Assessing An Oral Janus Kinase Inhibitor, AZD4205 as Monotherapy in Patients Who Have PTCL (JACKPOT8)
NCT ID: NCT04105010
Last Updated: 2025-04-04
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
171 participants
INTERVENTIONAL
2019-09-10
2024-02-22
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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golidocitinib Group A
Group A: Open label golidocitinib at dose A, once daily (Phase 1)
golidocitinib
golidocitinib will be administered orally as capsules. golidocitinib treatment will be continued until disease progression or intolerant adverse reactions
golidocitinib Group B
Group B: Open label golidocitinib at dose B, once daily (Phase 1)
golidocitinib
golidocitinib will be administered orally as capsules. golidocitinib treatment will be continued until disease progression or intolerant adverse reactions
golidocitinib Group C
Group C: Open label golidocitinib at a selected dose, once daily (Phase 1)
golidocitinib
golidocitinib will be administered orally as capsules. golidocitinib treatment will be continued until disease progression or intolerant adverse reactions
golidocitinib Group D
Group D: Open label golidocitinib at the RP2D, once daily (Phase 2)
golidocitinib
golidocitinib will be administered orally as capsules. golidocitinib treatment will be continued until disease progression or intolerant adverse reactions
Interventions
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golidocitinib
golidocitinib will be administered orally as capsules. golidocitinib treatment will be continued until disease progression or intolerant adverse reactions
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Dizal Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Won Seog Kim, PhD
Role: PRINCIPAL_INVESTIGATOR
Samsung Medical Center
Locations
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Yale Cancer Center
New Haven, Connecticut, United States
Winship Cancer Institute
Atlanta, Georgia, United States
Washington University School of Medicine
St Louis, Missouri, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Epworth Hospital
East Melbourne, , Australia
St Vincent's Hospital Melbourne
Fitzroy, , Australia
Royal Hobart Hospital
Hobart, , Australia
St George Hospital
Kogarah, , Australia
Royal Perth Hospital
Perth, , Australia
Westmead Hospital
Westmead, , Australia
Beijing Cancer Hospital
Beijing, , China
Beijing Friendship Hospital, Capital Medical University
Beijing, , China
Beijing Hospital
Beijing, , China
Peking University Third Hospital
Beijing, , China
The First Hospital of Jilin University
Changchun, , China
Hunan Cancer Hospital
Changsha, , China
Xiangya Hospital Central South University
Changsha, , China
Sichuan University - West China Hospital
Chengdu, , China
Chongqing University Cancer Hospital
Chongqing, , China
The Second Hospital of Dalian Medical University
Dalian, , China
Guangdong Provincial People's Hospital
Guangzhou, , China
NanFang Hospital of Southern Medical University
Guangzhou, , China
Sun Yat-sen University Cancer Center
Guangzhou, , China
Hainan General Hospital
Haikou, , China
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, , China
Zhejiang Cancer Hospital
Hangzhou, , China
Anhui Provincial Cancer Hospital
Hefei, , China
The Second Hospital of Anhui Medical University
Hefei, , China
Shandong Cancer Hospital
Jinan, , China
The First Hospital of Lanzhou University
Lanzhou, , China
Linyi Cancer Hospital
Linyi, , China
Jiangxi Province Cancer Hospital
Nanchang, , China
The First Affiliated Hospital of Nanchang University
Nanchang, , China
Jiangsu Cancer Hospital
Nanjing, , China
Fudan University Shanghai Cancer Center
Shanghai, , China
Ruijin Hospital Shanghai Jiaotong University School of Medicine
Shanghai, , China
The First Affiliated Hospital of Soochow University
Suzhou, , China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, , China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, , China
The First Affiliated Hospital of Xiamen University
Xiamen, , China
Henan Cancer Hospital
Zhengzhou, , China
Inje University Busan Paik Hospital
Busan, , South Korea
Pusan National University Hospital
Busan, , South Korea
Keimyung University Dongsan Hospital
Daegu, , South Korea
National Cancer Center
Goyang, , South Korea
Chonbuk National University Hospital
Jeonju, , South Korea
Seoul National University Bundang Hospital
Seongnam, , South Korea
Samsung Medical Center
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Countries
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References
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Song Y, Malpica L, Cai Q, Zhao W, Zhou K, Wu J, Zhang H, Mehta-Shah N, Ding K, Liu Y, Li Z, Zhang L, Zheng M, Jin J, Yang H, Shuang Y, Yoon DH, Gao S, Li W, Zhai Z, Zou L, Xi Y, Koh Y, Li F, Prince M, Zhou H, Lin L, Liu H, Allen P, Roncolato F, Yang Z, Kim WS, Zhu J. Golidocitinib, a selective JAK1 tyrosine-kinase inhibitor, in patients with refractory or relapsed peripheral T-cell lymphoma (JACKPOT8 Part B): a single-arm, multinational, phase 2 study. Lancet Oncol. 2024 Jan;25(1):117-125. doi: 10.1016/S1470-2045(23)00589-2. Epub 2023 Dec 9.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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DZ2019J0005
Identifier Type: -
Identifier Source: org_study_id
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