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OpenTrials
Completed

NCT Number: NCT04105010

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

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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Key information

Conditions

Relapsed or Refractory Peripheral T Cell Lymphoma Disease Attributes Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Non-Hodgkin Lymphoma, T-Cell Lymphoma, T-Cell, Peripheral Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Epworth Hospital, East Melbourne, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

golidocitinib

Drug

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

Other names: AZD4205

Primary outcomes

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

    Time frame: Up to approximately 3 years

    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.

Secondary outcomes

  1. 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

    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

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

    Time frame: Up to approximately 3 years

    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.

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

    Time frame: Up to approximately 3 years

    CRR is the percentage of patients with at least one visit response of CR based on CT scans evaluated by IRC per Lugano criteria.

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

    Time frame: Up to approximately 3 years

    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.

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

    Time frame: Up to approximately 3 years

    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.

  6. Part A and Part B: ORR Assessed by Investigator

    Time frame: Up to approximately 3 years

    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.

  7. Part A and Part B: DoR Assessed by Investigator

    Time frame: Up to approximately 3 years

    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.

  8. Part A and Part B: CRR Assessed by Investigator

    Time frame: Up to approximately 3 years

    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.

  9. Part A and Part B: PFS Assessed by Investigator

    Time frame: Up to approximately 3 years

    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.

  10. Part B: TTR Assessed by Investigator

    Time frame: Up to approximately 3 years

    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.

  11. 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).

    Maximum observed plasma concentration, obtained directly from the observed concentration versus time data. Calculated for the single dose.

  12. 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).

    Area under the plasma concentration-time curve from time zero to the last quantifiable time point, calculated by the linear up/log down rule.

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

    Time frame: 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).

    Maximum observed plasma concentration (ng/mL) at steady state, obtained directly from the observed concentration versus time data. Calculated for the multiple doses.

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

    Time frame: 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).

    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

Sponsors and collaborators

Lead sponsor

Dizal Pharmaceuticals

Industry

Registry information

Official study 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)

Important dates

Study start
2019
Primary completion
2023
Study completion
2024
First posted
Sep 26, 2019
Registry last updated
Apr 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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