Clinical Trials /

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

NCT04105010

Description:

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.

Related Conditions:
  • Peripheral T-Cell Lymphoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

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

Clinical Trial IDs

  • ORG STUDY ID: DZ2019J0005
  • NCT ID: NCT04105010

Conditions

  • Relapsed or Refractory Peripheral T Cell Lymphoma

Interventions

DrugSynonymsArms
AZD4205AZD4205 Group A

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
AZD4205 Group AExperimentalGroup A: Open label AZD4205 at dose A, once daily (Phase 1)
  • AZD4205
AZD4205 Group BExperimentalGroup B: Open label AZD4205 at dose B, once daily (Phase 1)
  • AZD4205
AZD4205 Group CExperimentalGroup C: Open label AZD4205 at a selected dose, once daily (Phase 1)
  • AZD4205
AZD4205 Group DExperimentalGroup D: Open label AZD4205 at the RP2D, once daily (Phase 2)
  • AZD4205

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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Objective Response Rate (ORR)
Time Frame:Through study completion, an average of 1 year
Safety Issue:
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 per Lugano criteria

Secondary Outcome Measures

Measure:Incidence of adverse events
Time Frame:The first dose until 28 days after last dose
Safety Issue:
Description:To evaluate the safety and tolerability of AZD4205 in patients with PTCL in terms of adverse events (AEs)
Measure:Peak Plasma Concentration (Cmax) of AZD4205
Time Frame:1,8,15, 21 days after first dose
Safety Issue:
Description:
Measure:Area under the plasma concentration versus time curve (AUC) of AZD4205
Time Frame:1,8,15, 21 days after first dose
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Dizal Pharmaceuticals

Last Updated

May 20, 2021