Clinical Trials /

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

NCT04105010

Description:

This is a multi-center, prospective, 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, who have progressed on or are refractory/intolerable 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 further enrolled to further explore the selected dose defined by dose escalation. Phase 2 part: After recommended phase 2 dose (RP2D) is defined, a single-arm open-label cohort will be triggered.

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

Recruiting

Phase:

Phase 1/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

  • Peripheral T Cell Lymphoma

Interventions

DrugSynonymsArms
AZD4205Group A

Purpose

This is a multi-center, prospective, 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, who have progressed on or are refractory/intolerable 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 further enrolled to further explore the selected dose defined by dose escalation. Phase 2 part: After recommended phase 2 dose (RP2D) is defined, a single-arm open-label cohort will be triggered.

Trial Arms

NameTypeDescriptionInterventions
Group AExperimentalGroup A: Open label AZD4205 dose A, once daily
  • AZD4205
Group BExperimentalGroup B: Open label AZD4205 dose B, once daily
  • AZD4205
Group CExperimentalOpen label AZD4205 selected dose from group A and B, once daily
  • AZD4205
Group DExperimentalOpen label AZD4205 RP2D, once daily
  • 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
             (Swerdlow SH et al, 2016).

          3. Patients must have measurable disease according to the 2014 Lugano classification.

          4. Patients must have progressed on or are refractory to standard systemic therapy, or
             patients were intolerable to standard systemic therapy.

          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:Incidence of Adverse Events
Time Frame:From first dose until 28 days after last dose
Safety Issue:
Description:To evaluate the safety and tolerability of AZD4205 in patients with peripheral T cell lymphoma (PTCL) at different dose levels in terms of adverse events (AEs)

Secondary Outcome Measures

Measure:Objective Response Rate (ORR)
Time Frame:Through study completion, an average of 1 year
Safety Issue:
Description:Per Lugano 2014 criteria for assessing FDG-PET/CT in lymphoma: ORR is the percentage of patients with at least 1 visit response of Complete Response (CR) or Partial Response (PR), prior to progression or further anti-cancer therapy
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 1/Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Dizal Pharmaceuticals

Last Updated

August 31, 2020