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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| golidocitinib Group A | Experimental | Group A: Open label golidocitinib at dose A, once daily (Phase 1) |
|
| golidocitinib Group B | Experimental | Group B: Open label golidocitinib at dose B, once daily (Phase 1) |
|
| golidocitinib Group C | Experimental | Group C: Open label golidocitinib at a selected dose, once daily (Phase 1) |
|
| golidocitinib Group D | Experimental | Group D: Open label golidocitinib at the RP2D, once daily (Phase 2) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| golidocitinib | Drug | golidocitinib will be administered orally as capsules. golidocitinib treatment will be continued until disease progression or intolerant adverse reactions |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part B: CT-based Objective Response Rate (ORR) by Independent Review Committee (IRC) | ORR is the percentage of patients with at least one visit response of Complete Response (CR) or Partial Response (PR) based on CT scans evaluated by IRC per Lugano criteria. | Up to approximately 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Part A and Part B: Number of Participants With Adverse Events | To evaluate the safety and tolerability of AZD4205 in patients with PTCL in terms of adverse events (AEs), such as number of participants with AEs | The first dose until 28 days after last dose, up to approximately 3 years |
| Part B: Duration of Response (DoR) Assessed by IRC |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Won Seog Kim, PhD | Samsung Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale Cancer Center | New Haven | Connecticut | 06510 | United States | ||
| Winship Cancer Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38092009 | Derived | 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. |
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171 enrolled participants met inclusion criteria and received study drug.
DZ2019J0005 study includes 2 parts: Part A, the dose escalation and extension part (group A, B, C), and part B, dose expansion part (group D).
51 and 120 participants were recruited in Part A and Part B respectively, based on physician referral at 31 sites in the U.S., Australia, China and South Korea. The first participant was enrolled on 10-Sep-2019 and the last participant was enrolled on 23-Aug-2023.
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| ID | Title | Description |
|---|---|---|
| FG000 | AZD4205 Group A | Group A: Open label AZD4205 at 150 mg, once daily (Phase 1) AZD4205: AZD4205 will be administered orally as capsules. AZD4205 treatment will be continued until disease progression or intolerant adverse reactions |
| FG001 | AZD4205 Group B |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 2, 2024 | Jan 3, 2025 |
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|
DoR is the time from the date of first documented response until the date of documented progression or death due to any cause. Documented response and progression are both identified based on CT scans evaluated by IRC per Lugano criteria. |
| Up to approximately 3 years |
| Part B: Complete Response Rate (CRR) Assessed by IRC | CRR is the percentage of patients with at least one visit response of CR based on CT scans evaluated by IRC per Lugano criteria. | Up to approximately 3 years |
| Part B: Progression Free Survival (PFS) Assessed by IRC | PFS is the time from the date of first dosing until the date of objective disease progression or death (by any cause) regardless of whether the participant discontinues the study treatments. Progression is identified based on CT scans evaluated by IRC per Lugano criteria. | Up to approximately 3 years |
| Part B: Time to Response (TTR) Assessed by IRC | TTR is the time from the date of first dosing to the time of the initial response of PR or CR. Response is identified based on CT scans evaluated by IRC per Lugano criteria. | Up to approximately 3 years |
| Part A and Part B: ORR Assessed by Investigator | ORR is the percentage of patients with at least one visit response of CR or PR based on CT and/or PET scans evaluated by investigator per Lugano criteria. | Up to approximately 3 years |
| Part A and Part B: DoR Assessed by Investigator | DoR is the time from the date of first documented response until the date of documented progression or death due to any cause. Documented response and progression are both identified based on CT and/or PET scans evaluated by investigator per Lugano criteria. | Up to approximately 3 years |
| Part A and Part B: CRR Assessed by Investigator | CRR is the percentage of patients with at least one visit response of CR based on CT and/or PET scans evaluated by investigator per Lugano criteria. | Up to approximately 3 years |
| Part A and Part B: PFS Assessed by Investigator | PFS is the time from the date of first dosing until the date of objective disease progression or death (by any cause) regardless of whether the participant discontinues the study treatments. Progression is identified based on CT and/or PET scans evaluated by investigator per Lugano criteria. | Up to approximately 3 years |
| Part B: TTR Assessed by Investigator | TTR is the time from the date of first dosing to the time of the initial response of PR or CR. Response is identified based on CT scans evaluated by investigator per Lugano criteria. | Up to approximately 3 years |
| Part A and Part B: Maximum Plasma Concentration (Cmax) of AZD4205 | Maximum observed plasma concentration, obtained directly from the observed concentration versus time data. Calculated for the single dose. | Cycle 1 Day 1 (each cycle = 21 days): 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, and 24 hours postdose (for Group A, B and C); 0 (predose), 1, 2, 4, 6, 8, and 24 hours postdose (for Group D). |
| Part A and Part B: Area Under the Plasma Concentration-time Curve From Zero to the Last Measurable Concentration (AUC0-t) of AZD4205 | Area under the plasma concentration-time curve from time zero to the last quantifiable time point, calculated by the linear up/log down rule. | Cycle 1, Day 1 (each cycle = 21 days): 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, and 24 hours postdose (for Group A, B and C); 0 (predose), 1, 2, 4, 6, 8, and 24 hours postdose (for Group D). |
| Part A and Part B: Cmax,ss, at Steady State of AZD4205 | Maximum observed plasma concentration (ng/mL) at steady state, obtained directly from the observed concentration versus time data. Calculated for the multiple doses. | Cycle 2 Day 1 (each cycle = 21 days): 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, and 24 hours postdose (for Group A, B and C); 0 (predose), 1, 2, 4, 6, 8, and 24 hours postdose (for Group D). |
| Part A and Part B: AUCss, at Steady State of AZD4205 | Area under the plasma concentration-time curve from time zero to the last quantifiable time point at steady state, calculated by the linear up/log down rule | Cycle 2 Day 1 (each cycle = 21 days): 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, and 24 hours postdose (for Group A, B and C); 0 (predose), 1, 2, 4, 6, 8, and 24 hours postdose (for Group D). |
| Atlanta |
| Georgia |
| 30322 |
| United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| The University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | 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 | 06133 | South Korea |
| Asan Medical Center | Seoul | South Korea |
| Seoul National University Hospital | Seoul | South Korea |
Group B: Open label AZD4205 at 250 mg, once daily (Phase 1) AZD4205: AZD4205 will be administered orally as capsules. AZD4205 treatment will be continued until disease progression or intolerant adverse reactions |
| FG002 | AZD4205 Group C | Group C: Open label AZD4205 at 150 mg, once daily (Phase 1) AZD4205: AZD4205 will be administered orally as capsules. AZD4205 treatment will be continued until disease progression or intolerant adverse reactions |
| FG003 | AZD4205 Group D | Group D: Open label AZD4205 at the 150 mg (RP2D), once daily (Phase 2) AZD4205: AZD4205 will be administered orally as capsules. AZD4205 treatment will be continued until disease progression or intolerant adverse reactions |
| COMPLETED |
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| NOT COMPLETED |
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|
Safety Analysis Set (all patients treated with at least one dose of AZD4205)
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| ID | Title | Description |
|---|---|---|
| BG000 | AZD4205 Group A | Group A: Open label AZD4205 at 150 mg, once daily (Phase 1) AZD4205: AZD4205 will be administered orally as capsules. AZD4205 treatment will be continued until disease progression or intolerant adverse reactions |
| BG001 | AZD4205 Group B | Group B: Open label AZD4205 at 250 mg, once daily (Phase 1) AZD4205: AZD4205 will be administered orally as capsules. AZD4205 treatment will be continued until disease progression or intolerant adverse reactions |
| BG002 | AZD4205 Group C | Group C: Open label AZD4205 at 150 mg, once daily (Phase 1) AZD4205: AZD4205 will be administered orally as capsules. AZD4205 treatment will be continued until disease progression or intolerant adverse reactions |
| BG003 | AZD4205 Group D | Group D: Open label AZD4205 at the 150 mg (RP2D), once daily (Phase 2) AZD4205: AZD4205 will be administered orally as capsules. AZD4205 treatment will be continued until disease progression or intolerant adverse reactions |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Part B: CT-based Objective Response Rate (ORR) by Independent Review Committee (IRC) | ORR is the percentage of patients with at least one visit response of Complete Response (CR) or Partial Response (PR) based on CT scans evaluated by IRC per Lugano criteria. | Evaluable for CT-based Response Set (all dosed and central pathology confirmed Peripheral T Cell Lymphoma (PTCL) patients with baseline measurable disease assessed by IRC using CT imaging) | Posted | Number | 95% Confidence Interval | percentage of participants | Up to approximately 3 years |
|
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| Secondary | Part A and Part B: Number of Participants With Adverse Events | To evaluate the safety and tolerability of AZD4205 in patients with PTCL in terms of adverse events (AEs), such as number of participants with AEs | Posted | Count of Participants | Participants | The first dose until 28 days after last dose, up to approximately 3 years |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Part B: Duration of Response (DoR) Assessed by IRC | DoR is the time from the date of first documented response until the date of documented progression or death due to any cause. Documented response and progression are both identified based on CT scans evaluated by IRC per Lugano criteria. | Subset of CR or PR responders in Evaluable for CT-based Response Set | Posted | Median | 95% Confidence Interval | months | Up to approximately 3 years |
|
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| Secondary | Part B: Complete Response Rate (CRR) Assessed by IRC | CRR is the percentage of patients with at least one visit response of CR based on CT scans evaluated by IRC per Lugano criteria. | Evaluable for CT-based Response Set | Posted | Number | 95% Confidence Interval | percentage of participants | Up to approximately 3 years |
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| Secondary | Part B: Progression Free Survival (PFS) Assessed by IRC | PFS is the time from the date of first dosing until the date of objective disease progression or death (by any cause) regardless of whether the participant discontinues the study treatments. Progression is identified based on CT scans evaluated by IRC per Lugano criteria. | Evaluable for Survival Set (all dosed and central pathology confirmed PTCL patients) | Posted | Median | 95% Confidence Interval | months | Up to approximately 3 years |
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| Secondary | Part B: Time to Response (TTR) Assessed by IRC | TTR is the time from the date of first dosing to the time of the initial response of PR or CR. Response is identified based on CT scans evaluated by IRC per Lugano criteria. | Subset of CR or PR responders in Evaluable for CT-based Response Set | Posted | Median | 95% Confidence Interval | months | Up to approximately 3 years |
|
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| Secondary | Part A and Part B: ORR Assessed by Investigator | ORR is the percentage of patients with at least one visit response of CR or PR based on CT and/or PET scans evaluated by investigator per Lugano criteria. | Part A: Evaluable for Response Set (All dosed patients with baseline measurable disease) Part B: Evaluable for CT-based Response Set | Posted | Number | 95% Confidence Interval | percentage of participants | Up to approximately 3 years |
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| Secondary | Part A and Part B: DoR Assessed by Investigator | DoR is the time from the date of first documented response until the date of documented progression or death due to any cause. Documented response and progression are both identified based on CT and/or PET scans evaluated by investigator per Lugano criteria. | Part A: Subset of CR or PR responders in Evaluable for Response Set Part B: Subset of CR or PR responders in Evaluable for CT-based Response Set | Posted | Median | 95% Confidence Interval | months | Up to approximately 3 years |
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| Secondary | Part A and Part B: CRR Assessed by Investigator | CRR is the percentage of patients with at least one visit response of CR based on CT and/or PET scans evaluated by investigator per Lugano criteria. | Part A: Evaluable for Response Set Part B: Evaluable for CT-based Response Set | Posted | Number | 95% Confidence Interval | percentage of participants | Up to approximately 3 years |
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| Secondary | Part A and Part B: PFS Assessed by Investigator | PFS is the time from the date of first dosing until the date of objective disease progression or death (by any cause) regardless of whether the participant discontinues the study treatments. Progression is identified based on CT and/or PET scans evaluated by investigator per Lugano criteria. | Part A: Safety Analysis Set Part B: Evaluable for Survival Set | Posted | Median | 95% Confidence Interval | months | Up to approximately 3 years |
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| Secondary | Part B: TTR Assessed by Investigator | TTR is the time from the date of first dosing to the time of the initial response of PR or CR. Response is identified based on CT scans evaluated by investigator per Lugano criteria. | Subset of CR or PR responders in Evaluable for CT-based Response Set | Posted | Median | 95% Confidence Interval | months | Up to approximately 3 years |
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| Secondary | Part A and Part B: Maximum Plasma Concentration (Cmax) of AZD4205 | Maximum observed plasma concentration, obtained directly from the observed concentration versus time data. Calculated for the single dose. | PK population (all dosed patients with at least one reportable AZD4205 plasma concentrations and no important AEs or protocol deviations that may impact PK) with Intensive PK sampling on Cycle 1, Day 1 | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Cycle 1 Day 1 (each cycle = 21 days): 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, and 24 hours postdose (for Group A, B and C); 0 (predose), 1, 2, 4, 6, 8, and 24 hours postdose (for Group D). |
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| Secondary | Part A and Part B: Area Under the Plasma Concentration-time Curve From Zero to the Last Measurable Concentration (AUC0-t) of AZD4205 | Area under the plasma concentration-time curve from time zero to the last quantifiable time point, calculated by the linear up/log down rule. | PK population with Intensive PK sampling on Cycle 1, Day 1 | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | Cycle 1, Day 1 (each cycle = 21 days): 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, and 24 hours postdose (for Group A, B and C); 0 (predose), 1, 2, 4, 6, 8, and 24 hours postdose (for Group D). |
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| Secondary | Part A and Part B: Cmax,ss, at Steady State of AZD4205 | Maximum observed plasma concentration (ng/mL) at steady state, obtained directly from the observed concentration versus time data. Calculated for the multiple doses. | PK population with Intensive PK sampling on Cycle 2, Day 1 | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Cycle 2 Day 1 (each cycle = 21 days): 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, and 24 hours postdose (for Group A, B and C); 0 (predose), 1, 2, 4, 6, 8, and 24 hours postdose (for Group D). |
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| Secondary | Part A and Part B: AUCss, at Steady State of AZD4205 | Area under the plasma concentration-time curve from time zero to the last quantifiable time point at steady state, calculated by the linear up/log down rule | PK population with Intensive PK sampling on Cycle 2, Day 1 | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | Cycle 2 Day 1 (each cycle = 21 days): 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, and 24 hours postdose (for Group A, B and C); 0 (predose), 1, 2, 4, 6, 8, and 24 hours postdose (for Group D). |
|
The first dose until 28 days after last dose, up to approximately 3 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | AZD4205 Group A | Group A: Open label AZD4205 at 150 mg, once daily (Phase 1) AZD4205: AZD4205 will be administered orally as capsules. AZD4205 treatment will be continued until disease progression or intolerant adverse reactions | 3 | 28 | 12 | 28 | 26 | 28 |
| EG001 | AZD4205 Group B | Group B: Open label AZD4205 at 250 mg, once daily (Phase 1) AZD4205: AZD4205 will be administered orally as capsules. AZD4205 treatment will be continued until disease progression or intolerant adverse reactions | 2 | 16 | 9 | 16 | 16 | 16 |
| EG002 | AZD4205 Group C | Group C: Open label AZD4205 at 150 mg, once daily (Phase 1) AZD4205: AZD4205 will be administered orally as capsules. AZD4205 treatment will be continued until disease progression or intolerant adverse reactions | 1 | 7 | 1 | 7 | 6 | 7 |
| EG003 | AZD4205 Group D | Group D: Open label AZD4205 at 150 mg (RP2D), once daily (Phase 2) AZD4205: AZD4205 will be administered orally as capsules. AZD4205 treatment will be continued until disease progression or intolerant adverse reactions | 54 | 120 | 44 | 120 | 114 | 120 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | Systematic Assessment |
| ||
| herpes zoster | Infections and infestations | Systematic Assessment |
| ||
| COVID-19 pneumonia | Infections and infestations | Systematic Assessment |
| ||
| Febrile infection | Infections and infestations | Systematic Assessment |
| ||
| Upper respiratory tract infection | Infections and infestations | Systematic Assessment |
| ||
| Anal abscess | Infections and infestations | Systematic Assessment |
| ||
| Bacteraemia | Infections and infestations | Systematic Assessment |
| ||
| Bacterial sepsis | Infections and infestations | Systematic Assessment |
| ||
| Cytomegalovirus chorioretinitis | Infections and infestations | Systematic Assessment |
| ||
| Cytomegalovirus infection reactivation | Infections and infestations | Systematic Assessment |
| ||
| Infection | Infections and infestations | Systematic Assessment |
| ||
| Meningitis viral | Infections and infestations | Systematic Assessment |
| ||
| Pneumonia viral | Infections and infestations | Systematic Assessment |
| ||
| Soft tissue infection | Infections and infestations | Systematic Assessment |
| ||
| Tonsillitis | Infections and infestations | Systematic Assessment |
| ||
| Urinary tract infection | Infections and infestations | Systematic Assessment |
| ||
| Viral infection | Infections and infestations | Systematic Assessment |
| ||
| Platelet count decreased | Investigations | Non-systematic Assessment |
| ||
| White blood cell count decreased | Investigations | Non-systematic Assessment |
| ||
| Alanine aminotransferase increased | Investigations | Non-systematic Assessment |
| ||
| Aspartate aminotransferase increased | Investigations | Non-systematic Assessment |
| ||
| Blood creatinine increased | Investigations | Non-systematic Assessment |
| ||
| Blood fibrinogen decreased | Investigations | Non-systematic Assessment |
| ||
| Gamma-glutamyltransferase increased | Investigations | Non-systematic Assessment |
| ||
| Cervical radiculopathy | Nervous system disorders | Systematic Assessment |
| ||
| Facial paralysis | Nervous system disorders | Systematic Assessment |
| ||
| Neuralgia | Nervous system disorders | Systematic Assessment |
| ||
| Spondylitic myelopathy | Nervous system disorders | Systematic Assessment |
| ||
| Syncope | Nervous system disorders | Systematic Assessment |
| ||
| Necrotising retinitis | Eye disorders | Systematic Assessment |
| ||
| Retinal vein occlusion | Eye disorders | Systematic Assessment |
| ||
| Retinopathy | Eye disorders | Systematic Assessment |
| ||
| Gastrointestinal haemorrhage | Gastrointestinal disorders | Systematic Assessment |
| ||
| Intestinal perforation | Gastrointestinal disorders | Systematic Assessment |
| ||
| Stomatitis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Pyrexia | General disorders | Systematic Assessment |
| ||
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Lung opacity | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Hypersplenism | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Splenic infarction | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| B-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Diffuse large B-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Acute kidney injury | Renal and urinary disorders | Systematic Assessment |
| ||
| Ureterolithiasis | Renal and urinary disorders | Systematic Assessment |
| ||
| Penile ulceration | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Cholecystitis | Hepatobiliary disorders | Systematic Assessment |
| ||
| Spinal fracture | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Hyperkalaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Pain in extremity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Confusional state | Psychiatric disorders | Systematic Assessment |
| ||
| Hypertension | Vascular disorders | Systematic Assessment |
| ||
| Hypopituitarism | Endocrine disorders | Systematic Assessment |
| ||
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Gastroduodenal ulcer | Gastrointestinal disorders | Systematic Assessment |
| ||
| Small intestinal perforation | Gastrointestinal disorders | Systematic Assessment |
| ||
| death | General disorders | Systematic Assessment |
| ||
| Drug-induced liver injury | Hepatobiliary disorders | Systematic Assessment |
| ||
| Hepatic failure | Hepatobiliary disorders | Systematic Assessment |
| ||
| Hepatic function abnormal | Hepatobiliary disorders | Systematic Assessment |
| ||
| Pneumocystis jirovecii pneumonia | Infections and infestations | Systematic Assessment |
| ||
| Bronchitis | Infections and infestations | Systematic Assessment |
| ||
| Cystitis | Infections and infestations | Systematic Assessment |
| ||
| Pneumonia fungal | Infections and infestations | Systematic Assessment |
| ||
| Staphylococcal sepsis | Infections and infestations | Systematic Assessment |
| ||
| Varicella | Infections and infestations | Systematic Assessment |
| ||
| Transaminases increased | Investigations | Systematic Assessment |
| ||
| Cerebral infarction | Nervous system disorders | Systematic Assessment |
| ||
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | Systematic Assessment |
| ||
| Neutrophil count decreased | Investigations | Systematic Assessment |
| ||
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Platelet count decreased | Investigations | Non-systematic Assessment |
| ||
| Neutrophil count decreased | Investigations | Non-systematic Assessment |
| ||
| White blood cell count decreased | Investigations | Non-systematic Assessment |
| ||
| Lymphocyte count decreased | Investigations | Non-systematic Assessment |
| ||
| Aspartate aminotransferase increased | Investigations | Non-systematic Assessment |
| ||
| Alanine aminotransferase increased | Investigations | Non-systematic Assessment |
| ||
| Blood lactate dehydrogenase increased | Investigations | Non-systematic Assessment |
| ||
| Blood creatinine increased | Investigations | Non-systematic Assessment |
| ||
| Blood fibrinogen decreased | Investigations | Non-systematic Assessment |
| ||
| Blood creatine phosphokinase increased | Investigations | Non-systematic Assessment |
| ||
| C-reactive protein increased | Investigations | Non-systematic Assessment |
| ||
| Gamma-glutamyltransferase increased | Investigations | Non-systematic Assessment |
| ||
| Blood cholesterol increased | Investigations | Non-systematic Assessment |
| ||
| Blood bilirubin increased | Investigations | Non-systematic Assessment |
| ||
| Weight increased | Investigations | Non-systematic Assessment |
| ||
| Hypertriglyceridaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypercholesterolaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hyperuricaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypoalbuminaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypokalaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hyponatraemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hyperglycaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hyperlipidaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Anaemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Leukocytosis | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| COVID-19 | Infections and infestations | Systematic Assessment |
| ||
| Herpes zoster | Infections and infestations | Systematic Assessment |
| ||
| Upper respiratory tract infection | Infections and infestations | Systematic Assessment |
| ||
| Constipation | Gastrointestinal disorders | Systematic Assessment |
| ||
| Stomatitis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Pyrexia | General disorders | Systematic Assessment |
| ||
| Fatigue | General disorders | Systematic Assessment |
| ||
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| protein urine present | Investigations | Systematic Assessment |
| ||
| Electrocardiogram QT prolonged | Investigations | Systematic Assessment |
| ||
| Blood chloride decreased | Investigations | Non-systematic Assessment |
| ||
| Blood alkaline phosphatase increased | Investigations | Non-systematic Assessment |
| ||
| Epstein-Barr virus test positive | Investigations | Non-systematic Assessment |
| ||
| Lung diffusion test decreased | Investigations | Non-systematic Assessment |
| ||
| Bilirubin conjugated increased | Investigations | Non-systematic Assessment |
| ||
| Blood bilirubin unconjugated increased | Investigations | Non-systematic Assessment |
| ||
| Prothrombin time shortened | Investigations | Non-systematic Assessment |
| ||
| Pulmonary function test decreased | Investigations | Non-systematic Assessment |
| ||
| Hyperkalaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypocalcaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Decreased appetite | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypoglycaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Leukopenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Thrombocytopenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Pneumonia | Infections and infestations | Systematic Assessment |
| ||
| Urinary tract infection | Infections and infestations | Systematic Assessment |
| ||
| Nasopharyngitis | Infections and infestations | Systematic Assessment |
| ||
| Bronchitis | Infections and infestations | Systematic Assessment |
| ||
| Skin infection | Infections and infestations | Systematic Assessment |
| ||
| Fungal infection | Infections and infestations | Systematic Assessment |
| ||
| Urethritis | Infections and infestations | Systematic Assessment |
| ||
| Oropharyngeal candidiasis | Infections and infestations | Systematic Assessment |
| ||
| Mouth ulceration | Gastrointestinal disorders | Systematic Assessment |
| ||
| Abdominal distension | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dyspepsia | Gastrointestinal disorders | Systematic Assessment |
| ||
| Enterocolitis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Oedema peripheral | General disorders | Systematic Assessment |
| ||
| Mucosal inflammation | General disorders | Systematic Assessment |
| ||
| Facial pain | General disorders | Systematic Assessment |
| ||
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Productive cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Obstructive airways disorder | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Epistaxis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Hypoxia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Dizziness | Nervous system disorders | Systematic Assessment |
| ||
| Atrioventricular block | Cardiac disorders | Systematic Assessment |
| ||
| Proteinuria | Renal and urinary disorders | Systematic Assessment |
| ||
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Papule | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Hypertension | Vascular disorders | Systematic Assessment |
| ||
| Pain in extremity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Flank pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Hepatic function abnormal | Hepatobiliary disorders | Systematic Assessment |
| ||
| Insomnia | Psychiatric disorders | Systematic Assessment |
| ||
| weight decreased | Investigations | Systematic Assessment |
| ||
| urinary occult blood positive | Investigations | Systematic Assessment |
| ||
| neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
| ||
| white blood cell count increased | Investigations | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rika Chen | Dizal Pharmaceuticals | 862161095875 | clinicaltrials@dizalpharma.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 25, 2023 | Jan 3, 2025 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D012008 | Recurrence |
| D016411 | Lymphoma, T-Cell, Peripheral |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D016399 | Lymphoma, T-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
Group D: Open label AZD4205 at the RP2D, once daily (Phase 2) AZD4205: AZD4205 will be administered orally as capsules. AZD4205 treatment will be continued until disease progression or intolerant adverse reactions |
|
|
|
|
|
|
| OG003 | AZD4205 Group D | Group D: Open label AZD4205 at 150 mg (RP2D), once daily (Phase 2) AZD4205: AZD4205 will be administered orally as capsules. AZD4205 treatment will be continued until disease progression or intolerant adverse reactions |
|
|
| OG003 | AZD4205 Group D | Group D: Open label AZD4205 at 150 mg (RP2D), once daily (Phase 2) AZD4205: AZD4205 will be administered orally as capsules. AZD4205 treatment will be continued until disease progression or intolerant adverse reactions |
|
|
| OG003 |
| AZD4205 Group D |
Group D: Open label AZD4205 at 150 mg (RP2D), once daily (Phase 2) AZD4205: AZD4205 will be administered orally as capsules. AZD4205 treatment will be continued until disease progression or intolerant adverse reactions |
|
|
| OG003 | AZD4205 Group D | Group D: Open label AZD4205 at 150 mg (RP2D), once daily (Phase 2) AZD4205: AZD4205 will be administered orally as capsules. AZD4205 treatment will be continued until disease progression or intolerant adverse reactions |
|
|
|
Group C: Open label AZD4205 at 150 mg, once daily (Phase 1)
AZD4205: AZD4205 will be administered orally as capsules. AZD4205 treatment will be continued until disease progression or intolerant adverse reactions
| OG003 | AZD4205 Group D | Group D: Open label AZD4205 at the RP2D, once daily (Phase 2) AZD4205: AZD4205 will be administered orally as capsules. AZD4205 treatment will be continued until disease progression or intolerant adverse reactions |
|
|
| OG003 | AZD4205 Group D | Group D: Open label AZD4205 at the RP2D, once daily (Phase 2) AZD4205: AZD4205 will be administered orally as capsules. AZD4205 treatment will be continued until disease progression or intolerant adverse reactions |
|
|
| OG003 | AZD4205 Group D | Group D: Open label AZD4205 at the RP2D, once daily (Phase 2) AZD4205: AZD4205 will be administered orally as capsules. AZD4205 treatment will be continued until disease progression or intolerant adverse reactions |
|
|
| OG003 | AZD4205 Group D | Group D: Open label AZD4205 at the RP2D, once daily (Phase 2) AZD4205: AZD4205 will be administered orally as capsules. AZD4205 treatment will be continued until disease progression or intolerant adverse reactions |
|
|