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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04105010
Recruitment Status : Recruiting
First Posted : September 26, 2019
Last Update Posted : August 26, 2022
Sponsor:
Information provided by (Responsible Party):
Dizal Pharmaceuticals

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Relapsed or Refractory Peripheral T Cell Lymphoma Drug: AZD4205 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : September 10, 2019
Estimated Primary Completion Date : January 2023
Estimated Study Completion Date : July 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arms and Interventions
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Arm Intervention/treatment
Experimental: AZD4205 Group A
Group A: Open label AZD4205 at dose A, once daily (Phase 1)
 Drug: AZD4205
AZD4205 will be administered orally as capsules. AZD4205 treatment will be continued until disease progression or intolerant adverse reactions
Experimental: AZD4205 Group B
Group B: Open label AZD4205 at dose B, once daily (Phase 1)
 Drug: AZD4205
AZD4205 will be administered orally as capsules. AZD4205 treatment will be continued until disease progression or intolerant adverse reactions
Experimental: AZD4205 Group C
Group C: Open label AZD4205 at a selected dose, once daily (Phase 1)
 Drug: AZD4205
AZD4205 will be administered orally as capsules. AZD4205 treatment will be continued until disease progression or intolerant adverse reactions
Experimental: AZD4205 Group D
Group D: Open label AZD4205 at the RP2D, once daily (Phase 2)
 Drug: AZD4205
AZD4205 will be administered orally as capsules. AZD4205 treatment will be continued until disease progression or intolerant adverse reactions


Outcome Measures
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Primary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: Through study completion, an average of 1 year ]
    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 :
  1. Incidence of adverse events [ Time Frame: The first dose until 28 days after last dose ]
    To evaluate the safety and tolerability of AZD4205 in patients with PTCL in terms of adverse events (AEs)

  2. Peak Plasma Concentration (Cmax) of AZD4205 [ Time Frame: 1,8,15, 21 days after first dose ]
  3. Area under the plasma concentration versus time curve (AUC) of AZD4205 [ Time Frame: 1,8,15, 21 days after first dose ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04105010


Contacts
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Contact: Jason Li, MD 862161097868 jason.li@dizalpharma.com
Contact: Pamela Yang, MD, PhD

Locations
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Sponsors and Collaborators
Dizal Pharmaceuticals
Investigators
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Principal Investigator: Won Seog Kim, PhD Samsung Medical Center
More Information
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Responsible Party: Dizal Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04105010    
Other Study ID Numbers: DZ2019J0005
First Posted: September 26, 2019    Key Record Dates
Last Update Posted: August 26, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, T-Cell
Lymphoma, T-Cell, Peripheral
Neoplasms by Histologic Type
Neoplasms
 Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin