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This is a modular, multicentre, open-label, Phase I/II, dose-setting study. AZD9829 will be administered intravenously as monotherapy or in combination in participants with CD123 positive hematological malignancies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Module 1: Dose Escalation | Experimental | Ascending dose level cohorts of AZD9829 in AML and MDS participants. |
|
| Module 1: Dose Optimization | Experimental | Characterizing the safety, tolerability, PK/PD, and preliminary antitumor activity of AZD9829 in CD123+ R/R AML participants, based on the data collected during dose escalation, dose optimization and backfill. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD9829 | Drug | AZD9829 will be administered by IV infusion |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of dose limiting toxicities (DLTs). | DLTs are dose-limiting toxicities as defined in the study protocol. | Module 1 - 28 days. |
| Safety evaluation of AZD9829: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | Frequency, severity and relationship to study drug of AEs and SAEs | Module 1 - From informed consent until 60 days after last dose of AZD9829. |
| Identify RP2D in R/R AML patients. | Incidence of AEs/SAEs and PK data | Moldule 1 -From informed consent until 60 days after last dose of AZD9829. |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics of AZD9829: Plasma Concentration of total antibody | Measurement of plasma concentration of conjugated and unconjugated antibody | Module 1 - From date of first dose of AZD9829 up until 30 days post last dose. |
| Pharmacokinetics of AZD9829: Plasma Concentration of total unconjugated warhead |
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Inclusion Criteria:
≥18 years of age;
CD123+ hematologic malignancy based on flow cytometry or immunohistochemistry by local laboratory;
Had at least 1 prior line of therapy at currents histology, and have no available treatment options;
ECOG performance status of ≤ 2.
The above is a summary, other inclusion criteria details may apply.
Exclusion Criteria:
The above is a summary, other exclusion criteria details may apply .
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Duarte | California | 91010 | United States | ||
| Research Site |
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request 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.
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
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| AZD9829 |
| Drug |
AZD9829 will be administered by IV infusion |
|
Measurement of plasma concentration of total unconjugated warhead |
| Module 1 - From date of first dose of AZD9829 up until 30 days post last dose. |
| Pharmacokinetics of AZD9829: Area under the concentration time curve (AUC). | Area under the plasma concentration-time curve. | Module 1 - From date of first dose of AZD9829up until 30 days post last dose. |
| Pharmacokinetics of AZD9829: Maximum plasma concentration of the study drug (Cmax). | Maximum observed plasma concentration of AZD9829. | Module 1 - From date of first dose of AZD9829 up until 30 days post last dose. |
| Pharmacokinetics of AZD9829: Time to maximum concentration (tmax) | Time to maximum observed plasma concentration of the study drug. | Module 1 - From date of first dose of AZD9829 up until 30 days post last dose. |
| Pharmacokinetics of AZD9829: Clearance | The volume of plasma from which the study drug is completely removed per unit time. | Module 1 - From date of first dose of AZD9829 up until 30 days post last dose. |
| Pharmacokinetics of AZD9829: Half-life (t 1/2) | Terminal elimination half-life. | Module 1 - From date of first dose of AZD9829 up until 30 days post last dose. |
| Pharmacokinetics of AZD9829: Anti-Drug Antibodies (ADA) | Evaluating the number of patients who develop anti-drug antibodies (ADA) during treatment. | Module 1 - From date of first dose of AZD9829 up until 30 days post last dose. |
| Pharmacokinetics of AZD9829: Anti-Drug Antibodies (ADA) | Evaluating the percentage of patients who develop anti-drug antibodies (ADA) during treatment. | Module 1 - From date of first dose of AZD9829 up until 30 days post last dose. |
| To determine the immunogenicity of AZD9829. | The number of participants who develop ADA (Anti Drug Antibodies). | Module 1 - From first dose to the 30-Day SFU visit |
| To determine the immunogenicity of AZD9829. | The percentage of participants who develop ADA (Anti Drug Antibodies). | Module 1 - From first dose to the 30-Day SFU visit |
| Overall Response Rate (ORR) | Overall response rate disease assessments in accordance with ELN2022 recommendations for AML and IWG 2006/2018 for MDS. | Module 1 - From first dose of AZD9829 until disease progression or end of the study (upto approximately 1 year) |
| Composite Complete Response Rate (CCRR) | Composite CR rate disease assessment in accordance with ELN2022 for AML and IWG 2006/2018 for MDS. | Module 1 - From first dose of AZD9829 up to approximately 1 year. |
| Complete remission with incomplete hematologic recovery (CRi) | The endpoint of complete remission with CRi as defined by ELN2022 criteria. | Module 1 - From first dose of AZD9829 up to approximately 1 year. |
| Complete Response (CR) | Complete response (CR) according to ELN2022 for AML and IWG 2006/2018 for MDS. | Module 1 - From first dose of AZD9829 up to approximately 1 year. |
| Duration of Response (DoR) | Time from first documented response until the date of relapse or death. | Module 1 -Time from first documented response until disease progression or death (approximately 1 year). |
| Time to Response (TTR) | Time from first dose to the achievement of first overall response. Disease assessments will follow ELN2022 for AML and IWG 2006/2018 for MDS. | Module 1 - From first dose of AZD9829 until complete remission, disease progression or death (approximately 1 year). |
| Time to Next Treatment (TTNT) | The time from the start of treatment date until the date of subsequent antileukemia therapy. | Module 1 - From first dose of AZD9829 until the date of subsequent anti-leukemia-therapy or death (approximately 1 year). |
| Progression-free Survival (PFS) | The time from the start of treatment date until the date of disease progression or death. | Module 1 - From first dose of AZD9829 until disease progression or death (approximately 1 year). |
| Overall Survival (OS) | The time from the start of treatment date until death. | Module 1 - From first dose of AZD9829 until death (approximately 1 year). |
| Event-free Survival (EFS) | The time from the start of treatment date to disease progression, death, or initiation of a new anti-leukemic therapy. | Module 1 - From first dose of AZD9829 until disease progression, death, or initiation of a new anti-leukemic therapy (approximately 1 year). |
| St Louis |
| Missouri |
| 63110 |
| United States |
| Research Site | New York | New York | 10021 | United States |
| Research Site | Chapel Hill | North Carolina | 27514 | United States |
| Research Site | Columbus | Ohio | 43210 | United States |
| Research Site | Houston | Texas | 77030 | United States |
| Research Site | Milwaukee | Wisconsin | 53226 | United States |
| Research Site | Heidelberg | 3084 | Australia |
| Research Site | Melbourne | VIC 3000 | Australia |
| Research Site | Tianjin | 300020 | China |
| Research Site | Frankfurt | 60590 | Germany |
| Research Site | Bologna | 40138 | Italy |
| Research Site | Kashiwa | 227-8577 | Japan |
| Research Site | Osaka | 545-8586 | Japan |
| Research Site | Yoshida-gun | 910-1193 | Japan |
| Research Site | Seoul | 03080 | South Korea |
| Research Site | Seoul | 05505 | South Korea |
| Research Site | Barcelona | 08035 | Spain |
| Research Site | Salamanca | 37007 | Spain |
| Research Site | Tainan | 704 | Taiwan |
| Research Site | Taipei | 10002 | Taiwan |
| Research Site | Manchester | M204BX | United Kingdom |
| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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