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Assessing An Oral Janus Kinase Inhibitor, AZD4205 as Monotherapy in Patients Who Have PTCL (JACKPOT8)

Primary Purpose

Relapsed or Refractory Peripheral T Cell Lymphoma

Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
AZD4205
Sponsored by
Dizal Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Relapsed or Refractory Peripheral T Cell Lymphoma

Eligibility Criteria

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

Inclusion Criteria:

  1. Obtained written informed consent
  2. Patients must have histologically confirmed peripheral T-cell lymphoma according to the 2016 revision of the World Health Organization classification of lymphoid neoplasms. Tumor samples are required for central pathology review to confirm the diagnosis.
  3. Patients must have measurable disease according to the Lugano criteria.
  4. Patients should be transplant-ineligible upon their entry into this study, and must have relapsed after or been refractory/intolerant to ≥ 1 (but not > 3) prior systemic therapy(ies) for PTCL.
  5. Adequate bone marrow reserve and organ system functions.

Exclusion Criteria:

  1. Any unsolved toxicity > Common Terminology Criteria for Adverse Events (CTCAE) grade 1 from previous anti-cancer therapy (except alopecia).
  2. Active infections, active or latent tuberculosis.
  3. Patients with severely decreased lung function.
  4. History of heart failure or QT interval prolongation.
  5. Central nervous system (CNS) or leptomeningeal lymphoma.
  6. History of treatment with Janus kinase (JAK) or signal transducer and activator of transcription 3 (STAT3) inhibitor.
  7. Patient has undergone an allogeneic stem cell transplant. Patient had autologous stem cell transplant within 6 months.

Sites / Locations

  • Yale Cancer Center
  • Winship Cancer Institute
  • Washington University School of Medicine
  • The University of Texas MD Anderson Cancer Center
  • Epworth Hospital
  • St Vincent's Hospital Melbourne
  • Royal Hobart Hospital
  • St George Hospital
  • Royal Perth Hospital
  • Westmead Hospital
  • Beijing Cancer Hospital
  • Beijing Friendship Hospital, Capital Medical University
  • Beijing Hospital
  • Peking University Third Hospital
  • The First Hospital of Jilin University
  • Hunan Cancer Hospital
  • Xiangya Hospital Central South University
  • Sichuan University - West China Hospital
  • Chongqing University Cancer Hospital
  • The Second Hospital of Dalian Medical University
  • Guangdong Provincial People's Hospital
  • NanFang Hospital of Southern Medical University
  • Sun Yat-sen University Cancer Center
  • Hainan General Hospital
  • The First Affiliated Hospital, Zhejiang University School of Medicine
  • Zhejiang Cancer Hospital
  • Anhui Provincial Cancer Hospital
  • The Second Hospital of Anhui Medical University
  • Shandong Cancer Hospital
  • The First Hospital of Lanzhou University
  • Linyi Cancer Hospital
  • Jiangxi Province Cancer Hospital
  • The First Affiliated Hospital of Nanchang University
  • Jiangsu Cancer Hospital
  • Fudan University Shanghai Cancer Center
  • Ruijin Hospital Shanghai Jiaotong University School of Medicine
  • The First Affiliated Hospital of Soochow University
  • Tianjin Medical University Cancer Institute and Hospital
  • Union Hospital Tongji Medical College Huazhong University of Science and Technology
  • The First Affiliated Hospital of Xiamen University
  • Henan Cancer Hospital
  • Inje University Busan Paik Hospital
  • Pusan National University Hospital
  • Keimyung University Dongsan Hospital
  • National Cancer Center
  • Chonbuk National University Hospital
  • Seoul National University Bundang Hospital
  • Samsung Medical Center
  • Asan Medical Center
  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

AZD4205 Group A

AZD4205 Group B

AZD4205 Group C

AZD4205 Group D

Arm Description

Group A: Open label AZD4205 at dose A, once daily (Phase 1)

Group B: Open label AZD4205 at dose B, once daily (Phase 1)

Group C: Open label AZD4205 at a selected dose, once daily (Phase 1)

Group D: Open label AZD4205 at the RP2D, once daily (Phase 2)

Outcomes

Primary Outcome Measures

Objective Response Rate (ORR)
ORR is the percentage of patients with at least one visit response of Complete Response (CR) or Partial Response (PR) based on CT scans per Lugano criteria

Secondary Outcome Measures

Incidence of adverse events
To evaluate the safety and tolerability of AZD4205 in patients with PTCL in terms of adverse events (AEs)
Peak Plasma Concentration (Cmax) of AZD4205
Area under the plasma concentration versus time curve (AUC) of AZD4205

Full Information

First Posted
September 18, 2019
Last Updated
September 26, 2023
Sponsor
Dizal Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT04105010
Brief Title
Assessing An Oral Janus Kinase Inhibitor, AZD4205 as Monotherapy in Patients Who Have PTCL (JACKPOT8)
Official Title
A Phase I/II, Open-Label, Multicentre Study to Investigate the Safety, Tolerability, Pharmacokinetics and Anti-tumor Activity of AZD4205 in Patients With Peripheral T Cell Lymphoma (PTCL)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 10, 2019 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dizal Pharmaceuticals

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 multinational, non-randomized, open-label, Phase 1/2 clinical study to evaluate the safety, tolerability and anti-tumor efficacy of AZD4205 as monotherapy in patients with peripheral T cell lymphoma (PTCL), who have relapsed from or are refractory/intolerant to standard systemic treatment. Phase 1 part: Around 20~40 patients will be subsequently enrolled into 2 different dose ascending cohorts. Additional 10~20 patients may be enrolled to further explore a selected dose defined by dose escalation cohorts. Phase 2 part: After the recommended phase 2 dose (RP2D) is defined, a phase 2 single-arm open-label pivotal study will be conducted to assess anti-tumor efficacy and safety of AZD4205 at RP2D in patients with refractory or relapsed PTCL.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsed or Refractory Peripheral T Cell Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
AZD4205 Group A
Arm Type
Experimental
Arm Description
Group A: Open label AZD4205 at dose A, once daily (Phase 1)
Arm Title
AZD4205 Group B
Arm Type
Experimental
Arm Description
Group B: Open label AZD4205 at dose B, once daily (Phase 1)
Arm Title
AZD4205 Group C
Arm Type
Experimental
Arm Description
Group C: Open label AZD4205 at a selected dose, once daily (Phase 1)
Arm Title
AZD4205 Group D
Arm Type
Experimental
Arm Description
Group D: Open label AZD4205 at the RP2D, once daily (Phase 2)
Intervention Type
Drug
Intervention Name(s)
AZD4205
Intervention Description
AZD4205 will be administered orally as capsules. AZD4205 treatment will be continued until disease progression or intolerant adverse reactions
Primary Outcome Measure Information:
Title
Objective Response Rate (ORR)
Description
ORR is the percentage of patients with at least one visit response of Complete Response (CR) or Partial Response (PR) based on CT scans per Lugano criteria
Time Frame
Through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
Incidence of adverse events
Description
To evaluate the safety and tolerability of AZD4205 in patients with PTCL in terms of adverse events (AEs)
Time Frame
The first dose until 28 days after last dose
Title
Peak Plasma Concentration (Cmax) of AZD4205
Time Frame
1,8,15, 21 days after first dose
Title
Area under the plasma concentration versus time curve (AUC) of AZD4205
Time Frame
1,8,15, 21 days after first dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Obtained written informed consent Patients must have histologically confirmed peripheral T-cell lymphoma according to the 2016 revision of the World Health Organization classification of lymphoid neoplasms. Tumor samples are required for central pathology review to confirm the diagnosis. Patients must have measurable disease according to the Lugano criteria. Patients should be transplant-ineligible upon their entry into this study, and must have relapsed after or been refractory/intolerant to ≥ 1 (but not > 3) prior systemic therapy(ies) for PTCL. Adequate bone marrow reserve and organ system functions. Exclusion Criteria: Any unsolved toxicity > Common Terminology Criteria for Adverse Events (CTCAE) grade 1 from previous anti-cancer therapy (except alopecia). Active infections, active or latent tuberculosis. Patients with severely decreased lung function. History of heart failure or QT interval prolongation. Central nervous system (CNS) or leptomeningeal lymphoma. History of treatment with Janus kinase (JAK) or signal transducer and activator of transcription 3 (STAT3) inhibitor. Patient has undergone an allogeneic stem cell transplant. Patient had autologous stem cell transplant within 6 months.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Won Seog Kim, PhD
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale Cancer Center
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Winship Cancer Institute
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
The University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Epworth Hospital
City
East Melbourne
Country
Australia
Facility Name
St Vincent's Hospital Melbourne
City
Fitzroy
Country
Australia
Facility Name
Royal Hobart Hospital
City
Hobart
Country
Australia
Facility Name
St George Hospital
City
Kogarah
Country
Australia
Facility Name
Royal Perth Hospital
City
Perth
Country
Australia
Facility Name
Westmead Hospital
City
Westmead
Country
Australia
Facility Name
Beijing Cancer Hospital
City
Beijing
Country
China
Facility Name
Beijing Friendship Hospital, Capital Medical University
City
Beijing
Country
China
Facility Name
Beijing Hospital
City
Beijing
Country
China
Facility Name
Peking University Third Hospital
City
Beijing
Country
China
Facility Name
The First Hospital of Jilin University
City
Changchun
Country
China
Facility Name
Hunan Cancer Hospital
City
Changsha
Country
China
Facility Name
Xiangya Hospital Central South University
City
Changsha
Country
China
Facility Name
Sichuan University - West China Hospital
City
Chengdu
Country
China
Facility Name
Chongqing University Cancer Hospital
City
Chongqing
Country
China
Facility Name
The Second Hospital of Dalian Medical University
City
Dalian
Country
China
Facility Name
Guangdong Provincial People's Hospital
City
Guangzhou
Country
China
Facility Name
NanFang Hospital of Southern Medical University
City
Guangzhou
Country
China
Facility Name
Sun Yat-sen University Cancer Center
City
Guangzhou
Country
China
Facility Name
Hainan General Hospital
City
Haikou
Country
China
Facility Name
The First Affiliated Hospital, Zhejiang University School of Medicine
City
Hangzhou
Country
China
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
Country
China
Facility Name
Anhui Provincial Cancer Hospital
City
Hefei
Country
China
Facility Name
The Second Hospital of Anhui Medical University
City
Hefei
Country
China
Facility Name
Shandong Cancer Hospital
City
Jinan
Country
China
Facility Name
The First Hospital of Lanzhou University
City
Lanzhou
Country
China
Facility Name
Linyi Cancer Hospital
City
Linyi
Country
China
Facility Name
Jiangxi Province Cancer Hospital
City
Nanchang
Country
China
Facility Name
The First Affiliated Hospital of Nanchang University
City
Nanchang
Country
China
Facility Name
Jiangsu Cancer Hospital
City
Nanjing
Country
China
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai
Country
China
Facility Name
Ruijin Hospital Shanghai Jiaotong University School of Medicine
City
Shanghai
Country
China
Facility Name
The First Affiliated Hospital of Soochow University
City
Suzhou
Country
China
Facility Name
Tianjin Medical University Cancer Institute and Hospital
City
Tianjin
Country
China
Facility Name
Union Hospital Tongji Medical College Huazhong University of Science and Technology
City
Wuhan
Country
China
Facility Name
The First Affiliated Hospital of Xiamen University
City
Xiamen
Country
China
Facility Name
Henan Cancer Hospital
City
Zhengzhou
Country
China
Facility Name
Inje University Busan Paik Hospital
City
Busan
Country
Korea, Republic of
Facility Name
Pusan National University Hospital
City
Busan
Country
Korea, Republic of
Facility Name
Keimyung University Dongsan Hospital
City
Daegu
Country
Korea, Republic of
Facility Name
National Cancer Center
City
Goyang
Country
Korea, Republic of
Facility Name
Chonbuk National University Hospital
City
Jeonju
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06133
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

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Assessing An Oral Janus Kinase Inhibitor, AZD4205 as Monotherapy in Patients Who Have PTCL (JACKPOT8)

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