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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04105010




Registration number
NCT04105010
Ethics application status
Date submitted
18/09/2019
Date registered
26/09/2019

Titles & IDs
Public title
Assessing An Oral Janus Kinase Inhibitor, AZD4205 as Monotherapy in Patients Who Have PTCL (JACKPOT8)
Scientific 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)
Secondary ID [1] 0 0
DZ2019J0005
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

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

Experimental: golidocitinib Group A - Group A: Open label golidocitinib at dose A, once daily (Phase 1)

Experimental: golidocitinib Group B - Group B: Open label golidocitinib at dose B, once daily (Phase 1)

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

Experimental: golidocitinib Group D - Group D: Open label golidocitinib at the RP2D, once daily (Phase 2)


Treatment: Drugs: golidocitinib
golidocitinib will be administered orally as capsules. golidocitinib treatment will be continued until disease progression or intolerant adverse reactions
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Part B: CT-based Objective Response Rate (ORR) by Independent Review Committee (IRC)
Timepoint [1] 0 0
Up to approximately 3 years
Secondary outcome [1] 0 0
Part A and Part B: Number of Participants With Adverse Events
Timepoint [1] 0 0
The first dose until 28 days after last dose, up to approximately 3 years
Secondary outcome [2] 0 0
Part B: Duration of Response (DoR) Assessed by IRC
Timepoint [2] 0 0
Up to approximately 3 years
Secondary outcome [3] 0 0
Part B: Complete Response Rate (CRR) Assessed by IRC
Timepoint [3] 0 0
Up to approximately 3 years
Secondary outcome [4] 0 0
Part B: Progression Free Survival (PFS) Assessed by IRC
Timepoint [4] 0 0
Up to approximately 3 years
Secondary outcome [5] 0 0
Part B: Time to Response (TTR) Assessed by IRC
Timepoint [5] 0 0
Up to approximately 3 years
Secondary outcome [6] 0 0
Part A and Part B: ORR Assessed by Investigator
Timepoint [6] 0 0
Up to approximately 3 years
Secondary outcome [7] 0 0
Part A and Part B: DoR Assessed by Investigator
Timepoint [7] 0 0
Up to approximately 3 years
Secondary outcome [8] 0 0
Part A and Part B: CRR Assessed by Investigator
Timepoint [8] 0 0
Up to approximately 3 years
Secondary outcome [9] 0 0
Part A and Part B: PFS Assessed by Investigator
Timepoint [9] 0 0
Up to approximately 3 years
Secondary outcome [10] 0 0
Part B: TTR Assessed by Investigator
Timepoint [10] 0 0
Up to approximately 3 years
Secondary outcome [11] 0 0
Part A and Part B: Maximum Plasma Concentration (Cmax) of AZD4205
Timepoint [11] 0 0
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).
Secondary outcome [12] 0 0
Part A and Part B: Area Under the Plasma Concentration-time Curve From Zero to the Last Measurable Concentration (AUC0-t) of AZD4205
Timepoint [12] 0 0
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).
Secondary outcome [13] 0 0
Part A and Part B: Cmax,ss, at Steady State of AZD4205
Timepoint [13] 0 0
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).
Secondary outcome [14] 0 0
Part A and Part B: AUCss, at Steady State of AZD4205
Timepoint [14] 0 0
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).

Eligibility
Key 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 classi?cation 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

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



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
10/09/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
22/02/2024
Sample size
Target
Accrual to date
Final
171
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Epworth Hospital - East Melbourne
Recruitment hospital [2] 0 0
St Vincent's Hospital Melbourne - Fitzroy
Recruitment hospital [3] 0 0
Royal Hobart Hospital - Hobart
Recruitment hospital [4] 0 0
St George Hospital - Kogarah
Recruitment hospital [5] 0 0
Royal Perth Hospital - Perth
Recruitment hospital [6] 0 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 0 0
- East Melbourne
Recruitment postcode(s) [2] 0 0
- Fitzroy
Recruitment postcode(s) [3] 0 0
- Hobart
Recruitment postcode(s) [4] 0 0
- Kogarah
Recruitment postcode(s) [5] 0 0
- Perth
Recruitment postcode(s) [6] 0 0
- Westmead
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Connecticut
Country [2] 0 0
United States of America
State/province [2] 0 0
Georgia
Country [3] 0 0
United States of America
State/province [3] 0 0
Missouri
Country [4] 0 0
United States of America
State/province [4] 0 0
Texas
Country [5] 0 0
China
State/province [5] 0 0
Beijing
Country [6] 0 0
China
State/province [6] 0 0
Changchun
Country [7] 0 0
China
State/province [7] 0 0
Changsha
Country [8] 0 0
China
State/province [8] 0 0
Chengdu
Country [9] 0 0
China
State/province [9] 0 0
Chongqing
Country [10] 0 0
China
State/province [10] 0 0
Dalian
Country [11] 0 0
China
State/province [11] 0 0
Guangzhou
Country [12] 0 0
China
State/province [12] 0 0
Haikou
Country [13] 0 0
China
State/province [13] 0 0
Hangzhou
Country [14] 0 0
China
State/province [14] 0 0
Hefei
Country [15] 0 0
China
State/province [15] 0 0
Jinan
Country [16] 0 0
China
State/province [16] 0 0
Lanzhou
Country [17] 0 0
China
State/province [17] 0 0
Linyi
Country [18] 0 0
China
State/province [18] 0 0
Nanchang
Country [19] 0 0
China
State/province [19] 0 0
Nanjing
Country [20] 0 0
China
State/province [20] 0 0
Shanghai
Country [21] 0 0
China
State/province [21] 0 0
Suzhou
Country [22] 0 0
China
State/province [22] 0 0
Tianjin
Country [23] 0 0
China
State/province [23] 0 0
Wuhan
Country [24] 0 0
China
State/province [24] 0 0
Xiamen
Country [25] 0 0
China
State/province [25] 0 0
Zhengzhou
Country [26] 0 0
Korea, Republic of
State/province [26] 0 0
Busan
Country [27] 0 0
Korea, Republic of
State/province [27] 0 0
Daegu
Country [28] 0 0
Korea, Republic of
State/province [28] 0 0
Goyang
Country [29] 0 0
Korea, Republic of
State/province [29] 0 0
Jeonju
Country [30] 0 0
Korea, Republic of
State/province [30] 0 0
Seongnam
Country [31] 0 0
Korea, Republic of
State/province [31] 0 0
Seoul

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

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Won Seog Kim, PhD
Address 0 0
Samsung Medical Center
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT04105010