AzTrials
AzTrials

Relapsed or Refractory Peripheral T Cell LymphomaPhase 1/2NCT04105010

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

A Phase 1/2 study testing golidocitinib in people with Relapsed or Refractory Peripheral T Cell Lymphoma, run by Dizal Pharmaceuticals at 50 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
golidocitinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
171 participants
Where
50 sitesin 4 countries
Study dates
10 Sep 2019to 22 Feb 2024
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

50 sites in 4 countries.

50 sites in 4 countries

China31 sites

  • Beijing Cancer Hospital

    Beijing

  • Beijing Friendship Hospital, Capital Medical University

    Beijing

  • Beijing Hospital

    Beijing

  • Peking University Third Hospital

    Beijing

  • The First Hospital of Jilin University

    Changchun

  • Hunan Cancer Hospital

    Changsha

  • Xiangya Hospital Central South University

    Changsha

  • Sichuan University - West China Hospital

    Chengdu

  • Chongqing University Cancer Hospital

    Chongqing

  • The Second Hospital of Dalian Medical University

    Dalian

  • Guangdong Provincial People's Hospital

    Guangzhou

  • NanFang Hospital of Southern Medical University

    Guangzhou

  • Sun Yat-sen University Cancer Center

    Guangzhou

  • Hainan General Hospital

    Haikou

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou

  • Zhejiang Cancer Hospital

    Hangzhou

  • Anhui Provincial Cancer Hospital

    Hefei

  • The Second Hospital of Anhui Medical University

    Hefei

  • Shandong Cancer Hospital

    Jinan

  • The First Hospital of Lanzhou University

    Lanzhou

  • Linyi Cancer Hospital

    Linyi

  • Jiangxi Province Cancer Hospital

    Nanchang

  • The First Affiliated Hospital of Nanchang University

    Nanchang

  • Jiangsu Cancer Hospital

    Nanjing

  • Fudan University Shanghai Cancer Center

    Shanghai

  • Ruijin Hospital Shanghai Jiaotong University School of Medicine

    Shanghai

  • The First Affiliated Hospital of Soochow University

    Suzhou

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin

  • Union Hospital Tongji Medical College Huazhong University of Science and Technology

    Wuhan

  • The First Affiliated Hospital of Xiamen University

    Xiamen

  • Henan Cancer Hospital

    Zhengzhou

Other trials in China

South Korea9 sites

  • Inje University Busan Paik Hospital

    Busan

  • Pusan National University Hospital

    Busan

  • Keimyung University Dongsan Hospital

    Daegu

  • National Cancer Center

    Goyang

  • Chonbuk National University Hospital

    Jeonju

  • Seoul National University Bundang Hospital

    Seongnam

  • Samsung Medical Center

    Seoul, 06133

  • Asan Medical Center

    Seoul

  • Seoul National University Hospital

    Seoul

Other trials in South Korea

Australia6 sites

  • Epworth Hospital

    East Melbourne

  • St Vincent's Hospital Melbourne

    Fitzroy

  • Royal Hobart Hospital

    Hobart

  • St George Hospital

    Kogarah

  • Royal Perth Hospital

    Perth

  • Westmead Hospital

    Westmead

Other trials in Australia

United States4 sites

  • Winship Cancer Institute

    Atlanta, Georgia, 30322

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

  • Yale Cancer Center

    New Haven, Connecticut, 06510

  • Washington University School of Medicine

    St Louis, Missouri, 63110

Other trials in United States

About this study

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)

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:

Read more

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.

Being tested
golidocitinib
Medical subject headings
Recurrence, Lymphoma, T-Cell, Peripheral

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • golidocitinibDrug

    Also called AZD4205

    golidocitinib will be administered orally as capsules. golidocitinib treatment will be continued until disease progression or intolerant adverse reactions

Study groups in NCT04105010
Study groupRoleWhat they receive
golidocitinib Group AExperimentalGroup A: Open label golidocitinib at dose A, once daily (Phase 1)
Receives: Drug: golidocitinib
golidocitinib Group BExperimentalGroup B: Open label golidocitinib at dose B, once daily (Phase 1)
Receives: Drug: golidocitinib
golidocitinib Group CExperimentalGroup C: Open label golidocitinib at a selected dose, once daily (Phase 1)
Receives: Drug: golidocitinib
golidocitinib Group DExperimentalGroup D: Open label golidocitinib at the RP2D, once daily (Phase 2)
Receives: Drug: golidocitinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to approximately 3 years

Secondary outcomes (14)

  1. 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

    Measured: The first dose until 28 days after last dose, up to approximately 3 years

  2. 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.

    Measured: Up to approximately 3 years

  3. 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.

    Measured: Up to approximately 3 years

  4. 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.

    Measured: Up to approximately 3 years

  5. 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.

    Measured: Up to approximately 3 years

  6. 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.

    Measured: Up to approximately 3 years

  7. 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.

    Measured: Up to approximately 3 years

  8. 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.

    Measured: Up to approximately 3 years

  9. 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.

    Measured: Up to approximately 3 years

  10. 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.

    Measured: Up to approximately 3 years

  11. 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.

    Measured: 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).

  12. 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.

    Measured: 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).

  13. 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.

    Measured: 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).

  14. 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

    Measured: 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).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Sep 2019
  2. Study start10 Sep 2019
  3. Primary completion12 Oct 2023
  4. Study completion22 Feb 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
171 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04105010
Sponsor's protocol ID
DZ2019J0005
Status last verified
Apr 2025
First submitted
18 Sep 2019
Last updated
4 Apr 2025
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 38092009

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing golidocitinib in people with Relapsed or Refractory Peripheral T Cell Lymphoma, run by Dizal Pharmaceuticals at 50 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 50 sites in China, South Korea, Australia, United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part B: CT-based Objective Response Rate (ORR) by Independent Review Committee (IRC) (time frame: Up to approximately 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04105010, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in