Skip to content
Triangle logo TriangleGet started
← Study library

NCT04105010 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE1, PHASE2
Status at capture
COMPLETED
Registry last update
2025-04-04

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

→

baseline

Baseline characteristics

→

outcome · POSTED

Part B: CT-based Objective Response Rate (ORR) by Independent Review Committee (IRC)

→

outcome · POSTED

Part A and Part B: Number of Participants With Adverse Events

→

outcome · POSTED

Part B: Duration of Response (DoR) Assessed by IRC

→

outcome · POSTED

Part B: Complete Response Rate (CRR) Assessed by IRC

→

outcome · POSTED

Part B: Progression Free Survival (PFS) Assessed by IRC

→

outcome · POSTED

Part B: Time to Response (TTR) Assessed by IRC

→

outcome · POSTED

Part A and Part B: ORR Assessed by Investigator

→

outcome · POSTED

Part A and Part B: DoR Assessed by Investigator

→

outcome · POSTED

Part A and Part B: CRR Assessed by Investigator

→

outcome · POSTED

Part A and Part B: PFS Assessed by Investigator

→

outcome · POSTED

Part B: TTR Assessed by Investigator

→

outcome · POSTED

Part A and Part B: Maximum Plasma Concentration (Cmax) of AZD4205

→

outcome · POSTED

Part A and Part B: Area Under the Plasma Concentration-time Curve From Zero to the Last Measurable Concentration (AUC0-t) of AZD4205

→

outcome · POSTED

Part A and Part B: Cmax,ss, at Steady State of AZD4205

→

outcome · POSTED

Part A and Part B: AUCss, at Steady State of AZD4205

→

adverse events

Adverse events

→

more info

Limitations, agreements, and source contact

→
Who could take part
eligibility Criteria
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.
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Group A: Open label golidocitinib at dose A, once daily (Phase 1)
    intervention Names
    1. Drug: golidocitinib
    label
    golidocitinib Group A
    type
    EXPERIMENTAL
  2. description
    Group B: Open label golidocitinib at dose B, once daily (Phase 1)
    intervention Names
    1. Drug: golidocitinib
    label
    golidocitinib Group B
    type
    EXPERIMENTAL
  3. description
    Group C: Open label golidocitinib at a selected dose, once daily (Phase 1)
    intervention Names
    1. Drug: golidocitinib
    label
    golidocitinib Group C
    type
    EXPERIMENTAL
  4. description
    Group D: Open label golidocitinib at the RP2D, once daily (Phase 2)
    intervention Names
    1. Drug: golidocitinib
    label
    golidocitinib Group D
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. golidocitinib Group A
    2. golidocitinib Group B
    3. golidocitinib Group C
    4. golidocitinib Group D
    description
    golidocitinib will be administered orally as capsules. golidocitinib treatment will be continued until disease progression or intolerant adverse reactions
    name
    golidocitinib
    other Names
    1. AZD4205
    type
    DRUG
Study design
allocation
NON_RANDOMIZED
intervention Model
SEQUENTIAL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
171
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. 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 evaluated by IRC per Lugano criteria.
    measure
    Part B: CT-based Objective Response Rate (ORR) by Independent Review Committee (IRC)
    time Frame
    Up to approximately 3 years
secondary Outcomes
  1. description
    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
    measure
    Part A and Part B: Number of Participants With Adverse Events
    time Frame
    The first dose until 28 days after last dose, up to approximately 3 years
  2. description
    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.
    measure
    Part B: Duration of Response (DoR) Assessed by IRC
    time Frame
    Up to approximately 3 years
  3. description
    CRR is the percentage of patients with at least one visit response of CR based on CT scans evaluated by IRC per Lugano criteria.
    measure
    Part B: Complete Response Rate (CRR) Assessed by IRC
    time Frame
    Up to approximately 3 years
  4. description
    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.
    measure
    Part B: Progression Free Survival (PFS) Assessed by IRC
    time Frame
    Up to approximately 3 years
  5. description
    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.
    measure
    Part B: Time to Response (TTR) Assessed by IRC
    time Frame
    Up to approximately 3 years
  6. description
    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.
    measure
    Part A and Part B: ORR Assessed by Investigator
    time Frame
    Up to approximately 3 years
  7. description
    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.
    measure
    Part A and Part B: DoR Assessed by Investigator
    time Frame
    Up to approximately 3 years
  8. description
    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.
    measure
    Part A and Part B: CRR Assessed by Investigator
    time Frame
    Up to approximately 3 years
  9. description
    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.
    measure
    Part A and Part B: PFS Assessed by Investigator
    time Frame
    Up to approximately 3 years
  10. description
    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.
    measure
    Part B: TTR Assessed by Investigator
    time Frame
    Up to approximately 3 years
  11. description
    Maximum observed plasma concentration, obtained directly from the observed concentration versus time data. Calculated for the single dose.
    measure
    Part A and Part B: Maximum Plasma Concentration (Cmax) of AZD4205
    time Frame
    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. description
    Area under the plasma concentration-time curve from time zero to the last quantifiable time point, calculated by the linear up/log down rule.
    measure
    Part A and Part B: Area Under the Plasma Concentration-time Curve From Zero to the Last Measurable Concentration (AUC0-t) of AZD4205
    time Frame
    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).
Full 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.
Source references
references
  1. citation
    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.
    pmid
    38092009
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
    1. release id
      ctgov-registry-1336d216cbd1bbff780dac70
      edge id
      nct-edge-7f97b84b9cf7e1335b85
      requested nct id
      NCT04105010
      primary nct id
      NCT04105010
      source kind
      ctgov_condition_query
      source record id
      Source null
      source file sha256
      e270600534699a676fe83226e7a7b0f73aeb00c1d0a05cfc115c748864ad8173
      payload sha256
      eb76a904bdebcfeb77a0af7fbf9bef0f5f8c623a97392b807fbb02460267cad7
      payload
      clinical indication matching status
      condition_index_match_asserted_by_registry_not_reviewed
      end exclusive
      true
      id
      nct-edge-7f97b84b9cf7e1335b85
      link basis
      returned_by_explicit_condition_and_posted_results_filter_query
      nct id
      NCT04105010
      occurrences
      1. context exact
        NCT04105010
        end
        11
        exact text
        NCT04105010
        start
        0
      offset unit
      unicode_code_points
      query cond
      Peripheral T-Cell Non-Hodgkin Lymphoma
      query disease state id
      ds-peripheral-t-cell-non-hodgkin-lymphoma
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-peripheral-t-cell-non-hodgkin-lymphoma-000.json
      source file sha256
      e270600534699a676fe83226e7a7b0f73aeb00c1d0a05cfc115c748864ad8173
      source json pointer
      /studies/20/protocolSection/identificationModule/nctId
      source kind
      ctgov_condition_query
      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      7e8041aacf043a3f2038b148f8afa4eff1ed6c479876ab988ccfea2c76f76c4f

    Preserved source evidence · Not medical advice