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.
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
Drug | Synonyms | Arms |
---|
AZD4205 | | AZD4205 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
Name | Type | Description | Interventions |
---|
AZD4205 Group A | Experimental | Group A: Open label AZD4205 at dose A, once daily (Phase 1) | |
AZD4205 Group B | Experimental | Group B: Open label AZD4205 at dose B, once daily (Phase 1) | |
AZD4205 Group C | Experimental | Group C: Open label AZD4205 at a selected dose, once daily (Phase 1) | |
AZD4205 Group D | Experimental | Group D: Open label AZD4205 at the RP2D, once daily (Phase 2) | |
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