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

  • STATUS
    Recruiting
  • End date
    Aug 27, 2022
  • participants needed
    160
  • sponsor
    Dizal Pharmaceuticals
Updated on 27 January 2021
systemic therapy
measurable disease
t-cell lymphoma
peripheral t-cell lymphoma

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.

Details
Condition Peripheral T-Cell Lymphoma, T-Cell Lymphoma
Treatment AZD4205
Clinical Study IdentifierNCT04105010
SponsorDizal Pharmaceuticals
Last Modified on27 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: T-Cell Lymphoma or Peripheral T-Cell Lymphoma?
Do you have any of these conditions: Peripheral T-Cell Lymphoma or T-Cell Lymphoma?
Do you have any of these conditions: Peripheral T-Cell Lymphoma or T-Cell Lymphoma?
Do you have any of these conditions: Peripheral T-Cell Lymphoma or T-Cell Lymphoma?
Do you have any of these conditions: T-Cell Lymphoma or Peripheral T-Cell Lymphoma?
Obtained written informed consent
Patients must have histologically confirmed peripheral T-cell lymphoma according to the 2016 revision of the World Health Organization classication 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
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