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

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ClinicalTrials.gov Identifier: NCT04105010
Recruitment Status : Recruiting
First Posted : September 26, 2019
Last Update Posted : May 20, 2021
Sponsor:
Information provided by (Responsible Party):
Dizal Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE September 18, 2019
First Posted Date  ICMJE September 26, 2019
Last Update Posted Date May 20, 2021
Actual Study Start Date  ICMJE September 10, 2019
Estimated Primary Completion Date May 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 29, 2020)
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
Original Primary Outcome Measures  ICMJE
 (submitted: September 24, 2019)
Incidence of Adverse Events [ Time Frame: From first dose until 28 days after last dose ]
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)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 29, 2020)
  • 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)
  • Peak Plasma Concentration (Cmax) of AZD4205 [ Time Frame: 1,8,15, 21 days after first dose ]
  • Area under the plasma concentration versus time curve (AUC) of AZD4205 [ Time Frame: 1,8,15, 21 days after first dose ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 24, 2019)
  • Objective Response Rate (ORR) [ Time Frame: Through study completion, an average of 1 year ]
    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
  • Peak Plasma Concentration (Cmax) of AZD4205 [ Time Frame: 1,8,15, 21 days after first dose ]
  • Area under the plasma concentration versus time curve (AUC) of AZD4205 [ Time Frame: 1,8,15, 21 days after first dose ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Assessing An Oral Janus Kinase Inhibitor, AZD4205 as Monotherapy in Patients Who Have PTCL (JACKPOT8)
Official Title  ICMJE 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)
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Relapsed or Refractory Peripheral T Cell Lymphoma
Intervention  ICMJE Drug: AZD4205
AZD4205 will be administered orally as capsules. AZD4205 treatment will be continued until disease progression or intolerant adverse reactions
Study Arms  ICMJE
  • Experimental: AZD4205 Group A
    Group A: Open label AZD4205 at dose A, once daily (Phase 1)
    Intervention: Drug: AZD4205
  • Experimental: AZD4205 Group B
    Group B: Open label AZD4205 at dose B, once daily (Phase 1)
    Intervention: Drug: AZD4205
  • Experimental: AZD4205 Group C
    Group C: Open label AZD4205 at a selected dose, once daily (Phase 1)
    Intervention: Drug: AZD4205
  • Experimental: AZD4205 Group D
    Group D: Open label AZD4205 at the RP2D, once daily (Phase 2)
    Intervention: Drug: AZD4205
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 31, 2020)
160
Original Estimated Enrollment  ICMJE
 (submitted: September 24, 2019)
100
Estimated Study Completion Date  ICMJE November 2022
Estimated Primary Completion Date May 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jason Li, MD 862161097868 jason.li@dizalpharma.com
Contact: Pamela Yang, MD, PhD
Listed Location Countries  ICMJE China,   Korea, Republic of,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04105010
Other Study ID Numbers  ICMJE DZ2019J0005
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Dizal Pharmaceuticals
Study Sponsor  ICMJE Dizal Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Won Seog Kim, PhD Samsung Medical Center
PRS Account Dizal Pharmaceuticals
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP