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AZD4573 as Monotherapy or in Combinations With Anti-cancer Agents in Patients With r/r PTCL or r/r cHL

Primary Purpose

Relapsed/Refractory Peripheral T-cell Lymphoma, Relapsed/Refractory Classical Hodgkins Lymphoma

Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
AZD4573
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Relapsed/Refractory Peripheral T-cell Lymphoma focused on measuring AZD4573, Modular study, Dose confirmation, Dose expansion

Eligibility Criteria

18 Years - 130 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 mandatory 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 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 criteria [Cheson et al 2014]).

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.

Sites / Locations

  • Research Site
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Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

AZD4573 (Monotherapy)

Arm Description

Eligible participants with either r/r PTCL, r/r NKTCL or r/r cHL will receive AZD4573 as monotherapy.

Outcomes

Primary Outcome Measures

Objective Response Rate (ORR)
The efficacy of AZD4573 will be assessed by evaluation of ORR. Proportion of participants who have a overall response of complete response [CR] or partial response [PR] according to the Lugano (2014) response criteria for malignant lymphoma.

Secondary Outcome Measures

Complete response (CR) rate
Efficacy of AZD4573 will be assessed by evaluation of tumour response. Proportion of participants who have a complete response according to the Lugano (2014) response criteria.
Duration of response (DoR)
Efficacy of AZD4573 will be assessed by evaluation of tumour response. The time from the first objective response to the time of documented disease progression or death due to any cause, whichever occurs first.
Progression-free survival (PFS)
Efficacy of AZD4573 will be assessed by evaluation of tumour response. The time from first dose date to documented disease progression, or death from any cause, whichever occurs first.
Overall survival (OS)
Efficacy of AZD4573 will be assessed by evaluation of overall survival. The time from first dose date to death from any cause.
Frequency of Adverse events (AE) and Serious AEs (SAE)
The safety and tolerability of AZD4573 will be assessed
Maximum observed plasma (peak) drug concentration (Cmax) of AZD4573
The plasma PK of AZD4573 will be assessed.
Area under the concentration-time curve from time zero to the last measurable concentration (AUC0-t) of AZD4573
The plasma PK of AZD4573 will be assessed.
Area under the plasma concentration curve from zero to the last quantifiable concentration (AUClast) of AZD4573
The plasma PK of AZD4573 will be assessed.
Area under plasma concentration time curve from zero to infinity (AUC0-inf) of AZD4573
The plasma PK of AZD4573 will be assessed.
Time to reach peak or maximum observed concentration or response following drug administration (tmax) of AZD4573
The plasma PK of AZD4573 will be assessed.
Half-life (t1/2) of AZD4573
The plasma PK of AZD4573 will be assessed.

Full Information

First Posted
November 17, 2021
Last Updated
August 22, 2023
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT05140382
Brief Title
AZD4573 as Monotherapy or in Combinations With Anti-cancer Agents in Patients With r/r PTCL or r/r cHL
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 15, 2021 (Actual)
Primary Completion Date
August 25, 2023 (Anticipated)
Study Completion Date
August 25, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a modular dose confirmation and expansion study. The core study design is to assess the efficacy of AZD4573, administered as monotherapy or combination therapy, to participants with either r/r PTCL or r/r cHL and to confirm the safety profiles and PK in these populations. Module 1 of this study will evaluate the efficacy, safety, and tolerability of AZD4573 monotherapy in participants with r/r PTCL or r/r cHL. If AZD4573 monotherapy is found to have promising anti-tumour efficacy in Module 1, an AZD4573 monotherapy Phase II expansion may be added via a substantial protocol amendment.
Detailed Description
Module 1 will consist of two r/r PTCL cohorts and one cHL cohort; and each cohort includes 21 participants. Each Cohort will include an intra-participant dose ramp-up. In addition to intra-participant dose ramp-up, a "no-ramp-up" dosing schedule will also be evaluated in Cohort 1. A comprehensive initial review of all safety and PK/PD data will be conducted in approximately the first 6 participants of each cohort (safety run-in), with separate Safety Review Committees (SRCs) for each cohort executed independently. The safety assessment will be undertaken by the SRC. Each cohort will have a separate dose confirmation, assessed independently by the SRC, to assess safety and PK/PD data compared to the known profiles in the first time in human study (Study D8230C00001) lymphoma population. These SRC reviews will confirm whether the recommended phase II dose for lymphoma (IV infusion 12 mg once weekly, including intra-participant ramp-up) is safe and tolerable or if additional dose optimisation is indicated at a revised dose and/or schedule. All cohorts can be opened and delivered independently of each other.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsed/Refractory Peripheral T-cell Lymphoma, Relapsed/Refractory Classical Hodgkins Lymphoma
Keywords
AZD4573, Modular study, Dose confirmation, Dose expansion

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
81 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
AZD4573 (Monotherapy)
Arm Type
Experimental
Arm Description
Eligible participants with either r/r PTCL, r/r NKTCL or r/r cHL will receive AZD4573 as monotherapy.
Intervention Type
Drug
Intervention Name(s)
AZD4573
Intervention Description
AZD4573 will be given intravenously
Primary Outcome Measure Information:
Title
Objective Response Rate (ORR)
Description
The efficacy of AZD4573 will be assessed by evaluation of ORR. Proportion of participants who have a overall response of complete response [CR] or partial response [PR] according to the Lugano (2014) response criteria for malignant lymphoma.
Time Frame
From Screening (Day -30 to Day-1) until disease progression or survival until death (approximately 6 months)
Secondary Outcome Measure Information:
Title
Complete response (CR) rate
Description
Efficacy of AZD4573 will be assessed by evaluation of tumour response. Proportion of participants who have a complete response according to the Lugano (2014) response criteria.
Time Frame
From Screening (Day -30 to Day-1) until disease progression or survival until death (approximately 6 months)
Title
Duration of response (DoR)
Description
Efficacy of AZD4573 will be assessed by evaluation of tumour response. The time from the first objective response to the time of documented disease progression or death due to any cause, whichever occurs first.
Time Frame
From Screening (Day -30 to Day-1) until disease progression or survival until death (approximately 6 months)
Title
Progression-free survival (PFS)
Description
Efficacy of AZD4573 will be assessed by evaluation of tumour response. The time from first dose date to documented disease progression, or death from any cause, whichever occurs first.
Time Frame
From Screening (Day -30 to Day-1) until disease progression or survival until death (approximately 6 months)
Title
Overall survival (OS)
Description
Efficacy of AZD4573 will be assessed by evaluation of overall survival. The time from first dose date to death from any cause.
Time Frame
From Screening (Day -30 to Day-1) until disease progression or survival until death (approximately 6 months)
Title
Frequency of Adverse events (AE) and Serious AEs (SAE)
Description
The safety and tolerability of AZD4573 will be assessed
Time Frame
From Cycle 1 (this cycle is 35 days in length) until Safety follow-up (30 days after the last dose of all study drug) and long term follow-up (upto 2 years)
Title
Maximum observed plasma (peak) drug concentration (Cmax) of AZD4573
Description
The plasma PK of AZD4573 will be assessed.
Time Frame
Cycle 1 (Cycle length is 35 days), Day 1 of Weeks 1-3 and Cycle 2 (Cycle length is 21 Days), Day 1 and Day 2
Title
Area under the concentration-time curve from time zero to the last measurable concentration (AUC0-t) of AZD4573
Description
The plasma PK of AZD4573 will be assessed.
Time Frame
Cycle 1 (Cycle length is 35 days), Day 1 of Weeks 1-3 and Cycle 2 (Cycle length is 21 Days), Day 1 and Day 2
Title
Area under the plasma concentration curve from zero to the last quantifiable concentration (AUClast) of AZD4573
Description
The plasma PK of AZD4573 will be assessed.
Time Frame
Cycle 1 (Cycle length is 35 days), Day 1 of Weeks 1-3 and Cycle 2 (Cycle length is 21 Days), Day 1 and Day 2
Title
Area under plasma concentration time curve from zero to infinity (AUC0-inf) of AZD4573
Description
The plasma PK of AZD4573 will be assessed.
Time Frame
Cycle 1 (Cycle length is 35 days), Day 1 of Weeks 1-3 and Cycle 2 (Cycle length is 21 Days), Day 1 and Day 2
Title
Time to reach peak or maximum observed concentration or response following drug administration (tmax) of AZD4573
Description
The plasma PK of AZD4573 will be assessed.
Time Frame
Cycle 1 (Cycle length is 35 days), Day 1 of Weeks 1-3 and Cycle 2 (Cycle length is 21 Days), Day 1 and Day 2
Title
Half-life (t1/2) of AZD4573
Description
The plasma PK of AZD4573 will be assessed.
Time Frame
Cycle 1 (Cycle length is 35 days), Day 1 of Weeks 1-3 and Cycle 2 (Cycle length is 21 Days), Day 1 and Day 2

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
130 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Certain countries may require older age to be eligible for clinical trials. Follow the local laws and regulations regarding age requirement for participant eligibility. 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) with prior therapy. 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. No growth factor support within 14 days prior to the date of the screening laboratory assessment. Growth factor support is not allowed during screening. No transfusions within 7 days prior to the date of the screening lab assessment. 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 or be ineligible for BV treatment. The total number of prior lines must be ≤ 4. NKTCL (Cohort 2): Prior treatment must have included a platinum agent and/or asparaginase. The total number of prior lines must be ≤ 4. 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]). Exclusion Criteria Type of Participant and Disease Characteristics: - 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); Monomorphic epitheliotropic intestinal T-cell lymphoma. 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). Anti-infective treatment (IV or oral) 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 tested positive for hepatitis B surface antigen (HBsAg) will be excluded. Participants who are HBsAg-negative but hepatitis B core antibody (anti-HBc)-positive will need to have a negative hepatitis B virus (HBV) PCR result before enrolment. Those who are HBV 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
Facility Information:
Facility Name
Research Site
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
Research Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Research Site
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Research Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Research Site
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Facility Name
Research Site
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Research Site
City
Clayton
ZIP/Postal Code
3168
Country
Australia
Facility Name
Research Site
City
Melbourne
ZIP/Postal Code
3000
Country
Australia
Facility Name
Research Site
City
Nedlands
ZIP/Postal Code
6009
Country
Australia
Facility Name
Research Site
City
Shenyang
ZIP/Postal Code
110004
Country
China
Facility Name
Research Site
City
Zhengzhou City
ZIP/Postal Code
450008
Country
China
Facility Name
Research Site
City
Besançon
ZIP/Postal Code
25000
Country
France
Facility Name
Research Site
City
Clermont Ferrand
ZIP/Postal Code
63003
Country
France
Facility Name
Research Site
City
Creteil
ZIP/Postal Code
94010
Country
France
Facility Name
Research Site
City
Lille Cedex
ZIP/Postal Code
59037
Country
France
Facility Name
Research Site
City
MONTPELLIER Cedex 5
ZIP/Postal Code
34295
Country
France
Facility Name
Research Site
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Research Site
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Research Site
City
Singapore
ZIP/Postal Code
119074
Country
Singapore
Facility Name
Research Site
City
Singapore
ZIP/Postal Code
169608
Country
Singapore
Facility Name
Research Site
City
Singapore
ZIP/Postal Code
322605
Country
Singapore
Facility Name
Research Site
City
Lund
ZIP/Postal Code
221 85
Country
Sweden
Facility Name
Research Site
City
Kaohsiung City
ZIP/Postal Code
83301
Country
Taiwan
Facility Name
Research Site
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Facility Name
Research Site
City
Tainan
ZIP/Postal Code
70403
Country
Taiwan
Facility Name
Research Site
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Research Site
City
Headington
ZIP/Postal Code
0X3 7LJ
Country
United Kingdom
Facility Name
Research Site
City
London
ZIP/Postal Code
NW1 2PG
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
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.
IPD Sharing Access Criteria
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.
IPD Sharing URL
https://astrazenecagroup-dt.pharmacm.com/DT/Home

Learn more about this trial

AZD4573 as Monotherapy or in Combinations With Anti-cancer Agents in Patients With r/r PTCL or r/r cHL

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