PK in Part A.
- Module 2: AZD0466 and voriconazole DDI study.
All participants will receive AZD0466, and administration will continue until disease progression, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or other reasons to discontinue study treatment.
- Conditions
- Haematological Malignancies
- Being tested
- AZD0466, Voriconazole
- Keywords
- Pharmacokinetics, AZD0466, Voriconazole, Drug-drug interaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD0466Drug
AZD0466 powder for concentrate for solution for infusion will be administered by IV infusion.
VoriconazoleDrug
Voriconazole film-coated tablet will be administered orally.
| Study group | Role | What they receive |
|---|---|---|
| Module 1: AZD0466 monotherapy | Experimental | Participants will receive intravenous infusion of AZD0466 monotherapy once weekly during Cycle 1 (35 days), Cycle 2 (28 days) and Cycle 3 (28 days) and also beyond Cycle 3 until progressive disease, unacceptable toxicity, or withdrawal of consent. Receives: Drug: AZD0466 |
| Module 2: AZD0466 + Voriconazole | Experimental | Participants may receive IV infusion of AZD0466 in combination with or without voriconazole during Cycle 1 (21 days), and Cycle 2 (28 days) and Cycle 3 (28 days) and also beyond Cycle 3 until progressive disease, unacceptable toxicity, or withdrawal of consent. Receives: Drug: AZD0466; Drug: Voriconazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [Module 1]
The safety and tolerability of AZD0466 in participants with advanced haematological malignancies were assessed.
Measured: From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years)
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [Module 2]
The safety and tolerability of AZD0466 in participants with advanced haematological malignancies were assessed.
Measured: From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years)
Number of Participants With Dose-limiting Toxicity (DLT) [Module 1]
The safety and tolerability of AZD0466 in participants with advanced haematological malignancies were assessed.
Measured: upto 35 days
Secondary outcomes (7)
Module 1: Complete Response Rate
Complete response rate (CR+CRi) is defined as the percentage of participants who have a complete remission (CR) or incomplete haematological response (CRi).
Measured: Day 1 until post treatment follow-up (28 days after last dose) (approximately 2.1 years)
Module 1: Time to Response (TTR)
Time to response is defined as the time from date of first dose until the date of first documented CR or CRi.
Measured: Day 1 until post treatment follow-up (28 days after last dose) (Approximately 2.1 years)
Module 1: Duration of Response
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.
Measured: Day 1 until post treatment follow-up (28 days after last dose) (approximately 2.1 years)
Module 1: Overall Survival
Overall survival (OS) is defined as time from date of first dose until the date of death due to any cause.
Measured: 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)
Module 2: Area Under the Plasma Concentration-curve (AUC) of AZD4320 After Administration of AZD0466 Alone and in Combination With Voriconazole
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.
Measured: 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)
Module 2: Maximum Observed Plasma (Peak) Drug Concentration (Cmax) of AZD4320 After Administration of AZD0466 Alone and in Combination With Voriconazole
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.
Measured: 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)
Module 1 and Module 2: Plasma Concentration of AZD4320
Assessment of AZD4320 to characterise the PK profile of AZD0466 following intravenous administration (via PK profiles of the active moiety AZD4320 in plasma).
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2021
- Study start11 Jun 2021
- Primary completion8 Aug 2023
- Study completion8 Aug 2023
Why it stopped: Trial terminated based on benefit-risk profile assessment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Haematological MalignanciesStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nitin Jain, MD, PhD, Principal investigator, The University of Texas MD Anderson Cancer Center 1515 Holcombe Boulevard, Unit 431 Houston, Texas 77030 United States of America
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04865419
- Sponsor's protocol ID
- D8241C00001
- Other IDs
- 2020-005106-25
- Status last verified
- May 2025
- First submitted
- 26 Apr 2021
- Last updated
- 15 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com /ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Modular Phase I/II, Open-Label, Multi-Centre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of AZD0466 Monotherapy or in Combination in Patients With Advanced Haematological Malignancies
- ClinicalTrials.gov ID
- NCT04865419
- Acronym / sponsor ID
- D8241C00001
- Conditions
- Haematological Malignancies
- Keywords
- Pharmacokinetics, AZD0466, Voriconazole, Drug-drug interaction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Trial terminated based on benefit-risk profile assessment
- Enrolment
- 46 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 11 Jun 2021 (actual)
- Primary completion
- 8 Aug 2023 (actual)
- Study completion
- 8 Aug 2023 (actual)
- First posted
- 29 Apr 2021 (actual)
- Results
- Posted 15 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to the evaluate safety, tolerability, pharmacokinetics (PK), and efficacy of AZD0466 as monotherapy in partciapants with advanced haematological malignancies and also to assess drug-drug interaction (DDI) potential between AZD0466 and the azole antifungal voriconazole.
Detailed description
The study consists of 2 individual modules as: Module 1 (AZD0466 monotherapy), and Module 2 (DDI study of AZD0466 with voriconazole).
Eligible participants will be assigned to study treatments across Modules 1 and 2.
- Module 1: AZD0466 monotherapy will include 2 parts- Part A dose escalation cohorts and Part B dose expansion cohorts. Initiation of Part B will depend on the evaluation of safety, tolerability, and PK in Part A.
- Module 2: AZD0466 and voriconazole DDI study.
All participants will receive AZD0466, and administration will continue until disease progression, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or other reasons to discontinue study treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Module 1: AZD0466 monotherapy | Experimental | Drug: AZD0466Participants will receive intravenous infusion of AZD0466 monotherapy once weekly during Cycle 1 (35 days), Cycle 2 (28 days) and Cycle 3 (28 days) and also beyond Cycle 3 until progressive disease, unacceptable toxicity, or withdrawal of consent. |
| Module 2: AZD0466 + Voriconazole | Experimental | Drug: AZD0466, Drug: VoriconazoleParticipants may receive IV infusion of AZD0466 in combination with or without voriconazole during Cycle 1 (21 days), and Cycle 2 (28 days) and Cycle 3 (28 days) and also beyond Cycle 3 until progressive disease, unacceptable toxicity, or withdrawal of consent. |
Who may qualify
- Ages
- 18 to 130 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Diagnosis of acute myeloid leukaemia (AML) or acute lymphoblastic leukaemia (ALL), or intermediate or higher risk myelodysplastic syndrome (MDS; Part A only), which is histologically proven based on criteria established by the World Health Organization (WHO) as documented by medical records. for which there are limited treatment options known to provide clinical benefit.
- Eastern cooperative oncology group performance status ≤2. Performance status must not have deteriorated by ≥2 levels within 2 weeks after providing informed consent.
- Predicted life expectancy ≥8 weeks.
- Adequate organ function at screening as per the protocol defined criteria.
- Adequate cardiac function as demonstrated by LVEF > 50% on screening cardiac multigated acquisition, magnetic resonance image or echocardiogram.
Key exclusion criteria (15 listed)
- Unresolved toxicity from prior anticancer therapy of Common Terminology Criteria for Adverse Events Grade ≥2. Participants with Grade 2 neuropathy or Grade 2 alopecia are eligible.
- Active idiopathic thrombocytopenic purpura.
- Stem cell transplant < 100 days prior to the first dose of study treatment.
- Immunosuppression for graft versus host disease (GVHD) or GVHD prophylaxis within 4 weeks prior to the first dose of study treatment.
- Active central nervous system (CNS) leukaemia/leptomeningeal disease/spinal cord compression. Participants who have a history of CNS leukaemia must be free of CNS leukaemia for >30 days prior to the first dose of study treatment, and the most recent 2 lumbar punctures must be negative for leukaemic cells, to be eligible.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AZD0466AZD0466 powder for concentrate for solution for infusion will be administered by IV infusion. | Drug | Module 1: AZD0466 monotherapy, Module 2: AZD0466 + Voriconazole |
| VoriconazoleVoriconazole film-coated tablet will be administered orally. | Drug | Module 2: AZD0466 + Voriconazole |
Primary outcome
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [Module 1]
Time frame: 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.
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [Module 2]
Time frame: 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.
Number of Participants With Dose-limiting Toxicity (DLT) [Module 1]
Time frame: upto 35 days
The safety and tolerability of AZD0466 in participants with advanced haematological malignancies were assessed.
7 secondary outcomes
Module 1: Complete Response Rate
Time frame: Day 1 until post treatment follow-up (28 days after last dose) (approximately 2.1 years)
Module 1: Time to Response (TTR)
Time frame: Day 1 until post treatment follow-up (28 days after last dose) (Approximately 2.1 years)
Module 1: Duration of Response
Time frame: Day 1 until post treatment follow-up (28 days after last dose) (approximately 2.1 years)
Module 1: Overall Survival
Time frame: 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)
Module 2: Area Under the Plasma Concentration-curve (AUC) of AZD4320 After Administration of AZD0466 Alone and in Combination With Voriconazole
Time frame: 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)
Module 2: Maximum Observed Plasma (Peak) Drug Concentration (Cmax) of AZD4320 After Administration of AZD0466 Alone and in Combination With Voriconazole
Time frame: 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)
Module 1 and Module 2: Plasma Concentration of AZD4320
Time frame: 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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Redacted CSPLink provided by the sponsor.
- Redacted SAPLink provided by the sponsor.
- Redacted CSR synopsisLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com /ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nitin Jain, MD, PhD principal investigator
The University of Texas MD Anderson Cancer Center 1515 Holcombe Boulevard, Unit 431 Houston, Texas 77030 United States of America
15 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AZD0466 and Voriconazole in people with Haematological Malignancies, run by AstraZeneca at 15 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States, Germany, Italy, Australia, France and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [Module 1] (time frame: From screening (Day -28 to Day 1) up to 28 days after last dose (Approximately 2.1 years)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2025.