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Anti-cancer agent

AZD0466 for Blood Cancers

Phase 1 & 2
Waitlist Available
Led By Dr. Marina Konopleva, MD, PhD
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up module 1: cycle 1 days 1-30 (cycle length 21 days) to cycle 3 days 1-28, and 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 and beyond (cycle length 28-days) (up to 3.5 years)
Awards & highlights

Study Summary

This trial will study the effects of the drug AZD0466 on patients with advanced blood cancers. The study will also look at how well the drug works when combined with the antifungal drug voriconazole.

Eligible Conditions
  • Blood Cancers

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~module 1: cycle 1 days 1-30 (cycle length 21 days) to cycle 3 days 1-28, and 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 and beyond (cycle length 28-days) (up to 3.5 years)
This trial's timeline: 3 weeks for screening, Varies for treatment, and module 1: cycle 1 days 1-30 (cycle length 21 days) to cycle 3 days 1-28, and 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 and beyond (cycle length 28-days) (up to 3.5 years) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants with Dose-limiting toxicity (DLT) [Module 1]
Number of participants with adverse events (AEs) and serious adverse events (SAEs) [Module 1]
Number of participants with adverse events (AEs) and serious adverse events (SAEs) [Module 2]
Secondary outcome measures
Module 1 and Module 2: Plasma concentration of AZD4320
Module 1: Complete Response Rate (CR+CRi)
Module 1: Duration of Response (DoR)
+4 more

Side effects data

From 2019 Phase 3 trial • 585 Patients • NCT01782131
27%
Hypokalaemia
26%
Pyrexia
23%
Nausea
18%
Diarrhoea
18%
Vomiting
14%
Alanine aminotransferase increased
13%
Aspartate aminotransferase increased
12%
Headache
11%
Oedema peripheral
11%
Epistaxis
11%
Constipation
10%
Hypertension
10%
Hypomagnesaemia
10%
Cough
9%
Decreased appetite
9%
Abdominal pain
9%
Dyspnoea
8%
Pneumonia
8%
Anaemia
8%
Thrombocytopenia
8%
Hypophosphataemia
8%
Febrile neutropenia
8%
Blood bilirubin increased
7%
Fatigue
7%
Pain in extremity
7%
Rash
7%
Dizziness
7%
Blood alkaline phosphatase increased
6%
Chest pain
6%
Arthralgia
6%
Insomnia
6%
Hypotension
6%
Septic shock
5%
Platelet count decreased
5%
Hypocalcaemia
5%
Cytomegalovirus infection
5%
Chills
5%
Blood lactate dehydrogenase increased
5%
Gamma-glutamyltransferase increased
4%
Tachycardia
4%
Hyponatraemia
3%
Sepsis
3%
Respiratory failure
3%
Acute kidney injury
3%
Confusional state
2%
Bronchopulmonary aspergillosis
2%
Bacteraemia
2%
Acute myeloid leukaemia
1%
Acute lymphocytic leukaemia
1%
Death
1%
Colitis
1%
Graft versus host disease in gastrointestinal tract
1%
Lymphoma
1%
Plasma cell myeloma
1%
Acute respiratory distress syndrome
1%
Hypoxia
1%
Atrial fibrillation
1%
Pulmonary embolism
1%
Neutropenia
1%
Cardiac failure
1%
Neutropenic colitis
1%
Hepatic function abnormal
1%
Hyperbilirubinaemia
1%
Clostridium difficile infection
1%
Escherichia bacteraemia
1%
Febrile infection
1%
Influenza
1%
Pneumonia cytomegaloviral
1%
Pseudomembranous colitis
1%
Systemic candida
1%
Urinary tract infection
1%
Hyperkalaemia
1%
Acute lymphocytic leukaemia recurrent
1%
Acute myeloid leukaemia recurrent
1%
Cerebral haemorrhage
1%
Encephalopathy
1%
Syncope
1%
Hallucination
1%
Haemoptysis
1%
Pneumonia aspiration
1%
Pneumothorax
1%
Pulmonary alveolar haemorrhage
1%
Bone marrow failure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Posaconazole
Voriconazole

Trial Design

2Treatment groups
Experimental Treatment
Group I: Module 2: AZD0466 + VoriconazoleExperimental Treatment2 Interventions
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.
Group II: Module 1: AZD0466 monotherapyExperimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Voriconazole
2008
Completed Phase 4
~5740

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,259 Previous Clinical Trials
288,593,856 Total Patients Enrolled
1 Trials studying Blood Cancers
32 Patients Enrolled for Blood Cancers
Dr. Marina Konopleva, MD, PhDPrincipal InvestigatorThe University of Texas MD Anderson Cancer Center 1515 Holcombe Boulevard, Unit 428 Houston, Texas 77030 United States of America
Nitin Jain, MD, PhDPrincipal InvestigatorThe University of Texas MD Anderson Cancer Center 1515 Holcombe Boulevard, Unit 431 Houston, Texas 77030 United States of America

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the age cutoff for this clinical trial lower than 35 years old?

"Applicants to this clinical trial are expected to be between the age of majority and 130 years old."

Answered by AI

Are there any past experiments involving AZD0466 that are noteworthy?

"Currently, there are 5 active studies of AZD0466 with 3 in Phase 3. Trials for this medication take place at 43 sites across Leuven and Zuid Holland."

Answered by AI

What maladies are typically treated with AZD0466?

"scedosporium infection is often managed with AZD0466. It has also proved to be beneficial for treating candidiasis, fungal infections such as Candida, and debridement in some cases."

Answered by AI

What are the chief aims of this experiment?

"According to the materials supplied by AstraZeneca, this study is primarily focused on quantifying adverse events and serious AEs over a 35 day interval. Additionally, they aim to characterize the Plasma concentration of AZD4320 as well as measure Time to Response (TTR) and Duration of Response (DoR)."

Answered by AI

Are there a multitude of centers conducting this research in Canada?

"This medical trial is currently seeking participants from 14 different clinics. The cities range from Duarte, Tampa and Milwaukee to many other locations. To minimize any potential travel disturbances, it could be beneficial to pick the closest clinic if one chooses to partake in this study."

Answered by AI

What is the enrollment for this research endeavor?

"Affirmative. As per the clinicaltrials.gov listing, this medical trial is currently seeking participants. It was first published on June 11th 2021 and most recently edited on September 7th 2022; 141 individuals must be enrolled at 14 distinct sites for the research to continue."

Answered by AI

Who is eligible to participate in this investigation?

"To be considered for this medical trial, individuals should possess hematologic neoplasms and must fall between 18 to 130 years of age. Approximately 141 participants are being sought out in total."

Answered by AI

Is recruitment still ongoing for this research endeavor?

"Affirmative. Clinicaltrials.gov provides evidence that this experiment, which was initially published on June 11th 2021, is actively seeking participants. 141 individuals are necessary to be enrolled from 14 distinct locations."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Study of AZD0466 Monotherapy or in Combination in Patients With Advanced Haematological Malignancies
2021. "Study of AZD0466 Monotherapy or in Combination in Patients With Advanced Haematological Malignancies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04865419.
~12 spots leftby Apr 2025
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