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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05140382




Registration number
NCT05140382
Ethics application status
Date submitted
17/11/2021
Date registered
1/12/2021

Titles & IDs
Public title
AZD4573 as Monotherapy or in Combinations With Anti-cancer Agents in Patients With r/r PTCL or r/r cHL
Scientific title
A Modular Phase II, Open-label, Multicentre Study to Assess AZD4573 Efficacy and Safety as Monotherapy or in Combination With Anti-cancer Agents in Patients With Relapsed/Refractory Peripheral T-cell Lymphoma or Classical Hodgkin Lymphoma
Secondary ID [1] 0 0
2021-002570-54
Secondary ID [2] 0 0
D8231C00001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Relapsed/Refractory Peripheral T-cell Lymphoma 0 0
Relapsed/Refractory Classical Hodgkins Lymphoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
Cancer 0 0 0 0
Hodgkin's

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - AZD4573

Experimental: AZD4573 (Monotherapy) - Eligible participants with either r/r PTCL, r/r NKTCL or r/r cHL will receive AZD4573 as monotherapy.


Treatment: Drugs: AZD4573
AZD4573 will be given intravenously
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Objective Response Rate (ORR)
Timepoint [1] 0 0
From Screening (Day -30 to Day-1) until disease progression or survival until death (26 months)
Secondary outcome [1] 0 0
Complete Response (CR) Rate
Timepoint [1] 0 0
From Screening (Day -30 to Day-1) until disease progression or survival until death (26 months).
Secondary outcome [2] 0 0
Duration of Response (DoR)
Timepoint [2] 0 0
From Screening (Day -30 to Day-1) until disease progression or survival until death (26 months).
Secondary outcome [3] 0 0
Progression-free Survival (PFS)
Timepoint [3] 0 0
From Screening (Day -30 to Day-1) until disease progression or survival until death (26 months).
Secondary outcome [4] 0 0
Overall Survival (OS)
Timepoint [4] 0 0
From Screening (Day -30 to Day-1) until disease progression or survival until death (26 months).
Secondary outcome [5] 0 0
Number of Participants With Adverse Events (AE) and Serious AEs (SAE)
Timepoint [5] 0 0
From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
Secondary outcome [6] 0 0
Maximum Observed Plasma (Peak) Drug Concentration (Cmax)
Timepoint [6] 0 0
Cycle 1 (Cycle length is 35 days), Day 1 of Weeks 1-3 and Cycle 2 (Cycle length is 21 Days), Day 1.
Secondary outcome [7] 0 0
Area Under the Plasma Concentration Curve From Zero to the Last Quantifiable Concentration (AUClast)
Timepoint [7] 0 0
Cycle 1 (Cycle length is 35 days), Day 1 of Weeks 1-3 and Cycle 2 (Cycle length is 21 Days), Day 1.
Secondary outcome [8] 0 0
Area Under Plasma Concentration Time Curve From Zero to Infinity (AUC0-inf) of AZD4573
Timepoint [8] 0 0
Cycle 1 (Cycle length is 35 days), Day 1 of Weeks 1-3 and Cycle 2 (Cycle length is 21 Days), Day 1.
Secondary outcome [9] 0 0
Time to Reach Peak Observed Concentration Following Drug Administration (Tmax)
Timepoint [9] 0 0
Cycle 1 (Cycle length is 35 days), Day 1 of Weeks 1-3 and Cycle 2 (Cycle length is 21 Days), Day 1.
Secondary outcome [10] 0 0
Half-life (t1/2) of AZD4573
Timepoint [10] 0 0
Cycle 1 (Cycle length is 35 days), Day 1 of Weeks 1-3 and Cycle 2 (Cycle length is 21 Days), Day 1.
Secondary outcome [11] 0 0
Systematic Clearance (CL)
Timepoint [11] 0 0
Cycle 1 (Cycle length is 35 days), Day 1 of Weeks 1-3 and Cycle 2 (Cycle length is 21 Days), Day 1.
Secondary outcome [12] 0 0
Volume of Distribution at Terminal Phase (Vz)
Timepoint [12] 0 0
Cycle 1 (Cycle length is 35 days), Day 1 of Weeks 1-3 and Cycle 2 (Cycle length is 21 Days), Day 1.
Secondary outcome [13] 0 0
Volume of Distribution at Steady State (Vss)
Timepoint [13] 0 0
Cycle 1 (Cycle length is 35 days), Day 1 of Weeks 1-3 and Cycle 2 (Cycle length is 21 Days), Day 1.

Eligibility
Key inclusion criteria
* Participants who are diagnosed with one of the following, as defined by the World Health Organisation:

* Peripheral T-cell Lymphoma
* Classical Hodgkin Lymphoma
* Eastern Cooperative Oncology Group performance status of = 2.
* Must have received at least 1 prior line of therapy for the treatment of current disease and have documented relapsed or refractory active disease requiring treatment, defined as:

* Recurrence of disease after response to prior line(s) of therapy, or
* Progressive disease after completion of or on the treatment regimen preceding entry into the study, or
* Disease which did not achieve an objective response (CR or PR).
* Uric acid level < ULN at screening. If hyperuricaemia is present at screening, SoC therapy should be administered (including IV fluid and rasburicase or allopurinol) to reduce the uric acid levels to < ULN before the start of study intervention.
* Willing and able to participate in all required evaluations and procedures in this study protocol including receiving IV administration of study drug and being admitted, if required, for at least 24 hours during study drug administration.
* Fresh tumour tissue or archival tumour tissue must be confirmed to be available at screening.
* Adequate haematologic function at screening.
* PTCL Only: All participants with PTCL must be willing and able to provide baseline bone marrow aspirate and/or biopsy no older than 3 months and agree to undergo post-treatment bone marrow biopsy when required to confirm response.

Additional Module 1 Inclusion Criteria

Prior lines of therapy:

* PTCL: Participants must have failed at least 1 prior therapy for the treatment of PTCL.

* Non NK-PTCL (Cohort 1): Prior therapy must have included an alkylating agent and/or anthracycline. In addition, ALCL participants must have received brentuximab vedotin (BV) as part of prior therapy.
* NKTCL (Cohort 2): Prior treatment must have included a platinum agent and/or asparaginase.
* cHL (Cohort 3): Participants must have failed at least 2 prior therapies for the treatment of cHL (including BV and anti-PD1) except where unable to receive BV or anti-PD1 due to neuropathy or autoimmune disease.
* Presence of at least 1 radiographically measurable, FDG-avid lymphoma disease lesion > 1.5 cm (according to the Lugano (2014) criteria [Cheson et al 2014]).
Minimum age
18 Years
Maximum age
130 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria

Type of Participant and Disease Characteristics:

* PTCL only: Presence of bulky disease (defined as largest lymphoma lesion = 10 cm) or a LDH value > 3 x ULN.
* PTCL only: Diagnosis of any of the following: Lymphoblastic/precursor T-cell lymphoma or leukaemia; T-cell prolymphocytic leukaemia; T-cell large granular lymphocytic leukaemia; Cutaneous T-cell lymphoma (eg, primary cutaneous type ALCL, mycosis fungoide/Sezary syndrome).

Medical Conditions:

* With the exception of alopecia and neuropathy, presence of any unresolved non haematological toxicities from prior therapy greater than CTCAE Grade 1 at the time of starting study treatment.
* Presence of, or history of, CNS lymphoma, leptomeningeal disease, or spinal cord compression.
* History of prior non-haematological malignancy except for the following:

* Malignancy treated with curative intent and with no evidence of active disease present for more than 1 year prior to screening and felt to be at low risk for recurrence by treating physician.
* Adequately treated lentigo maligna melanoma without current evidence of disease or adequately controlled non-melanomatous skin cancer.
* Adequately treated carcinoma in situ without current evidence of disease.
* Any evidence of:

* Severe or uncontrolled systemic disease (eg, severe hepatic impairment, interstitial lung disease [bilateral, diffuse, parenchymal lung disease]).
* Current unstable or uncompensated respiratory or cardiac conditions.
* Uncontrolled hypertension.
* Uncontrolled active systemic fungal, bacterial, viral, or other infection (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment).
* IV anti-infective treatment within 1 week before first dose of study drug.
* Known history of infection with HIV.
* Serologic status reflecting active hepatitis B or C infection:

* Participants who are hepatitis B core antibody (anti-HBc) positive and who are surface antigen negative will need to have a negative PCR result before enrolment. Those who are hepatitis B surface antigen positive or hepatitis B PCR-positive will be excluded.
* Participants who are hepatitis C antibody positive will need to have a negative PCR result before enrolment. Those who are hepatitis C PCR-positive will be excluded.
* Any of the following cardiac criteria:

* Resting QT interval corrected using Fridericia's formula (QTcF) = 470 msec obtained from a single ECG.
* Any clinically important abnormalities in rhythm (except for participants with a pacemaker in place), conduction or morphology of resting ECG (e.g., complete left bundle branch block, third degree heart block).
* Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age.
* Documented confirmation and ongoing treatment of adrenal gland insufficiency or pancreatitis.
* Undergone any of the following procedures or experienced any of the following conditions within 6 months prior to first dose:

* Coronary artery bypass graft
* Angioplasty
* Vascular stent
* Myocardial infarction
* Angina pectoris
* CHF (New York Heart Association Class = 2)
* Ventricular arrhythmias requiring continuous therapy
* Atrial fibrillation, which is judged as uncontrolled by the treating physician
* Haemorrhagic or thrombotic stroke, including transient ischemic attacks or any other CNS bleeding

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/12/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
16/02/2024
Sample size
Target
Accrual to date
Final
52
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Clayton
Recruitment hospital [2] 0 0
Research Site - Melbourne
Recruitment hospital [3] 0 0
Research Site - Nedlands
Recruitment postcode(s) [1] 0 0
3168 - Clayton
Recruitment postcode(s) [2] 0 0
3000 - Melbourne
Recruitment postcode(s) [3] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Massachusetts
Country [3] 0 0
United States of America
State/province [3] 0 0
New Jersey
Country [4] 0 0
United States of America
State/province [4] 0 0
Texas
Country [5] 0 0
United States of America
State/province [5] 0 0
Utah
Country [6] 0 0
United States of America
State/province [6] 0 0
Washington
Country [7] 0 0
France
State/province [7] 0 0
Besançon
Country [8] 0 0
France
State/province [8] 0 0
Clermont Ferrand
Country [9] 0 0
France
State/province [9] 0 0
Creteil
Country [10] 0 0
France
State/province [10] 0 0
Lille Cedex
Country [11] 0 0
France
State/province [11] 0 0
MONTPELLIER Cedex 5
Country [12] 0 0
Italy
State/province [12] 0 0
Bologna
Country [13] 0 0
Italy
State/province [13] 0 0
Napoli
Country [14] 0 0
Korea, Republic of
State/province [14] 0 0
Seoul
Country [15] 0 0
Sweden
State/province [15] 0 0
Lund
Country [16] 0 0
Taiwan
State/province [16] 0 0
Kaohsiung City
Country [17] 0 0
Taiwan
State/province [17] 0 0
Taichung
Country [18] 0 0
Taiwan
State/province [18] 0 0
Tainan
Country [19] 0 0
Taiwan
State/province [19] 0 0
Taipei
Country [20] 0 0
United Kingdom
State/province [20] 0 0
Headington
Country [21] 0 0
United Kingdom
State/province [21] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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.
When will data be available (start and end dates)?
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.
Available to whom?
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.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://astrazenecagroup-dt.pharmacm.com/DT/Home


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT05140382